drug formulary
Transcription
drug formulary
HOSPITAL TENGKU AMPUAN RAHIMAH DRUG FORMULARY AUGUST 2011 1 DISCLAIMER Editorial matter published herein is based on information supplied by Pharmaceutical Services Division, Ministry of Health, Malaysia. Although every effort has been made in compiling and checking the information contained in Drug Formulary for HTAR ensure that they are accurate and valid up to the time of publishing, the publisher, editors or agents shall not be responsible for the continued currency of the information or for any errors, omissions or inaccuracies in this publication whether arising from negligence or otherwise, how so ever or for any consequences arising therefrom. The publishers, authors and editors also expressly disclaim any and all liability to any person whosoever in respect of any loss, damage, death, personal injury or other consequences whatsoever, however caused or arising, suffered by any such person by their use or reliance upon, in any way, the information contained in this publication. Original version of this drug formulary adapted from Pharmaceutical Division Ministry of Health Malaysia and recompiled to suit the use in Hospital Tengku Ampuan Rahimah, Klang. © August 2011, Pharmacy Department, HTAR. All Right Reserved. No part of this publication may be reproduced, stored or transmitted in any form or by any means without electronic, mechanical, photocopying, tape recording or other without written permission of the copyright holder. 2 INTRODUCTION This is a listing of MOH drug list incorporating the HTAR Formulary which is a subset of the former. The drugs are listed according to the specialties and are in their non-proprietary names (generic names). Brand names are included only as reference and are not indicative of the actual stocks in the hospital. In fact, our policy is to use generics as far as possible in view of the escalating costs of drugs This updated August 2011 formulary is an updated version of the July 2007 formulary and thus supercedes the latter. In line with the concept of “belanja berhemah”, we have decided not to publish the hard copy HTAR Formulary but rather upload it into the hospital website. Please note that the MOH formulary as well as the HTAR formulary is only current at time of printing and may have changed since. While every effort is made to ensure its currency, errors and omissions may be expected. The formulary is not a comprehensive data reference but serves only as a guide. Use of certain drugs listed in this formulary and use of drugs not listed in this formulary is not allowed unless specifically approved by the Director General of Health (DG). Drugs which needs the approval by the DG are those which are : a. Registered but not available in the MOH Formulary b. Registered and available in the MOH Formulary but with different indication than those listed in the MOH Formulary c. Not registered and not available in the MOH Formulary d. Not registered but available in the MOH Formulary The secretariet of the Pharmaceutical Services Division will process the request of these drugs based on the criteria set by the MOH Drug List Review Panel. For any help whatsoever regarding this issue, please refer to our pharmacists. Normawati Muhammad Head of Pharmacy Department, Hospital Tengku Ampuan Rahimah, Klang 3 CONTENTS A EMERGENCY Toxicology/antidotes 8 9 B GASTROINTESTINAL Dyspepsia Antispasmodics and drug altering gutmotility Ulcer-healing drugs Anti diarrheals Laxatives Local preparations for anal and rectal disorders Drugs affecting intestinal secretions Miscellaneous gastro intestinal Antiemetic 17 18 19 21 27 27 29 30 31 33 C CARDIOVASCULAR Positive inotropic agents Diuretics Anti-arrhythmic drugs Beta adrenoceptor blocking drugs Drugs affecting the renin-angiotensin system and other antihypertensives Nitrates, calcum channel blockers and potassium channel activators Sympathomimetics Anticoagulants and protamine Antiplatelet drugs Myocardial infarction and fibrinolysis Lipid regulating drugs Miscellaneous cardiovascular 39 40 42 45 47 50 60 66 67 71 73 77 81 D RESPIRATORY Bronchodilators Corticosteroids Cromoglycate, related therapy and leukotriene receptor antagonists Respiratory stimulants and pulmonary surfactands Miscellaneous respiratory 82 83 90 92 93 94 E ANALGESICS Non opioid analgesics Opioid analgesics Non steroidal anti inflammatory drugs (NSAIDS) Neuropathic pain 95 96 98 106 110 F PSYCHIATRY Hypnotics and anxiolytics Anti psychotics Antidepressant drugs Miscellaneous psychiatric 111 112 113 124 129 4 G NEUROLOGY Antimigraine drugs Antiepileptics Drugs used in parkinsonism and related disorders Drugs used in substance dependence Drugs for dementia Central nervous system stimulants Miscellaneous neurology 131 132 133 144 150 151 152 153 H ANTIINFECTIVES Antibacterial drugs Antifungal drugs Antiviral drugs Antiprotozoal drugs Anthelmintics 157 158 185 190 200 202 I ENDOCRINE Drugs used in diabetes Thyroid and antithyroid drugs Corticosteroids Sex hormones Hypothalamic and pituitary hormones and antiestrogens Drugs affecting bone metabolism 204 205 212 215 218 219 222 J OBSTETRICS, GYNAECOLOGY Hormone replacement therapy Infertility Prostaglandin and oxytoxics Treatment of vaginal and vulva conditions Contraceptives Miscellaneous obstetrics and gynecology 228 229 233 235 237 238 242 K GENITOURINARY Drugs for urinary retention Drugs for urinary frequency, enuresis and continence Miscellaneous genitourinary 243 244 246 246 L DRUGS AFFECTING IMMUNE RESPONSE Immunosuppresants Immunomodulators 248 249 251 5 M HEMATOLOGY/ONCOLOGY Cytotoxic drugs Sex hormones and hormone antagonists in malignant disease Bleeding disorder Miscellaneous harmotology/oncology 254 255 271 273 273 N NUTRITION AND BLOOD DISORDER Fluids and electrolytes Intravenous nutrition Minerals Vitamins Miscellaneous nutrition and blood disorder 276 277 283 284 286 294 P RHEUMATOLOGY Antirheumatic Gout Drugs used in neuromuscular disorders Drugs for the relief of soft tissue inflammation Miscellaneous rheumatology 299 300 303 303 303 303 Q OPHTHALMOLOGY Anti infective eye preparations Anti infective with steroids Corticosteroids and other anti inflammatory preparations Anti virals Mydriatics and cycloplegics Treatment of glaucoma Local anesthetics Miscellaneous ophthalmology 305 306 309 310 311 311 313 317 317 R EAR, NOSE AND OROPHARYNX Ear preparations Nose preparations Oropharynx preparations Antihistamines, hyposensitization and allergic emergencies Mucolytics Aromatic inhalations Cough preparations Systemic nasal decongestant Miscellaneous ear, nose and oropharynx 320 321 322 325 327 332 332 333 334 334 6 S DERMATOLOGY Emollient and barrier preparations Topical local anaesthetics and anti pruritics Topical corticosteroids Preparations for exzema and psoriasis Acne and rasacea Preparations for warts and calluses Shampoos and other preparations for scalp conditions Anti infective skin preparations Disinfectants, skin cleansers and antiseptics Miscellaneous dermatology 336 337 337 339 342 346 348 348 349 355 358 T IMMUNOLOGICAL PRODUCTS AND VACCINES Vaccines and antisera Immunoglobulins 361 362 365 U ANAESTHESIA Induction/maintenance Neuromuscular blocker Topical anaesthesia Local anaesthesia Miscellaneous anaesthesia 367 368 372 374 376 380 V DIAGNOSTIC Radiocontrast media Diagnostic aids and test preparation 382 383 383 W MISCELLANEOUS General disinfectant Other disinfectants 385 386 386 7 1. EMERGENCY Toxicology / Antidotes 8 Acetylcysteine 200mg/ml A* Trade Name : Parvolex Indication : Antidote for paracetamol poisoning Dosage : Diluted with dextrose 5% and infused IV. Initial, 150 mg/kg IV in 200 ml over 60 minutes, then 50 mg/kg IV in 500 ml over 4 hours, followed by 100 mg/kg IV in 1000 ml over 16 hours. Total dose: 300mg/kg in 20 hour Precautions : Asthma, history of bronchospasm and risk of anaphylactoid reactions and history of peptic ulceration Adverse Reactions : Bronchoconstriction, nausea, vomiting, anaphylactic reactions, rash, hypotension, pruritus, rash, urticaria Contraindications : Hypersensitivity to acetylcysteine products Interactions : Carbamazepine : increased risk of subtherapeutic carbamazepine levels. Nitroglycerin : enhanced hypotension and nitroglycerin-induced headache. Penicillin G, tetracycline : loss of antibiotic efficacy -------------------------------------------------------------------------------------------------------------------------------------Antivenene Malaysian Pit Viper Injection B Indication : Bitten by pit viper Dosage : Reconstitute content for the vial with 5 ml sterile pyrogen-free distilled water. Administer by IV infusion 200 ml of normal saline over a period of 1 - 2 hours Precautions : Sensitivity testing should be performed before the administration Adverse Reactions : Chest pain, hypotension, chills, nervousness, cellulitis, bruising, pruritus, rash, urticaria, anorexia, nausea, coagulation disorder, back pain, circumoral paraesthesia, general paraesthesia, myalgia, asthma, cough, dyspnoea, sputum increased, wheezing, allergic reaction, serum sickness, subcutaneous nodule, wound infection, anaphylaxis, serum sickness Contraindications : Hypersensitivity to any component of the formulation, unless the benefits outweigh the risks and appropriate management for anaphylaxis is available Interactions : Not known -------------------------------------------------------------------------------------------------------------------------Antivenene Serum (Cobra) Injection B Indication : Treatment for cobra bites Dosage : The reconstituted antivenin should be given by slow intravenous infusion, approximately 2ml/min.Subsequent dose can be given every 12 hours according to the clinical symptoms Precautions : Respiratory support maybe essential. Sensitivity testing should be performed before the administration 9 Adverse Reactions : Anaphylaxis with hypotension, dyspnea, urticaris, Immune hypersensitivity reaction , shock, transfusion reaction due to serum protein reaction ,serum sickness Contraindications : Hypersensitivity to any component of the formulation, unless the benefits outweigh the risks and appropriate management for anaphylaxis is available Interactions : Not known -----------------------------------------------------------------------------------------------------------------------------Antivenene Serum (Sea snake) 1000 units/26.3 ml Injection B Indication : Treatment for sea snake bites Dosage : 1000 units by IV infusion over 1/2 to 1 hour. In severe cases 3000 -10000 units may be required Precautions : Sensitivity testing should be performed before the administration Adverse Reactions : Anaphylaxis with hypotension, dyspnea, urticaris, Immune hypersensitivity reaction , shock, transfusion reaction due to serum protein reaction ,serum sickness Contraindications : Hypersensitivity to any component of the formulation, unless the benefits outweigh the risks and appropriate management for anaphylaxis is available Interactions : Not known ---------------------------------------------------------------------------------------------------------------------------------Antivenene Serum Snake polyvalent Injection B Indication : Antidote for snake bites Dosage : Recommended initial dose is 20ml by intravenous infusion. The injection should be given very slowly as 5 minutes by direct slow intravenous route or 1hour by infusion. If symptoms continue, further doses are administered as required until symptoms completely disappear Precautions : Sensitivity testing should be performed before the administration Adverse Reactions : Anaphylaxis with hypotension, dyspnea, urticaris, Immune hypersensitivity reaction , shock, transfusion reaction due to serum protein reaction ,serum sickness Contraindications : Hypersensitivity to any component of the formulation, unless the benefits outweigh the risks and appropriate management for anaphylaxis is available Interactions : Not known ---------------------------------------------------------------------------------------------------------------------------------- 10 Calcium Disodium Edetate 200 mg Injection A Trade Name : Ca Disod. Versenate Indication : Lead Poisoning Dosage : 60 - 70 mg/kg body weight daily given IV infusion in 2 daily doses for up to 5 days; repeated if necessary after an interval of 2 days. Any further treatment with calcium edetate should not be recommended for 7 days Precautions : Renal impairment, haematuria, proteinuria, cerebral oedema. Capable of producing toxic effects which can be fatal, patients with lead encephalopathy, administer only after adequate urine flow is established, children must be given adequate oral fluids during outpatient therapy Adverse Reactions : Nephrotoxicity, malaise, chills, thirst, nausea, vomiting, diarrhoea, abdominal pain, injection site pain, myalgia, headache, hypotension (frequent), thrombophlebitis (frequent), immune hypersensitivity reaction Contraindications : Hypersensitivity to edetate products, anuria or active renal disease, hepatitis Interactions : Not known ------------------------------------------------------------------------------------------------------------------------------Calcium Polystyrene Sulphonate Powder A Trade Name : Kalimate Indication : Hyperkalemia resulting from acute or chronic renal failure Dosage : 15 - 30g daily in 2-3 divided doses. Each dose should be suspended in 30 - 50ml of water and administered orally Precautions : Patients should be monitored for electrolytes disturbances, especially hypokalaemia and hypercalcaemia. May cause perforation in intestine, necrosis in mucous membrane of intestine, large intestine ulcer, colon necrosis Adverse Reactions : Bronchopneumonia associated with inhalation of calcium polystyrene sulphonate. Anorexia, nausea, vomiting, constipation, diarrhea, colon perforation, hypopotassaemia, calcium overloading and hypercalcaemia Contraindications : Should be avoided in patients with conditions such as hyperparathyroidism, multiple myeloma, sarcoidosis, or metastatic carcinoma who may present with renal failure together with hypercalcaemia Interactions : Digitalis preparation, antacid and laxatives containing aluminium, magnesium or calcium, dried aluminium hydroxide gel, magnesium hydroxide, precipitate calcium carbonate. Calcium ions are released from the resin in the gastrointestinal tract and this may reduce the absorption of tetracycline given by mouth ------------------------------------------------------------------------------------------------------------------------------- 11 Charcoal, Activated 250 mg Tablet C Indication : i) Diarrhoea and food poisoning ii) Reduce absorption of drugs, plant, inorganic poison and chemicals in poisoning cases Dosage : i) ADULT 0.5-1 g given 3-4 times daily. CHILD half adult dose. ii) Need to be dissolved in liquid (slurry consistency). ADULT and CHILD over 12 years: initial 30-100 g or 1-2 g/kg; repeat initial dose as soon as possible or 20-50 g every 2-6 hours. CHILD over 1-12 years, 25-50 g or 1-2 g/kg; may repeat half the initial dose every 2-6 hour as needed. CHILD to 1 year of age, 1 g/kg; may repeat half the initial dose every 2-6 hours as needed. For maximum efficacy administer within 1 hour after ingestion of toxic compound Precautions : Aspiration of charcoal, hydrocarbons, corrosive, imaging of gastroesophageal. Caution in patient at risk of gastrointestinal obstruction Adverse Reactions : Black stools and gastrointestinal disturbances Contraindications : An unprotected airway, gastrointestinal tract not anatomically intact Interactions : Acarbose, carbamazepine, digoxin, frusemide, olanzapine, phenytoin; decreased effectiveness of these drugs, reduce absorption of oral therapy and render their effectiveness, simultaneous oral therapy should be avoided. Clear activated charcoal from stomach /avoid its usage if methionine (specific oral antidote) is to be used ------------------------------------------------------------------------------------------------------------------------------D-Penicillamine 0.25 g Capsule A Trade Name : Cuprimine Indication : i) Treatment of severe lead poisoning, it is used as adjunctive treatment following initial treatment with another chelating agent. May also be used as sole therapy in the treatment of asymptomatic patients with moderately elevated blood concentrations ii) Wilson's Disease: to aid in elimination of copper ions Dosage : i) 1.5 - 2 g daily in divided doses before food, maximum: 2 g daily for a year. Maintenance : 0.75 - 1 g daily ii) Initially 500 mg daily in divided doses, increased slowly over 3 months; usual maintenance : 1.25 g daily. Elderly not recommended Precautions : Allergy to penicillin, concomitant gold therapy, antimalarial, cytotoxic drug, renal dysfunction Adverse Reactions : Nausea, vomiting, myelosuppression, taste disorders, proteinuria, myasthenia gravis, optic neuritis, tinnitus Contraindications : Penicillamine-related aplastic anaemia/agranulocytosis, hypersensitivity to penicillamine producs, myasthenia gravis, pregnancy, lactation, rheumatoid arthritis patients with history of renal insufficient Interactions : Alluminium hydroxide or phosphate, magnesium carbonate or hydroxide or oxide or trisilicate, iron, digoxin, aurothioglucose ---------------------------------------------------------------------------------------------------------------------------------- 12 Flumazenil 0.5 mg/5 ml Injection B Trade Name : Anexate Indication : i) Diagnosis and/or management of benzodiazepine overdose due to self-poisoning or accidental overdose ii) Reversal of sedation following anaesthesia with benzodiazepine Dosage : i) Initial, 0.2 mg IV over 30 seconds; if desired level of consciousness not obtained after an additional 30 seconds, give dose of 0.3 mg IV over 30 seconds; further doses of 0.5 mg IV over 30 seconds may be given at 1-minutes intervals if needed to maximum total dose of 3 mg; patients with only partial response to 3 mg may require additional slow titration to a total dose of 5 mg; if no response 5 minutes after receiving total dose of 5 mg, overdose is unlikely to be benzodiazepine and further treatment with flumazenil will not help ii) 0.2 mg IV over 15 seconds; if desired level of consciousness is not obtained after waiting 45 seconds, a second dose of 0.2 mg IV may be given and repeated at 60-seconds intervals as needed (up to a maximum of 4 additional times) to a maximum total dose of 1 mg; most patients respond to doses of 0.6 to 1 mg; in the event of resedation, repeated doses may be given at 20-minutes intervals if needed; for repeat treatment, no more than 1 mg (given as 0.5 mg/minute) should be given at any one time and no more than 3 mg should be given in any one hour Precautions : Patients with a history of long-term benzodiazepine abuse, head injuries, history of panic disorder, liver disease, drug and alcohol dependent patients, neuromuscular blocking agents Adverse Reactions : Cardiac arrhythmias, bradycardia, dizziness, nausea, vomiting, seizure, injection site pain, headache, abnormal vision, blurred vision, agitation Contraindications : Hypersensitivity to flumazenil/benzodiazepines, cyclic antidepressant overdose, patients who have been given a benzodiazepine for control of a potentially life-threatening condition (eg, control of intracranial pressure or status epilepticus) Interactions : Thiopental : decreased duration of thiopental anaesthetic effects ---------------------------------------------------------------------------------------------------------------Fuller's Earth 30% Suspension C Trade Name : Fuller's Earth Indication : Adsorbent in pesticide poisoning Dosage : 200 - 500 ml of Fuller's Earth together with magnesium sulphate or mannitol every 2 hours for several days Precautions : Not known Adverse Reactions : Irritation of the skin, inflammation, blistering, cracking, shedding of the nails, delayed healing of cuts and wounds Contraindications : Not known Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------- 13 Mesna 400 mg/4 ml Injection A Trade Name : Uromitexan Indication : For prevention of urotoxic effects of oxazaphosphorines e.g. ifosfamide and cyclophosphamide Dosage : IV injection at a dosage of 20% of the corresponding oxazaphosphorine dose at the times 0 hour (concurrently with the oxazaphosphorine), 4 hours and 8 hours thereafter. CHILD: Dose given at greater frequency (e.g. 6 times) and a shorter intervals (e.g. 3 hours) Precautions : Do not use multi-dose vial in infants and neonates due to benzyl alcohol content, patients treated with mesna may have false positive test for urinary ketones, pregnancy Adverse Reactions : Hypotension, nausea, vomiting, headache, limb pain, headache, gastrointestinal effects, skin rash, diarrhoea, abdominal pain, transient drop in blood pressure, increase in pulse rate Contraindications : Hypersensitivity to mesna/other thiol compounds Interactions : Warfarin: increased risk of bleeding. In vitro mesna is incompatible with cisplatin. The combination of an oxazaphosphorine cytostatic agent with mesna and cisplatin in the same infusion solution is not stable and is not to be used -------------------------------------------------------------------------------------------------------------------------------Methylene Blue 1% Injection B Indication : For treatment of idiopathic and drug-induced methaemoglobinemia Dosage : 1 to 2 mg/kg (0.1 to 0.2 mL/kg of a 1% solution) IV very slowly over several minutes Precautions : Haemolytic anaemia (Heinz-body anaemia) and hyperbilirubinaemia in neonates who had been exposed to methylene blue in the amniotic cavity. Do NOT administer by subcutaneous or intrathecal injection. G6PD deficiency, renal impairment Adverse Reactions : Hypertension, hypotension, sweating symptom, abdominal pain, diarrhea, nausea, vomiting ,dizziness, headache, confusion, cardiac dysrhythmia, malignant hyperthermia, hemolytic anemia, methemoglobinemia Contraindications : Hypersensitivity to methylene blue, severe renal impairment, methaemoglobinemia in cyanide poisoning, intraspinal injection Interactions : Not known ---------------------------------------------------------------------------------------------------------------Naloxone HCl 0.4 mg/ml Injection B Trade Name : Narcan Indication : For the complete/partial reversal of narcotic depression including respiratory depression induced by opioids such as natural and synthetic narcotics. Diagnosis of suspected acute opioids overdosage Dosage : Initially 0.4 - 2 mg IV repeated at intervals of 2 - 3 minutes according to patient's needs 14 Precautions : Dependence may precipitate withdrawal symptoms, concurrent cardiotoxic drugs, pre-existing cardiac disease, narcotic dependency, pregnancy, lactation, neonates Adverse Reactions : Opiate withdrawal symptoms, nausea, vomiting, tachycardia, tremor, sweating, pulmonary oedema, hyperventilation, cardiac dysrhythmia, biliary colic, dysphagia, memory impairment, seizure, agitation, dyspnea, laryngeal spasm, pulmonary edema, tachyarrhythmia Contraindications : Hypersensitivity to naloxone Interactions : Clonidine: hypertension ---------------------------------------------------------------------------------------------------------------Pralidoxime 0.5 g/20 ml Injection B Trade Name : Protopam Indication : Antidote in the treatment of organophosphorus insecticide poisoning and in the control of overdosage by anticholinergic drugs used in the treatment of myasthenia gravis Dosage : 1 - 2 g by IV infusion in 100 ml saline over 15 - 30 minutes or slow IV injection over 10 minutes as 5 % solution. In water, followed after 1 hour by a second dose of 1 - 2 g. CHILD : 20 - 40 mg /kg body weight, may be given depending on the severity and response to treatment Precautions : Myasthenia gravis, renal dysfunction, slow IV infusion may prevent tachycardia, laryngospasm and muscle rigidity. Not effective in poisonings due to organophosphates without anticholinesterase activity, not effective in poisonings due to phosphorus/inorganic phosphates, renal impairment Adverse Reactions : Nausea, vomiting, dizziness, headache, blurred vision, bitter after taste, hyperventilation, laryngeal spasm Contraindications : Hypersensitivity to pralidoxime, phosphorus/inorganic phosphate poisoning, organophosphates without anticholinesterase activity Interactions : Not known ---------------------------------------------------------------------------------------------------------------Protamine Sulphate 50 mg/5 ml Injection B Indication : Heparin overdose and following cardiac or arterial surgery or dialysis procedures when required to neutralize the effects of heparin administered during extracorporeal circulation Dosage : 5 ml slow IV injected over 10 minutes. If administered within 15 minutes of heparin dose, 1 mg will neutralise approximately 100 units of heparin. If longer time has elapsed, less protamine is required. Not more than 50 mg should be injected at any one time Precautions : The rapid administration of protamine is associated with a higher incidence of adverse haemodynamic effects and anaphylactoid-like reactions. A solution of 10 mg/mL should be injected slowly over 1 to 3 minutes to prevent haemodynamic effects and anaphylactic-like reaction, patients with a history of fish allergy may also develop sensitivity reaction 15 Adverse Reactions : Hypotension, bradycardia, hypersensitivity reactions Contraindications : Hypersensitivity to protamine products Interactions : Not known ---------------------------------------------------------------------------------------------------------------Sodium Thiosulphate 500 mg/ml Injection B Indication : For cyanide poisoning Dosage : ADULT : 300 mg sodium nitrite IV over 3 minutes followed after 5 minutes with 50 ml sodium thiosulphate 50% injection administered over 10 minutes. CHILD : 4.5 - 10 mg/kg sodium nitrite IV followed by 1.65 ml/kg of 25% sodium thiosulphate injection Precautions : Too rapid intravenous administration has caused hypotension Adverse Reactions : Diarrhoea, allergic contact dermatitis Contraindications : Not known Interactions : Not known -------------------------------------------------------------------------------------------------------------------------- 16 2. GASTRO-INTESTINAL Dyspepsia Antispasmodics and drugs altering gut motility Ulcer-healing drugs Antidiarrheals Laxatives Local preparations for anal and rectal disorders Drugs affecting intestinal secretions Antiemetics Miscellaneous gastrointestinal 17 Magnesium Trisilicate Mixture C Indication : Heartburn, dyspepsia Dosage : 10-20 ml 3-4 times daily before meals Precaution: Renal impairment-nonabsorbable calcium, magnesium or aluminum preparations such as antacids or laxatives should not be used in patients receiving oral cation-exchange resins. Alternatively, the interaction may be avoided by administering the resin as an enema Adverse Drug Reaction: Diarrhoea, systemic alkalosis has been reported when administered orally with cation-exchange resins Contraindication: Acute surgical abdomen, hypersensitivity to antacids, hypophosphataemia Interaction: Major: sodium polystyrene sulfonate (advoid). Moderate: tetracyclines, ketoconazole, itraconazole, dipyridamole, quinolones, captopril, iron and aspirin (adjust frequency interval) ---------------------------------------------------------------------------------------------------------------Magnesium Trisilicate Tablet C Indication : Heartburn, dyspepsia Dosage : ADULT 1-2 tablet to be chewed up to 6 times a day before meals. CHILD over 6 years one tablet to be taken 3-4 times a day Precaution: Renal impairment Adverse Drug Reaction: Diarrhoea Contraindication: Hypersensitivity to antacids, hypophosphataemia Interaction: Tetracyclines, ketoconazole, itraconazole, dipyridamole, quinolones, captopril, iron and aspirin ---------------------------------------------------------------------------------------------------------------Sodium Bicarbonate Mixture (Paediatric) C Trade Name : Mist Carminative Paed Indication : Heartburn for rapid relief of dyspepsia Dosage : CHILD up to 1 year 5 ml; up to 1-5 years 10 ml in 4 to 6 divided doses Precaution: Excessive bicarbonate may lead to hypovolaemia and metabolic alkalosis in impaired renal function. History of congestive heart failure, history of renal impairment, cirrhosis, hypertension, concurrent corticosteroids, maintain high urine output, monitor acid-base balance and electrolyte Adverse Drug Reaction: Gastrointestinal cramps, flatulence, belching, alkalosis on prolong use Contraindication: Alkalosis, hypocalcaemia, hypochloraemia 18 Interaction: Major: sodium polystyrene sulfonate (systemic alkalosis). Minor: amphetamine, aspirin, chlorpropamide, itraconazole, ketoconazole, lithium, pseudoephedrine -------------------------------------------------------------------------------------------------------------------------------------Sodium Bicarbonate, Magnesium Carbonate, Tincture Cardamom Compound Mixture C Trade Name : Carminative Indication : Heartburn, for rapid relief of dyspepsia Dosage : ADULT 10-20 ml 3 times daily Precaution: Renal impairment Adverse Drug Reaction: Gastrointestinal cramps, flatulence, belching, alkalosis on prolong use Contraindication: Hypersensitivity to antacids, hypophosphataemia Interaction: Tetracyclines, ketoconazole, itraconazole, dipyridamole, quinolones, captopril, lithium and aspirin ----------------------------------------------------------------------------------------------------------------------------Domperidone 1 mg/ml Suspension B Trade Name : Motilium Indication : Nausea, vomiting, dyspepsia, gastro-esophageal reflux Dosage : Chronic dyspepsia : CHILD 2.5 mL/10 kg body weight 3 times daily and once more in the evening if necessary. Dosage may be doubled in adults & childs over 1 year. Acute and subacute conditions (particularly nausea and vomiting). CHILD: 5 mL/10 kg bodyweight. All to be taken 3-4 times daily Precaution: Baby under 1 year, hepatic impairment, renal insufficieny, pregnancy and lactation Adverse Drug Reaction: Mild abdominal cramps, raised serum prolactin level Contraindication: Known hypersensitivity to domperidone or any of the excipients. Prolactin-releasing pituitary tumour(prolactinoma). Should not be used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanicalobstruction or perforation Interaction: MAOIs, antacids, antisecretory drugs, azole antifungals, macrolide antibiotics, HIV protease inhibitors, anticholinergic drugs, CYP3A4 inhibitors. Antacids or antisecretory agents should be taken after meals when used concomitantly ----------------------------------------------------------------------------------------------------------------------------Domperidone 10 mg Tablet Trade Name : Motilium Indication : Nausea, vomiting, dyspepsia, gastro-esophageal reflux Dosage : Chronic dyspepsia ADULT 10 mg 3 times daily. Acute and subacute conditions (particularly nausea and vomiting):ADULT 20 mg 3-4 times daily 19 B Precaution: Dosage adjustment may be necessary in patients who are receiving domperidone concomitantly with cimetidine,pregnancy, lactation Adverse Drug Reaction: Mild abdominal cramps, raised serum prolactin level Contraindication: Known hypersensitivity to domperidone or any of the excipients. Prolactin-releasing pituitary tumour(prolactinoma.) Should not be used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation Interaction: MAOIs, antacids, antisecretory drugs, azole antifungals, macrolide antibiotics, HIV protease inhibitors, anticholinergic drugs, CYP3A4 inhibitors. Antacids or antisecretory agents should be taken after meals when used concomitantly ---------------------------------------------------------------------------------------------------------------------------Hyoscine N-Butylbromide 10 mg Tablet B Trade Name : Buscopan Indication : Gastrointestinal tract and genito-urinary tract spasm, dyskinesia of the biliary system Dosage : ADULT 10-20 mg 3-4 times daily. CHILD 6-12 years: 10 mg 3 times daily Precaution: Geriatric and pediatric patients, pregnancy, breastfeeding, intestinal atony, paralytic ileus and ulcerative colitis, coronary artery diseases, arrhythmias , heart failure, hypertension, xerostomia, hiatal hernia with reflux esophagitis, prostatic hypertrophy. Adverse Drug Reaction: Xerostomia, dyshidrosis, tachycardia, urinary hesistancy and retention, allergic reactions, skin reactions, confusions, excitement, constipation, paralytic ileus Contraindication: Obstructive disease of the gastrointestinal or urinary tract, narrow-angle glaucoma, cardiac tachyarrhythmias, myasthenia gravis, prostatic hypertrophy with urinary retention Interaction: Intensifies anticholinergic effects of tricyclic antidepressants, antihistamines, quinidine, amantadine and disopyramide. Enhances tachycardic effects of beta-adrenergic agents. Dopamine antagonist eg metoclopramide reduces effects of both drugs on gastrointestinal tract ----------------------------------------------------------------------------------------------------------------------------Hyoscine N-Butylbromide 20 mg/ml Injection B Trade Name : Buscopan Indication : Gastrointestinal tract and genito-urinary tract spasm, dyskinesia of the biliary system Dosage : ADULT 20 - 40 mg. Max : 40 mg 6 - 8 hourly. CHILD 0.5 mg/kg/dose Precaution: Geriatric and pediatric patients, pregnancy, breastfeeding, intestinal atony, paralytic ileus and ulcerative colitis, cardiac disease, coronary artery diseases, arrhythmias , heart failure, hypertension, xerostomia, hiatal hernia with reflux esophagitis, prostatic hypertrophy Adverse Drug Reaction: Xerostomia, dyshidrosis, tachycardia, urinary hesistancy and retention, allergic reactions, skin reactions, confusions, excitement, constipation, paralytic ileus, rarely anaphylactoid reactions & anaphylactic shock 20 Contraindication: Obstructive disease of the gastrointestinal or urinary tract, narrow-angle glaucoma, cardiac tachyarrhythmias, myasthenia gravis, prostatic hypertrophy with urinary retention, paraben allergy (multi-dose vial for injection contains parabens) Interaction: Intensifies anticholinergic effects of tricyclic antidepressants, antihistamines, quinidine, amantadine and disopyramide. Enhances tachycardic effects of beta-adrenergic agents. Dopamine antagonist eg metoclopramide reduces effects of both drugs on gastrointestinal tract ----------------------------------------------------------------------------------------------------------------------------Mebeverine HCl 135 mg Tablet B Trade Name : Duspatalin Indication : Irritable bowel syndrome Dosage : 135 mg 3 times daily Precaution: Hypersensitivity to mebeverine HCl, severe hepatic insufficency, porphyria Adverse Drug Reaction: Dizziness, headache, nausea, peritonitis, skin reactions Contraindication: Cystic fibrosis, porphyria, paralytic ileus, hypersensitivity to any component of formulation Interaction: Not known --------------------------------------------------------------------------------------------------------------------------Esomeprazole 20 mg Tablet A* Esomeprazole 40 mg Tablet A* Trade Name : Nexium Indication : i)Gastro-oesophageal reflux disease ii)H. pylori eradication Dosage : i)20mg daily for 4-8 weeks ii)40mg daily for 10 days in combination with amoxicillin 1g twice daily or clarithromycin 500mg twice daily Precaution: Exclude gastric malignancy prior to treatment. Severe renal or hepatic insufficiency. Pregnancy; lactation (discontinue). Long-term treatment should be kept under regular surveillance. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Monitoring when initiating and ending concomitant treatment with warfarin.Severe liver impairment, Hypersensitivity reactions e.g., angioedema and anaphylactic reaction/shock have been reported Adverse Drug Reaction: Abdominal pain , constipation , diarrhoea , dyspepsia , flatulence , nausea , dizziness, headache erythema multiforme , Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatitis Contraindication: Hypersensitivity to esomeprazole, in patients with known hypersensitivity to any component of the formulation Interaction: Citalopram, imipramine, clomipramine, phenytoin, diazepam, ketoconazole , itraconazole, warfarin, effects on absorption, effects on hepatic metabolism/cytochrome P-450 pathways,clarithromycin and amoxicillin (increase esomeprazole and 14-hydroxyclarithromycin plasma level) ----------------------------------------------------------------------------------------------------------------------------- 21 Esomeprazole 40 mg Injection A* Trade Name : Nexium Indication : i) Acute erosive/ ulcerative oesophagitis ii) Non -variceal upper gastrointestinal bleed Dosage : i) 20- 40 mg once daily for 2-5 days ii) 80 mg by IV bolus followed by 8mg/hour infusion for 72 hours Precaution: Exclude gastric malignancy prior to treatment. Severe renal or hepatic insufficiency. Pregnancy; lactation (discontinue). Long-term treatment should be kept under regular surveillance. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Monitoring when initiating and ending concomitant treatment with warfarin. Severe liver impairment Adverse Drug Reaction: Abdominal pain , constipation , diarrhoea , dyspepsia , flatulence , nausea , dizziness, headache erythema multiforme , Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatitis Contraindication: Hypersensitivity to esomeprazole in patients with known hypersensitivity to any component of the formulation Interaction: Citalopram, imipramine, clomipramine, phenytoin, diazepam, ketoconazole , itraconazole, warfarin,effects on absorption, effects on hepatic metabolism/cytochrome P-450 pathways,clarithromycin and amoxicillin (increase esomeprazole and 14-hydroxyclarithromy) -------------------------------------------------------------------------------------------------------------------------------Lansoprazole 30 mg Tablet A* Trade Name : Prevacid Indication : i) Peptic ulcer disease ii) Reflux oesophagitis iii) Zollinger-Ellison Syndrome iv) For eradication of Helicobacter pylori in combination with antibiotic Dosage : i) 30 mg daily for 8 weeks ii) 30 mg once 1-2 times daily for 4-8 weeks iii) 60-120mg once daily adjusted according to the patient's response iv) 30 mg twice daily in combination with any of the 2 antibiotics (clarithromycin 500 mg twice daily , amoxicillin 1 g twice daily or metronidazole 400 mg twice daily) for 1-2 weeks Precaution: Hepatic impairment, elderly, pregnancy, lactation Adverse Drug Reaction: Agitation, constipation, diarrhoea, dry mouth, abdominal distension, headache, sleepiness, insomnia, dizziness, rash, pruritus, fever Contraindication: Hypersensitivity to lansoprazole, in patients with known hypersensitivity to any component of the formulation Interaction: May retard metabolism and excretion of diazepam and phenytoin. May decrease plasma concentration of theophylline, inhibition of gastric acid secretion may interfere with dissolution of the drug -------------------------------------------------------------------------------------------------------------------------------------- 22 Omeprazole 20 mg Capsule A Trade Name : Losec Indication : Only for : i)Reflux oesophagitis ii)For eradication of Helicobacter pylori infection iii)Benign peptic ulcer not responding to conventional therapy iv)Zollinger-Ellison Syndrome Dosage : i)20 - 80 mg 1 - 2 times daily up to 8 - 12 weeks ii)20 mg twice daily in combination with any of the 2 antibiotics (clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily or metronidazole 400 mg twice daily)for 1 - 2 weeks iii) 20 mg once daily for 4 - 6 weeks iv) ADULT: 20 - 120 mg once daily adjusted according to the patient's response. CHILD 0.4 - 0.8 mg/kg/day Precaution: Proton pump inhibitors reduce gastric acidity and increase the risk of gastrointestinal infections. It may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers) Adverse Drug Reaction: Gastrointestinal effects such as diarrhoea, nausea and constipation, headache, cough, upper respiratory tract infection, rash Contraindication: Hypersensitivity to omeprazole or to any of its components Interaction: May prolong elimination of diazepam, warfarin and phenytoin. Increases plasma concentration of clarithromycin, ketoconazole -----------------------------------------------------------------------------------------------------------------------------Omeprazole 40 mg Injection A* Trade Name : Losec Indication : i) Reflux oesophagitis, eradication of H. Pylori infection, benign peptic ulcer not responding to conventional therapy, Zollinger-Ellison Syndrome ii) Endoscopically confirmed peptic ulcer Dosage : i) 40 mg IV once daily when oral therapy is inappropriate ii) 40- 160 mg by IV in single or divided doses Precaution: Proton pump inhibitors reduce gastric acidity & increase the risk of GI infections. It may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers) Adverse Drug Reaction: GI effects such as diarrhoea, nausea & constipation, headache, cough, upper respiratory tract infection, rash Contraindication: Hypersensitivity to omeprazole or to any of its components Interaction: May prolong elimination of diazepam, warfarin & phenytoin. Increases plasma concentration of clarithromycin, ketoconazole ----------------------------------------------------------------------------------------------------------------------------------Pantoprazole 40 mg Injection Trade Name : Controloc Indication : Bleeding peptic ulcer and acute stress ulceration Dosage : A* 40 mg twice daily until oral administration can be resumed. CHILD not recommended 23 Precaution: Proton pump inhibitors reduce gastric acidity and increase the risk of gastrointestinal infections. It may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers) Adverse Drug Reaction: Gastrointestinal disturbances (nausea and vomitting, diarrhoea, constipation, upper abdominal pain, flatulence) skin rash, pruritus, dizziness, oedema, fever, depression, vision disturbances, headache, liver enzyme changes, raised triglycerides Contraindication: Pregnancy, lactation, moderate to severe hepatic or renal impairment. Patients with known hypersensitivity to any component of the formulation Interaction: May affect absorption of drugs which are pH-dependant in patients with known hypersensitivity to any component of the formulation -----------------------------------------------------------------------------------------------------------------------------Pantoprazole 40 mg Tablet A* Trade Name : Controloc Indication : i) Helicobacter pylori eradication ii) Peptic ulcer disease iii) Erosive and non-erosive reflux oesophagitis (GERD and NERD) iv) Zollinger-Ellison Syndrome v) Prevention of NSAID induced gastropathy Dosage : i) 40 mg twice daily in combination with any of the 2 antibiotics (Clarithromycin 500 mg twice daily, Amoxicillin 1 g twice daily or Metronidazole 400 mg twice daily) for 1-2 weeks ii) 40 mg daily for 2 - 4 weeks iii) 20 - 40 mg daily on morning for 4 weeks iv) 40 mg twice daily. Maximum: 240 mg daily v) 20 mg daily. CHILD not recommended Precaution: Proton pump inhibitors reduce gastric acidity and increase the risk of gastrointestinal infections. It may mask symptoms of gastric cancer (exclude malignancy in suspected gastric ulcers) Adverse Drug Reaction: Gastrointestinal disturbances (nausea and vomitting, diarrhoea, constipation, upper abdominal pain, flatulence) skin rash, pruritus, dizziness, oedema, fever, depression, vision disturbances, headache, liver enzyme changes, raised triglycerides Contraindication: Pregnancy, lactation, moderate to severe hepatic or renal impairment. Patients with known hypersensitivity to any component of the formulation Interaction: May affect absorption of drugs which are pH-dependant in patients with known hypersensitivity to any component of the formulation ---------------------------------------------------------------------------------------------------------------------------------Rabeprazole Sodium 20 mg Tablet A* Trade Name : Pariet Indication : i) Treatment and maintenance of erosive or ulcerative gastroesophageal reflux disease (GERD) ii) Duodenal ulcers Dosage : i) 10-20 mg daily for 4-8 weeks, maintenance 10-20 mg daily ii) 20 mg daily at morning for up to 4-8 weeks Precaution: Liver disease, hepatic impairment, elderly, pregnancy, lactation 24 Adverse Drug Reaction: Agranulocytosis, thrombocytopenia, hepatic dysfunction, jaundice, interstitial pneumonia, abdominal pain, diarrhoea, oedema, headache, dizziness, rash Contraindication: Hypersensitivity to rabeprazole or substituted benzimidazoles Interaction: Ampicillin, digoxin, iron, itraconazole, ketoconazole, warfarin --------------------------------------------------------------------------------------------------------------------------------Ranitidine 150 mg Tablet B Ranitidine 300 mg Tablet B Trade Name : Zantac Indication : i) Benign gastric and duodenal ulcer ii) Reflux oesophagitis iii) Non-ulcer dyspepsia iv) ZollingerEllison Syndrome Dosage : i) 150 mg twice daily (at morning and night) or 300 mg on night for 4-8 weeks. Maintenance: 150300 mg on night ii) 150 mg twice daily or 300 mg on night for 8-12 weeks iii) 150 mg daily or twice daily iv) 150 mg and may be increased as necessary to 6 g/day Precaution: H2-receptor antagonists should be used with caution in hepatic impairment, in renal impairment, pregnancy and in breast-feeding. H2-receptor antagonists might mask symptoms of gastric cancer. Avoid in porphyrias. Ranitidine and phenytoin is not recommended. If no alternatives exist, clinical monitoring of patient response, tolerance and serum phenytoin concentrations is recommended, especially during the first month of therapy Adverse Drug Reaction: Gastrointestinal disturbances, diarrhoea, altered liver function tests (rarely liver damage), headache, dizziness, rash and tiredness. Rare side-effects include acute pancreatitis, bradycardia, AV block, confusion, depression and hallucinations particularly in the elderly or the very ill, hypersensitivity reactions (including fever, arthralgia, myalgia, anaphylaxis), blood disorders (including agranulocytosis, leucopenia, pancytopenia, thrombocytopenia) and skin reactions (including erythema multiforme and toxic epidermal necrolysis). There have been occasional reports of gynaecomastia and impotence Contraindication: Hypersensitivity to ranitidine Interaction: Absorption may be reduced by concomitant administration with high doses (2 g) of sucralfate ------------------------------------------------------------------------------------------------------------------------------Ranitidine 150 mg/10 ml Syrup B Trade Name : Zantac Indication : Peptic ulcer disease Dosage : CHILD 2-4 mg/kg 2 times daily. Maximum 300 mg daily Precaution: H2-receptor antagonists should be used with caution in hepatic impairment, in renal impairment, pregnancy and in breast-feeding. H2-receptor antagonists might mask symptoms of gastric cancer. Avoid in porphyrias. Ranitidine and phenytoin is not recommended. If no alternatives exist, clinical monitoring of patient response, tolerance and serum phenytoin concentrations is recommended, especially during the first month of therapy 25 Adverse Drug Reaction: Gastrointestinal disturbances, diarrhoea, altered liver function tests (rarely liver damage), headache, dizziness, rash and tiredness. Rare side-effects include acute pancreatitis, bradycardia, AV block, confusion, depression and hallucinations particularly in the elderly or the very ill, hypersensitivity reactions (including fever, arthralgia, myalgia, anaphylaxis), blood disorders (including agranulocytosis, leucopenia, pancytopenia, thrombocytopenia) and skin reactions (including erythema multiforme and toxic epidermal necrolysis). There have been occasional reports of gynaecomastia and impotence Contraindication: Hypersensitivity to ranitidine Interaction: Absorption may be reduced by concomitant administration with high doses (2 g) of sucralfate -----------------------------------------------------------------------------------------------------------------------------Ranitidine 50 mg/2 ml Injection B Trade Name : Zantac Indication : i) Benign gastric/ duodenal ulceration, reflux oesophagitis, Zollinger Ellison Syndrome ii) Stress ulcer prophylaxis in post-operative and high risk patients Dosage : i) ADULT: Slow IV injection of 50 mg diluted to 20 ml and given over at least 2 minutes. May be repeated every 6-8 hours or IV infusion at rate of 25 mg/hour for 2 hours, may be repeated at 6-8 hours intervals or IM. CHILD: 1 mg/kg/dose 6-8 hourly. ii) Initial slow IV injection of 50 mg, then continuous infusion of 125-250 mcg/kg/hour Precaution: H2-receptor antagonists should be used with caution in hepatic impairment, in renal impairment, pregnancy and in breast-feeding. H2-receptor antagonists might mask symptoms of gastric cancer. Avoid in porphyrias. Ranitidine and phenytoin is not recommended. If no alternatives exist, clinical monitoring of patient response, tolerance and serum phenytoin concentrations is recommended, especially during the first month of therapy Adverse Drug Reaction: Hypersensitivity to ranitidine Contraindication: Hypersensitivity to ranitidine Interaction: Absorption may be reduced by concomitant administration with high doses (2 g) of sucralfate --------------------------------------------------------------------------------------------------------------------------------Sucralfate 1 g Tablet A Indication : i) Benign gastric and duodenal ulceration ii) Stress ulcer prophylaxis Dosage : i) 2 g twice daily or 1 g 4 times daily for 4-6 weeks or in resistant cases up to 12 weeks (maximum 8 g daily) ii) 1 g 6 times daily (maximum 8 g daily). CHILD not recommended Precaution: Chronic renal failure and on dialysis (avoid if severe), pregnancy, breast feeding. Administration of sucralfate and enteral feeds should be separated by 1 hour dosing Precaution: Chronic renal failure and on dialysis (avoid if severe), pregnancy, breast feeding. Administration of sucralfate and enteral feeds should be separated by 1 hour dosing 26 Adverse Drug Reaction: Constipation, diarrhoea, nausea, gastric discomfort, indigestion, dry mouth, drowsiness, dizziness, skin rash, hypersensitive reaction including pruritus, back pain, vertigo Contraindication: Hypersensitivity to sucralfate products Interaction: Reduced the extent of absorption (bioavailability). Fluoroquinolones, tetracycline, warfarin, phenytoin, ketoconazole, lansoprazole, digoxin, ranitidine, cimetidine, theophylline and levothyroxine -------------------------------------------------------------------------------------------------------------------------Diphenoxylate with Atropine Sulphate Tablet B Trade Name : Lomotil Indication : Acute diarrhoea Dosage : ADULT initially 4 tablet followed by 2 tablet 4 times daily until diarrhoea is controlled Precaution: Advanced hepatorenal disease, abnormal liver function, Down Syndrome Adverse Drug Reaction: Euphoria, paraesthesia, central nervous system effects, anoneurotic oedema and other allergic reactions, toxic megacolon, paralytic ileus, gastrointestinal disturbance. Atropine effects: Hyperthermia, tachycardia, urinary retention, flushing, dry skin and mucous membranes. At therapeutic dose- dryness of the mouth, difficulty in swallowing, thirst, reduce bronchial secretion, mydriasis with cycloplegia Contraindication: Hypersensitivity to diphenoxylate hydrochloride or atropine, jaundice, acute diarrhoeal conditions like antibiotic associated diarrhoea, pseudomembranous enterocolitis, acute ulcerative colitis and infective diarrhoeas. Paralytic ileus and a ganglionosis. Not recommended for use in children Interaction: Barbiturates, tranquilizers, alcohol, MAOIs -----------------------------------------------------------------------------------------------------------------------------Bisacodyl 10 mg Suppository C Trade Name : Dulcolax Indication : i) Constipation ii) Bowel preparation for radiological procedures and surgery Dosage : i) ADULT and CHILD over 10 years: 10 mg, CHILD less than 10 years 5 mg insert rectally ii) ADULT 1020 mg, CHILD over 4 years 5 mg the following morning before procedures insert rectally Precaution: Prolonged use, abdominal pain, inflammatory bowel disease, sudden, persistent change in bowel habits and ulcerated haemorrhoids of rectal fissures Adverse Drug Reaction: Rarely,electrolyte and fluid imblances, abdominal discomfort, diarrhoea, rectal burning, vomiting Contraindication: Ileus, intestinal obstruction, acute abdominal conditions, rectal bleeding, appendicitis Interaction: Milk, antacids, warfarin ------------------------------------------------------------------------------------------------------------------------------------- 27 Bisacodyl 5 mg Tablet C Trade Name : Dulcolax Indication : i) Constipation ii) Bowel preparation for radiological procedures and surgery Dosage : i) ADULT and CHILD over 10 years 5-10 mg, CHILD 4-10 years 5 mg. To be taken at night for effect on the following morning ii) ADULT 10-20 mg the night before procedures, CHILD over 4 years 5 mg the night before procedures Precaution: Prolonged use, abdominal pain, inflammatory bowel disease, sudden, persistent change in bowel habits Adverse Drug Reaction: Rarely,electrolyte and fluid imblances, abdominal discomfort, diarrhoea, rectal burning, vomiting Contraindication: Ileus, intestinal obstruction, acute abdominal conditions, rectal bleeding, appendicitis Interaction: Milk, antacids, warfarin -----------------------------------------------------------------------------------------------------------------------------Glycerin 25% and Sodium Chloride 15% Enema Trade Name : Ravin Indication : Constipation Dosage : 1 enema as required Precaution: Frequent or prolonged use of laxatives may result in dependence Adverse Drug Reaction: Rectal discomfort, burning sensation Contraindication: Hypersensitivity to any component in the preparation Interaction: Not known ----------------------------------------------------------------------------------------------------------------------------- C Lactulose 3.35 g/5 ml Liquid B Trade Name : Duphalac Indication : i) Constipation ii) Hepatic encephalopathy Dosage : i) ADULT 15 ml twice daily adjusted to patient's need. CHILD 0.5 ml/kg/dose once or twice daily ii) 30-50 ml 3-4 times daily, dose adjusted to produce 2-3 soft stools daily. CHILD 1 ml/kg/dose 3-4 times daily Precaution: Diabetics, patients with lactose intolerance, pregnancy, lactation Adverse Drug Reaction: Flatulence, cramps and abdominal discomfort Contraindication: Galactosaemia, intestinal obstruction Interaction: Response may be altered by anti-infective agents ------------------------------------------------------------------------------------------------------------------------------------- 28 Liquid Paraffin C Indication : Constipation Dosage : ADULT 10-30 ml daily at night but should not be taken immediately before going to bed. CHILD not recommended Precaution: Avoid prolong use, patients with with recent change of bowel habits or suspected bowel malignancy and rectal bleeding Adverse Drug Reaction: Anal seepage of paraffin and consequent anal irritation after prolonged use, granulomatous reactions caused by absorption of small quantities of liquid paraffin, lipoid pneumonia and interference with the absorption of fat soluble vitamins Contraindication: Nausea, vomiting, undiagnosed abdominal pain, pregnancy, difficulty swallowing, bedridden patients, children less than 3 years Interaction: May impair the absorption of fat soluble vitamin --------------------------------------------------------------------------------------------------------------------------------Bismuth Subgallate and Benzyl Benzoate Suppository C Trade Name : Anusol Indication : For relief of pruritus, burning and soreness in patients with haemorrhoids and perianal conditions Dosage : Insert 1 suppository night and morning after bowel movements; do not use for longer than 7 days Precaution: Not for prolonged use. Use in children is not recommended Adverse Drug Reaction: Local irritation Contraindication: Hypersensitivity to any component of preparation Interaction: Not known --------------------------------------------------------------------------------------------------------------------------------Hydrocortisone Enema 0.1% B Indication : Adjunctive treatment for ulcerative colitis and proctitis Dosage : ADULT 100 mg 1-2 times/day for 2-3 weeks. If used for longer than 3 weeks, taper treatment over 23 weeks Precaution: Prolonged use, untreated infection Adverse Drug Reaction: Local irritation Contraindication: Hypersensitivity, bowel obstruction and perforation, extensive fistulas Interaction: Not known ------------------------------------------------------------------------------------------------------------------------------- 29 Lignocaine, Aluminium Acetate, Zinc Oxide and Hydrocortisone Ointment A/KK Trade Name : Xyloproct Indication : Anorectal pain, pruritis, inflammation and irritation Dosage : Apply once or twice daily. Not for prolonged use Precaution: Children less than 12 years, traumatised mucosa, sepsis in anorectal region or suspected herpes simplex infection Adverse Drug Reaction: Dry skin, pruritus, irritation, transient burning/stinging and atrophy of anal skin Contraindication: Hypersensitivity to local anaesthetics or to other components of the product Interaction: With large doses of lidocaine, risk of additional systemic toxicity in patients receiving other local anaesthetics ----------------------------------------------------------------------------------------------------------------------------------Lignocaine, Aluminium Acetate, Zinc Oxide and Hydrocortisone Suppository B Trade Name : Xyloproct Indication : Anorectal pain, pruritis, inflammation and irritation Dosage : 1 suppository to be used once or twice daily. Not for prolonged use Precaution: Children less than 12 years old, traumatised mucosa, sepsis in anorectal region or suspected herpes simplex infection Adverse Drug Reaction: Dry skin, pruritus, irritation, transient burning/stinging and atrophy of anal skin Contraindication: Hypersensitivity to local anaesthetics or to other components of the product Interaction: With large doses of lidocaine, risk of additional systemic toxicity in patients receiving other local anaesthetics ----------------------------------------------------------------------------------------------------------------------------------Ursodeoxycholic Acid 250 mg Capsule B Trade Name : Ursofalk Indication : Cholestatic liver diseases (eg. primary biliary cirrhosis, primary cholangitis etc) Dosage : 10-15 mg/kg daily in 2 to 4 divided doses usually for 3 months to 2 years. If there is no decrease in stone size after 18 months, further treatment seems not to be useful Precaution: Hepatic enzymes (alanine and aspartate transaminase) should be monitored upon the initiation of therapy and thereafter as indicated by the particular clinical circumstances Adverse Drug Reaction: Nausea, vomiting, diarrhoea, gallstone calcification, pruritus, pulpy stools Contraindication: 30 Radio-opaque stones, pregnancy, non-functioning gall bladder, chronic liver disease, peptic ulceration, inflammatory diseases and other conditions of the small intestine, colon and liver which interfere with enterohepatic circulation of bile salts Interaction: Absorption decreased by cholestyramine, colestipol or aluminium hydroxide containing antacids. Should not be used with drugs such as oestrogenic hormones that increase bile cholesterol ---------------------------------------------------------------------------------------------------------------------------------Diosmin 450 mg and Hesperidin 50 mg Tablet A/KK Trade Name : Daflon Indication : i) Haemorrhoids ii) Chronic venous insufficiency Dosage : i) Acute attack: 6 tablets daily for the first 4 days, then 4 tablets daily in 2 divided doses for 3 days and 2 tablets thereafter. Chronic: 2 tablets daily ii) 2 tab daily with meals Precaution: Lactation Adverse Drug Reaction: Minor gastrointestinal disturbances, neurovegetative disorders Contraindication: Hypersensitivity to any component of preparation Interaction: Not known ---------------------------------------------------------------------------------------------------------------Essential Phospholipids Capsule A/KK Trade Name : Essentiale Indication : Nutritional supplement in liver disorders Dosage : ADULT 1-2 capsule Precaution: Not Known Adverse Drug Reaction: Not known Contraindication: Not known Interaction: Cholestyramine, colestipol or antacids containing aluminium hydroxide -----------------------------------------------------------------------------------------------------------------------------Magnesium, Aluminium Hydroxide and Simethicone Suspension C Trade Name : Maalox Plus Indication : As a buffering agent for reconstituting didanosine powder for oral administration so as to prevent acid degradation of didanosine which is used for the treatment of paediatric patients (more than 6 months old) with symptomatic HIV infection Dosage : DDI should be mixed with water and diluted with the appropriate dose of antacids to a final concentration of 10 mg per ml 31 Precaution: Aluminium hydroxide may react with phosphate to form insoluble aluminium phosphate. This can be overcome by regular intake of milk or phosphorus supplements. Elevated serum magnesium ion concentration may cause central nervous system depression. Impaired bowel motility, gastrointestinal obstruction, upper gastrointestinal bleeding Adverse Drug Reaction: Gastrointestinal disturbances (constipation or diarrhoea), hypophosphatemia, seizures (serious) Contraindication: Severe debilitation, kidney failure Interaction: Inhibits absorption of tetracyclines, vitamin -------------------------------------------------------------------------------------------------------------------------Mesalazine 500 mg Tablet A Trade Name : Salofalk Indication : Inflammatory bowel disease of ulcerative colitis and Crohn's disease. Only for patients who cannot tolerate or do not respond to Sulfasalazine Dosage : ADULT: 250 - 500 mg 3 - 4 times daily for 3 - 6 weeks. CHILD up 2 years with Crohn's disease: 20 - 30 mg/daily in divided doses Precaution: Pregnancy, lactation, elderly Adverse Drug Reaction: Allergic exanthema, drug fever, bronchospasm, lupus erythematosus-like syndrome, hepatitis, pancreatitis, hair loss Contraindication: Severe hepatic and renal function disorders, active peptic ulcer, blood clotting abnormalities, salicylate hypersensitivity, babies and infants Interaction: Sulfonylureas, coumarins, methotrexate, probenecid, sulfinpyrazone, frusemide, rifampicin ------------------------------------------------------------------------------------------------------------------------------Salicylazosulphapyridine (Sulfasalazine) 500 mg Tablet A/KK Trade Name : Salazopyrin Indication : i) Treatment of inflammatory bowel disease of ulcerative colitis and Crohn's disease ii) Rheumatoid arthritis Dosage : i) ADULT, acute attack 1-2 g 4 times daily until remission occurs (if necessary corticosteroids may also be given), reducing to a maintenance dose of 500 mg 4 times daily, CHILD over 2 years, acute attack 40-60 mg/kg daily, maintenance dose 20-30 mg/kg daily ii) ADULT, initially; 0.5-1 g/day, increase weekly to maintenance dose of 2 g/day in 2 divided doses, maximun 3 g/day. CHILD over 6 years, juvenile rheumatoid arthritis: 30-50 mg/kg/day in 2 divided doses up to a maximum of 2 g/day Precaution: Hepatic or renal impairment, G6PD deficiency, risk of haematological and hepatic toxicity (differential white cell, red cell and platelet counts initially and at monthly intervals for first 3 months, liver function tests at monthly intervals for first 3 months), kidney function tests at regular intervals, upper gastro-intestinal side-effects common over 4 g daily, porphyria 32 Adverse Drug Reaction: Nausea, anorexia, fever, blood disorders (megaloblastic anaemia), hypersensitivity reactions (including exfoliative dermatitis, epidermal necrolysis, pruritus, photosensitisation, anaphylaxis, serum sickness, ocular complications (including periorbital oedema), stomatitis, parotitis, ataxia, aseptic meningitis, vertigo, tinnitus, insomnia, depression, hallucinations, kidney reactions (including proteinuria, crystalluria, haematuria), oligospermia, urine may be coloured orange, bone marrow depression, peripheral neuropathy Contraindication: Hypersensitivity to sulfonamides and salicylates, acute intermittent porphyria and children less than 2 years Interaction: Reduced absorption of folate, digoxin, antibacterial ---------------------------------------------------------------------------------------------------------------Sodium Biphosphate 16%, Sodium Phosphate 6% Solution A Trade Name : Fleet solution Indication : Bowel cleansing before colonic surgery, colonoscopy or radiological examination to ensure the bowel is free of solid contents. It is not to be used for treatment of constipation Dosage : 45 ml diluted with half a glass (120 mL) of water, followed by one full glass (240 mL) of water. Timing of doses is dependent on the time of the procedure. For morning procedure, first dose should be taken at 7 a.m. and second at 7 p.m. on day before the procedure. For afternoon procedure, first dose should be taken at 7 p.m. on day before and second dose at 7 a.m. on day of the procedure. Solid food should not be taken during the bowel preparation period. However clear fluids or water can be taken liberally. CHILD under 12 years not recommended Precaution: Pregnancy, severe renal impairment, heart disease (chronic cardiac failure, hypertension and oedema), ulcerative colitis (IBS) reflux oesophagitis, preexisting electrolyte disturbances (low serum calcium concentration, hyperkalaemia) Adverse Drug Reaction: Nausea, bloating, less frequently abdominal cramps and vomiting Contraindication: Gastrointestinal obstruction, gastric retention, gastrointestinal ulceration, perforated bowel, congestive cardiac failure, toxic colitis, toxic megacolon or ileus Interaction: Salts of magnesium, aluminium and calcium will bind with phosphate and reduce the absorption. Vitamin D will increase absorption of phosphate with diuretics and drugs affect serum electroytes may induce hyperphosphataemia, hypocalcaemia and hypernatraemia ------------------------------------------------------------------------------------------------------------------------------Aprepitant 125 mg Capsule A* Trade Name : Emend Indication : In combination with other antiemetic agents for prevention of delayed nausea and vomiting associated with initial and repeat course of highly emetogenic chemotherapy Dosage : 125 mg 1 hour prior to chemotherapy on Day 1. To be given as part of a 3-day regimen that includes a corticosteroid and a 5-HT3 antagonist 33 Precaution: Moderate to severe liver impairment, pregnancy. Caution is advised both during and up to 2 weeks after the end of treatment due to the inhibitory and inductive effects of aprepitant on CYP3A4 substrates Adverse Drug Reaction: Hiccups, asthenia or fatigue, increased ALT/AST, constipation, diarrhea, dyspepsia, eructation, headache, dizziness, anorexia, Stevens-Johnson syndrome and somnolence Contraindication: Hypersensitivity, breastfeeding, concurrent use of pimozide, terfenadine, astemizole, cisapride Interaction: Alfuzosin, alprazolam, astemizole, carbamazepine, cisapride, clarithromycin, dexamethasone, diltiazem, eletriptan, ethinyl estradiol, etonogestrel, fentanyl ,ifosfamide, imatinib, irinotecan, iraconazole, ketoconazole, levonorgestrel, medroxyprogesterone, methylprednisolone, midazolam, norethindrone, norgestrel, paclitaxel, paroxetine, phenytoin, rifampin, ritonavir, etrfenadine, tolbutamide, vinblastine ,vincristine, liposome vinorelbine, warfarin -------------------------------------------------------------------------------------------------------------------------------------Granisetron HCl 1 mg Tablet A Trade Name : Kytril Indication : Prevention and treatment of nausea and vomiting associated with chemotherapy and radiotherapy Dosage : ADULT 1 mg twice daily or 2 mg once daily with the first dose to be administered within 1 hour prior to cytostatic therapy. Maximum 9 mg/day Precaution: Subacute intestinal obstruction, pregnancy and lactation, liver disease Adverse Drug Reaction: Headache, asthenia, fever, pain, bradycardia, constipation, nausea, leukopenia, thrombocytopenia, hypersensitivity reaction, transiet increases in liver enzymes, rash Contraindication: Hypersensitivity to granisetron and other 5-HT3 receptor antagonists Interaction: Cytochrome P450 effect (minor). Apomorphine -------------------------------------------------------------------------------------------------------------------------------------Granisetron HCl 3 mg/3 ml Injection A Trade Name : Kytril Indication : i) Prevention and treatment of nausea and vomiting associated with chemotherapy and radiotherapy ii) Post-operative nausea and vomiting Dosage : i) ADULT 1-3 mg as an IV bolus not not less than 30 seconds; maximum 9 mg/day. CHILD over 2 years; single dose of 10-40 mcg/kg as an IV infusion; maximum 3 mg/day ii) ADULT 1 mg by slow IV injection over 30 seconds prior to induction of anaesthesia Precaution: Subacute intestinal obstruction, pregnancy and lactation, liver disease Adverse Drug Reaction: Headache, asthenia, fever, pain, bradycardia, constipation, nausea, leukopenia, thrombocytopenia, hypersensitivity reaction, transiet increases in liver enzymes, rash 34 Contraindication: Hypersensitivity to granisetron and other 5-HT3 receptor antagonists. Injection contains benzyl alcohol and should not be used in neonates Interaction: Cytochrome P450 effect (minor). Apomorphine ---------------------------------------------------------------------------------------------------------------Meclozine HCl 25 mg and Pyridoxine 50 mg Tablet B Trade Name : Navidoxine Indication : Nausea and vomiting of pregnancy Dosage : 1 - 2 tablet 2 - 3 times daily in severe cases Precaution: Use with caution in prostatic hyperthrophy, urinary retention, glaucoma and pyloroduodenal obstruction, hepatic disease, severe heart failure, asthma. Avoid operating vehicles and machinery Adverse Drug Reaction: Drowsiness, dry mouth, blurred vision, headache, gastrointestinal disturbance Contraindication: Hypersensitivity to meclozine Interaction: May enhanced sedative effect of central depressants including alcohol ---------------------------------------------------------------------------------------------------------------Metoclopramide HCl 10 mg Tablet B Trade Name : Maxolon Indication : i) Dyspepsia, flatulence, hiatus hernia, peptic ulceration, reflux oesophagitis, gastritis, duodenitis, cholelithiasis, nausea, vomiting ii) Promote bowel transit during diagnostic procedures Dosage : i) ADULT over 20 years: 10 mg 3 times daily. ADULT between 12 - 20 years: 5 mg 3 times daily. CHILD under 12 years: 0.12 mg/kg/dose 6 - 12 hourly ii) Single dose 5 - 10 minutes before examination; ADULT and CHILD over 15 years: 10 - 20 mg; CHILD less than 15 years: 0.12 mg/kg/dose 6 - 12 hourly Precaution: Hepatic and renal impairment, elderly, young adults and children; may mask underlying disorders such as cerebral irritation; avoid for 3 - 4 days following gastro-intestinal surgery, may cause acute hypertensive response in phaeochromocytoma; pregnancy and breast feeding; porphyria. Use cautiously in patients with depression, Parkinson's disease or hypertension Adverse Drug Reaction: Extrapyramidal effects (especially in children and young adults), hyperprolactinaemia, tardive dyskinesia, drowsiness, restlessness, anxiety, drowsiness, fatigue, akathisia, insomnia, depression, neuroleptic malignant syndrome, diarrhoea, bronchospasm and cardiac conduction abnormalities Contraindication: Concomitant therapy with drugs which are likely to cause extrapyramidal reactions, epileptics, gastrointestinal haemorrhage, obstruction (mechanical), or perforation, hypersensitivity to metoclopramide, pheochromocytoma Interaction: Increased absorption of aspirin and paracetamol; opioid analgesics and antimuscarinics antagonise effect on gastro-intestinal activity, antipsychotics (increased risk of extrapyramidal effects). Decrease absorption of digoxin ---------------------------------------------------------------------------------------------------------------35 Metoclopramide HCl 10 mg/2 ml Injection B Trade Name : Maxolon Indication : i) Dyspepsia, flatulence, hiatus hernia, peptic ulceration, reflux oesophagitis, gastritis, duodenitis, cholelithiasis, nausea, vomiting ii) Promote bowel transit during diagnostic procedures Dosage : i) ADULT over 20 years: 10 mg 3 times daily. ADULT between 12 - 20 years: 5 mg 3 times daily. CHILD under 12 years: 0.12 mg/kg/dose 6 - 12 hourly ii) Single dose 5 - 10 minutes before examination; ADULT and CHILD over 15 years: 10 - 20 mg; CHILD less than 15 years: 0.12 mg/kg/dose 6 - 12 hourly Precaution: Hepatic and renal impairment, elderly, young adults and children; may mask underlying disorders such as cerebral irritation; avoid for 3 - 4 days following gastro-intestinal surgery, may cause acute hypertensive response in phaeochromocytoma; pregnancy and breast feeding; porphyria. Use cautiously in patients with depression, Parkinson's disease or hypertension Adverse Drug Reaction: Extrapyramidal effects (especially in children and young adults), hyperprolactinaemia, tardive dyskinesia, drowsiness, restlessness, anxiety, drowsiness, fatigue, akathisia, insomnia, depression, neuroleptic malignant syndrome, diarrhoea, bronchospasm and cardiac conduction abnormalities Contraindication: Concomitant therapy with drugs which are likely to cause extrapyramidal reactions, epileptics, gastrointestinal haemorrhage, obstruction (mechanical), or perforation, hypersensitivity to metoclopramide, pheochromocytoma Interaction: Increased absorption of aspirin and paracetamol; opioid analgesics and antimuscarinics antagonise effect on gastro-intestinal activity, antipsychotics (increased risk of extrapyramidal effects). Decrease absorption of digoxin -------------------------------------------------------------------------------------------------------------------------------------Metoclopramide HCl 5 mg/5 ml Syrup B Trade Name : Maxolon Indication : i) Dyspepsia, flatulence, hiatus hernia, peptic ulceration, reflux oesophagitis, gastritis, duodenitis, cholelithiasis, nausea, vomiting ii) Promote bowel transit during diagnostic procedures Dosage : i) CHILD over 5 years: 2.5 - 5 ml 3 times daily. 3 - 5 years 2 ml 2 - 3 times daily. 1 - 3 years: 1 ml 2 - 3 times daily. Under 1 year: 1 ml 2 times daily ii) Single dose given 10 minutes before examination. CHILD over 5 years: 2.5 - 5 ml. Between 3 - 5 years: 2 ml. Under 1 year: 1 ml Precaution: Hepatic and renal impairment, elderly, young adults and children; may mask underlying disorders such as cerebral irritation; avoid for 3 - 4 days following gastrointestinal surgery, may cause acute hypertensive response in phaeochromocytoma, pregnancy and breast feeding, porphyria. Use cautiously in patients with depression, Parkinson's disease or hypertension, insulin dosage or timing of dosage may require adjustment Adverse Drug Reaction: Extrapyramidal effects (especially in children and young adults), hyperprolactinaemia, tardive dyskinesia, drowsiness, restlessness, anxiety, drowsiness, fatigue, akathesia, insomnia, depression, neuroleptic malignant syndrome, diarrhoea, bronchospasm and cardiac conduction abnormalities Contraindication: Concomitant therapy with drugs which are likely to cause extrapyramidal reactions, epileptics, gastrointestinal haemorrhage, obstruction (mechanical), or perforation, hypersensitivity to metoclopramide, pheochromocytoma 36 Interaction: Increased absorption of aspirin, paracetamol, tetracycline, levodopa, ethanol, cyclosporine, opioid analgesics and antimuscarinics antagonise effect on gastro-intestinal activity, antipsychotics (increased risk of extrapyramidal effects). Decrease absorption of digoxin, antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects with alcohol, sedatives, hypnotics, narcotics or tranquilizers -------------------------------------------------------------------------------------------------------------------------------------Ondansetron 4 mg/2ml Injection A Trade Name : Zofran Indication : i)Prevention of nausea and vomiting induced by chemotherapy and radiotherapy ii)Postoperative nausea and vomiting Dosage : i)8 mg given by IV infusion over 15 minutes or by IM immediately before treatment followed by 8 mg orally every 12 hours for up to 5 days. CHILD 5 mg/m2 body surface IV over 15 minutes immediately before chemotherapy followed by 4 mg orally every 12 hours for up to 5 days ii)Prevention : 4 mg given by IV at induction of anaesthesia. CHILD over 2 years, 100 mcg/kg (max 4mg) by slow IV before, during or after induction of anaesthesia. Treatment of postoperative: 4 mg by IM or slow. CHILD over 2 years 100 mcg/kg (maximum 4mg) by slow IV Precaution: Pregnancy, lactation, hepatic impairment. May mask progressive ileus and/or gastric distension Adverse Drug Reaction: Headache, malaise, fatique, sedation, diarrhea, constipation, anaphylaxis sensation of flushing or warmth in the head and epigastrium, occasionally transient visual disturbances and dizziness, involuntary movements, seizures and arrhythmias Contraindication: Hypersensitivity to any component of the preparation or other selective 5-HT3 antagonists Interaction: In patients treated with potent inducers of CYP3A4 (ie phenytoin, carbamazepine and rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased. Ondansetron may reduce the analgesic effect of tramadol -------------------------------------------------------------------------------------------------------------------------------------Prochlorperazine Maleate 5mg Tablet B Trade Name : Stemetil Indication : i) Severe nausea and vomiting ii) Vertigo/labyrinthine disorders Dosage : i) Injection IM 12.5 mg stat and repeated if necessary after 6 hours or orally 20 mg stat followed by 10 mg after 2 hours. Prevention: 5 - 10 mg 2 - 3 times a day. CHILD (over 10 kg only) 250 mcg/kg 2 - 3 times a day ii) For labyrinthine disorders 5 mg 3 times daily, gradually increased to 30 mg daily in divided doses, then reduced after several weeks to 5 - 10mg daily. Not recommended in children Precaution: Hypotension, pregnancy and lactation, glaucoma, prostatic hypertrophy, stenosing peptic ulcer, children with acute illnesses, dehydration or electrolyte imbalance, signs and symptoms suggestive of Reye's syndrome in children and adolescents, patients with tardive dyskinesia or a history of neuroleptic malignant syndrome, epilepsy, acute narrow angle glaucoma, liver damage, insomnia 37 Adverse Drug Reaction: Extrapyramidal symptoms, drowsiness, postural hypotension, coma, neuroleptic malignant syndrome, cholestatic jaundice, leucopenia and agranulocytosis, constipation, dry mouth, urinary retention, liver damage and insomnia Contraindication: CNS depression or coma, bone marrow depression, phaeochromocytoma, hypersensitivity to phenothiazines, comatose states, cardiovascular collapse Interaction: Tramadol, increased risk of seizures. Procyclidine, decreased phenothiazine serum concentrations, decreased phenothiazine effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Levodopa, loss of levodopa efficacy. Ethanol, increased central nervous system depression and an increased risk of extrapyramidal reactions ---------------------------------------------------------------------------------------------------------------Prochlorperazine Mesylate 12.5 mg/ml Injection B Trade Name : Stemetil Indication : i) Severe nausea and vomiting ii) Vertigo/labyrinthine disorders Dosage : Deep IM injection, 12.5 mg repeated if necessary after 6 hours and then followed by an oral dose. Not recommended in children Precaution: Hypotension, pregnancy and lactation, glaucoma, prostatic hypertrophy, stenosing peptic ulcer, children with acute illnesses, dehydration or electrolyte imbalance, signs and symptoms suggestive of Reye's syndrome in children and adolescents, patients with tardive dyskinesia or a history of neuroleptic malignant syndrome, epilepsy, acute narrow angle glaucoma, liver damage, insomnia Adverse Drug Reaction: Extrapyramidal symptoms, drowsiness, postural hypotension, coma, neuroleptic malignant syndrome, cholestatic jaundice, leucopenia and agranulocytosis, constipation, dry mouth, urinary retention, liver damage and insomnia Contraindication: CNS depression or coma, bone marrow depression, phaeochromocytoma, hypersensitivity to phenothiazines, comatose states, cardiovascular collapse Interaction: Tramadol, increased risk of seizures. Procyclidine, decreased phenothiazine serum concentrations, decreased phenothiazine effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Levodopa, loss of levodopa efficacy. Ethanol, increased central nervous system depression and an increased risk of extrapyramidal reactions ---------------------------------------------------------------------------------------------------------------- 38 3. CARDIOVASCULAR Positive inotropic drugs Diuretics Anti-arrhythmic drugs Beta-adrenoceptor blocking drugs Drugs affecting the renin-angiotensin system and some other antihypertensive drugs Nitrates, calcium-channel blockers, and potassium-channel activators Sympathomimetics Anticoagulants and protamine Antiplatelet drugs Mycocardial infarction and fibrinolysis Antifibrinolytic drug and haemostatics Lipid regulating drugs Miscellaneous cardiovascular 39 Digoxin 0.25 mg Tablet B Trade Name : Lanoxin Indication : Heart failure , with atrial fibrillation, supraventricular arrhythmias (particularly, atrial fibrillation) Dosage : Rapid digitalisation: 1-1.5 mg in divided doses over 24 hours; less urgent digitalisation, 250 mcg-500 mcg daily (higher dose may be divided). Maintenance : 62.5mg -500 mcg daily (higher dose may be divided) according to renal function and , in atrial fibrillation, on heart rate response; usual range, 125-250 mcg daily (lower dose may be appropriate in elderly) Precaution: Acute myocardial infarction, acute myocarditis, amyloid cardiomyopathy, AV block. Chronic constrictive pericarditis, electrolyte imbalance (eg. hypokalaemia, hypocalcaemia or hypercalcaemia, hypomagnesaemia), hypothyroidism, hypoxia, idiopathic hypertrophic subaortic stenosis. Renal disease, severe bradycardia, severe heart failure and pulmonary disease, ventricular tachycardia and Wolff-Parkinson-White syndrome Adverse Reaction: Nausea, vomiting, anorexia, diarrhoea, abdominal pains, salivation, sweating; headache, facial pain, malaise, fatigue, drowsiness, depression, disorientation, mental confusion, delirium, hallucination, visual disturbance.Hypokalaemia. Ventricular premature contractions, atrial or ventricular arrhythmias and conduction defects Contraindication: Ventricular fibrillation, ventricular tachycardia except in certain cases, digitalis toxicity, beriberi heart disease, hypersensitivity to digoxin, some cases of hypersensitive carotid sinus syndrome Interaction: Plasma concentration increased by quinidine, verapamil, nifedipine, amiodarone. Hypokalaemia may be associated with diuretics, lithium, carbenoxolone, corticosteroids. Antacids, neomycin may reduce serum level of digoxin ---------------------------------------------------------------------------------------------------------------Digoxin 50 mcg/ml Elixir B Trade Name : Lanoxin Indication : Heart failure, supraventricular arrhythmias (particularly atrial fibrillation) Dosage : Rapid digitalization, give in divided doses; PREMATURE: 20-30 mcg/kg; FULLTERM: 25-35 mcg/kg; CHILD 1-2 years : 35 to 60 mcg/kg; CHILD 2-5 years: 30-40 mcg/kg; CHILD 5-10 years: 20- 35 mcg/kg; CHILD over 10 years: 10-15 mcg/kg. For daily maintenance doses or for gradual digitalization, give 20% to 30% of oral digitalizing dose for premature infants or 25% to 35% of oral digitalizing dose for all other pediatric patients Precautions: Acute myocardial infarction, acute myocarditis, amyloid cardiomyopathy, AV block. Chronic constrictive pericarditis, electrolyte imbalance (eg. hypokalaemia, hypocalcaemia or hypercalcaemia, hypomagnesaemia), hypothyroidism, hypoxia, idiopathic hypertrophic subaortic stenosis. Renal disease, severe bradycardia, severe heart failure and pulmonary disease, ventricular tachycardia and Wolff-Parkinson-White syndrome Adverse Reaction: Nausea, vomiting, anorexia, diarrhoea, abdominal pains, salivation, sweating; headache, facial pain, malaise, fatigue, drowsiness, depression, disorientation, mental confusion, delirium, hallucination, visual disturbance.Hypokalaemia.Ventricular premature contractions, atrial or ventricular arrhythmias and conduction defects 40 Contraindication: Ventricular fibrillation, ventricular tachycardia except in certain cases, digitalis toxicity, beriberi heart disease, hypersensitivity to digoxin, some cases of hypersensitive carotid sinus syndrome Interaction: Plasma concentration increased by quinidine, verapamil, nifedipine, amiodarone. Hypokalaemia may be associated with diuretics. Antacids and neomycin may reduce serum level of digoxin. Lithium, carbenoxolone, corticosteroids ---------------------------------------------------------------------------------------------------------------Digoxin 500 mcg/2 ml Injection A Trade Name : Lanoxin Indication : Heart failure with atrial fibrillation, supraventricular arrhythmias (particularly atrial fibrillation) Dosage : Rapid digitilisation: ADULT & CHILD over 10 years, initially 0.75 - 1.5 mg, followed by 250 mcg 6 hourly until digitilisation is complete Precautions: Acute myocardial infarction, acute myocarditis, amyloid cardiomyopathy, AV block. Chronic constrictive pericarditis, electrolyte imbalance (eg. hypokalaemia, hypocalcaemia or hypercalcaemia, hypomagnesaemia), hypothyroidism, hypoxia, idiopathic hypertrophic subaortic stenosis. Renal disease, severe bradycardia, severe heart failure and pulmonary disease, ventricular tachycardia and Wolff-Parkinson-White syndrome Adverse Reaction: Nausea, vomiting, anorexia, diarrhoea, abdominal pains, salivation, sweating; headache, facial pain, malaise, fatigue, drowsiness, depression, disorientation, mental confusion, delirium, hallucination, visual disturbance.Hypokalaemia.Ventricular premature contractions, atrial or ventricular arrhythmias and conduction defects Contraindications: Ventricular fibrillation, ventricular tachycardia except in certain cases, digitalis toxicity, beriberi heart disease, hypersensitivity to digoxin, some cases of hypersensitive carotid sinus syndrome Interactions: Plasma concentration increased by quinidine, verapamil, nifedipine, amiodarone. Hypokalaemia may be associated with diuretics, lithium, carbenoxolone, corticosteroids. Antacids, neomycin may reduce serum level of digoxin ---------------------------------------------------------------------------------------------------------------Dobutamine HCl 250 mg/20 ml Injection A Trade Name : Dobutrex Indication : Hypotension and heart failure Dosage : Initial 0.5-1 mcg/kg/min by IV; maintenance 2.5-20 mcg/kg/min by IV; titrate according to response; maximum dose 40 mcg/kg/min Precautions: Arrhythmias, hypovolaemia . May be ineffective in patients who have recently received a betablocker, in such cases peripheral vascular resistance may increase. Monitor EKG and blood pressure constantly, serum potassium, pulmonary wedge pressure and cardiac output. Myocardial infarction and severe coronary artery disease. Adverse Reaction: Increased heart rate, blood pressure and ventricular ectopic activity, , anginal pain, nonspecific chest pain, palpitations shortness of breath, nausea, headache 41 Contraindications: Hypersensitivity to dobutamine, idiopathic hypertrophic subaortic stenosis Interactions: Beta-blockers, nitroprusside ---------------------------------------------------------------------------------------------------------------Dopamine HCl 40 mg/ml Injection B Trade Name : Intropin Indication : Non-hypovolemic hypotension Dosage : Initial dose 2-5 mcg/kg/min with incremental changes of 5-10 mcg/kg/min at 10-15 minutes intervals until adequate response is noted. Most patients are maintained at less than 20 mcg/kg/min. If dosage exceeds 50 mcg/kg/min, assess renal function frequently Precautions: Angina pectoris, conditions such as hypovolaemia, hypoxia, hypercapnia, and acidosis should be corrected prior to administration of dopamine. Patients allergic to sulfite. Patients receiving MAOIs will exhibit enhanced dopamine effects. Patients with pre-existing vascular damage secondary to atherosclerosis, diabetes, Raynaud's disease or frostbite since dopamine can produce peripheral necrosis or gangrene Adverse Reaction: Increased heart rate, blood pressure and ventricular ectopic activity, anginal pain, nonspecific chest pain, palpitations and shortness of breath, nausea, headache Contraindications: Pheochromocytoma, tachyarrhythmias or ventricular fibrillation Interactions: Beta-blockers, methyldopa, phenytoin, tricyclic antidepressants ---------------------------------------------------------------------------------------------------------------Amiloride HCl 5 mg & Hydrochlorothiazide 50 mg Tablet B Trade Name : Moduretic Indication : i) Diuretic as an adjunct to the management of oedematous states ii) Hypertension Dosage : i) Initially 1 - 2 tab daily adjusted according to response. Max : 4 tabs daily. ii) 1 -2 tabs daily as a single or divided dose Precautions: Diabetes mellitus. Electrolyte imbalance, concomitant use of other diuretics can result in hyponatraemia and hypochloremia as well as increases in BUN levels. This is more frequent in patients with hepatic cirrhosis and ascites, metabolic alkalosis or those with resistant oedema. Metabolic or respiratory acidosis Adverse Reaction: Hyperkalaemia, rash, dizziness, headache, asthenia Contraindications: Hypersensitivity to hydrochlorothiazide/amiloride or sulfonamides, hyperkalaemia, anuria, renal failure Interactions: Beta-blockers, nitroprusside ---------------------------------------------------------------------------------------------------------------- 42 Bumetanide 0.5 mg/ml Injection A* Trade Name : Burinex Indication : Oedema used in furosemide allergic patient Dosage : IV injection: 1 - 2 mg repeated after 20 mins. IV infusion: 2 - 5 mg over 30 - 60 mins Precautions: Alterations in glucose metabolism, blood dyscrasias (thrombocytopenia), hepatic disease, hyperuricaemia, hypokalaemia, hypovolaemia, ototoxicity particularly potentiation of aminoglycoside ototoxicity, coadministration not recommended Adverse Reaction: Hypokalaemia, hyperuricaemia, muscle cramps, arthralgias Contraindications: Hypersensitivity to bumetanide products, anuria, severe electrolyte imbalance, hepatic coma Interactions: Amikacin, angiotensin converting enzyme inhibitors, digitoxin, digoxin, gentamicin, kanamycin, lithium, neomycin, netilmicin, nonsteroidal antiinflammatory agents, streptomycin, tobramycin ---------------------------------------------------------------------------------------------------------------Furosemide 20 mg/2 ml Injection B Trade Name : Lasix Indication : Pulmonary oedema Dosage : Initially 20 -40 mg IM or slow IV (rate not exceeding 4 mg/min). CHILD: 0.5 - 1.5 mg/kg. Max: 20 mg daily Precautions: Alterations in blood glucose and glucose tolerance tests. Diabetes mellitus, electrolyte imbalance (eg: hypokalaemia, hyponatraemia), fluid imbalance, dehydration, blood volume reduction with circulatory collapse and possible vascular thrombosis and emboli may occur with excessive diuresis, especially in elderly patients. Gout or hyperuricaemia. Hepatic disease (cirrhosis and ascites). Hypersensitivity to sulfonamides. Ototoxicity (hearing loss, tinnitus), avoid rapid injection, high doses or concurrent administration of other ototoxic agents. If high-dose therapy is used, controlled intravenous infusion is recommended at a rate not to exceed 4 mg/min. Severe progressive renal disease (azotemia, oliguria). Systemic lupus erythematosus Adverse Reaction: Hypokalaemia, hyperuricaemia, hypotension, hyperglycaemia Contraindications: Anuria, hypersensitivity to furosemide, hepatic coma and pre-coma. Severe hypokalaemia, severe hyponatraemia, hypovolaemia with or without concomitant hypotension Interactions: Activated charcoal, amikacin, gentamicin, kanamycin, angiotensin converting enzyme inhibitors, aspirin, chloral hydrate, digoxin steroids, NSAIDs ---------------------------------------------------------------------------------------------------------------Furosemide 40 mg Tablet Trade Name : Lasix Indication : Pulmonary oedema B 43 Dosage : ADULT: Initial 40 - 80 mg on morning if required, can be increased to a max of 1 g/day in certain cases especially in chronic renal failure. CHILD : 1 - 3 mg/kg daily Precautions: Alterations in blood glucose and glucose tolerance tests. Diabetes mellitus, electrolyte imbalance (eg, hypokalaemia, hyponatraemia), fluid imbalance, dehydration, blood volume reduction with circulatory collapse and possible vascular thrombosis and emboli may occur with excessive diuresis especially in elderly patients. Gout or hyperuricaemia. Hepatic disease (cirrhosis and ascites). Hypersensitivity to sulfonamides. Ototoxicity (hearing loss, tinnitus), systemic lupus erythematosus Adverse reaction: Hypokalaemia, hyperuricaemia, hypotension, hyperglycaemia Contraindications: Anuria, hypersensitivity to furosemide, hepatic coma and pre-coma. Severe hypokalaemia, severe hyponatraemia, hypovolaemia with or without concomitant hypotension Interactions: Activated charcoal, amikacin, gentamicin, kanamycin, angiotensin converting enzyme inhibitors, aspirin, chloral hydrate, digoxin steroids, NSAIDs ---------------------------------------------------------------------------------------------------------------Hydrochlorothiazide 50 mg Tablet B Indication : Diuretic, hypertension Dosage : ADULT: Diuretics; 25-200 mg daily. Hypertension 12.5-25 mg daily CHILD: Oedema and hypertension; Adjunct; 1 to 2 mg/kg ORALLY daily in single or two divided doses; Children 2-12 years old MAX dose, not to exceed 100 mg ORALLY daily; Infants less than 6 months old, may require doses up to 3 mg/kg ORALLY daily in two divided doses, Infants up to 2 yrs old: MAX dose, not to exceed 37.5 mg ORALLY daily Precautions: Renal or hepatic impairment, pregnancy and lactation, elderly, debilitated patients, syndrome lupus erythematous. Monitor fluid and electrolytes, bronchial asthma Adverse Reaction: Metabolic disturbances, electrolyte imbalance, anorexia, gastrointestinal disturbances, headache, dizziness, postural hypotension, paresthesia, impotence, yellow vision, hypersensitivity. Rarely cholestatic jaundice, pancreatitis, blood dyscrasias Contraindications: Anuria, concurrent lithium therapy, renal decompensation Interactions: May enhance toxicity of digitalis glycosides, neuromuscular-blocking action of competitive muscle relaxants, effect of antihypertensives. Increased risk of postural hypotension with alcohol, barbiturates, opioids. Potassium-depleting effect enhanced by corticosteroids, ACTH, carbenoxolone ---------------------------------------------------------------------------------------------------------------Mannitol 10% Injection (10 g/100 ml) A Mannitol 20% Injection (20 g/100 ml) A Indication : Cerebral oedema Dosage : 0.25- 2 g/kg IV of a 15% to 25% solution over 30-60 minutes. Safety and efficacy not established in children under 12 years of age Precautions: 44 Cardiopulmonary dysfunction, renal dysfunction. An in-line filter should be used during intravenous administration. Maintain proper fluid and electrolyte balance. Monitor urinary output. Renal dysfunction and solutions should be examined for crystals before use. Solutions of 15% and 20% should always be filtered Adverse reaction: Hyperkalaemia, diarrhoea, renal failure, acidosis, pulmonary oedema, seizure, thrombophlebitis, urinary retention Contraindications: Anuria, pulmonary oedema/congestion, severe chronic heart failure, intracranial bleeding, renal damage/dysfunction (after initiation of mannitol) Interactions: Lithium toxicity (with diuretic induce hyponatraemia) ---------------------------------------------------------------------------------------------------------------Spironolactone 25 mg Tablet B Trade Name : Aldactone Indication : Oedema and ascites in cirrhosis of the liver, congestive heart failure Dosage : ADULT: 100 - 200 mg daily in divided doses. Increase to 400 mg if required. CHILD: initially 3 mg/kg daily in divided doses Precautions: Hyperkalaemia or progressive renal failure, impaired hepatic or renal function, diabetes mellitus, patients likely to develop acidosis. Pregnancy and lactation Adverse Reaction: Headache, drowsiness, gastrointestinal disturbances including cramp and diarrhoea, ataxia, mental confusion, hirsutism, deepening of the voice, menstrual irregularities, impotence, skin rashes, hyponatraemia, hyperkalaemia Contraindications: Hypersensitivity, hyperkalaemia, renal failure, anuria, patients receiving other potassium-sparing diuretics or potassium supplements Interactions: Angiotensin converting enzyme inhibitors, ciclosporin: hyperkalaemia. Aspirin: decreased spironolactone effectiveness. Digoxin: digoxin toxicity (nausea, vomiting, cardiac arrhythmias). NSAIDs: reduced diuretic effectiveness, hyperkalaemia ---------------------------------------------------------------------------------------------------------------Adenosine 3 mg/ml Injection B Trade Name : Adenocor Indication : Rapid conversion of paroxysmal supraventricular tachycardia to sinus rhythm Dosage : ADULT: Initially: 3 mg given as a rapid IV bolus (over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia with in 1 or 2 minutes, 6 mg should be given also as a rapid IV bolus. Third dose: If the second dose does not result in elimination of the supraventicular tachycardia with in 1-2 minutes, 12 mg should be given also as a rapid IV bolus Precautions: Avoid concomitant use of dipyridamole and methylxanthines (eg: caffeine, theophylline). Cardiac arrest, heart block, heart transplant patients, hypertension, hypotension, myocardial infarction. Proarrhythmic events; new rhythms, particularly at time of conversion and unstable angina 45 Adverse Reaction: Facial flush, dyspnoea, a feeling of thorasic constriction, nausea, lightheadedness, feeling of discomfort, sweating, palpitations, hyperventilation, head pressure, apprehension, blurred vision, burning sensation, bradycardia, chest pains, headache, dizziness, heaviness in arms, arm, back and neck pains; metallic taste Contraindications: Bradycardia, bronchoconstrictive or bronchospastic lung disease (eg. asthma). Hypersensitivity to adenosine, second-degree or third-degree AV block (unless pacemaker fitted), sinus node disease (eg. sick sinus syndrome) Interactions: Actions may be potentiated by dipyridamole and carbamazepine. Theophylline & caffeine inhibit its action ---------------------------------------------------------------------------------------------------------------Amiodarone 150mg/3 ml Injection A* Trade Name : Cordarone Indication : Arrhythmias when other drugs are contraindicated or ineffective Dosage : Initial infusion of 5mg/kg via large venous access over 20-120 minutes with ECG monitoring; subsequent infusion given if necessary according to response up to a maximum of 1.2 g in 24 hours Precautions: Acute myocardial infarction, sino-atrio, block AV or other severe conduction disorder ( unless the patient has a pacemaker),severe hypotension,severe respiratory failure, bradycardia, cardiomegaly,corneal microdeposits (impaired vision) Adverse Reaction: Reversible corneal microdeposits; colored halos. Hyper or hypothyroidism. Rarely; photosensitization and pigmentation. Reversible diffuse interstitial pneumopathy or peripheral neuropathy Contraindications: Cardiogenic shock, hypersensitivity to amiodarone, second or third degree AV block (if no pacemaker is present). Severe sinus bradycardia and severe sinus-node dysfunction Interactions: Antiarrhythmics, beta-blockers, stimulating laxatives, diuretics inducing hypokalaemia, systemic corticosteroids, tetracosactide, amphotericin B, digitalis, anticoagulants, phenytoin, general anaesthetic, ciclosporin ---------------------------------------------------------------------------------------------------------------Amiodarone 200 mg Tablet A* Trade Name : Cordarone Indication : Arrhythmias Dosage : 200 mg 3 times daily for 1 week, then reduced to 200 mg twice daily for another week. Maintenance dose, usually 200 mg daily or the minimum required to control the arrhythmia Precautions: Acute myocardial infarction, sino-atrio, block AV or other severe conduction disorder (unless the patient has a pacemaker),severe hypotension,severe respiratory failure,bradycardia, cardiomegaly, corneal microdeposits (impaired vision) 46 Adverse Reaction: Reversible corneal microdeposits; colored halos. Hyper or hypothyroidism. Rarely; photosensitization and pigmentation. Reversible diffuse interstitial pneumopathy or peripheral neuropathy Contraindications: Cardiogenic shock, hypersensitivity to amiodarone, second or third degree AV block (if no pacemaker is present). Severe sinus bradycardia and severe sinus-node dysfunction Interactions: Antiarrhythmics, beta-blockers, stimulating laxatives, diuretics inducing hypokalaemia, systemic corticosteroids, tetracosactide, amphotericin B, digitalis, anticoagulants, phenytoin, general anaesthetics, ciclosporin ---------------------------------------------------------------------------------------------------------------Atenolol 100 mg Tablet B Trade Name : Tenormin Indication : Hypertension, angina pectoris, myocardial infarction and arrhythmias Dosage : Hypertension and arrythmias; 50 - 100 mg daily, Angina; 100 mg daily, Myocardial infarction; individualized Precautions: Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus, hyperthyroidism/thyrotoxicosis. Patients receiving clonidine - discontinue atenolol several days prior to withdrawal of clonidine. Peripheral vascular and renal disease Adverse Reaction: Chronic heart failure, AV block, bradycardia, bronchospasm, dizziness, vertigo, nausea, fatigue, diarrhea Contraindications: Hypersensitivity to atenolol products, bradycardia, 2nd and 3rd degree AV block overt cardiac failure, cardiogenic shock, metabolic acidosis, severe peripheral circulatory disturbances, sick sinus syndrome Interactions: Clonidine, catecholamine-depleting agents, beta-blockers ---------------------------------------------------------------------------------------------------------------Bisoprolol Fumarate 2.5 mg Tablet A Bisoprolol Fumarate 5 mg Tablet A Trade Name : Concor Indication : Treatment of stable moderate to severe congestive cardiac failure in addition to ACEI's and diuretics Dosage : 1.25 mg once daily to 5 - 10 mg daily Precautions: Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus, hyperthyroidism/thyrotoxicosis. Peripheral vascular and renal disease Adverse Reaction: Arrythmia, bradycardia, chest pain, oedema, hypotension, dizziness, headache, fatique, diarrhoea, nausea, impotency, cough, rhinitis Contraindications: 47 Hypersensitivity, cardiac failure, pulmonary oedema, pregnancy, severe asthma or severe chronic obstructive pulmonary disease, hypotension Interactions: Prazosin, digoxin, amiodarone, ACEI, antidiabetic agent, calcitriol, cholestyramine, Clonidine ---------------------------------------------------------------------------------------------------------------Carvedilol 25 mg Tablet A* Carvedilol 6.25 mg Tablet A* Trade Name : Dilatrend Indication : Treatment of stable moderate to severe congestive cardiac failure in addition to ACEI's and diuretics Dosage : 3.125 mg twice daily for 2 weeks, then 6.25 mg twice daily for 2 weeks, then 12.5 mg twice daily for 2 weeks then 25 mg twice daily (titrated up to the highest tolerated level) Precautions: Avoid abrupt withdrawal, gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus Adverse Reaction: Dizziness, headache, tiredness, gastrointestinal disorders, flu-like symptoms Contraindications: Hypersensitivity to carvedilol, asthma, bradycardia, 2nd and 3rd degree AV block, cardiogenic shock overt cardiac failure, obstructive airway disease, severe chronic heart failure and hepatic impairment Interactions: Hypotensive effects potentiated by adrenergic neurone-blocking drugs, catecholamine depletors, central nervous system depressants, diuretics and vasodilators. Action decreased by rifampicin. Concurrent administration with cardiac glycosides may cause a sharp drop in heart rate ---------------------------------------------------------------------------------------------------------------Labetalol HCl 100 mg Tablet B Trade Name : Trandate Indication : Hypertension (including in pregnancy) Dosage : ADULT: 100 mg (50 mg in elderly) daily with food, increased at intervals of 14 days to usual dose of 200 mg twice daily, up to 800 mg twice daily (3 - 4 divided doses if higher dose). Max: 2.4 g daily Precautions: Anaesthesia/surgery, including when used in cases to control bleeding (myocardial depression). Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus Adverse Reaction: Hypotension, bradycardia, nausea, vomiting Contraindications: Hypersensitivity to labetalol products, bradycardia, asthma/obstructive airway disease, cardiogenic shock, heart block overt cardiac failure Interactions: Alpha-1 adrenergic blockers, amiodarone, cimetidine, clonidine, digoxin, dihydropyridine, calcium channel blockers, diltiazem, enflurane, epinephrine, flunarizine, halothane, hypoglycemic agents, imipramine, isoflurane, lidoflazine, methyldopa, verapamil ---------------------------------------------------------------------------------------------------------------- 48 Labetalol HCl 100 mg/20 ml Injection B Trade Name : Trandate Indication : Hypertension crisis Dosage : ADULT: Bolus injection 50 mg IV for at least 1 min. Max: 200 mg. IV infusion, dilute 2 amps to 200ml with sodium chloride and dextrose injection or 5% dextrose IV infusion, Hypertension of pregnancy; 20mg per hour doubled every 30 min to max 160 mg per hour Precautions: Anaesthesia/surgery, including when used in cases to control bleeding (myocardial depression). Avoid abrupt withdrawal; gradual withdrawal over a period of 1 to 2 weeks is recommended. Bronchospastic disease, congestive heart failure, diabetes mellitus Adverse Reaction: Hypotension, bradycardia, nausea, vomiting Contraindications: Hypersensitivity to labetalol products, bradycardia, asthma/obstructive airway disease, cardiogenic shock, heart block overt cardiac failure Interactions: Alpha-1 adrenergic blockers, amiodarone, bepridil, cimetidine, clonidine, digoxin, dihydropyridine, calcium channel blockers, diltiazem, enflurane, epinephrine, flunarizine, halothane, hypoglycemic agents, imipramine, isoflurane, lidoflazine, methyldopa, verapamil ---------------------------------------------------------------------------------------------------------------Metoprolol Tartrate 100 mg Tablet B Trade Name : Betaloc Indication : Hypertension, angina, myocardial infarction, arrhythmias Dosage : Hypertension: Initially 100 mg to maximum 400 mg daily, Angina: 50 mg - 100 mg in 2 - 3 times daily. Myocardial infarction: 200 mg daily in divided doses. Arrythmias: 50 mg - 300 mg in 2 - 3 times daily Precautions: Pregnancy, lactation Adverse Reaction: Lassitude, gastrointestinal and sleep pattern disturbances; rarely, non-specific skin reactions and coldness of extremities Contraindications: Hypersensitivity to metoprolol products, bradycardia, 2nd and 3rd degree AV block overt cardiac failure, cardiogenic shock, obstructive pulmonary disease Interactions: Alpha-1 adrenergic blockers, amiodarone, chlorpromazine, chlorprothixene, cimetidine, clonidine, digoxin, dihydropyridine, calcium channel blockers, flunarizine, fluoxetine, fluvoxamine, hydralazine, hypoglycemic agents, lidocaine, methyldopa -----------------------------------------------------------------------------------------------------------Propranolol HCl 40 mg Tablet B Trade Name : Inderal Indication : i) Hypertension ii) Angina iii) Myocardial infarct iv) Cardiac arrhythmia v) Portal hypertension vi) Migraine vii) Thyrotoxicosis 49 Dosage : i) Initially 80 mg twice daily increased as required to a usual range of 160 - 320 mg daily. CHILD: Initial doses of 1 mg/kg in divided doses, can be increased to 2 - 4 mg/kg/day in divided doses ii) Initial dose of 40 mg 2 - 3 times daily. Maintenance 120 - 240 mg daily iii) 40mg 4 times daily for 2 - 3 days then 80 mg twice daily, beginning 5 - 21 days after infarction iv) 10 - 40 mg 3 - 4 times daily v) Initially 40 mg twice daily. The dose may be increased as required up to 160 mg twice daily vi) Initial prophylaxis dose: 40 mg 2 - 3 times daily. The dose may be increased at weekly intervals up to 160 mg daily vii) Adjunct: 10 - 40 mg 3 - 4 times daily. CHILD: Arrythmias, thyrotoxicosis: 0.25 - 0.5 mg/kg 3 - 4 times daily as required Precautions: Avoid abrupt withdrawal, bronchospastic disease, congestive heart failure, diabetes, hepatic disease, peripheral vascular disease, renal disease, myasthenia gravis, pregnancy, breast feeding Adverse Reaction: Bronchospasm, bradycardia, depression, nausea, vomiting, dizziness, central nervous system effects, muscle cramps, fluid retention, skin rashes, dry mouth Contraindications: Hypersensitivity to propranolol, asthma, bradycardia, 2nd and 3rd degree AV block, cardiogenic shock, overt cardiac failure, obstructive airway disease Interactions: Alpha-1 adrenergic blockers, amiodarone, chlorpromazine, cimetidine, clonidine, cocaine, digoxin, dihydroergotamine, dihydropyridine, calcium channel blocker, disopyramide, epinephrine, ergotamine, flecainide, flunarizine, fluvoxamine, furosemide, risk of lignocaine toxicity increased ---------------------------------------------------------------------------------------------------------------Captopril 25 mg Tablet B Trade Name : Capoten Indication : i) Hypertension ii) Congestive heart failure iii) Post-myocardial infarction iv) Diabetic nephropathy Dosage : i) Initially 12.5 mg twice daily. Maintenance: 50 mg 2 - 3 times daily, may be increased to maximum 450 mg/day ii) Initially 6.25 - 12.5 mg 3 times daily, increase after several days to 25 - 50 mg 3 times daily iii) Initially 6.25 mg daily, gradually increased to 37.5 mg daily in divided doses iv) 75 - 100 mg daily in divided doses Precautions: Anaphylaxis during lipid apheresis with dextran sulfate membranes and during hymenoptera desensitization, angioedema; discontinue if laryngeal stridor or angioedema of the face, tongue, or glottis is observed, aortic stenosis, breast feeding period, cough, impaired renal function Adverse Reaction: Rash, pruritus, flushing, angioedema, loss of taste perception, stomatitis, gastrointestinal irritation and abdominal pain, leucopenia, cough Contraindications: Angioedema induced by other angiotensin converting enzyme (ACE) inhibitors during prior exposure. Anuric renal failure during prior exposure to ACE inhibitors. Hypersensitivity to this or any other ACE inhibitor. Pregnancy (second and third trimester pregnancy) Interactions: May increase serum K with Kalium K-sparing diuretics. Hypotensive effects enhanced by diuretics. Antihypertensive effect diminished by indomethacin, salicylates, NSAIDs ---------------------------------------------------------------------------------------------------------------- 50 Enalapril 10 mg Tablet B Enalapril 20 mg Tablet B Enalapril 5 mg Tablet B Trade Name : Renitec Indication : i) Hypertension ii) Congestive heart failure Dosage : i) Initially 5 mg daily, (ELDERLY 2.5 mg once daily), usual maintenance dose 10 - 20 mg daily. Maximum: 40 mg/day in 1 - 2 divided doses ii) Initially 2.5 mg daily, usual maintenance dose 20 mg daily in 1 - 2 divided doses; maximum: 40 mg/day Precautions: Symptomatic hypotension likely to occur in volume depleted patients eg. by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting, patients with heart failure with or without associated renal insufficiency. Caution in severe heart failure, especially ischemic heart or cerebrovascular disease. Patients with obstruction in the outflow tract of the left ventricle. Renal impairment patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Dosage reduction and or discontinuation of the diuretic and or enalapril may be required. Serum potassium should be monitored. Not recommended during pregnancy. Lactation. Children Adverse Reaction: Dizziness, headache, diarrhoea, fatigue, asthenia, cough, orthostatic hypotension, hyperkalaemia, angioneurotic oedema (discontinue therapy) Contraindications: Angioedema induced by other angiotensin converting enzyme (ACE) inhibitors. hypersensitivity to this or any other angiotensin converting enzyme inhibitor. Pregnancy (second and third trimesters particularly) Interactions: May have additive effects with other antihypertensives, potassium supplement, potassium-sparing diuretics or potassium-containing salt substitutes. Increased lithium level ---------------------------------------------------------------------------------------------------------------Hydralazine HCl 20 mg Injection B Indication : Hypertensive crisis in pregnancy Dosage : i) Slow IV injection, ADULT: 5-10 mg diluted with 10ml sodium chloride 0.9%. May be repeated after 20-30 minutes if necessary. ii) IV infusion 200-300 mcg/minutes. Maintenance dose 50-150 mcg/minutes Precautions: Hepatic impairment, renal impairment, coronary artery disease, cerebrovascular disease Adverse Reaction: Tachycardia, palpitation, hypotension, fluid retention, gastrointestinal disturbances, headache, dizziness, systemic lupus erythematosus-like syndrome, abnormal liver function, jaundice, blood disorders including haemolytic anaemia, leukopenia, thrombocytopenia Contraindications: Idiopathic systemic lupus erythematous, severe tachycardia, high output heart failure, myocardial insufficiency due to mechanical obstruction, dissecting aortic aneurysm, cor pulmonale, porphyria Interactions: Concomitant treatment with other vasodilators, calcium antagonists, ACE inhibitors, diuretics, antihypertensives, tricyclic antidepressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the blood pressure-lowering effect ---------------------------------------------------------------------------------------------------------------51 Irbesartan 300 mg & Hydrochlorothiazide 12.5 mg Tablet A* Trade Name : CoAprovel Indication : Hypertension in patients who cannot tolerate ACE inhibitors because of cough Dosage : 1 tablet daily Precautions: Caution in aortic or mitral valve stenosis, obstructive hyperthrophic cardiomyopathy, renal artery stenosis. Monitoring of plasma potassium concentration is advised, particularly in elderly and patients with renal impairment Adverse Reaction: Symptomatic hypotension including dizziness, hyperkalaemia, angioedema, nausea, vomiting, fatigue, musculoskeletal pain,diarrhoea, dyspepsia, flushing, tachycardia, cough, sexual dysfunction, rash, urticaria, headache, myalgia, athralgia, tinnitus, taste disturbances, hepatitis and renal dysfunction Contraindications: Pregnancy (2nd and 3rd trimesters), lactation, severe hepatic and renal impairment, refractory hypokalaemia, hypercalcaemia, biliary cirrhosis and cholestatis Interactions: Lithium, potassium-sparing diuretics, potassium supplements, central nervous system depressants, antidiabetic drugs, cholestyramine, corticosteroids, ACTH, digitalis glycosides, NSAIDs, nondepolarising muscle relaxants, antigout medications and calcium salts ---------------------------------------------------------------------------------------------------------------Irbesartan 300 mg Tablet A/KK Irbesartan 150 mg Tablet A/KK Trade Name : Aprovel Indication : Hypertension, diabetic nephropathy (in patients who cannot tolerate ACE inhibitors because of cough) Dosage : 150 mg to 300 mg daily Precautions: Angioedema (present or past), lactation period, excessive hypotension, hepatic or renal impairment, hyperkalaemia, hypertrophic cardiomyopathy, stenosis, aortic or mitral valve stenosis, surgery or anaesthesia Adverse Reaction: Diarrhoea, dyspepsia or heart burn, fatigue, headache, upper respiratory tract infection, angioedema of the face, lips or throat Contraindications: Hypersensitivity, pregnancy Interactions: Potassium supplements, potassium sparing diuretics, lithium, NSAIDs ---------------------------------------------------------------------------------------------------------------Losartan 50 mg Tablet A/KK Trade Name : Cozaar Indication : Patients intolerant of ACE inhibitors, only in the treatment of i) Hypertensive patient with left ventricular hypertrophy ii) Hypertension in diabetics with proteinuria or nephropathy 52 Dosage : Hypertension: Usual starting and maintenance dose: 50 mg once daily. Maximum increasing the dose to 100 mg once daily. Patients with intravascular volume-depletion starting dose of 25 mg once daily. Renal protection in Type 2 diabetic patients with proteinuria and hypertension, starting dose: 50 mg once daily, may be increased to 100 mg once daily based on blood pressure response Precautions: Angioedema: intravascular volume depletion (eg those treated with high-dose diuretics), electrolyte imbalance: lower dose should be considered for patients with a history of hepatic impairment, changes in renal function including renal failure may occur in susceptible individuals. Blood urea and serum creatinine may be increased in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, lactation, children Adverse Reaction: Angioedema, headache, dizziness, cough Contraindications: Hypersensitivity to losartan, pregnancy Interactions: Fluconazole, lithium, rifampicin ---------------------------------------------------------------------------------------------------------------Losartan Potassium 100 mg and Hydrochlorothiazide 12.5 mg Tablet A* Trade Name : Hyzaar Indication : Hypertension in patients who cannot tolerate ACE inhibitors because of cough, hypertensive patient with left ventricular hypertrophy Dosage : 1 tablet once daily, may increase to maximum dose losartan 100 mg/ hydrochlorothiazide 25 mg once daily Precautions: Angioedema. Not recommended for hepatic impairment or severe renal impairment (creatinine clearance less or equal to 30 mL/min). Changes in renal function including renal failure may occur. Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Hypotension and electrolyte or fluid imbalance may occur. Thiazide therapy may impair glucose tolerance, decrease urinary calcium excretion, intermittent and slight increases in serum calcium may occur, increase cholesterol and triglyceride levels, precipitate with or without a history of allergy or bronchial asthma. Thiazides have also been reported to exacerbate or activate systemic lupus erythematosus. Should not be initiated in patients with intravascular volume depletion (eg those treated with high dose diuretics), black patients, lactation, children Adverse Reaction: Dizziness, asthenia and fatigue, vertigo. Anaphylactic reactions, angioedema, vasculitis including Henoch-Schonlein purpura, hepatitis, diarrhoea, cough, urticaria, erythroderma, oedema, palpitations, headache, electrolyte abnormalities, abdominal pain, nausea, bronchitis, pharyngitis, sinusitis, upper respiratory infection, skin rash, back pain Contraindications: Hypersensitivity including to other sulfonamide-derived drugs, anuria. When used during second and third trimesters, drugs that act directly on the renin-angiotensin system can cause foetal injury and death. Discontinue as soon as possible if pregnancy is detected 53 Interactions: Angiotensin converting enzyme inhibitors, calcitriol, chlorpropamide, cholestyramine, corticotropin, cortisone, diazoxide, digitalis glycosides, diuretics, droperidol, hydrocortisone, indomethacin, liquorice, lithium, methotrexate, methylprednisolone, prednisolone, propranolol, tolbutamide, triamcinolone ---------------------------------------------------------------------------------------------------------------Losartan Potassium 50 mg and Hydrochlorothiazide 12.5 mg Tablet A/KK Trade Name : Hyzaar Indication : Hypertension in patients who cannot tolerate ACE inhibitors because of cough, hypertensive patient with left ventricular hypertrophy Dosage : 1 tablet once daily, may increase to maximum dose losartan 100 mg/ hydrochlorothiazide 25 mg once daily Precautions: Angioedema. Not recommended for hepatic impairment or severe renal impairment (creatinine clearance less than 30 mL/min). Changes in renal function including renal failure may occur. Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Hypotension and electrolyte or fluid imbalance may occur. Thiazide therapy may impair glucose tolerance, decrease urinary calcium excretion, intermittent and slight increases in serum calcium may occur increase cholesterol and triglyceride levels, precipitate with or without a history of allergy or bronchial asthma. Thiazides have also been reported to exacerbate or activate systemic lupus erythematosus. Should not be initiated in patients with intravascular volume depletion (eg those treated with high dose diuretics), black patients, lactation, children Adverse Reaction: Dizziness, asthenia and fatigue, vertigo. Anaphylactic reactions, angioedema, vasculitis including Henoch-Schonlein purpura, hepatitis, diarrhoea, cough, urticaria, erythroderma, oedema, palpitations, headache, electrolyte abnormalities, abdominal pain, nausea, bronchitis, pharyngitis, sinusitis, upper respiratory infection, skin rash, back pain Contraindications: Hypersensitivity including to other sulfonamide-derived drugs, anuria. When used during second and third trimesters, drugs that act directly on the renin-angiotensin system can cause foetal injury and death. Discontinue as soon as possible if pregnancy is detected Interactions: Angiotensin converting enzyme inhibitors, calcitriol, chlorpropamide, cholestyramine, corticotropin, cortisone, diazoxide, digitalis glycosides, diuretics, droperidol, hydrocortisone, indomethacin, liquorice, lithium, methotrexate, methylprednisolone, prednisolone, propranolol, tolbutamide, triamcinolone ---------------------------------------------------------------------------------------------------------------Methyldopa 250 mg Tablet B Trade Name : Aldomet Indication : Hypertension Dosage : 250 mg 2 - 3 times daily, gradually increased at intervals of 2 or more days, maximum; 3 g/day. ELDERLY initially 125 mg twice daily, increased gradually, maximum; 2 g daily 54 Precautions: Avoid abrupt withdrawal, congestive heart failure, dialysis patients (risk of hypertension following procedure), oedema, haemolytic anaemia, hypotension, liver disease, severe bilateral cerebrovascular disease (risk of choreoathetotic movements) Adverse Reaction: Sedation, headache, weakness, dizziness, parkinsonism, bradycardia, orthostatic hypotension, GI symptoms, hepatic impairment, impotence Contraindications: Hypersensitivity to methyldopa, history of hepatitis, autonomic dysfunction, bilateral cardiovascular disease Interactions: Antihypertensive drugs, lithium, monoamine oxidase inhibitors (MAOIs) ---------------------------------------------------------------------------------------------------------------Minoxidil 5 mg Tablet A* Trade Name : Loniten Indication : Severe hypertension Dosage : ADULTS and CHILD above 12 years old: Initially 5 mg daily in single or divided doses (elderly 2.5 mg). May increase by 5 - 10 mg daily at intervals of 3 or more days until optimum control is achieved. Maximum 50 mg daily Precautions: Angina pectoris, breast feeding, cerebrovascular disease, cerebrovascular accident (recent), congestive heart failure (without adequate diuretic therapy), dialysis, fluid retention, impaired renal function, myocardial infarction Adverse Reaction: Salt and water retention, tachycardia, pericardial effusion and tamponad, hypertrichosis. Occasionally; allergic rashes, gastrointestinal effects, breast tenderness, thrombocytopenia, leucopenia Contraindications: Hypersensitivity to minoxidil products Interactions: Combination with guanethidine may produce orthostatic hypotension -------------------------------------------------------------------------------------------------------------------------Perindopril 4 mg and Indapamide 1.25 mg Tablet A/KK Trade Name : Coversyl Plus Indication : Essential hypertension Dosage : One tablet daily Precautions: Renal insufficiency especially when associated with systemic autoimmune collagen vascular diseases. Concomitant treatment with immunosuppressant or treatment causing leucopoenia. Marked sodium and water depletion, hypotension, chronic heart failure, cirrhosis with oedema and ascites, ischemic heart disease, cerebral circulatory insufficiency, severe cardiac insufficiency (grade IV) or IDDM patients. Monitor serum potassium regularly. Surgery, elderly, hyperaldosteronism, malnourishment, acute porphyria Adverse Reaction: 55 Headache, asthenia, dizziness, sleep disturbances, cramps, hypotension, rash, gastrointestinal disturbances, slight reversible increase in urea and plasma creatinine, hypokalaemia, hyponatraemia with hypovolaemia, raised uric acid and blood glucose levels Contraindications: Bilateral renal artery stenosis or single functioning kidney, severe renal failure (creatinine clearance less than 30 mL/min), dialysis patients, hepatic encephalopathy, severe hepatic impairment, hyperkalaemia or hypokalaemia, untreated decompensated cardiac insufficiency. Previous history of angioneurotic oedema linked to treatment with ACE inhibitor, hereditary or idiopathic angioneurotic oedema. Pregnancy and lactation Interactions: Lithium, insulin, sulfonylureas, baclofen, NSAIDs, high dose salicylates, tricyclic antidepressants, neuroleptics, corticosteroids, tetracosactide, potassium-sparing diuretics, potassium salts, potassium-lowering drugs, anaesthesia, allopurinol, immunosuppressant, cardiac glycosides, procainamide and other drugs which cause torsades de pointes, antihypertensive drugs, metformin, calcium salts, ciclosporin, iodinated contrast media ---------------------------------------------------------------------------------------------------------------Perindopril 4 mg Tablet B Perindopril 8 mg Tablet B Trade Name : Coversyl Indication : i) Hypertension ii) Congestive heart failure iii) Stable coronary artery disease Dosage : i) 4 mg as single dose, may be increased to a single 8 mg dose. ELDERLY: Start treatment with 2 mg dose. In renal insufficiency, dose should be adapted according to creatinine clearance ii) Single starting oral dose of 2 mg should be increased to a single 4 mg once BP acceptability has been demonstrated iii) 4 mg once daily for 2 weeks, may be increased to 8 mg once daily. ELDERLY: 2 mg once daily for 1 week, then 4 mg once daily for the following week, may be increased up to 8 mg once daily Precautions: Arterial hypotension, renal failure, water and sodium depletion, renovascular hypertension, surgery or anaesthesia, elderly. Haemodialysis, avoid combination with highly permeable membranes (polyacrylonitrile). Measure plasma creatinine at baseline and during the month following institution of treatment. May precipitate excessive hypotension in severe chronic heart failure with or without associated renal insufficiency. Patients with ischaemic heart disease or cerebrovascular disease in whom excessive fall in blood pressure may result in myocardial infarction or cerebrovascular accident, hepatic impairment Adverse Reaction: Gastrointestinal disorders, dizziness, headaches, mood and or sleep disorders, asthenia, taste disorder, cramps, localized skin rashes, dry cough, angioneurotic oedema Contraindications: Angioedema induced by other angiotensin converting enzyme (ACE) inhibitors. Hypersensitivity to this or any other angiotensin converting enzyme inhibitor. Pregnancy (second and third trimesters particularly) Interactions: Potassium supplements or potassium-sparing diuretics may induce hyperkalaemia especially in renal failure. Neuroleptics or imipramine-like antidepressants increase risk of postural hypotension. Serum lithium concentrations may rise during lithium therapy ---------------------------------------------------------------------------------------------------------------- 56 Prazosin HCl 1 mg Tablet B Prazosin HCl 2 mg Tablet B Trade Name : Minipress Indication : Hypertension Dosage : Initially 0.5 mg 2 - 3 times daily, the initial dose on retiring to bed at night; increased to 1 mg 2 - 3 times daily after 3 - 7 days: further increased if necessary to maximum 20 mg daily Precautions: Dizziness, lightheadedness, orthostatic hypotension, syncope, fainting and sudden loss of consciousness due to first-dose effect Adverse Reaction: Dizziness, orthostatic hypotension, oedema, palpitations, urinary incontinence, dyspnoea, priapism, headache, lack of energy, nausea Contraindications: Hypersensitivity to prazosin products or other quinazolines Interactions: Additive hypotensive effect with diuretics or other antihypertensives ---------------------------------------------------------------------------------------------------------------Ramipril 5 mg Tablet A Trade Name : Tritace Indication : i) Hypertension and congestive heart failure ii) Post-myocardial infarction iii) Reducing risk of myocardial infarction, stroke or cardiovascular death in diabetics or patients with increased cardiovascular risks Dosage : i) Initially 2.5 mg once daily, increased at intervals of 1 - 2 weeks to maximum 10 mg once daily ii) Initially 2.5 mg twice daily for 2 days then increased to maximum 5 mg twice daily iii) Initially 1.25 2.5 mg once daily, increased to 5 mg once daily after 1 week, maximum dose: 10 mg once daily after 3 weeks Precautions: Renal or hepatic impairment, hyperstimulated renin-angiotensin system Adverse Reaction: Nausea, dizziness & headache, dry cough, hypotension, hypokalemia, fatigue, pruritus, rash & fever ,pancreatitis, angioedema Contraindications: Hypersensitivity, history of angioedema with ACE inhibitors, bilateral renal artery stenosis or a single kidney with unilateral renal artery stenosis. Pregnancy and lactation Interactions: Enhanced hypotensive effects by alcohol, alprostadil and anaesthetics ---------------------------------------------------------------------------------------------------------------Sodium Nitroprusside 50 mg/5 ml Injection A Trade Name : Nipride Indication : i) Hypertensive crisis ii) Controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures Dosage : i) By IV infusion, initially 0.5-1.5 mcg/kg/min, then adjusted before increasement of 0.5 mcg/kg/min every 5 mins within range 0.5-8 mcg/kg/min (lower doses in patients already receiving other 57 antihypertensives); stop if marked response not obtained with max dose in 10 minutes. Use only in infusion with 5 % Dextrose IV. ii) By IV infusion, max: 1.5 mcg/kg/min Precautions: Excessive hypotension, acute heart failure associated with reduced peripheral vascular resistance. Cyanide toxicity, methaemoglobinemia, NADH-methaemoglobin reductase deficiency, drug-induced (phenacetin, nitrites, nitrates, sulfonamides, dapsone, chlorates, chloroquine, primaquine and phenazopyridine). Pre-existing anaemia and or hypovolaemia Adverse reaction: Tachycardia, postural hypotension, nausea, retching, diaphoresis, apprehension, headache, restlessness, muscle twitching, retrosternal discomfort, palpitation, perspiration, dizziness, drowsiness, paraesthesial warmth, abdominal pain. Irritation and reddening at injection site Contraindications: Hypersensitivity to nitroprusside, head trauma, symptomatic hypotension, encephalopathy Interactions: Hypotensive effect potentiated by ganglion blockers, other antihypertensive agents, volatile liquid anaesthetics and other circulatory depressants ---------------------------------------------------------------------------------------------------------------Telmisartan 40 mg Tablet A/KK Telmisartan 80 mg Tablet A/KK Trade Name : Micardis Indication : Hypertension in patients who cannot tolerate ACE inhibitors because of cough Dosage : 40 - 80 mg a day Precautions: Angioedema (associated with aspirin and or penicillin allergy), discontinue with laryngeal stridor or angioedema of the face, tongue or glottis. Aortic or mitral valve stenosis, biliary cirrhosis or biliary obstruction, coronary artery disease and elderly Adverse Reaction: Headache, dizziness, upper respiratory infection and cough Contraindications: Hypersensitivity to telmisartan products, pregnancy and renal artery stenosis Interactions: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may cause hyperkalaemia (esp digoxin, lithium) May increase hypotensive effect of other antihypertensive ---------------------------------------------------------------------------------------------------------------Telmisartan 80 mg & Hydrochlorothiazide 12.5 mg Tablet A/KK Trade Name : Micardis Plus Indication : Hypertension in patients who cannot tolerate ACE inhibitors because of cough Dosage : 1 tablet daily Precautions: Hepatic impairment, progressive liver impairment, severe congestive heart failure, diabetes, gout, obstructive hyperthropic cardiomyopathy, electrolyte imbalance, high cholesterol or triglycerides Adverse Reaction: Respiratory disorders, urinary tract infection, blood dyscrasias, precipitation of gout or latent diabetes, electrolyte and fluid imbalances, metabolic and nutritional disorders, dizziness, vertigo, visual disturbances, cardiovascular and gastrintestinal disturbances, systemic lupus erythematosus 58 Contraindications: Cholestasis, biliary obstruction, severe hepatic impairment, severe renal impairment, lactation, pregnancy, refractory hypokalaemia Interactions: Lithium, bepridil, calcitriol, calcium carbonate, carbamazepine, chlorpropamide, cholestyramine, corticotropin, cortisone, cyclophosphamide, diazoxide, digoxin, droperidol, fludrocortisone, fluorouracil, memantine, methotrexate, methylprednisolone, prednisolone, propranolol, tolbutamide, triamcinolone ---------------------------------------------------------------------------------------------------------------Valsartan 80 mg and Hydrochlorothiazide 12.5 mg Tablet A/KK Trade Name : Co-Diovan Indication : Hypertension in patients who cannot tolerate ACE inhibitors because of cough Dosage : 1 tablet once daily Precautions: Risk of hypotension in sodium and or volume depleted patients, renal artery stenosis, renal and liver disease, disturbance of serum electrolyte balance. Caution when driving or operating machinery Adverse Reaction: Headache, dizziness, fatigue, hypokalaemia, hyperuricaemia and other electrolyte imbalance, orthostatic hypotension and increased lipids Contraindications: Pregnancy, lactation, severe hepatic impairment, biliary cirrhosis and cholestasis, anuria, severe renal impairment. Refractory hypokalaemia, hyponatraemia, hypercalcaemia and symptomatic hyperuricaemia Interactions: Concomitant treatment with potassium sparing diuretics or potassium supplements may increase serum potassium levels. Caution if combined with other antihypertensives or lithium (serum lithium monitoring) ---------------------------------------------------------------------------------------------------------------Valsartan 80 mg Tablet A/KK Trade Name : Diovan Indication : Patients who cannot tolerate ACE inhibitors because of cough, in i) Hypertension ii) Heart failure iii) Post myocardial infarction Dosage : i) 80 or 160 mg once daily. May be increased to 320 mg once daily. ii) 40 mg twice daily. Uptitration to 80 mg and 160mg twice daily. Max: 320 mg in divided doses. iii) 20 mg twice daily increased over several weeks to 160mg twice daily if tolerated. Precautions: Volume depletion, unilateral renal artery stenosis, monitor serum potassium concentrations, severe heart failure, aortic or mitral valve stenosis, coronary artery disease, hypertrophic cardiomyopathy, elderly, severe renal impairment, biliary cirrhosis or obstruction. Combination of ACE inhibitor, âblocker may impair ability to drive or operate machinery, pregnancy, lactation Adverse reaction: Headache, dizziness, viral infection, neutropenia, upper respiratory tract infection, hyperkalaemia, cough, diarrhoea, abdominal pain, back pain, fatigue, asthenia, oedema, syncope, rhinitis, sinusitis, nausea, pharyngitis and arthralgia Contraindications: Hypersensitivity to valsartan products 59 Interactions: Potassium-sparing diuretics, potassium supplements, cimetidine, co-trimoxazole, ACE inhibitors, phenobarbital, ketoconazole ---------------------------------------------------------------------------------------------------------------Amlodipine 10 mg Tablet B Amlodipine 5 mg Tablet B Trade Name : Norvasc Indication : Hypertension Dosage : 5 mg once daily. Max: 10 mg Precautions: Angina (exacerbation) during initiation of treatment; with dosage increases; during beta-blocker withdrawal; taper slowly prior to calcium channel blocker therapy. Aortic stenosis (reduced myocardial oxygenation with drug-induced hypotension), congestive heart failure, pregnancy, hepatic impairment Adverse Reaction: Headache, dizziness, gingival hyperplasia, tachycardia, peripheral oedema Contraindications: Hypersensitivity to amlodipine, symptomatic hypotension, persistent dermatologic reactions, congestive heart failure Interactions: Cyclosporin, fluconazole, itraconazole, ketoconazole, vardenafil ---------------------------------------------------------------------------------------------------------------Amlodipine 5 mg and Valsartan 160 mg Tablet A* Trade Name : Exforge Indication : Essential hypertension in patients whose blood pressure is not adequately controlled by monotherapy Dosage : Doses range from amlodipine besylate 5 mg/valsartan 160 mg to amlodipine besylate 10 mg/valsartan 320 mg ORALLY once daily, with dose titration occurring every 1 to 2 weeks if necessary. MAX amlodipine besylate 10 mg/valsartan 320 mg Precautions: Risk of hypotension in sodium or volume depleted patient, beta blocker withdrawal should be gradual. Severe renal impairment, dialysis. Unilateral/ bilateral renal stenosis, stenosis to a solitary kidney, after recent kidney transplantation, hepatic impairment, biliary obstructive disorders. Aortic or mitral stenosis, obstructive hyperthrophic cardiomyopathy Adverse reaction: Nasopharyngitis, flu, headache, oedema, peripheral oedema, fatigue, flushing, asthenia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, gastointestinal disturbances, rash, erythema, joint swelling, back pain, arthralgia. Rare: Hypersensitivity. Amlodipine: Gastritis, gingival hyperplasia, gynaecomastia, leucopaenia, myalgia, pancreatitis, hepatitis, thrombocytopaenia, vasculitis. Valsartan: Neutropaenia, increases in creatinine, serum potassium and BUN Contraindications: Pregnancy and lactation, hypersensitivity to amlodipine, valsartan or any component of the product 60 Interactions: Potassium Supplement. Potassium-sparing diuretic, potassium containing salt substitutes or other drugs that may increase potassium level ---------------------------------------------------------------------------------------------------------------Diltiazem HCl 30 mg Tablet B Trade Name : Herbesser Indication : Treatment of angina pectoris in the following cases: i) inadequate response or intolerance to betablockers and Isosorbide Dinitrate ii) contraindication to beta-blockers iii) coronary artery spasm Dosage : 60 mg 3 times daily (elderly initially twice daily); increased if necessary to 360 mg daily Precautions: AV block (first degree), combination therapy with beta-blockers (with left ventricular dysfunction), congestive heart failure, gastrointestinal hypermotility (extended release dose forms), gastrointestinal obstruction (extended release dose forms), hypotension, impaired liver function (reduced metabolism, enhanced response). Impaired renal function. Paroxysmal supraventricular tachycardia conversion, persistent dermatologic reactions induced by calcium antagonists have progressed to erythema multiforme or exfoliative dermatitis Adverse reaction: Headache, dizziness, peripheral oedema, gingival hyperplasia, AV block, bradycardia Contraindications: Acute myocardial infarction with pulmonary congestion, atrial fibrillation or flutter (IV dose forms): i) Accessory bypass tract (Wolff-Parkinson-White, Lown-Ganong-Levine) ii) Short PR syndromes. Hypersensitivity to this or other calcium channel blocker Interactions: Aspirin, beta-adrenergic blockers, carbamazepine, cimetidine, cisapride, cyclosporin, digitoxin, digoxin, enflurane, lithium, lovastatin, methylprednisolone, midazolam, nifedipine, oral anticoagulants, phenytoin, quinidine, rifampin, saquinavir, simvastatin ---------------------------------------------------------------------------------------------------------------Felodipine 10 mg Tablet A/KK Felodipine 5 mg Tablet A/KK Trade Name : Plendil Indication : Hypertension Dosage : Initiate at 5 mg once daily. Usual dose, 5 - 10 mg once daily in the morning Precautions: Rarely precipitate significant hypotension which can lead to myocardial ischaemia Adverse Reaction: Flushing, headache, palpitations, dizziness, fatigue. Ankle swelling (appears to be dose-related). Mild gingival hyperplasia Contraindications: Hypersensitivity to felodipine or other calcium channel blockers, symptomatic hypotension, peripheral vascular disease, persistent dermatologic reactions, cardiovascular arterial disease and congestive haeart failure 61 Interactions: Beta-adrenergic blockers, cyclosporin, fluconazole, itraconazole, ketoconazole, magnesium, oral anticoagulants, phenobarbital and saquinavir ---------------------------------------------------------------------------------------------------------------Glyceryl Trinitrate 0.5 mg Tablet C Trade Name : Angised Indication : Prophylaxis and treatment of angina and left ventricular failure Dosage : 0.5-1 mg sublingually Precautions: Severe hepatic , renal impairment, hypothyroidism, malnutrition, hypothermia. Cerebrovascular disease, lung disease or cor pulmonale, pregnancy, lactation, glaucoma, mitral valve prolapse, cardiac tamponade, syncope. Avoid prolonged excessive hypotension. Nitrate-free interval is recommended in patients on continuous treatment with nitrates to reduce the risk of tolerance Adverse Reaction: Flushing, dizziness, throbbing headache, vomiting, restlessness, blurred vision,tachycardia,bradycardia , hypotension (which can be severe), syncope, and cyanosis rarely),methaemoglobinaemia, respiratory impairment Contraindications: For sublingual:Severe anaemia, early myocardial infarction, increased intracranial pressure, symptomatic hypotension, hypersensitivity to organic nitrates Interactions: Imipramine, atropine, nitrates and sildenafil ---------------------------------------------------------------------------------------------------------------Glyceryl Trinitrate 25 mg/5 ml Injection A Trade Name : Nitro-bid Indication : Prophylaxis and treatment of angina, left ventricular failure. Not for direct IV injection. Dosage : Initial 5 mcg/min delivered via infusion pump. Subsequent titration must be adjusted to clinical situation with dose increment becoming more cautious as partial response is seen. Precautions: Severe renal or hepatic impairment. Need to be diluted for infusion via approved administration sets only. Absorption by plastics & filters. Nitrate-free interval is recommended in patients on continuous treatment with nitrates to reduce the risk of tolerance Adverse Reaction: Flushing, dizziness, tachycardia and throbbing headache. Large doses cause vomiting, restlessness, blurred vision, hypotension (which can be severe), syncope and rarely cyanosis and methaemoglobinaemia, impairment of respiration and bradycardia Contraindications: For IV :Constrictive pericarditis, pericardial tamponade, restrictive cardiomyopathy, symptomatic hypotension, hypersensitivity to organic nitrates Interactions: Hypotensive effect enhanced by alcohol, beta blockers, antihypertensives, tricyclic antidepressants, narcotics, sildenafil. May potentiate effects of antihistamines, anticholinergics. Antagonises pressor action of sympathomimetics ---------------------------------------------------------------------------------------------------------------62 Isosorbide Dinitrate 10 mg Tablet B Trade Name : Isordil Indication : Prophylaxis and treatment for: i) Angina ii) Left ventricular failure Dosage : i) 30 - 120 mg daily in divided doses ii) 40 - 160 mg, up to 240 mg if required; in acute episodes: 5 10 mg by sublingually Precautions: Acute myocardial infarction,cerebral hemorrhage,congestive heart failure, glaucoma, hyperthyroidism,hypertrophic, cardiomyopathy, hypotension,methemoglobinemia, recent head trauma, severe anemia, volume depletion Adverse Reaction: GI disturbances, headache, hypotension, tachycardia Contraindications: Hypersensitivity to organic nitrates, anaemia, symptomatic hypotension Interactions: Hypotensive effects may be enhanced by alcohol, beta-blocker, calcium channel blocker, antihypertensive, sildenafil, tricyclic antidepressant ---------------------------------------------------------------------------------------------------------------Isosorbide-5-Mononitrate 30 mg SR Tablet A Trade Name : Imdur Indication : Prophylaxis and treatment of angina pectoris Dosage : 30-120 mg daily Precautions: Acute myocardial infarction,cerebral hemorrhage, congestive heart failure, glaucoma, hyperthyroidism, hypertrophic, cardiomyopathy, hypotension,methemoglobinemia, recent head trauma, severe anemia, volume depletion Adverse Reaction: GI disturbances, headache, hypotension, tachycardia Contraindications: Hypersensitivity to organic nitrates, anaemia, symptomatic hypotension Interactions: Hypotensive effects may be enhanced by alcohol, beta-blocker, calcium channel blocker, antihypertensive, sildenafil and tricyclic antidepressant ---------------------------------------------------------------------------------------------------------------Nifedipine 10 mg Tablet B Trade Name : Adalat Indication : Hypertension Dosage : Initial dose of 10 mg twice daily. Usual range 10 - 30 mg 3 times daily. Maximum: 120 - 180 mg per day Precautions: Angina (exacerbation) during initiation of treatment, with dosage increases during beta-blocker withdrawal, taper slowly prior to calcium channel blocker therapy. Chronic renal insufficiency, combination therapy with beta-blockers (with left ventricular dsfunction) 63 Adverse Reaction: Peripheral oedema, headache, dizziness, tachycardia Contraindications: Hypersensitivity to nifedipine, symptomatic hypotension, persistent dermatologic reactions, chronic heart failure Interactions: Beta-adrenergic blockers, cimetidine, digoxin, diltiazem, fluconazole, itraconazole, ketoconazole, magnesium, oral anticoagulants, phenytoin, quinidine, rifampin, saquinavir, vincristine ---------------------------------------------------------------------------------------------------------------Nimodipine 10 mg/50 ml Infusion Solution A* Trade Name : Nimotop Indication : Prophylaxis & treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin Dosage : IV infusion of 1 mg/hour for a period of 2 hours (about 15 mcg/kg/hour). IV therapy should be started no later than 4 days after haemorrhage & continue for up to 10 - 14 days Precautions: Generalised cerebral oedema or raised intracranial pressure, hypotension. Pregnancy. Monitor renal function when used with nephrotoxic drugs Adverse Reaction: Severe blood pressure lowering. Gastrointestinal disturbances. In addition for infusion: deterioration of renal function, disturbances of heart rhythm, phlebitis, increase of liver enzymes Contraindications: Hypersensitivity to nimodipine, within 1 month of myocardial infarction, unstable angina Interactions: Potentiates effects of antihypertensives. IV beta-blockers (avoid). Possible increase of nimodipine blood concentration with cimetidine. Possible decrease of nimodipine efficacy with rifampicin. Nephrotoxic drugs, monitor renal function, zidovudine, cimetidine, antiepileptics, rifampicin, grapefruit juice ---------------------------------------------------------------------------------------------------------------Pentoxifylline 400 mg Tablet A/KK Trade Name : Trental Indication : Peripheral vascular disease Dosage : 400 mg 2 - 3 times daily Precautions: Hypotension, coronary artery disease, renal impairment, severe hepatic impairment Adverse reaction: Gastrointestinal effects, hypersensitivity reactions, dizziness, agitation, sleep disturbances, headache Contraindications: Cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction, pregnancy and lactation Interactions: Increased risk of bleeding with ketorolac, possibly increased risk of bleeding with other NSAIDs ---------------------------------------------------------------------------------------------------------------- 64 Verapamil HCl 40 mg Tablet B Trade Name : Isoptin Indication : i) Supraventricular tachyarrhythmias (SVT) prophylaxis ii) angina Dosage : ADULT: 40 - 80 mg 3-4 times daily. In oral long term therapy, max: 480 mg daily Precautions: First degree AV block, bradycardia, hypotension. May impair ability to drive or operate machinery. Pregnancy, lactation. Severe hepatic impairment. Slows down markedly the elimination of alcohol and prolongs the duration of alcohol Adverse Reaction: Constipation, dizziness, nausea or vertigo, headache, hypotension, ankle oedema, flushing, fatigue, nervousness, paraesthesia, bradycardiac arrhythmias, dyspnoea, raised prolactin levels, single cases of galactorrhoea, myalgia, arthralgia, allergic skin reactions, purpura, photosensitisation dermatitis, gynaecomastia, reversible increase in transaminases and or alkaline phosphatase, gingival hyperplasia, tachycardia, palpitations, impotence, tinnitus, tremor, heart failure Contraindications: Cardiovascular shock, complicated acute myocardial shock, severe conduction disorders (2nd and 3rd degree AV block, SA block), sick sinus syndrome, heart failure, atrial fibrillation/flutter and simultaneous preexcitation syndrome, myasthenia gravis Interactions: Increased risk of myocardial depression with beta-blockers or inhalation anaesthetic. May increase plasma digoxin concentration and plasma cyclosporin concentration ---------------------------------------------------------------------------------------------------------------Verapamil HCl 5 mg/2 ml Injection A/KK Trade Name : Isoptin Indication : Supraventricular tachycardia Dosage : 5 mg by slow IV. The dose can be repeated after 5 - 10 mins. Recommended max. total dose : 15 mg Precautions: Cardiac failure, complicated acute myocardial infarction, atrial fibrillation with Wolff-ParkinsonWhite syndrome, hepatic impairment Adverse Reaction: Constipation, dizziness, nausea or vertigo, headache, hypotension, ankle oedema, flushing, fatigue, nervousness, paraesthesia, bradycardiac arrhythmias, dyspnoea, raised prolactin levels, single cases of galactorrhoea, myalgia, arthralgia, allergic skin reactions, purpura, photosensitisation dermatitis, gynaecomastia, reversible increase in transaminases and or alkaline phosphatase, gingival hyperplasia, tachycardia, palpitations, impotence, tinnitus, tremor, heart failure Contraindications: Marked bradycardia, sick-sinus syndrome. 2nd or 3rd degree AV block. Chronic heart failure, cardiogenic shock. Pregnancy Interactions: Effects enhanced by beta-blockers, antiarrhythmics or inhalation anaesthetic. May intensify effects of other antihypertensives. Lithium (attenuated by verapamil, enhanced neurotoxicity). Increases plasma level of cyclosporin, theophylline, digoxin, carbamazepine ---------------------------------------------------------------------------------------------------------------- 65 Adrenaline Acid (Epinephrine) Tartrate 1 mg/ml Injection B Indication : Cardiopulmonary resuscitation Dosage : 0.5-1 mg given by SC or IM Precautions: Elderly patients, patients with; CV disease, pulmonary oedema, hypertension, hyperthyroidism, diabetes, psychoneurotic illness, asthma, prefibrillatory rhythm, or anesthetic cardiac acidents. Bronchial asthma/emphysema,cerebrovascular hemorrhage, pregnancy, lactation, children Adverse Reaction: Hypertension, arrhythmias, nausea, vomiting, headache, shortness of breath, sneezing Contraindications: Cardiac dilatation, coronary insufficiency. Within 2 weeks of MAOI use.Organic brain damage, narrow-angle glaucoma. Shock. Concurrent use with local anesthetics for injection of certain areas (eg; fingers, toes, ears); increased risk of vasoconstriction and sloughing of tissue. oncurrent use with cyclopropane or halogenated hydrocarbon anaesthetics; may produce fatal ventricular arrhythmias. Labor; may delay the second stage Interactions: Beta-blocking,alpha-adrenergic blockers agents,antihistamines,tricyclic antidepressants carvedilol, chlorpromazine, halothane, moclobemide, rocuronium, selegiline, timolol,methyldopa, diuretics, oxytoxic drugs ---------------------------------------------------------------------------------------------------------------Ephedrine HCl 30 mg/ml Injection B Indication : Treatment of bronchial spasm in asthma, adjunct to correct haemodynamic imbalances and treat hypotension in epidural and spinal anaesthesia Dosage : By IM, SC or IV. Severe, acute bronchospasm : 12.5-25 mg. Further dosage should be determine by patient response. When used as a pressor agent : ADULT 25 - 50 mg SC/IM. If necessary, a second IM dose of 50 mg or an IV dose of 25 mg may be given. Direct IV injection, 10 - 25 mg may be given slowly. Maximum parenteral ADULT dose : 150 mg in 24 hours. CHILD : 3 mg/kg or 100 mg/m2 SC or IV daily, in 4 - 6 divided doses Precautions: Angina pectoris, chronic heart disease. Chronic use may cause an anxiety state. Prostatic hypertrophy, pregnancy Adverse reaction: Nervousness, anxiety, apprehension, fear, tension, agitation, excitation, restlessness, weakness, irritability, insomnia, dizziness, lightheadness, vertigo, confusion, delirium, hallucinations or euphoria. Throbbing headache, respiratory difficulty, fever or a feeling of warmth, pallor, dryness of the nose and throat, precordial pain, sweating, mild epigastric distress, anorexia, nausea or vomiting. Acute urinary retention or difficulty in urination. May initially decrease urine formation. Palpitation and tachycardia. Extrasystoles and potentially fatal arrhythmias including ventricular fibrillation especially in patients with organic heart disease Contraindications: Anaesthesia with cyclopropane or halothane, diabetes (for ephedrine injection). Hypersensitivity to ephedrine or other sympathomimetic amines. Hypertension or other cardiovascular disorders, obstetrical procedures with maternal blood pressure, lactation 66 Interactions: Should not be administered concomitantly with other sympathomimetic agents. Alpha and betaadrenergic blocking agents. Cyclopropane or halogenated hydrocarbons general anaesthetics. MAOIs ---------------------------------------------------------------------------------------------------------------Noradrenaline Acid Tartrate (Norepinephrine Bitartrate) 4 mg/4 ml Injection A Trade Name : Levophed Indication : Septic shock and shock where peripheral vascular resistance is low Dosage : Infuse and titrate to desired pressure response. Range: 0.05 - 0.5 mcg/kg/minute Precautions: Peripheral vascular thrombosis, concomitant cyclopropane and halothane anaesthesia, profound hypoxia. Coadministration with MOAIs or tricyclic antidepressants. Sulfite allergy (seen more frequently in asthmatic than nonasthmatic patients) Adverse Reaction: Gangrene, cyanosis peripheral. Occasionally, bradycardia, anxiety, transient headache, plasma volume depletion (prolonged administration), respiratory difficulty, ischaemic injury Contraindications: Blood volume deficit Interactions: MAOIs, tricyclic antidepressants ---------------------------------------------------------------------------------------------------------------Enoxaparin Sodium 40 mg Injection A* Enoxaparin Sodium 60 mg Injection A* Trade Name : Clexane Indication : i) Prevention of Deep Vein Thrombosis(DVT) especially in perioperative and high risk surgical cases ii) Treatment of DVT iii) Unstable angina and non Q wave Myocardial Infarction Dosage : i) Prophylaxis fo DVT especially in surgical patients: moderate risk, 20 mg SC approximately 2 hours before surgery then 20 mg every 24 hours for minimum 7 - 10 days, high risk (eg orthopaedic surgery, medical patients, 40mg every 24 hours for at least 6 days until patient ambulant, max 14 days. ii) Treatment of DVT or pulmonary embolism, 1.5 mg/kg every 24 hours, usually for 5 days and until adequate oral anticoagulation established. iii) Unstable angina and non-ST-segment-elevation myocardial infarction 1 mg/kg every 12 hours, usually for 2 - 8 days Precautions: Carefully monitor patients for possible spinal or epidural bleeding and if neurological impairment is detected, treat immediately. Active or history of recent gastrointestinal ulceration and haemorrhage, bacterial endocarditis, bleeding diathesis. Concomitant therapy with agents that inhibit platelets. Congenital or acquired bleeding disorders. Do not give via intramuscular injection. Elderly patients and patients with renal insufficiency may experience delayed elimination of enoxaparin. Haemorrhagic stroke, post-op period following brain & spinal cord or ophthalmological surgery. Uncontrolled arterial hypertension. Use with extreme caution in patients with history of heparin-induced thrombocytopenia. Diabetic retinopathy, low molecular weight heparins or unfractionated heparin cannot be used interchangeably, unit for unit Adverse Reaction: Haemorrhagic symptoms, thrombocytopenia (rare), haematomas & skin necrosis at injection site; skin allergies or systemic allergic reactions 67 Contraindications: Active major bleeding, hypersensitivity to enoxaparin, heparin, thrombocytopenia due to enoxaparin, acute GI ulcer Interactions: Increased risk of haemorrhage when used with NSAIDs, ticlopidine, corticosteroids, dextran 40. May potentiate effects of oral anticoagulants. Vit K antagonists, anti-platelet drugs ---------------------------------------------------------------------------------------------------------------Fondaparinux Sodium 2.5 mg/0.5 ml Injection A* Trade Name : Arixtra Indication : i) Prevention of venous thromboembolic events (VTE) in orthopedic surgery (e.g. hip fracture, major knee or hip replacement surgery), abdominal surgery in patients at risk of thromboembolic complication. ii) Treatment of unstable angina or non-ST segment elevation myocardial infarction [UA/NSTEMI] in patients for whom urgent invasive management (PCI) is not indicated. iii) Treatment of ST segment elevation myocardial infarction (STEMI) in patients managed with thrombolytics or are not receiving other forms of reperfusion therapy Dosage : i) 2.5 mg once daily given by SC, administered 6 hr following surgical closure provided homeostasis has been established. Usual duration of therapy is 5 to 9 days; for hip fracture patients, an extended course of up to 24 days is recommended. ii) ADULT more than 18 years: 2.5 mg once daily given by SC, initiated as soon as possible after diagnosis and continued for up to 8 days or until hospital discharge. If patient needs to undergo PCI, unfractionated heparin to be admin as per local practice protocol, taking into account the patient's bleeding risk and time of last dose of fondaparinux. Fondaparinux may be restarted no earlier than 2 hr after sheath removal. iii) ADULT more than 18 years: 2.5 mg once daily; first dose to be given IV (directly through an existing IV line or as infusion in 25 or 50 ml of 0.9% saline over 1-2 min), subsequent doses to be given SC. Treatment to be initiated as soon as diagnosis is made and continued up to a max of 8 days or until hospital discharge, whichever comes earlier. If patient needs to undergo non-primary PCI, unfractionated heparin to be admin as per local practice protocol, taking into account the patient's bleeding risk and time of last dose of fondaparinux. Fondaparinux may be restarted no earlier than 3 hr after sheath removal Precautions: Increased haemorrhagic risk eg congenital or acquired coagulopathy, active ulcerative GI disease, recent intracranial haemorrhage or shortly after brain, spinal or ophth surgery, diabetic retinopathy, uncontrolled arterial hypertension, moderate renal impairment (CrCl < 30-50 mL/min), severe hepatic impairment. Measure platelet counts at baseline & end of treatment. Elderly. Pregnancy & lactation. Avoid concurrent administration with drugs that may increase haemorrhagic risk Adverse Reaction: Pruritus, rash, injection site hemorrhage, fever, anemia, bleeding, thrombocytopenia, fever, nausea, vomiting, constipation Contraindications: Active major bleeding; increased risk for major bleeding episodes;risk of uncontrollable hemorrhage, bacterial endocarditis, body weight less than 50 kg for prophylactic therapy of hip fracture, hip replacement or knee replacement surgery, or abdominal surgery; increased risk for major bleeding episode. Fondaparinux-related thrombocytoenia. Hypersensitivity to fondaparinux. Severe renal impairment (CrCl less than 30 ml/min) Interactions: Agents that increase the risk of hemorrhage (eg, other anticoagulants, NSAIDs, platelet inhibitors). Discontinue prior to administration of fondaparinux ---------------------------------------------------------------------------------------------------------------68 Heparin 1000 units/ml Injection B Heparin 5000 units/ml Injection B Indication : i) Prophylaxis and treatment of venous thrombosis and pulmonary embolism. ii) Treatment of myocardial infarction and arterial embolism. iii) Prevention of clotting in arterial and heart surgery and for prevention of cerebral thrombosis Dosage : i) By IV injection, loading dose of 5000 units (10,000 units in severe pulmonary embolism) followed by continuous infusion of 15-25 units/kg/hr. By SC injection (for DVT) of 15,000 units every 12 hours (laboratory monitoring on daily basis essential to adjust dose). Small adult or child, lower loading dose then, 15-25 units/kg/hr by IV infusion, or 250 units/kg every 12 hours by SC injection. ii) As i), for unstable angina and acute peripheral arterial occlusion. iii) Prophylaxis in general surgery, by SC injection, 5000 units 2 hour before surgery, then every 8-12 hours for 7 days or until patient is ambulant, during pregnancy (with monitoring), 5000-10000 units every 12 hours. An adjusted dose regimen may be used for major orthopaedic surgery or low molecular weight heparin may be selected Precautions: Heparin should be used cautiously in patients with allergies since it is of animal origin, renal and hepatic disease. Hypertension during menstruation. Patients with indwelling catheters. Precaution must be taken if using long-term subcutaneous heparin in pregnant women and bacterial endocarditis Adverse Reaction: Haemorrhage, cutaneous necrosis, thrombocytopenia, anaphylaxis, hyperkalaemia Contraindications: Hypersensitivity, in patients who are actively bleeding, or have blood dyscrasias, in patients with haemophilia or other blood disorders, and in cases where sufficient blood coagulation tests are not available Interactions: Alprostadil, alteplase, aspirin, cefoperazone, clopidogrel, dextran, moxalactam, reteplase, urokinase, warfarin, digitalis, tetracyclines, nicotine, antihistamines, ACE inhibitors, analgesics, dipyridamole,drotrecogin Alfa, iloprost, nitrates, sibutramine ---------------------------------------------------------------------------------------------------------------Heparin Sodium 50 units in Sodium Chloride Injection B Trade Name : Hepsal Indication : To maintain patency of peripheral venous catheters Dosage : Flush with 5 ml (50 units) every 4 hours or as required Precautions: Heparin should be used cautiously in patients with allergies since it is of animal origin, renal and hepatic disease. Hypertension during menstruation. Patients with indwelling catheters. Precaution must be taken if using long-term subcutaneous heparin in pregnant women. Bacterial endocarditis Adverse Reaction: Haemorrhage, cutaneous necrosis, thrombocytopenia, anaphylaxis, hyperkalaemia Contraindications: Hypersensitivity in patients who are actively bleeding or have blood dyscrasias, in patients with haemophilia or other blood disorders and in cases where sufficient blood coagulation tests are not available 69 Interactions: Alprostadil, alteplase, aspirin, cefoperazone, clopidogrel, dextran, moxalactam, reteplase, urokinase, warfarin, digitalis, tetracyclines, nicotine, antihistamines, ACE inhibitors, analgesics, dipyridamole,drotrecogin Alfa, iloprost, nitrates, sibutramine ---------------------------------------------------------------------------------------------------------------Warfarin Sodium 1 mg Tablet B Warfarin Sodium 2 mg Tablet B Warfarin Sodium 3 mg Tablet B Warfarin Sodium 5 mg Tablet B Trade Name : Coumadin Indication : Treatment and prophylaxis of thromboembolic disorders Dosage : Initially 10 mg daily for 2 days. Maintenance dose, 3-9 mg daily according to the INR (taken at the same time each day) Precautions: Severe to moderate hepatic or renal insufficiency, concomitant use of antiplatelet drugs or drugs with ulcerogenic activity. Surgery and dental extraction, congestive heart failure. Concurrent use with thrombolytic drugs, known or suspected protein C deficiency. Moderate to severe hypertension, severe diabetes, severe allergic or anaphylactic disorders. Patients with hyperthyroidism or hypothyroidism may have a substantially altered response to warfarin. Avoid concurrent use with herbal medicines and limit Vitamin K rich vegetables Adverse Reaction: Haemorrhage, alopecia, fever, gastrointestinal disorders, hypersensitivity reactions, `purple toes'. Occasionally skin necrosis (obese elderly patients), jaundice, hepatic dysfunction, nausea, vomiting, pancreatitis Contraindications: Haemorrhagic tendencies, pregnancy, blood dyscrasias, hypersensitivity to warfarin products Interactions: Activity potentiated by cimetidine, clofibrate, co-trimoxazole, erythromycin, quinidine, phenylbutazone, sulfonamides, amiodarone, rifampicin, carbamazepine, phenytoin, azole antifungals, metronidazole. Drugs which may increase risk of bleeding including aspirin, NSAIDs, dipyridamole, clopidrogel, ticlopidine ---------------------------------------------------------------------------------------------------------------Dabigatran Etexilate 110 mg Capsule A* Trade Name : Pradaxa Indication : Prevention of venous thromboembolic events in patients who have undergone total knee replacement or total hip replacement surgery Dosage : Following total knee replacement: Initially ADULT 110 mg (ELDERLY, 75 mg) within 1- 4 hours after surgery, then 220 mg (ELDERLY, 150 mg) once daily thereafter for 6-10 days Following total hip replacement: Initially ADULT 110 mg (ELDERLY, 75 mg) within 1- 4 hours after surgery, then 220 mg (ELDERLY, 150 mg) once daily thereafter for 28-35 days Precautions: Patients at risk for bleeding, recent biopsy or major trauma, spinal & epidural anaesthesia, lumbar puncture, pregnancy & lactation, children 70 Adverse Reaction: Bleeding, anaemia, haematoma, haemorrhage, haematuria, decreased haemoglobin, wound secretion, post-procedural discharge Contraindications: Severe renal and hepatic impairment, active bleeding, organic lesion at risk of bleeding, concomitant treatment with quinidine, pregnancy and lactation Interactions: Heparins, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, clopidogrel, ticlopidine, dextran, sulfinpyrazone, vitamin K antagonists, amiodarone, quinidine, NSAIDs, sibutramine ---------------------------------------------------------------------------------------------------------------Acetylsalicylic Acid 100 mg, Glycine 45 mg Tablet B IndIication : Prevention of myocardial infarct, stroke, vascular occlusion and deep vein thrombosis. Transient ischaemic attacks Dosage : 1 tablet daily Precautions: Dyspepsia, gastric mucosal lesions, haemorrhagic disorders, gout, intolerant to aspirin, renal or hepatic impairment, asthma and G6PD deficiency Adverse Reaction: Nausea, vomiting, dyspepsia, GI ulceration, haematemesis, malaena. Occasionally hepatotoxicity Contraindications: Bleeding disorders. Hypersensitivity to salicylate Interactions: Alcohol, dipyridamole, metoclopramide, metoprolol, carbonic anhydrase inhibitors, corticosteroids, coumarin anticoagulants, sulphonylureas, methotrexate, phenytoin, valproic acid, probenecid, sulphinpyrazone ---------------------------------------------------------------------------------------------------------------Clopidogrel 75 mg Tablet A* Trade Name : Plavix Indication : Prevention of myocardial infarct, stroke or established peripheral arterial disease. As second/third line treatment in patients who are sensitive to acetylsalicylic acid & intolerant to ticlopidine Dosage : 75 mg once daily Precautions: Avoid for first few days after MI and for 7 days after ischaemic stroke; not recommended in unstable angina, coronary artery bypass grafting and percutaneous transluminal coronary angioplasty; patients at risk of increased bleeding from trauma, surgery or other pathological conditions; discontinue 7 days before elective surgery if antiplatelet effect not desirable, liver impairment, renal impairment, pregnancy. Based on literature data, patients with genetically reduced CYP2C19 function (intermediate or poor metabolisers) have lower systemic exposure to the active metabolite of clopidogrel and diminished antiplatelet responses, and generally exhibit higher cardiovascular events rates following myocardial infarction than do patients with normal CYP2C19 function Adverse reaction: GI bleeding, purpura, bruising haematoma, epistaxis, haematuria, ocular haemorrhage, intra cranial bleeding, abdominal pain, dyspepsia, gastritis & constipation, rash, pruritus 71 Contraindications: Active pathological bleeding such as peptic ulcer & intracranial haemorrhage, breast feeding Interactions: Cytochrome P450 effect. Amiodarone, cisapride, ciclosporin, diltiazem, irbesartan, losartan, oral hypoglycemics, paclitaxel, phenytoin, quinidine, sildenafil, tamoxifen, verapamil, warfarin, aspirin, heparin, thrombolytics, NSAIDs, atorvastatin, erythromycin, clarithromycin. Concomitant use of the drugs that inhibit CYP2C19 should be discouraged ----------------------------------------------------------------------------------------------------------Dipyridamole 75 mg Tablet B Trade Name : Persantin Indication : As an adjunct to oral anticoagulation/ antiplatelet therapy in the prophylaxis of cerebrovascular events Dosage : 75-150 mg 3 times daily to be taken 1 hour before meals Precautions: Rapidly worsening angina, aortic stenosis, recent myocardial infarction, heart failure, may exacerbate migraine, hypotension, myasthenia gravis Adverse Reactions: Gastrointestinal effects, dizziness, myalgia, headache, hypotension, hot flushes and tachycardia, rash, urticaria, exacerbation of angina pectoris, bronchospasm and angioedema, increased bleeding during and after surgery Contraindications: Hypersensitivity to dipyridamole or tartrazine dye (25 mg tablets) Interactions: Adenosine, indomethacin, low molecular weight heparins, streptokinase, theophylline ---------------------------------------------------------------------------------------------------------------Ticlopidine HCl 250 mg Tablet A/KK Trade Name : Ticlid Indication : i) Prevention of thrombotic stroke for patients who are sensitive /intolerant to Acetysalicylic Acid ii) Maintenance of coronary bypass surgery or angioplasty iii) Maintenance of patency of access in patients on chronic haemodialysis Dosage : 250 mg twice daily taken with food Precautions: Predisposition to bleeding, including gastric or duodenal ulcers. Underlying haematologic disorders. Concomitant oral anticoagulant therapy or nonsteroidal antiinflammatory agents (including aspirin). Liver disease, patients undergoing lumbar puncture or surgical procedure. Ticlopidine should be discontinued if the absolute neutrophil count falls below 1200/mm3 or if the platelet count falls below 80,000/mm3. If possible, ticlopidine should be discontinued 10 to 14 days prior to surgery Adverse reaction: Minor gastrointestinal disorders. Rarely cutaneous allergic manifestations, thrombocytopenia, cholestatic icterus and or rise in transaminases. Neutropenia and thrombocytopenia (monitor full blood count weekly initially) Contraindications: Hypersensitivity to ticlopidine or its components, patients with active bleeding disorders. Neutropenia or thrombocytopenia, severe liver impairment 72 Interactions: Any drugs likely to produce coagulation ---------------------------------------------------------------------------------------------------------------Streptokinase 1,500,000 IU Injection A* Trade Name : Streptase Indication : Acute myocardial infarction, acute pulmonary embolism Dosage : Myocardial infarction: 1,500,000 units over 30 - 60 minutes. Pulmonary embolism: 250,000 units by IV infusion over 30 minutes, then 100,000 units every hour for up to 12-72 hours with monitoring of clotting factors Precautions: Arterial invasive procedures should be avoided before and during treatment and invasive venous procedures should be performed carefully. Spontaneous bleeding from internal sites may occur. Concurrent use of anticoagulants with streptokinase is not recommended. Concurrent use of heparin may be required during intracoronary administration of streptokinase. Precaution must be taken during concurrent use of drugs that may alter platelet function (dextran, aspirin, indomethacin, phenylbutazone) and anticoagulants Adverse reaction: Nausea, vomiting, bleeding, reperfusion arrhythmias, hypotension, bronchospasm Contraindications: Hypersensitivity to streptokinase products, streptococcal infections within 6 months haemorrhage, cardiovascular arrest, surgery or trauma within 1 month, subacute bacterial endocarditis Interactions: Aspirin, dipyridamole, eptifibatide, warfarin ---------------------------------------------------------------------------------------------------------------Tenecteplase 10,000 unit (50 mg) Injection A* Trade Name : Metalyse Indication : Acute myocardial reinfarction where streptokinase is contraindicated due to previous streptokinase induced antibodies. [Indicated when antibodies was given more than 5 days and less than 12 months] Dosage : Less than 60 kg: 30 mg, 60 - 69 kg: 35 mg, 70 - 79 kg: 40 mg; 80 -90 kg: 45 mg, 90 kg or above: 50 mg. Administer single IV bolus over 5-10 seconds Precautions: SBP > 180 mmHg, cerebrovascular disease, known/suspected stroke or TIA, recent GI or GUT bleeding, recent IM injection, elderly > 75 years, low body weight < 60 kg Adverse Reaction: Nausea, vomiting, hemorrhage, bleeding, epistaxis, GI & GU bleeding, superficial bleeding, reperfusion arrhythmia, hypotension, allergic reaction, fever Contraindications: Active internal bleeding, hypersensitivity to tenecteplase, history of cerebrovascular accident, intracranial or intraspinal surgery or trauma within 2 months, intracranial neoplasm, arteriovenous malformation, or aneurysm, known bleeding diathesis, severe uncontrolled hypertension, intracranial aneurysm Interactions: Drug that affected coagulation and alter platelet function ------------------------------------------------------------------------------------------------------73 Urokinase 6000 IU Injection A Trade Name : Urokinase Indication : Treatment of thromboembolic disease such as mycocardial infarction, peripheral artery occlusion, pulmonary embolism, retinal artery thrombosis and other ophthalmologic use Dosage : ADULT: Acute pulmonary embolism: IV loading dose 4400 iu/kg over 10 mins, maintenance 4400 iu/kg/hour for 12 hours. Peripheral vascular occlusion: infuse 2500 iu/ml into clot at a rate of 4000 iu/min for 2 hours. This may be repeated up to 4 times. Hyphaema: 5000 IU in 2 ml saline solution is injected and withdrawn repeatedly over the iris. If residual clot remains, leave 0.3ml in the anterior chambers for 24-48 hours to facilitate futher dissolution Precautions: Surgery within 10 days. Intra arterial diagnostic procedure within 10 days. Ulcerative wounds. Recent trauma with possibility of internal injuries. Pregnancy and the first 10 days of the postpartum period. Ulcerative colitis, diverticulitis or an active bleeding lesion of the gastrointestinal or genitourinary tract Adverse Reaction: Bleeding, hypotension, epistaxis, bronchospasm Contraindications: Hypersensitivity to urokinase products, cerebrovascular accident, internal bleeding, surgery or trauma within 10 days Interactions: Heparin, oral anticoagulants ---------------------------------------------------------------------------------------------------------------Factor VIII Inhibitor Bypassing Activity Injection A *[Drug taken from National Blood Bank – Not kept in hospital] Trade Name : Feiba Indication : Treatment and prophylaxis of hemorrhage in hemophilia A, B and non-hemophiliacs with acquired inhibitors to factor VIII, IX, XI Dosage : Individualized dosage Precautions: Hepatic disease ,newborn ,non-hemophilic patients ,thrombosis risk factors .Risk of disseminated intravascular coagulation, liver damage, CHD, acute thrombosis and or embolism. Pregnancy and lactation Adverse Reaction: Complication of infusion, headache, flushing, fever, chills, change in blood pressure or pulse rate ,myocardial infarction , hives ,disseminated intravascular coagulation, DIC, thromboembolic disorder , anaphylactoid reaction Contraindications: Bleeding episodes resulting from coagulation factor deficiencies , disseminated intravasular coagulation , fibrinolysis ,normal coagulation mechanism Interactions: Antifibrinolytics, tranexamic acid ---------------------------------------------------------------------------------------------------------------- 74 Factor IX Injection A *[Drug taken from National Blood Bank – Not kept in hospital] Trade Name : Alphanine,profilnine Indication : Prevention and control of bleeding in patients with factor IX deficiency due to haemophilia B Dosage : Dose varies according to the patient and the circumstances of the bleeding. i) Mild haemorrhage: initial dose of 30 units/kg body weight. ii) Moderate haemorrhage: initial dose of 50 units/kg iii) Major haemorrhage/surgery: Initial dose of 75 - 100 units/kg. Half of these doses may be repeated after 18-24 hrs if necessary. Precautions: Risk of thrombosis. Use with caution in patients with liver dysfunction Adverse Reaction: Allergic reactions, mild chills, nausea, fever,nausea, vomiting, headache, flushing, intravascular coagulation,thrombosis Contraindications: Hypersensitivity to Factor IX or any component of the formulation. Disseminated intravascular coagulation Interactions: Coadministeration with aminocaproic acid may increase risk for thrombosis ---------------------------------------------------------------------------------------------------------------Factor VIIa (Recombinant) eptacog alfa (activated) 60 KIU (1.2 mg) Injection A* Trade Name : Novoseven Indication : Treatment of bleeding episodes and prevention of excessive bleeding in connection with surgery in patients with inherited or acquired haemophilia with inhibitors to coagulation factors VIII or IX Dosage : Initially 4.5 KIU (90 mcg)/kg body weight IV bolus over 2-5 minutes, followed by 3-6 KIU (60-120 mcg)/kg body weight depending on type & severity of haemorrhage or surgery performed. Dosing interval: initially 2-3 hour to obtain haemostasis and until clinically improved. If continued therapy is needed, dose interval can be increased successively to every 4, 6, 8 or 12 hours Precautions: Advanced atherosclerotic disease: increased risk of thrombotic events. Concomitant use of activated or nonactivated prothrombin complex concentrates: increased risk of thrombotic events .Crush injury; disseminated intravascular coagulation (DIC),Septicemia: increased risk of thrombotic events .Elderly, non-hemophilia, intracerebral hemorrhage patients: increased risk of arterial thromboembolic adverse events, including myocardial ischemia, myocardial infarction, cerebral ischemia and or infarction. Adverse Reaction: Rash, itching, nausea, fever, headache, malaise, diaphoresis, changes in blood pressure,renal failure, cerebrovascular disorder, angina pectoris, atrial arrhythmia, circulatory shock, hemorrhage, hemarthrosis Contraindications: Hypersensitivity to Factor VII or any component of the formulation Interactions: Simultaneous use of prothrombin complex concentrates, activated or not should be avoided ---------------------------------------------------------------------------------------------------------------- 75 Factor VIII Injection A *[Drug taken from National Blood Bank – Not kept in hospital] Trade Name : Alphanate,Hemofil M Indication : Prevention and control of bleeding in patients with factor VIII deficiency due to classical haemophilia A Dosage : Dose varies according to the patient and the circumstances of the bleeding. i) Mild to moderate: Usually a single dose of 10-15units/kg. ii) More serious haemorrhage/minor surgery:Initially 15-25 units/kg followed by 10-15 units/kg every 8 - 12 hours if required iii) Severe haemorrhage/major surgery: Initial : 40 - 50 units/kg followed by 20 - 25 units/kg every 8-12 hrs. Precautions: Risk of thrombosis and transmission of infection, pregnancy. Intravascular haemolysis after large/frequently repeated doses in patients with blood groups A,B, or AB Adverse reaction: Allergic reactions (chills, urticaria, fever), headache, intravascular haemolysis, increased body temp, development of factor VIII antibodies Contraindications: Disseminated intravascular coagulation, underlying thrombosis Interactions: Not known ---------------------------------------------------------------------------------------------------------------Tranexamic Acid 100 mg/ml Injection B Trade Name : Transamin, Cyklokapron Indication : Haemorrhage associated with excessive fibrinolysis Dosage : ADULT: Slow IV 0.5-1 g (10 - 15 mg/kg) 3 times daily. Continuous infusion at a rate of 25 - 50 mg/kg daily. CHILD: slow IV 10 mg/kg/day 2-3 times daily Precautions: Cardiovascular disease, cerebrovascular disease, concomitant antifibrinolytic therapy. Concomitant therapy with oestrogens or thrombolytics. Renal impairment and transurethral prostatectomy (potential for intravesicular clotting) Adverse reaction: Nausea, vomiting, diarrhoea, hypotension, thrombosis, disturbances in colour vision Contraindications: Severe renal impairment, thromboembolic disease, intravascular clotting process, disturbance of colour vision, subarachnoid haemorrhage Interactions: Anti-inhibitor coagulant complex oral contraceptive, oestrogen, tretinoin ---------------------------------------------------------------------------------------------------------------Tranexamic Acid 250 mg Capsule B Trade Name : Transamin Indication : Haemorrhage associated with excessive fibrinolysis Dosage : ADULT: 1-1.5 g (15-25 mg/kg) 2-4 times daily. CHILD: 25 mg/kg/day 2-3 times daily. Menorrhagia (initiated when menstruation has started), 1 g 3 times daily for up to 4 days; maximum 4 g daily 76 Precautions: Cardiovascular disease, cerebrovascular disease, concomitant antifibrinolytic therapy. Concomitant therapy with oestrogens or thrombolytics. Renal impairment and transurethral prostatectomy (potential for intravesicular clotting) Adverse Reaction: Nausea, vomiting, diarrhoea, hypotension, thrombosis, disturbances in colour vision Contraindications: Severe renal impairment, thromboembolic disease, intravascular clotting process, disturbance of colour vision and subarachnoid haemorrhage Interaction: Anti-inhibitor coagulant complex, oral contraceptive, oestrogen, tretinoin -------------------------------------------------------------------------------------------------------------------------Atorvastatin 20 mg Tablet A* Trade Name : Lipitor Indication : Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy Dosage : 10 mg once daily. Maximum: 80 mg daily Precautions: Heavy alcohol use, history of liver disease. Discontinue therapy if serum transaminase levels rise to 3 times upper limit of normal and are persistent. This class of drug has been known to cause myopathy and renal failure due to rhabdomyolysis. Concomitant administration of fibrates, niacin, cyclosporin or erythromycin may increase the risk of myopathy Adverse Reaction: Gastrointestinal disturbances, headache, myalgia, asthenia, insomnia, angioneurotic oedema, muscle cramps, myostitis, myopathy, cholestatic jaundice, peripheral neuropathy, pruritus Contraindications: Liver disease, hypersensitivity to atorvastatin, pregnancy or lactation Interactions: Risk of myopathy increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, niacin or azole antifungals. Decreased atorvastatin plasma concentration with oral antacid suspensions containing magnesium and aluminium hydroxides and colestipol ---------------------------------------------------------------------------------------------------------------Ezetimibe 10 mg & Simvastatin 20 mg Tablet A* Trade Name : Vytorin Indication : Primary hypercholesterolemia Dosage : Usual starting dose: 10/20 mg/day Precautions: Unexplained muscle pain, tenderness or weakness, heavy alcohol use, past history of liver disease or current moderate to severe hepatic insufficiency, major surgery, renal insufficiency Adverse Reactions: Myalgia, headache, upper respiratory infection, hepatotoxicity, anaphylaxis, angioedema druginduced myopathy, rhabdomyolysis, abdominal pain, diarrhoea, fatigue, thrombocytopenia, hepatitis, hypersensitivity reactions including rash and angioedema, pancreatitis, nausea, anaemia, constipation, asthenia, jaundice, muscle cramps, dizziness, paresthesia, peripheral neuropathy, alopecia, pruritus 77 Contraindications: Hypersensitivity to ezetimibe or simvastatin or any of its components. Active liver disease or unexplained persistent elevations in serum transaminases, pregnancy, lactation Interactions: Itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, gemfibrozil, niacin, cyclosporine, danazol, amiodarone, verapamil, cholestyramine, diltiazem, fibrates, grapefruit juice, coumarin derivatives, antacids ---------------------------------------------------------------------------------------------------------------Ezetimibe 10 mg Tablet A* Trade Name : Ezetrol Indication : i) Co-administration with statins for patients who have chronic heart disease or are chronic heart disease equivalent or familial hypercholesterolaemia with target LDL-C not achieved by maximum dose of statins ii) Monotherapy in patients with documented biochemical intolerance to statins Dosage : 10 mg once daily. Not recommended for children less than 10 years old Precautions: Children under 10 years old, moderate to severe hepatic insufficency, myopathy, pregnancy and lactation Adverse Reaction: Abdominal pain, arthralgia, back pain, cough, diarrhoea, fatigue, headache, sinusitis Contraindications: Avoid co-administration with fibrates. Hypersensitivity to ezetimibe, active liver disease or persistently elevated liver enzymes Interactions: Cholestyramine, fibrates, cyclosporin ---------------------------------------------------------------------------------------------------------------Gemfibrozil 300 mg Capsule A/KK Trade Name : Lopid Indication : Treatment of hyperlipoprotinaemias (TYPES IIA, IIB, III, IV, V) Dosage : ADULT: 1200 mg/day in 2 divided doses, 30 minutes before breakfast and dinner. Dose range from 0.9-1.5 g daily Precautions: Cholelithiasis, concomitant use of anticoagulants and hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) risk of rhabdomyolysis. Diabetes, hypothyroidism, not recommended for patients with type IIa hyperlipidemia (low-density lipoproteins cholesterol elevations only) Adverse Reaction: Dizziness, chest pain, fatigue, rash, pruritis, dermatitis, urticaria, pain in extremities, abdominal and epigastric pain, diarrhoea, vomiting, flatulence, gout, headache, paraesthesia, blurred vision. Myalgia, rhabdomyolysis especially when coadministered with a statin Contraindications: Hypersensitivity to gemfibrozil, severe hepatic or renal dysfunction, gall stones, neonates, children, pregnancy, lactation 78 Interactions: Co-admin with repaglinide may lead to an increase in the serum levels of repaglinide. May enhance the effects of oral anticoagulants. May also increase the plasma concentrations of ciclosporin and associated nephrotoxicity when used concurrently ---------------------------------------------------------------------------------------------------------------Lovastatin 20 mg Tablet B Trade Name : Mevacor Indication : Hypercholesterolaemia and coronary heart disease Dosage : 20 mg once daily. Maximum: 80 mg daily Precautions: Heavy alcohol use, history of liver disease. Discontinue therapy if serum transaminase levels rise to 3 times upper limit of normal and are persistent. This class of drug has been known to cause myopathy and renal failure due to rhabdomyolysis. Concomitant administration of fibrates, niacin, ciclosporin or erythromycin may increase the risk of myopathy Adverse reactions: Gastrointestinal upsets, headache, skin rashes, fatigue, pruritis, dry mouth, sleep disorders. Rarely, hepatitis, hypersensitivity syndrome, erythema multiforme, toxic epidermal necrolysis Contraindications: Pregnancy, liver disease, hypersensitivity to lovastatin, lactation Interactions: Use with caution with coumarin anticoagulants and with immunosuppressive drugs, gemfibrozil or niacin (as a lipid lowering agent) or erythromycin. Itraconazole ---------------------------------------------------------------------------------------------------------------Pravastatin Sodium 20 mg Tablet A Trade Name : Pravachol Indication : Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy Dosage : 10 - 20 mg once daily. Maximum: 40 mg daily Precautions: Heavy alcohol use, history of liver disease. Discontinue therapy if serum transaminase levels rise to 3 times upper limit of normal and are persistent. May cause myopathy and renal failure due to rhabdomyolysis. Concomitant administration of fibrates, nicotinic acid, immunosuppressives including cyclosporin, macrolide antibiotics (erythromycin, clarithromycin), itraconazole and ketoconazole, may increase the risk of myopathy Adverse Reaction: Rash, myalgia, headache, non-cardiac chest pain, nausea, vomiting, diarrhoea, fatigue Contraindications: Hypersensitivity to pravastatin, liver disease, pregnancy or lactation Interactions: Cholestyramine, ciprofibrate, colestipol, cyclosporin, erythromycin, fenofibrate, gemfibrozil, niacin ---------------------------------------------------------------------------------------------------------------- 79 Rosuvastatin 10 mg Tablet A* Rosuvastatin 20 mg Tablet A* Trade Name : Crestor Indication : Dyslipidaemia not responsive to atorvastatin 40 mg or equivalent doses of other statins Dosage : Initially 5-10 mg once daily increased if necessary at intervals of at least 4 weeks to 20 mg once daily, increased after further 4 weeks to 40 mg daily ONLY in severe hypercholesterolemia with high cardiovascular risk. Patient of Asian origin, patients on concomitant ciclosporin/fibrate and patients with risk factors for myopathy/rhabdomyolysis (including personal/family history of muscular disorders/toxicity), the maximum dose should be 20 mg daily Precautions: Monitor renal and liver function. Predisposing factors for myopathy such as renal impairment, advanced age, hypothyroidism. Acute serious conditions suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. Concurrent use of fibrates may cause severe myositis and myoglobinuria, concurrent use of other lipid-lowering therapies/ciclosporin may increase the risk of myopathy Adverse Reactions: Pharyngitis, headache, diarrhoea, dyspepsia, nausea, myalgia, asthenia, back pain, flu syndrome, urinary tract infection, rhinitis, sinusitis, altered liver function tests, paraesthesia, abdominal pain, flatulence, constipation and vomiting Contraindications: Active liver disease including elevated serum transaminases more than 3 times upper limit of normal. Severe renal impairment (creatinine clearance less than 30 mL/min). Patients with myopathy. Patients receiving concomitant ciclosporin. Pregnancy and lactation Interactions: Warfarin, vitamin K antagonists, ciclosporin, gemfibrozil, lopinavir/ritonavir, antacids (aluminium and magnesium hydroxide), erythromycin, ketoconazole, spirinolactone, cimetidine, oral contraceptives, digoxin, fenofibrate ---------------------------------------------------------------------------------------------------------------Simvastatin 20 mg Tablet A/KK Simvastatin 40 mg Tablet A/KK Trade Name : Zocor Indication : Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy Dosage : 10 - 20 mg once daily. Maximum: 80 mg daily Precautions: Heavy alcohol use, history of liver disease. Discontinue therapy if serum transaminase levels rise to 3 times upper limit of normal and are persistent. May cause myopathy and renal failure due to rhabdomyolysis. Concomitant administration of fibrates, nicotinic acid, immunosuppressives including ciclosporin, macrolide antibiotics (erythromycin, clarithromycin), itraconazole and ketoconazole or nefazodone may increase the risk of myopathy Adverse Reaction: Abdominal pain, flatulence, constipation, asthenia and headache, rarely hepatitis, hypersensitivity syndrome, upper respiratory infection Contraindications: Hypersensitivity to simvastatin products, active liver disease, pregnancy and lactation 80 Interactions: May cause slight elevation of serum digoxin. Cholestyramine and colestipol increase bioavailability of simvastatin. Increased concentrations with mibefradil ---------------------------------------------------------------------------------------------------------------Alprostadil 500 mcg/ml Injection Trade Name : Prostin VR Indication : For treatment of congenital heart diseases which are ductus arteriosus dependent Dosage : 0.05 - 0.1 mcg/kg/min by continuous IV infusion, then decreased to lowest effective dose Precautions: Concurrent anticoagulants, neonates with bleeding tendencies, spinal cord injury Adverse Reactions: Bradycardia, fever, hypotension, tachycardia, neonatal apnoea, seizures Contraindications: Neonates with respiratory distress syndrome Interactions: Heparin A* ---------------------------------------------------------------------------------------------------------------Trimetazidine 20 mg Tablet B Trade Name : Vastarel Indication : Prophylactic treatment of episodes of angina pectoris Dosage : 20mg 3 times daily Precautions: Pregnancy especially first trimester, unstable angina, hypertension, renal or hepatic insufficiency Adverse reaction: Gastrointestinal disorders such as nausea and vomiting Contraindications: Concomitant administration with MAOIs Interactions: Not known ---------------------------------------------------------------------------------------------------------------Trimetazidine 35 mg MR Tablet B Trade Name : Vastarel MR Indication : Prophylactic treatment of episodes of angina pectoris Dosage : 35 mg twice daily in the morning and evening with meals Precautions: Pregnancy especially first trimester, unstable angina, hypertension, renal or hepatic insufficiency Adverse reaction: Gastrointestinal disorders such as nausea and vomiting Contraindications: Concomitant administration with MAOIs Interactions: Not known ---------------------------------------------------------------------------------------------------------------81 4. RESPIRATORY Bronchodilators Corticosteroids Cromoglycate, related therapy and leukotriene receptor antagonists Respiratory stimulants and pulmonary surfactants Miscellaneous respiratory 82 Aminophylline 25 mg/ml Injection B Indication : Reversible airways obstruction, acute severe asthma Dosage : Deteriorating acute asthma not previously treated with theophylline, by slow IV injection over 20 minutes 250 - 500 mg (5 mg/kg), then as for acute severe asthma. Acute severe asthma by IV infusion : 500 mcg/kg/hour, adjusted according to plasma-theophylline concentration. CHILD : 6 month - 9 years : 1 mg/kg/hour, 10 - 16 years : 800 mcg/kg/hour Precautions : Hyperthyroidism, glaucoma, diabetes mellitus, angina pectoris, pulmonary, cardiovascular, renal or hepatic diseases. Pregnancy, children and elderly. Active peptic ulcer disease, seizure disorders, cardiac arrhythmias (not including bradyarrhythmias). Patients with migraine headaches may experience an increased frequency of headaches. Patients with congestive heart failure, cor pulmonale, prolonged fever, hypothyroidism, liver disease, sepsis with multi-organ failure, and shock may require reduced theophylline dosage. Concommitant medication use which results in reduced theophylline clearance Adverse Reactions : Tachycardia, palpitations, nausea and other gastrointestinal disturbances, headache, CNS stimulation, insomnia, arrythmias, also allergy to ethylenediamine which can cause urticaria, erythema, and exfoliative dermatitis Contraindication : Hypersensitivity to theophylline or derivatives, hypersensitivity to ethylenediamine Interactions : Azole antifungals, ciprofloxacin, clarithromycin, erythromycin : increased risk of theophylline toxicity. Caffeine : increased caffeine level. Halothane : increased risk of arrthmia -------------------------------------------------------------------------------------------------------------------------Ipratropium Bromide 0.0125% Inhalation Solution (125 mcg/ml) B Ipratropium Bromide 0.025% Inhalation Solution (250 mcg/ml) B Trade Name : Atrovent Indication : Only for treatment of : i) Patients with ischaemic heart disease who develop extrasystole with salbutamol or terbutaline ii) Patients with chronic bronchitis who have airway obstruction and who do not respond to salbutamol or terbutaline. Reversible airways obstruction, particularly in chronic obstructive pulmonary disease Dosage : ADULT : 500 mcg up to 4 times daily. CHILD 5 - 12 years : 125 - 250 mcg up to 4 times daily, 12 years : 250 - 500 mcg up to 4 times daily Precautions : Narrow-angle glaucoma, prostatic hypertrophy, cystic fibrosis, bladder-neck obstruction Adverse Reactions : Headache, nausea, dry mouth, rare and reversible anticholinergic side effects, ocular side effects if substances enters eyes, cough Contraindication : Hypersensitivity to ipratropium products, atropine, soya lecithin or related food products Interactions : Bronchodilatory effect intensified by beta-adrenergic and xanthine preparation. Anticholinergic effects of other drugs may be enhanced. Cisapride - loss of cisapride efficacy ---------------------------------------------------------------------------------------------------------------83 Ipratropium Bromide 0.5 mg and Salbutamol 2.5 mg per UDV B Trade Name : Combivent Indication : Management of reversible bronchospasm associated with obstructive airway diseases Dosage : Acute attacks : 1 unit dose vial. In severe cases not relieved by 1 unit dose vial, 2 unit dose vials may require, patient should consult a doctor immediately. Maintenance : 1 unit dose vial 3 - 4 times daily Precautions : Patients predisposed to glaucoma, insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism, phaechromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction, hypoxia, cystic fibrosis, pregnancy and lactation, uriticaria, angioedema, rash, broncospasm, oropharyngeal oedema Adverse Reactions : Headache, dizziness, nervousness, tachycardia, fine tremor, palpitations. Potentially serious hypokalaemia may result from beta2-agonist therapy, dryness of mouth, dysphonia, ocular complications, allergic type reactions Contraindication : Hypersensitivity to atropine or its derivatives or to any other component. Hypertrophic obstructive cardiomyopathy or tachyarrythmia Interactions : Xanthine derivatives, other anticholinergics, beta2-agonists, beta-blockers, tricyclic anti depressants, MAOIs, glucocorticoids - increased risk of tachycardia, agitation, hypomania, hypokalaemia ---------------------------------------------------------------------------------------------------------------Ipratropium Bromide 20 mcg and Salbutamol base 100 mcg/dose Inhalation B Trade Name : Combivent Indication : Management of reversible bronchospasm associated with obstructive airway diseases Dosage : ADULT and ELDERLY : 2 inhalations 4 times daily. Maximum : 12 inhalations daily. CHILD under 12 years not recommended Precautions : Patients predisposed to glaucoma, insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism, phaechromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction, hypoxia, cystic fibrosis, pregnancy and lactation, urticaria, angioedema, rash, broncospasm, oropharyngeal oedema Adverse Reactions : Headache, dizziness, nervousness, tachycardia, fine tremor, palpitations. Potentially serious hypokalaemia may result from beta2-agonist therapy, dryness of mouth, dysphonia, ocular complications, allergic type reactions Contraindication : Hypersensitivity to atropine or its derivatives or to any other component. Hypertrophic obstructive cardiomyopathy or tachyarrythmia Interactions : Xanthine derivatives, other anticholinergics, beta2-agonists, beta-blockers, tricyclic anti depressants, MAOIs, glucocorticoids : increased risk of tachycardia, agitation, hypomania, hypokalaemia -------------------------------------------------------------------------------------------------------------------------- 84 Ipratropium Bromide 20 mcg/dose Inhalation Trade Name : Atrovent Indication : Only for treatment of : i) Patients with chronic bronchitis who have airway obstruction and who do not respond to Salbutamol or Terbutaline ii) Patients with ischaemic heart disease who develop extrasystole with Salbutamol or Terbutaline Dosage : 20 - 40 mcg 3 - 4 times daily. In the early treatment, up to 80 mcg 3 - 4 times daily. CHILD up to 6 years : 20 mcg 3 times daily, 6 - 12 years : 20 - 40 mcg 3 times daily B Precautions : Narrow - angle glaucoma, prostatic hypertrophy, cystic fibrosis Adverse Reactions : Headache, nausea, dry mouth, rare and reversible anticholinergic side effects, ocular side effects if substances enters eyes, cough Contraindication : Hypersensitivity to atropine and its derivatives Interactions : Bronchodilatory effect intensified by beta-adrenergic and xanthine preparation. Anticholinergic effects of other drugs may be enhanced. Cisapride - loss of cisapride efficacy ---------------------------------------------------------------------------------------------------------------Salbutamol 0.5 % Inhalation Solution Trade Name : Ventolin Indication : Asthma and other conditions associated with reversible airways obstruction Dosage : 2 ml may be inhaled up to 4 times daily over a period of 3 minutes per inhalation (0.5 ml diluted in 2.5 ml of normal saline by inhalation over 5 to 15 minutes) B Precautions : Thyrotoxicosis, hyperthyroidism, cardiovascular disease, arrhythmias, susceptiility to QT-interval prolongation, hypokalaemia, diabetes mellitus, not appropriate for managing premature labour, pregnancy and lactation Adverse Reactions : Slight tremor (particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children, muscle cramps, hypersensitivity reactions including paradoxical bronchospasm, urticaria, angioedema, hypotension, pulmonary oedema, erythema multiforme Contraindication : Hypersensitivity to any of their components Interactions : Antagonism with beta-blockers. Use with caution with additional adrenergic drugs, MAOI inhibitors or tricyclic antidepressants - increased risk of tachycardia, agitation or hypomania ---------------------------------------------------------------------------------------------------------------Salbutamol 0.5 mg/ml Injection Trade Name : Ventolin Indication : Asthma and other conditions associated with reversible airways obstruction 85 A Dosage : 500 mcg by SC/IM injection 4 hourly or 250 mcg by slow IV. If required, by IV infusion, initially 5 mcg/min adjusted according to response and heart rate, usually in the range 3 - 20 mcg/min Precautions : Thyrotoxicosis, pregnancy and lactation. Potential for paradoxical bronchospasm, patients with cardiovascular disorders, hyperthyroidism, diabetes mellitus, phaeochromocytoma, patients with history of aneursym and patients who are usually responsive to sympathomimetics amines. Labour and delivery may be complicated Adverse Reactions : Haemorrhage, thrombocytopenia, tachycardia and palpitations, erythema, ventricular ectopic beats, myocardial ischaemia and infarction have been reported following IV administration. Fine tremor (particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children. Muscle cramps and hypersensitivity reactions including paradoxical bronchospasm, urticaria, and angioedema Contraindication : Hypersensitivity, hyperthyroidism or thyrotoxicosis, tachycardia or tachycardiac arrthymias, subvalvular aortic stenosis Interactions : Monoamine oxidase inhibitors - increased risk of tachycardia, agitation or hypomania ---------------------------------------------------------------------------------------------------------------Salbutamol 100 mcg/dose Inhalation Trade Name : Ventolin Indication : Asthma and other conditions associated with reversible airways obstruction Dosage : ADULT : 100 - 200 mcg up to 3 - 4 times daily. CHILD : 100 mcg increased to 200 mcg if necessary B Precautions : Thyrotoxicosis, pregnancy and lactation, hyperthyroidism, cardiovascular disease, arrhythmias, susceptiility to QT-interval prolongation, hypokalaemia, diabetes mellitus, not appropriate for managing premature labour, pregnancy and lactation Adverse Reactions : Slight tremor (particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children, muscle cramps, hypersensitivity reactions including paradoxical bronchospasm, urticaria, angioedema, hypotension, pulmonary oedema, erythema multiforme Contraindication : Hypersensitivity to any of their components Interactions : Antagonism with beta-blockers. Use with caution with additional adrenergic drugs, MAOI inhibitors or tricyclic antidepressants - increased risk of tachycardia, agitation or hypomania ---------------------------------------------------------------------------------------------------------------Salbutamol 2 mg Tablet Trade Name : Ventolin Indication : Asthma and other conditions associated with reversible airways obstruction 86 B Dosage : CHILD 2 - 6 years : 1 - 2 mg 3 - 4 times daily, 6 - 12 years : 2 mg 3 - 4 times daily. CHILD over 12 years and ADULT : 2 - 4 mg 3 - 4 times daily Precautions : Thyrotoxicosis Adverse Reactions : Fine tremor (particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children Contraindication : Hypersensitivity to any of their components. Premature labour e.g. placenta praevia, associated with toxaemia of pregnancy or antepartum haemorrhage from whatever cause Interactions : Monoamine oxidase inhibitors - increased risk of tachycardia, agitation or hypomania ---------------------------------------------------------------------------------------------------------------Salbutamol 200 mcg Inhalation Powder B Trade Name : Buventhol Indication : Asthma and other conditions associated with reversible airways obstruction Dosage : CHILD : 100 - 200 mcg. Maintenance : 100 - 200 mcg 2 - 4 times daily. ADULT : 100 - 400 mcg. Maitenance : 100 - 400 mcg 2 - 4 times daily Precautions : Thyrotoxicosis, pregnancy and lactation, hyperthyroidism, cardiovascular disease, arrhythmias, susceptiility to QT-interval prolongation, hypokalaemia, diabetes mellitus, not appropriate for managing premature labour, pregnancy and lactation Adverse Reactions : Slight tremor (particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias, disturbances of sleep and behaviour in children, muscle cramps, hypersensitivity reactions including paradoxical bronchospasm, urticaria, angioedema, hypotension, pulmonary oedema, erythema multiforme Contraindication : Hypersensitivity to any of their components Interactions : Antagonism with beta-blockers. Use with caution with additional adrenergic drugs, MAOI inhibitors or tricyclic antidepressants - increased risk of tachycardia, agitation or hypomania ---------------------------------------------------------------------------------------------------------------Terbutaline Sulphate 0.3 mg/ml Syrup Trade Name : Bricanyl Indication : Asthma and other conditions associated with reversible airways obstruction Dosage : CHILD less than 7 years : 75 mcg/kg 3 times daily, 7 - 15 years : 2.5 mg 2 - 3 times daily B Precautions : Hypertension, cardiovascular disease, unstable diabetes, hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathy, hypokalaemia, convulsive disorders and hyperthyroidism 87 Adverse Reactions : Palpitations, tachycardia, increases in ejection fraction, increases in cardiac output have been reported following subcutaneous terbutaline, tremor and tonic cramp Contraindication : Hypersensitivity to terbutaline and other sympathomimetic amines Interactions : Beta-blockers - inhibit bronchodilating effect. Monoamine oxidase inhibitors - increased risk of tachycardia, agitation, or hypomania. Theophylline - decreased theophylline concentrations -------------------------------------------------------------------------------------------------------------------------------------Terbutaline Sulphate 0.5 mg/ml Injection Trade Name : Bricanyl Indication : B Bronchial asthma, chronic bronchitis, emphysema and other lung diseases where broncoconstriction is a complicating factor Dosage : SC, IM or slow IV : 250-500 mcg up to 4 times daily. CHILD 2 - 15 years 10mcg/kg to a maximum of 300 mcg. Continuous IV infusion, as a solution containing 3 - 5 mcg/ml, 1.5 - 5 mcg/minute for 8 - 10 hours; reduce dose for children Precautions : Hypertension, cardiovascular disease, unstable diabetes, hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathy, hypokalaemia, convulsive disorders and hyperthyroidism Adverse Reactions : Tremor, tonic cramp and palpitations (reversible within first 1 - 2 week of treatment) Contraindication : Thyrotoxicosis Interactions : Beta-blockers - inhibit bronchodilating effect. Monoamine oxidase inhibitors - increased risk of tachycardia, agitation or hypomania. Theophylline - decreased theophylline concentrations ---------------------------------------------------------------------------------------------------------------Terbutaline Sulphate 10 mg/ml Inhalation Solution B Trade Name : Bricanyl Indication : Asthma and other conditions associated with reversible airways obstruction Dosage : ADULT : 5 - 10 mg 2 -4 times daily, additional doses may be necessary in severe acute asthma. CHILD up to 3 years : 2 mg, 3 - 6 years : 3 mg, 6 - 8 years : 4 mg, over 8 years : 5 mg 2 - 4 times daily Precautions : Hypertension, cardiovascular disease, unstable diabetes, hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathy, hypokalaemia Adverse Reactions : Tremor, tonic cramp, and palpitations (reversible within first 1 - 2 week of treatment) Contraindication : Hypersensitivity to terbutaline and other sympathomimetic amines Interactions : Beta-blockers : inhibit bronchodilating effect. Monoamine oxidase inhibitors : increased risk of tachycardia, agitation, or hypomania. Theophylline : decreased theophylline concentrations. ---------------------------------------------------------------------------------------------------------------88 Terbutaline Sulphate 2.5 mg Tablet B Trade Name : Bricanyl Indication : Asthma and other conditions associated with reversible airways obstruction Dosage : ADULT: Initially 2.5 mg 3 times daily for 1 - 2 week, then up to 5 mg 3 times daily. CHILD less than 7 years: 75 mcg/kg 3 times daily, 7 - 15 years: 2.5 mg 2 - 3 times daily Precautions : Hypertension, cardiovascular disease, unstable diabetes, hypersensitivity to sympathomimetic amines, hypertrophic cardiomyopathy, hypokalaemia, convulsive disorders and hyperthyroidism Adverse Reactions : Palpitations, tachycardia, increases in ejection fraction, increases in cardiac output have been reported following subcutaneous terbutaline, tremor and tonic cramp Contraindication : Hypersensitivity to terbutaline and other sympathomimetic amines Interactions : Beta-blockers - inhibit bronchodilating effect. Monoamine oxidase inhibitors - increased risk of tachycardia, agitation or hypomania. Theophylline - decreased theophylline concentrations ---------------------------------------------------------------------------------------------------------------Theophylline 125 mg Tablet B Trade Name : Nuelin Indication : Reversible airways obstruction, acute severe asthma Dosage : ADULT: 125 mg 3 - 4 times daily after food, increased to 250 mg if required. CHILD: 1 - 15 years : 5 mg/kg/dose (up to 600 mg/ day) every 3 - 4 times daily Precautions : Active peptic ulcer disease, seizure disorders, cardiac arrhythmias (not including bradyarrhythmias). Patients with migraine headaches may experience an increased frequency of headaches. Patients with congestive heart failure, cor pulmonale, prolonged fever, hypothyroidism, liver disease, sepsis with multi-organ failure and shock may require reduced theophylline dosage. Concomittant medication use which results in reduced theophylline clearance Adverse Reactions : Tachycardia, palpitations, nausea and other gastrointestinal disturbances, headache, central nervous system stimulation, insomnia, arrythmias Contraindication : Hypersensitivity to theophylline Interactions : Azole antifungals, ciprofloxacin, clarithromycin, erythromycin: increased risk of theophylline toxicity. Caffeine: increased caffeine level. Halothane: increased risk of arrythmia ---------------------------------------------------------------------------------------------------------------Theophylline 250 mg Long Acting Tablet Trade Name : Nuelin SR Indication : Reversible airways obstruction and acute severe asthma Dosage : ADULT: 250 mg 2 times daily. CHILD under 12 years : Up to 10 mg/kg body weight 2 times daily 89 B Precautions : Active peptic ulcer disease, seizure disorders, cardiac arrhythmias (not including bradyarrhythmias). Patients with migraine headaches may experience an increased frequency of headaches. Patients with congestive heart failure, cor pulmonale, prolonged fever, hypothyroidism, liver disease, sepsis with multi-organ failure and shock may require reduced theophylline dosage. Concomitant medication use which results in reduced theophylline clearance Adverse Reactions : Tachycardia, palpitations, nausea and other gastrointestinal disturbances, headache, central nervous system stimulation, insomnia, arrythmias Contraindication : Hypersensitivity to theophylline Interactions : Azole antifungals, ciprofloxacin, clarithromycin, erythromycin: increased risk of theophylline toxicity. Caffeine: increased caffeine level. Halothane: increased risk of arrythmia ---------------------------------------------------------------------------------------------------------------Tiotropium Bromide Inhalation 18 mcg Capsules A* Trade Name : Spiriva Indication : Long term maintenance treatment of bronchospasm and dypsnoea associated with COPD. Tiotropium has usually been added to standard therapy (e.g. inhaled steroids, theophylline, albuterol rescue) Dosage : Inhale the contents of one capsule once daily with the handihaler device at the same time of day. Child and adolescent under 18 years, not recommended Precautions : Myasthenia gravis, narrow angle glaucoma, prostatic hyperplasia, renal impairment, pregnancy, bladder neck obstruction, moderate to severe renal failure Adverse Reactions : Xerostomia, upper respiratory tract infection, sinusitis, rash, cataract, angioedema, tachycardia, urinary retention, angina pectoris, hypercholesterolemia, hyperglycemia Contraindication : Hypersensitivity to tiotropium and its derivatives or any component of the formulation (contains lactose). Not for use as an acute ("Rescue") bronchodilator Interactions : Beta-agonists and other anticholinergics ---------------------------------------------------------------------------------------------------------------Beclomethasone Dipropionate 100 mcg/dose Inhalation B Trade Name : Becotide Indication : Prophylaxis of asthma especially if not fully controlled by bronchodilators Dosage : ADULT : 100 mcg 3 - 4 times daily or 200 mcg twice daily. CHILD more than 6 years : 50 - 100 mcg 2 4 times daily Precautions : Pulmonary tuberculosis, pregnancy. Adrenal insufficiency (when replacing systemic corticosteroid therapy), exposure to viral infection (chickenpox, measles), ocular herpes simplex, tuberculosis (active or quiescent), untreated fungal, bacterial, or systemic viral infections 90 Adverse Reactions : Candidiasis of the mouth and throat, hoarseness or throat irritation, headache, secondary hypocortisolism, osteoporosis, cataract, glaucoma, paradoxical bronchospasm (discontinue immediately). Patients are advised to gargle after using the medication Contraindication : Hypersensitivity to beclomethasone dipropionate, acute asthma exacerbations, status asthmaticus. Special care is necessary in patients with active or quiescent pulmonary tuberculosis Interactions : Not known ---------------------------------------------------------------------------------------------------------------Budesonide 1 mg/2 ml Nebulising Solution Budesonide 500 mcg/2 ml Nebulising Solution Trade Name : Pulmicort Indication : Maintenance treatment of asthma as prophylactic therapy especially if not fully controlled by bronchodilators Dosage : ADULT : Initially 1 - 2 mg twice daily. CHILD 3 months - 12 years of age : 500 mcg - 1 mg. Maintenance dose : half of the above doses B B Precautions : Acute exacerbations, accompanied by increased mucous viscosity and mucous plugging. Caution in viral infections such as varicella, in untreated fungal and bacterial infections of the respiratory system. Pregnancy and lactation Adverse Reactions : Mild irritation of the throat, coughing, and generally reversible hoarseness of the voice. Bad taste, dryness of the throat. Candidiasis of the mouth and throat, paradoxical bronchoconstriction, headache, nausea, tiredness, thirst, diarrhoea, skin reaction Contraindication : Hypersensitivity to budesonide. Moderate to severe bronchiectasis Interactions : Oral or parenteral corticosteroids - effects enhanced by the concomitant use. Amiodarone increased risk of developing Cushing's syndrome. Ketoconazole, erytromycin, ritonavir - increased budesonide plasma concentrations ---------------------------------------------------------------------------------------------------------------Budesonide 200 mcg/dose Inhalation B Trade Name : Pulmicort Indication : Maintenance treatment of asthma as prophylactic therapy especially if not fully controlled by bronchodilators Dosage : ADULT : 200 - 1600 mcg daily in 2 - 4 divided doses. Maintenance with twice daily dosing. CHILD more than 7 years 200 - 800 mcg, 2 - 7 years 200 - 400 mcg. To be taken orally in 2 - 4 divided doses Precautions : Acute exacerbations, accompanied by increased mucous viscosity and mucous plugging. Caution in viral infections such as varicella, in untreated fungal and bacterial infections of the respiratory system. Pregnancy and lactation 91 Adverse Reactions : Mild irritation of the throat, coughing, and generally reversible hoarseness of the voice. Bad taste, dryness of the throat. Candidiasis of the mouth and throat, paradoxical bronchoconstriction, headache, nausea, tiredness, thirst, diarrhoea, skin reaction Contraindication : Hypersensitivity to budesonide. Moderate to severe bronchiectasis Interactions : Oral or parenteral corticosteroids - effects enhanced by the concomitant use. Amiodarone increased risk of developing Cushing's syndrome. Ketoconazole, erytromycin, ritonavir - increased budesonide plasma concentrations ---------------------------------------------------------------------------------------------------------------Montelukast Sodium 10 mg Tablet A* Trade Name : Singulair Indication : Chronic treatment of asthma and relief of symptoms of seasonal allergic rhinitis for children more than 15 years and adults Dosage : CHILD more than 15 years and ADULT: 10 mg daily at bedtime Precautions : Should not be used for treatment of acute asthma attacks. Should not be abruptly substituted for inhaled or oral corticosteroids. Pregnancy and lactation. Patients with known aspirin sensitivity should continue avoidance of aspirin or NSAIDs while taking montelukast. Paediatric less than 6 month Adverse Reactions : Abdominal pain, headache ,thirst, diarrhea, hyperkinesia, flu-like symptoms, eczematous dermatitis and rash Contraindication : Hypersensitivity to any component of montelukast Interactions : Phenobarbitone ---------------------------------------------------------------------------------------------------------------Montelukast Sodium 4 mg Oral Granules A* Trade Name : Singulair Indication : Asthmatics, not controlled on high dose inhaled corticosteroids more than 1600 mcg/day and with co-morbid allergic disorders. Chronic treatment of asthma Dosage : 12 months - 5 years: 1 packet of 4mg oral granules daily at bedtime Precautions : Should not be used for treatment of acute asthma attacks. Should not be abruptly substituted for inhaled or oral corticosteroids. Pregnancy and lactation. Patients with known aspirin sensitivity should continue avoidance of aspirin or NSAIDs while taking montelukast. Paediatric less than 6 month Adverse Reactions : Abdominal pain, headache ,thirst, diarrhea, hyperkinesia, flu-like symptoms, eczematous dermatitis and rash 92 Contraindication : Hypersensitivity to any component of montelukast Interactions : Phenobarbitone ---------------------------------------------------------------------------------------------------------------Montelukast Sodium 5 mg Chewable Tablet A* Trade Name : Singulair Indication : Asthmatics, not controlled on high dose inhaled corticosteroids more than 1600 mcg/day and with co-morbid allergic disorders. Chronic treatment of asthma Dosage : CHILD 6 - 14 years: One 5 mg chewable tablet daily at bedtime Precautions : Should not be used for treatment of acute asthma attacks. Should not be abruptly substituted for inhaled or oral corticosteroids. Pregnancy and lactation. Patients with known aspirin sensitivity should continue avoidance of aspirin or NSAIDs while taking montelukast. Paediatric less than 6 month Adverse Reactions : Abdominal pain, headache ,thirst, diarrhea, hyperkinesia, flu-like symptoms, eczematous dermatitis and rash Contraindication : Hypersensitivity to any component of montelukast Interactions : Phenobarbitone ---------------------------------------------------------------------------------------------------------------Beractant Intratracheal Suspension (200 mg phospholipids in 8 ml vial) A* Trade Name : Survanta Indication : Treatment of newborn baby with birth weight of 700 g or greater undergoing mechanical ventilation for respiratory distress syndrome, whose heart rate and arterial oxygenation are continuously monitored Dosage : 100 mg/kg (4 ml/kg) body weight via endotracheal tube every 6 hours (1 - 4 doses) Precautions : Continuous monitoring with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide Adverse Reactions : Transient bradycardia, hypoxia, endotracheal tube reflux Contraindication : Not known Interactions : Not known ---------------------------------------------------------------------------------------------------------------- 93 Budesonide 160 mcg and Formoterol 4.5 mcg Inhalation A Trade Name : Symbicort Indication : Mild, moderate and severe persistent asthma Dosage : ADULT : 1 - 2 puff twice daily, maximum : 4 puff twice daily. ADOLESCENT (12 - 17 years) : 1 - 2 puff twice daily. CHILD less than 6 years are not recommended Precautions : Not for acute attack. Taper dose when discontinuing treatment. Thyrotoxicosis, diabetes mellitus, heart disease, hypokalaemia, severe cardiovascular disorders, hypertropic obstructive cardiomyopathy, tuberculosis, phaeocromocytoma Adverse Reactions : Headache, insomnia, tremor, restlessness, oral candidiasis, cough, hoarseness Contraindication : Hypersensitivity to budesonide or formoterol or inhaled lactose Interactions : Itraconazole, ketoconazole, MAOI, tricyclic antidepressan, ritonavir, phenothiazines ---------------------------------------------------------------------------------------------------------------Salmeterol 25 mcg and Fluticasone Propionate 125 mcg Inhalation A* Salmeterol 50 mcg and Fluticasone Propionate 250 mcg Inhalation A/KK Trade Name : Seretide Indication : Regular treatment of reversible obstructive airways diseases including asthma Dosage : ADULT and CHILD more than 12 years : 1 - 2 puff twice daily. CHILD over 4 years : 1 puff twice daily Precautions : Not for acute unstable or acutely deteriorating asthma. Active or quiescent pulmonary tuberculosis, thyrotoxicosis. When transferring from systemic to inhaled steroid therapy, monitor adrenocortical function regularly and withdraw systemic corticosteroid therapy gradually. Pregnancy and lactation Adverse Reactions : Hoarseness and dystonia, throat irritation, headache, oropharyngeal candidiasis and palpitations, tremor, cardiac arrhythmias (atrial fibrillation and supraventricular tachycardia) Contraindication : Hypersensitivity to any of the ingredients of salmeterol, fluticasone or any component of the product Interactions : Beta-blockers, strong CYP3A4 inhibitors e.g. ketoconazole, ritonavir ---------------------------------------------------------------------------------------------------------------- 94 5. ANALGESICS Non-opioid analgesics Opioid analgesics Non-steroidal anti-inflammatory drugs (NSAIDs) Neuropathic pain 95 Acetylsalicylic Acid 300 mg Soluble Tablet C Trade Name : Aspirin Soluble Indication : Mild to moderate pain Dosage : 300 - 900 mg every 4 - 6 hours as required. Max 4 g daily. Use in children not recommended Precautions : Renal disorders, G6PD deficiency, pregnancy, patients with flu, chicken pox or haemorrhagic fever. History of peptic ulcer or those prone to dyspepsia and those with gastric mucosal lesion; asthma or allergic disorders; dehydrated patients; uncontrolled hypertension; impaired renal or hepatic function; elderly Adverse Reactions : Gastric haemorrhage, hypersensitivity, thrombocytopenia,GI disturbances; prolonged bleeding time, rhinitis, urticaria and epigastric discomfort; angioedema, salicylism, tinnitus; bronchospasm Contraindications : Gastric and duodenal ulcers, haemorrhagic diathesis, hypersensitivity to aspirin or other NSAIDs, children under 12 years old.Hypersensitivity (attacks of asthma, angioedema, urticaria or rhinitis); pregnancy (third trimester); patients with haemophilia or haemorrhagic disorders; gout; severe renal or hepatic impairment; lactation Interactions : Acetazolamide, Dipyridamol : salicylate toxicity (vomiting, tachycardia, hyperpnea, mental confusion) or acetazolamide toxicity (fatigue, lethargy, somnolence, confusion, hyperchloremic metabolic acidosis). Alendronate : GI distress. Antacids, calcium. Alcohol, corticosteroids, phenylbutazone and oxyphenbutazone may increase risk of GI ulceration. Aspirin increases phenytoin levels. May antagonize actions of uricosurics and spironolactone -------------------------------------------------------------------------------------------------------------------------Ketorolac Tromethamine 30 mg/ml Injection A* Trade Name : Toradol Indication : Short term management of moderate to severe postoperative pain Dosage : ADULT : By IM/IV injection.(over not less than 15 seconds.) Initially 15 mg 4 - 6 hourly. MAXIMUM: 90 mg daily Precautions : Active hepatitis and cholestasis, conditions predisposing to GI toxicity, conditions predisposing to or exacerbated by fluid retention, cardiac or hepatic impairment, elderly. History of GIT disease, Coagulation disorders Adverse Reactions : Bronchospasm, dyspnoea, gastrointestinal disturbances and ulceration, dizziness, drowsiness, dry mouth, hallucinations, headache, insomnia, myalgia, sweating, tinnitus, vertigo, urinary tract and kidney disorders, bradycardia, flushing, hypertension, pallor, purpura, thrombocytopenia, asthma, dyspnoea, pulmonary oedema, skin reactions, hypersensitivity reactions, bleeding, asthenia, injection site pain, weight gain Contraindications : Hystory of peptic ulcer or coagulation disorders, hypersensitivity to ketorolac, NSAIDs, aspirin, oxpentifylline, probenecid, lithium or other prostaglandin synthesis inhibitors. Gastrointestinal bleeding, suspected or confirmed cerebrovascular (intracranial) bleeding, history of haemorrhagic diatheses, including coagulation disorders. Individuals with complete or partial syndrome of nasal polyps, angioedema or bronchospasm. Dehydration or hypovolaemia from any cause. Moderate or 96 severe renal impairment (serum creatinine more than 180 mmol/L). History of asthma. Patients who have had operations with a high risk of haemorrhage or incomplete haemostasis. Patients on anticoagulants including low dose heparin. Pregnancy, labour, delivery or lactation. Children less than 16 year Interactions : ACEIs : decreased antihypertensive and natriuretic effects. Aspirin, NSAIDs : enhanced gastrointestinal adverse effects (peptic ulcers, gastrointestinal bleeding and or perforation) and possible increase in serum ketorolac levels. Beta-adrenergic block ---------------------------------------------------------------------------------------------------------------Paracetamol 120 mg/5 ml Syrup C Trade Name : Panadol Indication : Mild to moderate pain and pyrexia Dosage : CHILD: up to 1 year: 60 - 120 mg. 1 - 5 years: 120 - 240 mg. 6 - 12 years: 240 - 480 mg per dose. Repeat every 4 - 6 hours when necessary. Maximum of 4 doses in 24 hours Precautions : Renal and hepatic failure. Avoid chronic use Adverse Reactions : Allergic reactions, skin rash Contraindications : Nephropathy Interactions : Anticoagulants, alcohol, liver enzyme inducers, aspirin, chloramphenicol and phenobarbitone ---------------------------------------------------------------------------------------------------------------Paracetamol 125 mg Suppository B Paracetamol 250 mg Suppository B Indication : Symptomatic relief of fever and post operative pain for paediatric cases Dosage : CHILD 1 - 5 years: 125 - 250 mg; 6 - 12 years: 250 - 500 mg; 3 - 11 months: 80 mg inserted every 4 - 6 hours if necessary, maximum 4 doses in 24 hours. INFANTS under 3 months should not be given Paracetamol unless advised by doctor; a dose of 10 mg/kg (5 mg/kg if jaundiced) is suitable Precautions : Renal and hepatic failure. Avoid chronic use Adverse Reactions : Allergic reactions, skin rash Contraindications : Nephropathy Interactions : Anticoagulants, alcohol, liver enzyme inducers, aspirin, chloramphenicol and phenobarbitone ---------------------------------------------------------------------------------------------------------------Paracetamol 500 mg Tablet Trade Name : Panadol Indication : Mild to moderate pain and pyrexia Dosage : ADULT: 500 - 1000 mg every 4 - 6 hours, maximum of 4 g daily 97 C Precautions : Renal and hepatic failure. Avoid chronic use Adverse Reactions : Allergic reactions, skin rash Contraindications : Nephropathy Interactions : Anticoagulants, alcohol, liver enzyme inducers, aspirin, chloramphenicol and phenobarbitone ---------------------------------------------------------------------------------------------------------------Parecoxib Sodium 40mg Injection A* Trade Name : Dynastat Indication : Management of post operative pain in the immediate post operative setting only Dosage : 40 mg followed by 20 or 40 mg every 6 to 12 hours, as required. Use limited to two days only with a maximum dose of 80 mg/day. Reduce the initial dose by 50% in elderly less than 50 kg Precautions : Moderate hepatic impairment, severe renal impairment, pre-disposition to fluid retention, coronary artery bypass graft surgery, dehydration, history of G1 perforations, ulcers or bleeds. Patients with hypertension or with bleeding disorders Adverse Reactions : Hypotension, back pain, dizziness, alveolar osteitis, ecchymosis, peripheral oedema, bradycardia , increased creatinine, hypokalaemia, agitation, insomnia, cerebrovascular disorders, Stevens-Johnson Syndrome, pharyngitis oliguria erythema multiforme, acute renal failure Contraindications : Patients undergoing Coronary Bypass Grafting (CABG) procedures and patients with elevated cardiovascular risk such as those with congestive heart failure (NYHA II-IV), established ischaemic heart disease and or cerebrovascular disease, patients who have experienced asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid, NSAIDs, COX-2 specific inhibitors, hypersensitivity to sulphonamides Interactions : Warfarin, diuretics, antihypertensives, ACEI, ciclosporin, tacrolimus, fluconazole, ketoconazole, propafenone, metoprolol, phenytoin, diazepam, lithium, CYP2C19 substances ---------------------------------------------------------------------------------------------------------------Dihydrocodeine Tartrate 30 mg Tablet B Trade Name : DF 118 Indication : For the control of moderate to severe chronic pain Dosage : ADULT: 30 - 60 mg every 4 - 6 hours. PAED, over 4 yrs: 0.5 - 1 mg/kg body weight every 4-6 hours Precautions : Hypothyroidism, chronic hepatic or adrenocortical disease, renal insufficiency, elderly Adverse Reactions : GI disturbance, headache, vertigo, respiratory depression Contraindications : Respiratory depression, obstuctive airway disease, acute alcoholism, acute asthmatic attack 98 Interactions : Naltrexone : precipitation of opioid withdrawal symptoms.MAOIs, phenothiazines, CNS depressants, cimetidine ---------------------------------------------------------------------------------------------------------------Fentanyl 25 mcg/h Transdermal Patch A* Fentanyl 50 mcg/h Transdermal Patch A* Trade Name : Durogesic Indication : As a second line drug in the management of chronic cancer pain. The use is to be restricted to pain specialists, palliative medicine specialists and oncologists. Dosage : Patients who have not previously received a strong opioid analgesic, initial dose , one 25 mcg/hour patch to be replaced after 72 hours. Patients who have received a strong opioid analgesic, initial dose based on previous 24 hours opioid requirement (oral morphine sulphate 90 mg over 24 hours = one 25 mcg/hour patch). Not recommended in children. Precautions : Elderly, neonates, children, obstetric patients,hepatic/renal dysfunction, pulmonary disease, increased intracranial pressure, pregnancy, lactation. Avoid exposing patch to direct heat.Not for acute or post-op pain. COPD or other pulmonary disease, bradyarrhythmias, brain tumour, impaired consciousness or coma. Withdraw gradually. May impair ability to drive or operate machinery. Fever Adverse Reactions : Local skin reaction, constipation, nausea, vomiting, drowsiness, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (clinically significant respiratory depression is a rare occurance in patients whose opioid doses have been titrated against pain), physical dependence (physical dependence can be prevented by gradual withdrawal of opioids).Hypoventilation, somnolence, confusion, hypotension, bradycardia, headache, pruritus, sweating, rash, erythema. Contraindications : Hypersensitivity, acute pain, raised intra-cranial pressure, respiratory depression and biliary colic (these conditions are not contra-indicated in patients who are terminally ill) Interactions : CNS depressant, including opiods, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines and alcohol beverages : additive depressant effects, ritonavir. ---------------------------------------------------------------------------------------------------------------Fentanyl Citrate 50 mcg/ml Injection A Indication : Analgesia during operation, relief of pain in the immediate postoperative period. Adjunct in maintenance of general / regional anaesthesia. Dosage : Dose should be individualized according to age, body weight, physical status, underlying pathological conditions and type of surgery and anaesthesia. With spontaneous respiration, 50 - 200 mcg, then 50 mcg every 20 - 30 minutes. as required. With assisted respiration: 0.3 - 3.5 mg, then 100 - 200 mcg as required up to 600 mcg. CHILD:Child with spontaneous respiration: 3 - 5 mcg/kg, then 1 mcg/kg as required. Child with assisted ventilation : 10 - 15 mcg/kg, then 1 - 3 mcg/kg as required Precautions : Pulmonary function impairment, liver/kidney dysfunction, cardiac arrhythmias, myasthenia gravis 99 Adverse Reactions : Respiratory depression, apnoea, muscle rigidity, bradycardia, cardiac dysrhythmia, tachyarrhythmia, chest pain, hypertension, hypotension, hypoventilation, neutropenia Contraindications : Children more than 2 years, asthma, respiratory depression, head injury, patients receiving MAOIs within previous 14 days, hypersensitivity, increased intracranial pressure, pregnancy and lactation Interactions : Amiodarone : cardiac toxicity (low cardiac output). Azole antifungals, macrolide antibiotics : increased or prolonged opioid effects (CNS depression, respiratory depression). Beta-adrenergic blockers, calcium channel blockers : severe hypotension. Carbamazepine : decreased plasma concentrations of fentanyl. Diazepam : significant decreases of mean arterial pressure and systemic vascular resistance. Naltrexone : precipitation of opioid withdrawal symptoms. Phenytoin : decreased plasma concentrations of fentanyl. Protease inhibitors : increased risk of fentanyl toxicity (CNS depression, respiratory depression). -------------------------------------------------------------------------------------------------------------------------Morphine HCl 10 mg/5 ml Solution Indication : For use in management of moderate to severe pain especially that associated with neoplastic disease Dosage : 5 - 20 mg or more regularly every 4 hours in terminal pain B Precautions : Neonates, children, infants less than 3 months, elderly, obstetric patients, chronic obstructive airway disease, asthma; pregnancy, lactation, renal and hepatic impairment, hypothyroidism, head injury, intracranial lesions; hypotension, circulatory shock; seizure-prone patients; adrenocortical insufficiency; prostatic hyperplasia; inflammatory or obstructive bowel disease; myasthaenia gravis Adverse Reactions : Constipation, nausea, vomiting, drowsiness, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (rare). Convulsions; dry mouth, headache, vertigo; palpitations; hypothermia; pruritus, urticaria; tachycardia, bradycardia; blurred vision; miosis; dependency Contraindications : Raised intra-cranial pressure, respiratory depression and biliary colic (these conditions are not contra-indicated in patients who are terminally ill). Hypersensitivity to morphine, acute or severe asthma; paralytic ileus; obstructive airway disease; acute liver disease; comatose patients; pregnancy, acute alcoholism Interactions : MAOIs: hypotension and exaggeration of CNS and respiratory depressant effects. Naltrexone: precipitation of opioid withdrawal symptoms. Cimetidine : morphine toxicity (CNS depression, respiratory depression) -------------------------------------------------------------------------------------------------------------------------Morphine Sulphate 10 mg Controlled Release Tablet Morphine Sulphate 30 mg Controlled Release Tablet Trade Name : MST Continus Indication : Prolonged relief of severe pain associated with neoplastic disease; assists in procuring sleep where sleeplessness is due to pain or shock 100 A A Dosage : 10 - 60 mg 12 hourly intervals, depend upon the severity of the pain Precautions : Neonates, children, elderly, obstetric patients, chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism Adverse Reactions : Constipation, nausea, vomiting, drowsiness, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (rare). Convulsions; dry mouth, headache, vertigo; palpitations; hypothermia; pruritus, urticaria; tachycardia, bradycardia; blurred vision; miosis; dependency Contraindications : Raised intra-cranial pressure, respiratory depression and biliary colic (these conditions are not contra-indicated in patients who are terminally ill). Hypersensitivity to morphine, acute or severe asthma; paralytic ileus; obstructive airway disease; acute liver disease; comatose patients; pregnancy. acute alcoholism, head injury, paralytic ileus, delayed gastric emptying, obstructive airways disease, cardiac arrhythmias, acute hepatic disease; concurrent MAOIs (or within 2 week). Not recommended for pre-operation use or for the 1st 24 hour post-operation. Pregnancy & lactation. Children Interactions : MAOIs: hypotension and exaggeration of CNS and respiratory depressant effects including sedatives or hypnotics, general anaesthetic, phenothiazines, other tranquillizers, muscle relaxants, antihypertensives, alcohol; respiratory depression, cimetidine. Naltrexone: precipitation of opioid withdrawal symptoms. Cimetidine: morphine toxicity -------------------------------------------------------------------------------------------------------------------------Morphine Sulphate 10 mg/ml Injection Indication : For moderate to severe pain especially that associated with neoplastic disease Dosage : ADULT: 10 - 20 mg/kg or more SC or IM every 4 hours in terminal pain. CHILD: Up to 1 month: 0.15 mg/kg body weight; 1 - 12 months: 0.2 mg/kg body weight; 1 - 5 years: 2.5 - 5 mg ; 6 - 12 years: 5 - 10 mg B Precautions : Children less then 1 year, neonates, premature infants, elderly, chronic obstructive airway disease, pregnancy, lactation, renal and hepatic impairment, hypothyroidism Adverse Reactions : Constipation, nausea, vomiting, drowsiness, dry mouth, psychomimetic effect (dysphoria, hallucination, nightmare), urinary retention, respiratory depression (rare). Convulsions; dry mouth, headache, vertigo; palpitations; hypothermia; pruritus, urticaria; tachycardia, bradycardia; blurred vision; miosis; dependency Contraindications : Acute bronchial asthma, respiratory insufficiency, severe CNS depression, GI obstruction, biliary colic (these conditions are not contra-indications in patients who are terminally ill), hypersensitivity to morphine, MAOIs Interactions : MAOIs: hypotension and exaggeration of CNS and respiratory depressant effects. Naltrexone: precipitation of opioid withdrawal symptoms. Cimetidine : morphine toxicity (CNS depression, respiratory depression) ---------------------------------------------------------------------------------------------------------------101 Nalbuphine HCl 10 mg/ml Injection Trade Name : Nubain Indication : Perioperative analgesia, for relief of moderate to severe pain Dosage : 10 - 20 mg SC, IM or IV every 3 - 6 hours B Precautions : Impaired renal/hepatic function, MI, impaired respiration, biliary tract surgery Adverse Reactions : Sedation, sweating, GI upsets, vertigo, dry mouth, allergic reactions Contraindications : Hypersensitivity to nalbuphine Interactions : Phenothiazines, alcohol, CNS depressants -------------------------------------------------------------------------------------------------------------------------Oxycodone HCl 10 mg Prolonged Release Tablet A* Oxycodone HCl 20 mg Prolonged Release Tablet A* Trade Name : Oxycontin Indication : Management of moderate to severe chronic cancer pain non-responsive to morphine (in accordance with WHO step-wise ladder of chronic pain management) [Initiated by Chronic Pain Specialist only] Dosage : ADULT, ELDERLY and CHILDREN more than 18 years, opioid-naive patients: 10 mg 12 hourly. Renal or hepatic impairment: 5 mg 12 hourly. Titrate dose carefully, as frequently as once a day if necessary, to achieve pain relief Precautions : History or tendency for drug abuse. Risk of criminal diversion similar to morphine; obstructive pulmonary disease or cor pulmonale, substantial decrease in respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis associated with respiratory depression (increased risk for respiratory depression); circulatory shock, hypovolemia, concurrent use with other drugs which may decrease blood pressure; concomitant administration with central nervous system depressants; elderly or debilitated patients (greater risk of respiratory depression); head injury, increased intracranial pressure, central nervous system depression or coma; acute abdominal conditions; acute alcoholism, delirium tremens; Addison?s disease; iliary tract disease, including acute pancreatitis. Hypothyroidism, biliary tract disease, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency; renal/hepatic disease; 24 hours prior to cordotomy or other pain relieving surgery; abdominal surgery, chronic non-malignant pain. Avoid abrupt cessation of prolonged use & therapy. May impair ability to drive or operate machinery. Pregnancy Adverse Reactions : GI and CNS disturbances, bronchospasm, dyspnoea, pharyngitis, voice alteration, orthostatic hypotension, rash, sweating, pruritus, fever and chills, constipation, xerostomia, asthenia, dizziness, sedated, apnoea, respiratory arrest, respiratory depression Contraindications : Acute or severe bronchial asthma or hypercarbia, hypersensitivity to oxycodone, paralytic ileus, respiratory depression. Acute respiratory depression, cor pulmonale, cardiac arrhythmias, acute asthma or other obstructive airways disease, paralytic ileus, suspected surgical abdomen, severe renal impairment, delayed gastric emptying, acute alcoholism, brain tumour, increased cerebrospinal or intracranial pressure, head injury, severe CNS depression, convulsive disorders, 102 delirium tremens, hypercarbia. Concurrent MAOIs (or within 2 weeks). Pre-operative or within 24 hours post-operative. Lactation Interactions : Anticholinergics, antihypertensives, CNS depressants including sedatives or hypnotics, general anaesthetics, phenothiazines, other tranquillizers, alcohol, other opioids & neuroleptics; muscle relaxants, coumarin derivatives, metoclopramide, MAOIs, neuromuscular blockers, opioid analgesics, drugs that involve cytochrome P450 enzyme system eg CYP3A4, CYP2D6 ---------------------------------------------------------------------------------------------------------------Oxycodone HCl 5 mg Immediate Release Capsules A* Oxycodone HCl 10 mg Immediate Release Capsules A* Trade Name : Oxynorm Indication : i)As a second line drug in the management of opioid responsive, moderate to severe chronic cancer pain ii)As a step-down analgesic drug in post-operative procedures (Initiated by palliative medicine physicians, oncologists, anaesthesiologists, haematologists and pain specialists only) Dosage : Initially 5 mg every 4 to 6 hours, increased if necessary according to severity of pain, usual max. 400 mg daily, but some patients may require higher doses Precautions : History or tendency for drug abuse. Risk of criminal diversion similar to morphine; obstructive pulmonary disease or cor pulmonale, substantial decrease in respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis associated with respiratory depression (increased risk for respiratory depression); circulatory shock, hypovolemia, concurrent use with other drugs which may decrease blood pressure; concomitant administration with central nervous system depressants; elderly or debilitated patients (greater risk of respiratory depression); head injury, increased intracranial pressure, central nervous system depression or coma; acute abdominal conditions; acute alcoholism, delirium tremens; Addison?s disease; iliary tract disease, including acute pancreatitis. Hypothyroidism, biliary tract disease, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency; renal/hepatic disease; 24 hours prior to cordotomy or other pain relieving surgery; abdominal surgery, chronic non-malignant pain. Avoid abrupt cessation of prolonged use & therapy. May impair ability to drive or operate machinery. Pregnancy Adverse Reactions : GI and CNS disturbances, bronchospasm, dyspnoea, pharyngitis, voice alteration, orthostatic hypotension, rash, sweating, pruritus, fever and chills, constipation, xerostomia, asthenia, dizziness, sedated, apnoea, respiratory arrest, respiratory depression Contraindications : Acute or severe bronchial asthma or hypercarbia, hypersensitivity to oxycodone, paralytic ileus, respiratory depression. Acute respiratory depression, cor pulmonale, cardiac arrhythmias, acute asthma or other obstructive airways disease, paralytic ileus, suspected surgical abdomen, severe renal impairment, delayed gastric emptying, acute alcoholism, brain tumour, increased cerebrospinal or intracranial pressure, head injury, severe CNS depression, convulsive disorders, delirium tremens, hypercarbia. Concurrent MAOIs (or within 2 weeks). Pre-operative or within 24 hours post-operative. Lactation Interactions : Anticholinergics, antihypertensives, CNS depressants including sedatives or hypnotics, general anaesthetics, phenothiazines, other tranquillizers, alcohol, other opioids & neuroleptics; muscle relaxants, coumarin derivatives, metoclopramide, MAOIs, neuromuscular blockers, opioid analgesics, drugs that involve cytochrome P450 enzyme system eg CYP3A4, CYP2D6 ---------------------------------------------------------------------------------------------------------------103 Pethidine HCl 100 mg/2 ml Injection Pethidine HCl 50 mg/ml Injection Indication : For relief of moderate to severe pain (medical and surgical), pre-anaesthetic medication and obstetrical analgesia Dosage : ADULT: 0.5 - 2 mg/kg SC or IM every 3 - 4 hours if necessary. CHILD: by IM 0.5 - 2 mg/kg. Up to 1 year : 1- 2 mg/kg weight IM, 1 - 5 years : 12.5 - 25 mg IM, 6 - 12 years: 25 - 50 mg IM B B Precautions : Cirrhosis, elderly, neonates, children, liver/renal dysfunction, convulsive disorders, reduced cardiac output, cardiac infarction, cardiac disease, supraventricular tachycardia, pregnancy, lactation.May impair ability to drive or operate machinery. Elderly. Reduced plasma protein binding. Phaeochromocytoma. Hypothyroidism, Addison's disease. Prostatic hypertrophy, urethral stricture. Diabetes. Glaucoma Adverse Reactions : Respiratory depression, dizziness, sweating, disorientation, hallucination,agitation, tremor, multifocal myoclonus, convulsion, Gastrointestinal disturbances, hypotension, hypertension, bradycardia, urine retention, Lightheadedness, dizziness, sedation, sweating, bizzare feeling, disorientation, hallucinations, psychosis. Dry mouth, nausea, vomiting, constipation. Hypotension, vasodilation, tachycardia, bradycardia, gangrene. Rash, pruritus, urticaria, erythema, injection site complications, anuria. Increased biliary tract pressure, choledochoduodenal sphincter spasm. Neurotoxicity, neuropsychiatric toxicity. Hyperactivity or agitation, depression, mental clouding, dysphoria Contraindications : Hypersensitivity, concurrent use of MAOIs, intracranial lesions causing increased pressure, atrioventricular flutter, respiratory depression, renal failure and a predisposition to convulsions or seizures. Head injury, brain tumour. Cardiac arrhythmias. Concurrent use of MAOIs. Pre-eclampsia, eclampsia. Convulsive states. Diabetic acidosis. Acute alcoholism or delerium tremens. Severe liver disease, incipient encephalopathy, low platelet count, coagulation disorders or receiving anticoagulant treatment. Continuous IV infusion in renal impairment. Patient-controlled analgesia in young children & adult wiith poor cognitive function Interactions : Cimetidine: pethidine toxicity (respiratory depression, central nervous system depression, hypotension). Isoniazid: hypotension and central nervous system depression. Moclobemide: cardiovascular instability, hyperpyrexia, coma or possible serotonin syndrome (hypertension, hyperthermia, myoclonus, mental status changes). Naltrexone: precipitation of opioid withdrawal symptoms. Phenothiazines: increase in central nervous system and respiratory depression. Phenytoin: decreased pethidine effectiveness. Procarbazine, selegiline: cardiac instability, hyperpyrexia, coma. Ritonavir: increased risk of central nervous system stimulation and excitation. Barbiturates, chloral hydrate, benzodiazepines. Butyrophenones, CNS depressants: pethidine enhances the CNS depressant effects of these drugs. MAOIs, amphetamine reactions. Anticoagulants. Reduces paracetamol absorption ---------------------------------------------------------------------------------------------------------------Tramadol HCl 50 mg Capsule Trade Name : Tramal Indication : Post-operative pain, chronic cancer pain, analgesia/pain relief for patients with impaired renal function Dosage : 50 - 100 mg every 4 hours. Max 400 mg daily. Not recommended in children 104 A/KK Precautions : Reduced level of consciousness, respiratory disorders, increased intracranial pressure, pregnancy, lactation, history of epilepsy. Opiate dependence, hypersensitivity to morphine-like analgesics, children less than 1 year. Myxedema, hypothyroidism or hypoadrenalism. Hepatic or renal function disorders Adverse Reactions : Sweating, dizziness, vomiting, dry mouth, gastrointestinal disturbances, cerebral convulsions especially on co-medication with neuroleptics, physical dependence. Rarely, palpitations, tachycardia, faintness, circulatory collapse, headaches, constipation, skin reactions. Very rarely, muscular weakness, altered appetite, micturition disturbances Contraindications : Narcotic withdrawal treatment, hypersensitivity, acute alcoholism. Acute intoxication with alcohol, analgesics, sedatives or psychotropic drugs. MAOI therapy Interactions : Amitryptiline, chlorpromazine, clozapine, dothiepin, fluoxetine, fluvoxamine, haloperidol, risperidone, sertraline, sulpiride, thioridazine, trifluoperazine: increased risk of seizures. Moclobemide, selegiline: nausea, vomiting, cardiovascular collapse, respiratory depression, seizures. Carbamazepine: decreased tramadol efficacy. Digoxin: increased risk of digoxin toxicity (nausea, vomiting, cardiac arrhythmias). Increased incidence of seizures when used with tricyclic antidepressants eg cyclobenzaprine, MAOI, SSRIs, neuroleptic agents and other drugs that lower the seizure threshold ---------------------------------------------------------------------------------------------------------------Tramadol HCl 50 mg/ml Injection Trade Name : Tramal Indication : Post-operative pain, chronic cancer pair and analgesia/pain relief for patients with impaired renal function Dosage : ADULT: By IM / IV inj. (over 2-3 mins) or by IV infusion. Initially 100 mg then 50 - 100 mg every 4 - 6 hours. Max: 600 mg daily. Child not recommended A Precautions : Reduced level of consciousness, respiratory disorders, increased intracranial pressure, pregnancy, lactation, history of epilepsy. Opiate dependence, hypersensitivity to morphine-like analgesics, children less than 1 year. Myxedema, hypothyroidism or hypoadrenalism. Hepatic or renal function disorders Adverse Reactions : Sweating, dizziness, vomiting, dry mouth, gastrointestinal disturbances, cerebral convulsions especially on co-medication with neuroleptics, physical dependence. Rarely, palpitations, tachycardia, faintness, circulatory collapse, headaches, constipation, skin reactions. Very rarely, muscular weakness, altered appetite, micturition disturbances Contraindications : Narcotic withdrawal treatment, hypersensitivity, acute alcoholism. Acute intoxication with alcohol, analgesics, sedatives or psychotropic drugs. MAOI therapy Interactions : Amitryptiline, chlorpromazine, clozapine, dothiepin, fluoxetine, fluvoxamine, haloperidol, risperidone, sertraline, sulpiride, thioridazine, trifluoperazine: increased risk of seizures. Moclobemide, selegiline: nausea, vomiting, cardiovascular collapse, respiratory depression, seizures. Carbamazepine: decreased tramadol efficacy. Digoxin: increased risk of digoxin toxicity (nausea, vomiting, cardiac arrhythmias). Increased incidence of seizures when used with tricyclic 105 antidepressants eg cyclobenzaprine, MAOI, SSRIs, neuroleptic agents and other drugs that lower the seizure threshold ---------------------------------------------------------------------------------------------------------------Celecoxib 200 mg Capsule Trade Name : Celebrex Indication : i) Osteoarthritis ii) Rheumatoid Arthritis iii) Acute pain iv) Ankylosing Spondylitis Dosage : i) ADULTS: 200 mg once daily. CHILD not recommended ii) 100mg twice daily, increased if necessary to 200 mg 2 times daily; CHILD not recommended iii) 400mg as a single dose on first day followed by 200mg once daily on subsequent days iv) Initial, 200 mg once daily or 100 mg twice daily; if no effect after 6 weeks, may increase to max. 400 mg daily in 1-2 divided doses. If no response following 2 weeks of treatment with 400 mg/day, consider discontinuation and alternative treatment A* Precautions : Hypertension, cardiac conditions, liver/renal dysfunction, elderly, fluid retention, children, asthmatic, coagulation defects, pregnancy (third trimester) Adverse Reactions : Gastrointestinal disorders, flatulence, insomnia, pharyngitis, sinusitis, dizziness, vertigo, hearing disturbance, photosensitivity, blood disorder, fluid retention, renal failure, hepatic impairment, Steven-Johnson syndrome, allergic reactions, chest pain, oedema, hot flushes, flu-like symptoms. Gastric side effects are lesser with this drug as compared to other NSAIDs Contraindications : Hypersensitivity to celecoxib, allergic-type reaction to sulphonamides, aspirin or other nonsteroidal anti-inflammatory agents, ischaemic heart disease and stroke patient Interactions : Diuretics, anti-coagulants, sulphonylureas, captopril, phenytoin, digoxin, fluconazole, lithium, antacids, aspirin, glucocorticoids, warfarin ---------------------------------------------------------------------------------------------------------------Diclofenac 1% Emulgel A Trade Name : Voltaren Indication : Post-traumatic inflammation of the tendons,ligaments & joints. Localised forms of soft tissue rheumatism and degenerative rheumatism Dosage : Apply 3 - 4 times daily and gently rubbed in Precautions : Do not apply to diseased skin or open wounds or injuries. Avoid contact with eyes or mucous membranes. Systemic side effects when applied to large areas of skin & over a prolonged period of time Adverse Reactions : Allergic or non allergic contact dermatitis. Generalized skin rash, hypersensitivity and photosensitivity reactions Contraindications : Hypersensitivity to diclofenac or other NSAIDs, proctitis and isopropanol or propylene glycol Interactions : Increase plasma concentration of lithium, methotrexate & warfarin. Reduces effects of diuretics & beta blockers ---------------------------------------------------------------------------------------------------------------106 Diclofenac Sodium 12.5 mg Suppository Diclofenac Sodium 50 mg Suppository Diclofenac Sodium 25 mg Suppository Trade Name : Voltaren Indication : Pain and inflammation in rheumatic disease and juvenile arthritis Dosage : 75 - 150 mg daily in divided doses. CHILD 1-12 years, Juvenile arthritis; 12.5- 25 mg daily A A A Precautions : Previous history of gastrointestinal ulceration, bleeding or perforation. Renal dysfunction. Hypertension or cardiac conditions aggravated by fluid retention and oedema. History of liver dysfunction, coagulation defects Adverse Reactions : Occasionally gastrointestinal disorders, headache, dizziness, vertigo, rash, proctitis Contraindications : Patients with history of hypersensitivity to diclofenac or aspirin/other NSAIDs. Peptic or intestinal ulcer. Lactation. Use of suppository is contraindicated in patients with recent rectal bleeding Interactions : Increases plasma concentration of warfarin, lithium, & methotrexate. May reduce effects of diuretics & beta blockers. May alter plasma concentration of sulfonylureas. Caution with concomitant use of diuretics and antihypertensives (eg beta-blockers, ACEI ), methotrexate, other NSAIDs and corticosteroids, SSRIs. Monitoring recommended for patients receiving anticoagulants, antiplatelets agents as well as blood glucose level if used concomitantly with antidiabetics. Digoxin, ciclosporin, quinolones ---------------------------------------------------------------------------------------------------------------Diclofenac Sodium 50 mg Tablet Trade Name : Voltaren Indication : Pain and inflammation in rheumatic disease Dosage : ADULTS: Initial dose of 150 mg daily. Mild or long term: 75 - 150 mg daily in 2 to 3 divided doses after food. PAEDS 1 year and above : 1 - 3 mg/kg body weight daily B Precautions : Previous history of gastrointestinal ulceration, bleeding, or perforation. Renal dysfunction. Hypertension or cardiac conditions aggravated by fluid retention and oedema. History of liver dysfunction, coagulation defects Adverse Reactions : Epigastric pain, GI disturbances, slight dizziness Contraindications : Hypersensitivity, rhinitis, urticaria, asthma or allergic reactions to aspirin or other anti-inflammatory agents Interactions : Increases plasma concentration of warfarin, lithium and methotrexate. May reduce effects of diuretics & beta blockers. May alter plasma concentration of sulfonylureas. Aspirin, warfarin, digoxin, methotrexate, ciclosporin ---------------------------------------------------------------------------------------------------------------- 107 Diclofenac Sodium 75 mg/3 ml Injection Trade Name : Voltaren Indication : Pain and inflammation in rheumatic disease Dosage : 75 mg once daily (2 times daily in severe cases) for not more than 2 days A Precautions : Patient with CHF, dehydration, hypertension, decreased renal or hepatic function, active GIT ulceration or bleeding, pre-existing asthma Adverse Reactions : Pruritus, rash, contact dermatitis, pain, dry skin, exfoliation, paraesthesia, constipation, diarrhoea, headache, dizziness, vertigo, nausea, vomiting, gastrointestinal disorders, anorexia, increase transaminases Contraindications : Hypersensitivity to diclofenac or any component of the formulation, aspirin or other NSAIDs, asthma, rhinitis, porphyria, pregnancy (third trimester) Interactions : ACEI, angiotensin II antagonists, anticoagulants, cholestyramine and colestipol, ticlopidine, aspirin. Monitoring recommended for patients receiving anticoagulants, antiplatelets agents as well as blood glucose level if used concomitantly with antidiabetics. Lithium, digoxin, ciclosporin, quinolones ---------------------------------------------------------------------------------------------------------------Ibuprofen 200 mg Tablet B Trade Name : Brufen Indication : Pain and inflammation in rheumatic disease Dosage : ADULT : 200 - 400 mg 3 times daily after food, maximum. 2.4 g daily CHILD : 20-30 mg/kg body weight daily in divided doses Precautions : Patients with active or severe peptic ulceration, history of bronchial asthma, renal or hepatic disorders, bleeding disorders, CV disease, pregnancy and lactation Adverse Reactions : Peptic ulceration, GI bleeding, headache, dizziness, nervousness, skin rash, pruritus, tinnitus, oedema depression, drowsiness, insomnia, blurred vision, hypersensitivity, impairment of renal function, dyspepsia, thrombocytopaenia, visual disturbances, nausea, vomiting, epigastric pain, heartburn, jaundice, hepatitis, depression Contraindications : Patients with history of hypersensitivity to aspirin/other NSAIDs, active peptic ulcer, hypersensitivity, lactation, neonates Interactions : Coumarin-type anticoagulants, aspirin or NSAIDs, digitalis glycosides, lithium, methotrexate, diuretics, cefoperazone, valproic acid, ciclosporin, gold compound, other nephrotic medications, probenecid. Moclobemide enhances effects of ibuprofen. Increased risk of gastrointestinal bleeding with warfarin. Lost of BP response with ACEI ---------------------------------------------------------------------------------------------------------------- 108 Indomethacin 25 mg Capsule Trade Name : Indocid Indication : Pain and inflammation in rheumatic disease Dosage : 50 - 200 mg daily in divided doses, with food. Child not recommended B Precautions : Active or previous history of gastrointestinal ulceration, bleeding, or perforation. History of renal/liver dysfunction. Hypertension or cardiac conditions aggravated by fluid retention and oedema. May aggravate depression/psychiatric disorders such as epilepsy, mental depression, Parkinsonism. Patients with coagulation defects. Renal impairment. Retinal disturbances. Elderly. Pregnancy and lactation Adverse Reactions : Gastrointestinal disturbances and bleeding, headache, vertigo, depression, epigastric disease, dizziness, somnolence, depression & fatigue, anxiety, psychic disturbances including psychotic episodes, mental confusion, tinnitus, corneal deposits, retinal disturbances, oedema, weight gain, flushing, sweating, thrombocytopenia, rash, pruritus & urticaria Contraindications : Hypersensitivity, rhinitis, urticaria, asthma or allergic reactions to aspirin or other anti-inflammatory agents, proctitis, pregnancy & lactation Interactions : Salicylates, anticoagulant drugs, probenecid, methotrexate, ciclosporin, lithium, digoxin, betablockers, captopril, heparin or thrombolytic agents, aminoglycosides, digitalis glycosides. antihypertensives, diuretics especially triamterene, diflunisal, other salicylates, cefamandole, cefoperazone, cefotetan, plicamycin, valproic acid, gold compound, other nephrotoxics & zidovudine ---------------------------------------------------------------------------------------------------------------Ketoprofen 2.5% Gel Trade Name : Orudis Indication : As a short term treatment for traumatic lesions, sprains, tendinitis, oedema, bruises Dosage : Apply twice daily. Maximum 20 g daily A Precautions : Avoid in children less than 5 years. If skin rash occurs after gel application, treatment should be stopped Adverse Reactions : Pruritus and localised erythema Contraindications : Avoid in patient with exudative dermatoses, eczema, sores, infected skin. Do not apply to the mucous membranes or eyes Interactions : Not known -------------------------------------------------------------------------------------------------------------------------Ketoprofen 30 mg Transdermal Plaster A Trade Name : Ketotop Indication : Treatment of signs & symptoms of arthritis deformans, periarthritis humero-scapularis, tendinitis, peritendinitis, sore muscle, swelling, pain resulting from trauma (eg. contusion, distorsion, sprain). 109 Dosage : Apply 1 plaster to the affected area twice daily Precautions : Avoid in children less than 5 years. If skin rash occurs after application, treatment should be stopped. Pregnancy Adverse Reactions : Pruritus and localised erythema. Contraindications : Avoid in patient with exudative dermatoses, eczema sores & infected skin. Do not apply to the mucous membranes or eyes. Interactions : Not known -------------------------------------------------------------------------------------------------------------------------Mefenamic Acid 250 mg Tablet B Trade Name : Ponstan Indication : Mild to moderate pain Dosage : ADULT: 250 - 500 mg 3 times daily after meals. CHILD over 6 months: 6.5 - 25 mg/kg daily 3 - 4 times daily for not longer than 7 days except in juvenile arthritis Precautions : Elderly, renal impairment, asthmatic sensitive to NSAIDs or salicylates, pregnancy, increased risk of serious cardivascular thrombotic events, myocardial infarction Adverse Reactions : Diarrhoea, skin rash, allergic, glomerulonephritis, non-oliguric renal failure, thrombocytopenia, reversible haemolytic anaemia, hypertension, oedema, myocardial infarction Contraindications : Gastrointestinal ulceration or inflammatory bowel disease, renal/hepatic impairment Interactions : Alendronate, ACEIs, antacids, beta-adrenergic blockers, calcium channel blocker, ciclosporin, diuretics, methotrexate, sulphonylureas, warfarin ---------------------------------------------------------------------------------------------------------------Methyl Salicylate 25% Ointment Indication : Relief of pain associated with musculoskeletal discomfort Dosage : To be applied to affected area C Precautions : Avoid contact with eyes, open wounds Adverse Reactions : Extreme overdosage results in excessive irritation, tinnitus, nausea, vomiting Contraindications : Patient with aspirin or salicylate idiosyncrasy Interactions : Not known -------------------------------------------------------------------------------------------------------------------------- 110 6. PSYCHIATRY Hypnotics and anxiolytics Anti-psychotics Antidepressants Miscellaneous psychiatry 111 Alprazolam 0.25 mg Tablet A/KK Trade Name : Xanax Indication : Anxiety disorders Dosage : 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 mg 2-3 times daily), increased if necessary to a total dose of 3 mg/day. Not recommended for children Precautions : Avoid operating vehicles or machinery, abuse prone patient, pregnancy and breastfeeding, renal or hepatic dysfunction, elderly patients, obesity, untreated open angle glaucoma, impaired pulmonary function. Prolonged use can lead to dependence Adverse Reactions : Drowsiness, blurred vision, coordination disorder, gastrointestinal disturbance, agitation, lightheadedness, dry mouth, depression, headache, confusion, hypotension, syncope, tachycardia, seizures, respiratory depression, coma, constipation, diarrhoea, nausea, vomiting, insomnia, nasal congestion, rigidity, increased salivation, dermatitis, sedation Contraindications : Hypersensitivity to benzodiazepines, acute narrow angle glaucoma, concomitant use of ketoconazole/ itraconazole, CNS depression Interactions : Ketoconazole, fluconazole, itraconazole, contraceptives; increased alprazolam serum concentrations and potential alprazolam toxicity (sedation, slurred speech, CNS depression). Omeprazole, erythromycin, clarithromycin, cimetidine; benzodiazepine toxicity (CNS depression, ataxia, lethargy). Sertraline, increased risk of psychomotor impairment and sedation. Fluoxetine, increased risk of alprazolam toxicity (somnolence, dizziness, ataxia, slurred speech, hypotension, psychomotor impairment). Fluvoxamine, increased risk of CNS side effects. Ritonavir, increased plasma concentrations of alprazolam and enhanced alprazolam effects. Antihistamine/decongestant combinations, antipsychotic, ethanol, mirtazapine, phenothiazines, venlafaxine (increased risk of CNS depression, psychomotor impairment), sedative/hypnotics, tricyclic antidepressants (CNS depression) -------------------------------------------------------------------------------------------------------------------------Chloral Hydrate 200 mg/5 ml Mixture Indication : Preoperative sedation Dosage : ADULT : 0.5 - 1 g (max 2 g) with plenty of water at bedtime.CHILD : 30 - 50 mg/kg up to a max dose of 1 g B Precautions : History of gastritis or duodenal ulcers, mentally depressed patients, severe cardiac disease, respiratory disease, lactation, acute intermitent porphyria, skin/mucous membrane irritation, avoid prolonged use and abrupt withdrawal Adverse Reactions : Arrhythmias, hallucination, disorientation, nausea, vomiting, diarrhoea, gastric irritation, vertigo, nightmares, delirium, flatulence, abdominal distention, leucopenia, eosinophilia, ketonuria, respiratory depression, rashes Contraindications : Hypersensitivity to chloral hydrate products, cardiac disease, hepatic or renal impairment, pregnancy, breast feeding, porphyria, gastritis 112 Interactions : Warfarin, increased risk of bleeding. Frusemide, cardiovascular toxicity (diaphoresis, hypertension, tachycardia). Alcohol, increased sedation. May reduce effect of phenytoin -------------------------------------------------------------------------------------------------------------------------Lorazepam 1 mg Tablet A/KK Trade Name : Ativan Indication : i) Severe anxiety ii) Insomnia Dosage : i) 1 - 4 mg increase to 10 mg daily in divided doses. ELDERLY (or delibitated) half adult dose ii) 1 - 2 mg at bedtime. Not recommended in children Precautions : Concomitant use of central nervous system drugs such as phenothiazines, narcotic analgesics, barbiturates, antidepressants, scopolamine and MAOIs; elderly and debilitated patients, patients with a limited pulmonary reserve, doses exceeding 2 mg/day in geriatric patients or debilitated patients, not recommended in patients with primary depressive disorder or psychosis. Potential for drug abuse, impaired liver/renal function Adverse Reactions : Fatigue, hypotension, ataxia, respiratory depression, sedation, confusion, depression, headache, nausea, tremor, urinary retention, vertigo, withdrawal syndrome, bradycardia, dependence or abuse Contraindications : Respiratory depression, acute pulmonary insufficiency, sleep apnoea syndrome, severe hepatic impairment, myasthenia gravis, phobic or obsessional states, depression or anxiety with depression, acute narrow-angle glaucoma, hypersensitivity to benzodiazepines Interactions : Theophylline, decreased benzodiazepine effectiveness. Valproic acid, increased lorazepam concentrations. Clozapine, alcohol or central nervous system depressants, will give additive central nervous system depression effect. Contraceptive, decreased lorazepam effect. Rifampicin, decreased effect of lorazepam. Digoxin, increased serum digoxin concentrations ---------------------------------------------------------------------------------------------------------------Aripiprazole 10mg Tablet A* Aripiprazole 15mg Tablet A* Trade Name : Abilify, AripMT Indication : i) Treatment of acute episodes of schizophrenia and for maintenance of clinical improvement during continuation therapy. ii) Treatment of acute manic episodes associated with bipolar I disorder Dosage : Schizophrenia: 10 or 15 mg/day. Maintenance dose: 15 mg/day. Bipolar mania: Starting dose: 15 or 30 mg/day. Dose adjustment should occur at intervals of not less than 24 hour Precautions : Suicide, tardive dyskinesia, neuroleptic malignant syndrome, seizure disorder, diabetes mellitus, CV disease, cerebrovascular disease, dementia-related psychosis and CV adverse events in elderly. May disrupt body's ability to increase/reduce core body temperature. Dysphagia, pregnancy & lactation. May impair ability to drive or operate machinery. Safety and efficacy have not been established in children less than 13 years of age Adverse Reactions : Insomnia, restlessness, headache, dizziness, akathisia, somnolence, sedation, tremor, extrapyramidal disorder, blurred vision, tachycardia, orthostatic hypotension, nausea, vomiting, constipation, 113 dyspepsia, asthenia/fatigue, weight gain, anxiety diabetic ketoacidosis , neuroleptic malignant syndrome, seizure, peripheral oedema Contraindications : Patients who are hypersensitive to aripiprazole or to any of the excipients. Interactions : Enhance effect of antihypertensive agents, alcohol, quinidine, ketoconazole, carbamazepine -------------------------------------------------------------------------------------------------------------------------Chlorpromazine HCl 100 mg Tablet B Chlorpromazine HCl 25 mg Tablet B Trade Name : Largactil Indication : Psychosis mania and agitation Dosage : ADULT : Initial dose - 25 mg 3 times daily according to response up to 1 g daily. PAEDIATRIC: Up to 5 years: 0.5 mg/kg body weight every 4 - 6 hours (Maximum 40 mg daily). CHILD 6 - 12 years: A third to half adult dose (Maximum 75 mg daily) Precautions : Pregnancy and lactation, elderly, epilepsy or history of seizure, impaired kidney and liver function, Parkinson's disease, severe hypotension, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis & prostate hypertrophy. Avoid in patient hypersensitive to phenothiazines, history of narrow-angle glaucoma or agranulocytosis. Monitor BP & complete blood count. Avoid exposure to sunlight Adverse Reactions : Postural hypotension, akathisia, tardive dyskinesia, arrhythmias, constipation, haematologic effects, agranulocytosis, aplastic anaemia, thrombocytopenia, neuroleptic malignant syndrome, jaundice, agitation, insomnia, parkinsonism symptoms, drowsiness, convulsion and tachycardia, acute dystonia, leukopenia, angioedema, bronchospasm, urticaria, hyperprolactinemia, eye, cardiac, skin & subcutanoues tissue disorders, dry mouth, respiratory depression, neuroleptic malignant syndrome. Rarely agranulocytosis, priapism Contraindications : Hypersensitivity to chlorpromazine products, phenothiazines, myelosuppression, coma, severe CNS depression, bone marrow depression Interactions : Alcohol, CNS depressant, anticholinergic, tramadol, phenobarbitone, beta-blockers (metoprolol, atenolol, propranolol), captopril,norepinephrine, procyclidine, warfarin, epinephrine, cimetidine, ethanol, adrenaline, antacids, amphetamine, amiodarone, bumetamide, chlorothiazides, clarithromycin, erythromycin, frusemide, phenytoin, antiarrhythmics, antidepressants & other antipsychotics, carbamazepine -------------------------------------------------------------------------------------------------------------------------Clozapine 100 mg Tablet A Trade Name : Clozaril Indication : Treatment of resistant schizophrenia Dosage : Initial dose : 12.5 mg ( once or twice ) daily, increase slowly in steps of 25 - 50 mg up to 300 mg daily within 2 - 3 weeks. Maximum 900 mg/day Precautions : Patients who are elderly, cachectic, or have serious underlying medical illnesses; cardiovascular and or pulmonary disease; discontinue treatment if myocarditis is suspected; history of seizures; history 114 of neuroleptic malignant syndrome; rapid escalation of dose, prostatic hypertrophy, hypotension, impaired renal or liver function, seizure disorder, hyperglycemia and diabetes mellitus. WBC & absolute neutrophil counts (weekly during the 1st 18 week, at least monthly thereafter) can be performed, eosinophilia, thrombocytopenia. Concurrent use of drugs with a substantial potential to depress bone marrow function & of long-acting depot antipsychotics should be avoided. Caution when patients drive vehicles or operate machinery. Narrow-angle glaucoma, chronic constipation, , lactation, pregnancy. Monitoring of standing & supine BP is necessary during the 1st few week of treatment in patients with Parkinson's disease Adverse Reactions : Hyperglycemia, agranulocytosis, sedation, salivation, cardiovascular effects, dizziness / vertigo, seizures, drowsiness, confusion, blurred vision, dry mouth, jaundice, leucopenia, neuroleptic malignant syndrome, anticholinergic toxicity, hepatitis, hypotension, syncope, constipation, tremor, weight gain, tachycardia, hypersalivation. Eosinophilia, ketoacidosis, hyperosmolar coma, convulsions, ECG changes, circulatory collapse, arrhythmias, myocarditis, cardiomyopathy, thromboembolism, aspiration of ingested food, intestinal obstruction, ileus, faecal impaction, hepatitis, pancreatitis, fulminant hepatic necrosis, interstitial nephritis, neuroleptic malignant syndrome, unexplained sudden death Contraindications : Severe hepatic and renal impairment, myeloproliferative disorders, uncontrolled epilepsy, pregnancy, lactation, coma, hypersensitivity to clozapine products, myocarditis with clozapine history, agranulocytosis with clozapine history (except due to previous chemotherapy), WBC less than 3500, GI/GU obstruction, narrow angle glaucoma, CNS depression Interactions : Tramadol, carbamazepine, fluoxetine, sertraline, fluvoxamine, erythromycin, phenobarbitone, phenytoin, rifampicin, cimetidine, benzodiazepines, other antipsychotics, tricyclic antidepressants, valproic acid derivatives. Alcohol, MAOIs, CNS depressants, narcotics, antihistamines, anticholinergic drugs, antihypertensive agents, adrenaline, drugs with resp depressant effects, omeprazole, cimetidine, carbamazepine, SSRIs, lithium, azole antimycotics, protease inhibitors, caffeine, nicotine -------------------------------------------------------------------------------------------------------------------------Flupenthixol Decanoate Depot 20 mg/ml lnjection B Trade Name : Fluanxol Indication : Chronic psychoses Dosage : By deep IM, initial test dose of 5-20 mg, then after at least 7 days. 20 - 40 mg repeated at intervals of 2 - 4 weeks. Maximum 400 mg weekly. Usual maintenance dose 50 mg every 4 weeks to 300 mg every 2 weeks. ELDERLY, initially quarter to half adult dose. CHILD not recommended. Deep IM recommended. Not for IV use Precautions : Patients known to have a predisposition to movement disorders (may cause extrapyramidal symptoms). Hepatic or renal impairment. CV or respiratory disease, phaeochromocytoma. Convulsive disorders. Withdraw gradually if patient was previously treated with neuroleptics with sedative effect. Patients on high doses and long-term therapy should be monitored carefully. Should not be given during pregnancy and lactation Adverse Reactions : Sedation, restlesness, extrapyramidal symptoms, anticholinergic effects, weight gain. Insomnia, drowsiness. Rarely extrapyramidal symptoms, if recommended dose is exceeded. Occasionally tardive dyskinesia in long-term therapy Contraindications : Hypersensitivity to flupenthixol. Extremely excitable or overactive patients. Acute alcohol, barbiturate or opiate poisoning. Bone marrow depression, coma 115 Interactions : Barbiturates, guanethidine or similar compounds, metoclopramide and piperazine, tramadol. May enhance the response to alcohol, and other CNS depressants -------------------------------------------------------------------------------------------------------------------------Haloperidol 1.5 mg Tablet B Haloperidol 5 mg Tablet B Trade Name : Serenace Indication : Schizophrenia and other psychoses Dosage : ADULT : 1.5 - 5 mg 2 - 3 times daily up to 30 mg daily. Paed : Initial: 0.05 mg/kg/day or 0.25-0.5 mg/day given in 2-3 divided doses; increase by 0.25-0.5 mg every 5-7 days; maximum: 0.15 mg/kg/day. Maximum 10 mg Precautions : Concomitant anticoagulant use, concomitant CNS depressant use (anaesthetics, opiates, and alcohol), history of convulsive disorders, known allergies or allergic reactions to drugs, manic patients, neuroleptic malignant syndrome, elderly patients, impaired liver function, CV disease, thyrotoxicosis. Parkinsonism, angle-closure glaucoma, benign prostatic hyperplasia; severe cardiac or hepatic disease, presence of acute infections or leucopaenia; hyperthyroidism; pregnancy, elderly, children. Patients receiving anticoagulants. Discontinue treatment upon signs of neurological toxicity in patients taking lithium. Temperature regulation: Impaired core body temperature regulation may occur Adverse Reactions : Extrapyramidal symptoms (EPS), tardive dyskinesia, sedation, hypotension, tachycardia, insomnia, anxiety, weight changes, anticholinergic effects, gynaecomastia, galactorrhoea, menstrual irregularities, neuroleptic malignant syndrome, arrhythmias, seizure, jaundice, hyperpyrexia. Anxiety, depression, anorexia, leukopaenia Contraindications : Parkinson's disease, severe CNS depression, bone marrow suppression, severe cardiac or hepatic disease, comatose states, hypersensitivity to haloperidol. Lactation Interactions : Tramadol, fluoxetine, fluvoxamine, carbamazepine, cisapride,dicoumarol, procyclidine, methyldopa, olanzapine, rifampicin, lithium, tricyclic antidepressants. May increase the plasma levels of haloperidol when used with clozapine or chlorpromazine -------------------------------------------------------------------------------------------------------------------------Haloperidol 5 mg/ml Injection B Trade Name : Serenace Indication : Acute psychoses and mania Dosage : ADULT: IM or IV , 2 mg - 10 mg then every 4 - 8 hours according to response to total maximum 18 mg daily. Use in child is not recommended Precautions : Concomitant anticoagulant use, concomitant CNS depressant use (anaesthetics, opiates, and alcohol), history of convulsive disorders, known allergies or allergic reactions to drugs, manic patients, neuroleptic malignant syndrome, elderly patients, impaired liver function, CV disease, thyrotoxicosis. Parkinsonism, angle-closure glaucoma, benign prostatic hyperplasia; severe cardiac or hepatic disease, presence of acute infections or leucopaenia; hyperthyroidism; pregnancy, elderly, children. Patients receiving anticoagulants. Discontinue treatment upon signs of neurological toxicity 116 in patients taking lithium. Temperature regulation: Impaired core body temperature regulation may occur Adverse Reactions : Extrapyramidal symptoms (EPS), tardive dyskinesia, sedation, hypotension, tachycardia, insomnia, anxiety, weight changes, anticholinergic effects, gynaecomastia, galactorrhoea, menstrual irregularities, neuroleptic malignant syndrome, arrhythmias, seizure, jaundice, hyperpyrexia. Anxiety, depression, anorexia, leukopaenia Contraindications : Parkinson's disease, severe CNS depression, bone marrow suppression, severe cardiac or hepatic disease, comatose states, hypersensitivity to haloperidol. Lactation Interactions : Tramadol, fluoxetine, fluvoxamine, carbamazepine, cisapride,dicoumarol, procyclidine, methyldopa, olanzapine, rifampicin, lithium, tricyclic antidepressants. May increase the plasma levels of haloperidol when used with clozapine or chlorpromazine -------------------------------------------------------------------------------------------------------------------------Lithium Carbonate 300 mg Tablet A Indication : i) Prophylaxis and treatment of acute mania and hypomania episodes ii)Prophylaxis of manic depression in bipolar illness or bipolar depression and recurrent depression Dosage : 1800 mg/day in 2-3 divided doses, desired serum lithium level ranging between 0.4-1 mmol/litre. Maintenance 900-1200 mg/day in 2-3 divided doses Precautions : Cardiovascular insufficiency, elderly, electrolyte imbalance, current infection, impaired renal function, volume depletion, thyroid disorder, CAD, myasthaenia gravis, pregnancy and lactation. Monitor serum levels cardiac, renal and thyroid function regularly. Maintain adequate fluid intake. Avoid alcohol. May impair ability to perform skilled tasks. Discontinue temporarily 24 hours prior to major surgery Adverse Reactions : Gastrointestinal effect, vertigo, dazed feeling, fine hand tremor, polyuria, drowsiness, muscle weakness, anorexia, dry mouth, fatigue, seizures, leucocytosis, goitre, coma. Exacerbation of psoriasis, acne, rash, nausea, diarrhoea, vertigo,loss of concentration, tremors, hypothyroidism, weight gain, cardiac arrhythmias; exophthalmos, restlessness Contraindications : Renal insufficiency, Addison's disease, untreated hypothyrodism, lactation, delibated or dehydrated patient, pregnancy, disturbed electrolyte balance, major surgery Interactions : Diuretics, steroids, haloperidol, fluphentixol, diazepam, methyldopa, tetracyclines, phenytoin, carbamazepine, Lithium toxicity with ACE inhibitors, caffeine, COX2 inhibitors, metronidazole, nondepolarising neuromuscular blockers, NSAIDs, potassium iodide, SSRIs, tricyclic antidepressants -------------------------------------------------------------------------------------------------------------------------Olanzapine 5mg Disintegrating Tablet A* Olanzapine 10mg Disintegrating Tablet A* Trade Name : Zyprexa Zydis Indication : i) Acute and maintenance treatment of schizophrenia and other psychoses where positive and or negative symptoms are prominent ii) Short-term use for acute mania episodes associated with Bipolar 1 disorder 117 Dosage : i) 5 - 10 mg once daily, increase to 10 mg once daily within 5 - 7 days, adjust by 5 - 10 mg/day at 1 week intervals, maximum 20 mg/day ii) 10 - 15 mg once daily, increase by 5 mg/day at intervals of not less than 24 hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day Precautions : History of neuroleptic malignant syndrome, patients with liver disease, seizure disorder, pneumonia, narrow angle glaucoma, pregnancy, cardiovascular disease, history of breast cancer, tardive dyskinesia, gastrointestinal obstruction, paralytic ileus, cerebrovascular disease, elderly, hypotension, hypovolaemia, dehydration, risk of aspiration pneumonia, hyperglycemia and diabetes mellitus. Elevated ALT and or AST, hepatic impairment, limited hepatic functional reserve, seizures, low leukocyte/neutrophil counts, history or existing bone marrow depression, hypereosinophilic conditions, myeloproliferative disease, prostatic hypertrophy, paralytic ileus. Pregnancy and lactation. May impair ability to drive or operate machinery Adverse Reactions : Somnolence, agitation, dizziness, constipation, drowsiness, weight gain, peripheral oedema, dry mouth, postural hypotension, elevated liver transaminases, hyperglycaemia, diabetic ketoacidosis, weight gain, dizziness, increased appetite, orthostatic hypotension, dry mouth, constipation, tardive dyskinesia Contraindications : Hypersensitivity to olanzapine products, narrow angle glaucoma, lactation Interactions : Carbamazepine, ciprofloxacin, fluvoxamine, levodopa, haloperidol, activated charcoal, ethanol, central alpha-2 agonists, cimetidine, epinephrine, muscle relaxants, tricyclic antidepressants. May antagonise the effects of dopamine agonist. Other centrally-acting drugs including alcohol. Activated charcoal -------------------------------------------------------------------------------------------------------------------------Perphenazine 4 mg Tablet B Indication : Schizophrenia and other psychoses Dosage : ADULT: Initially 4 mg 3 times daily adjusted according to response, maximum 24 mg daily. ELDERLY: 1/4 to 1/2 adult dose. CHILD not recommended Precautions : Concomitant epinephrine use, seizure disorder, patients undergoing alcohol withdrawal, pregnancy and lactation, respiratory impairment secondary to pulmonary infection or chronic pulmonary disorders, increased risk of tardive dyskinesia development in older patients, sulfite hypersensitivity, history of neuroleptic malignant syndrome, patients with hepatic or renal impairment; cardiovascular disease, Parkinson's disease, epilepsy, depression, myasthenia gravis, paralytic ileus, prostatic hypertrophy, history of jaundice, blood dyscrasias. May affect driving especially when first started, elderly Adverse Reactions : CNS effects (extrapyramidal effects), drowsiness, insomnia, convulsion, allergic reaction, tachycardia, postural hypotension, dizziness, impaired glucose tolerance, tardive dyskinesia, liver damage, nausea, vomiting, cardiac arrest, agranulocytosis, haemolytic anaemia, hepatotoxicity, alter temperature regulation, neuroleptic malignant syndrome, GI disturbances, nasal congestion, antimuscarinic symptoms, cardiovascular symptoms, ECG changes, endocrine effects, blood dyscrasias, photosensitisation, contact sensitisation, rashes, jaundice, corneal and lens opacities, purplish pigmentation of the skin and eye 118 Contraindications : Blood dyscrasias, bone marrow suppression, subcortical brain damage, comatose/obtunded patients, hypersensitivity to perphenazine products, severe liver disease, high doses of CNS depressants, hypersensitivity to perphenazine, lactation Interactions : Tramadol, increased risk of seizures. Cisapride, levofloxacin, cardiotoxicity. Procyclidine, decreased phenothiazine serum concentrations, decreased phenothiazine effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Pethidine, increase in central nervous system and respiratory depression. Levodopa, loss of levodopa efficacy. Ethanol, increased central nervous system depression and an increased risk of extrapyramidal reactions. Class Ia and III antiarrhythmics, beta 2 agonists, carbamazepine, central alpha 2 agonists, systemic corticosteroids, diuretics, lithium, tricyclic antidepressants. MAOIs, antiepileptics. Avoid alcohol, kava kava, gotu kola, valerian & St John's wort -------------------------------------------------------------------------------------------------------------------------Quetiapine Fumarate 300 mg Extended Release Tablet Quetiapine Fumarate 400 mg Extended Release Tablet Trade Name : Seroquel XR® Indication : i) Schizophrenia ii) Moderate to severe manic episodes in bipolar disorder iii) Major depressive episodes in bipolar disorder Dosage : i) & ii) 300 mg once daily on Day 1 and 600 mg on Day 2. Maintenance dose: 400 800 mg once daily. Maximum dose: 800 mg daily iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily A* A* Precautions : Pregnancy, hepatic impairment, renal impairment, cerebrovascular disease, hyperglycaemia and diabetes mellitus. Cardiovascular disease, use with drugs known to prolong QTc interval. Renal & hepatic impairment. History of seizures & diabetes mellitus. Pregnancy & lactation. Elderly. May affect ability to drive or operate machinery Adverse Reactions : Headache, somnolence, weight gain, postural hypotension, tachycardia, palpitations, dizziness, rash, abdominal pain, constipation, dyspepsia, anorexia, dry mouth, constipation, leucopenia, dyspepsia, elevated serum transaminases (ALT, AST), mild asthenia, peripheral oedema, weight gain, syncope, rhinitis Contraindications : Hypersensitivity, severe CNS depression, bone marrow suppression, blood dyscrasias, severe hepatic disease, coma Interactions : Antihypertensives, cimetidine, CNS depressants, alcohol, carbamazepine, barbiturates, valproate, phenytoin, rifampicin, thioridazine, ketoconazole, erythromycin. Other centrally-acting drugs, alcohol, macrolide antibiotics -------------------------------------------------------------------------------------------------------------------------Risperidone 1 mg Tablet Risperidone 2 mg Tablet Trade Name : Risperdal Indication : Psychoses and schizophrenia A A 119 Dosage : ADULT : 2 mg in 1 - 2 divided doses on first day then 4 mg in 1 - 2 divided doses on 2nd day then 6 mg in 1 - 2 divided doses on 3rd day (slower titration appropriate in some patients); usual range 4 - 8 mg daily; dose above 10 mg daily only if benefit outweigh risk (maximum 16 mg daily). Elderly (or in hepatic or renal impairment): initially 0.5 mg twice daily increased in steps of 0.5 mg twice daily to 1 - 2 mg twice daily. Not recommended in children under 15 years Precautions : Neuroleptic malignant syndrome, tardive dyskinesia, QT prolongation, cardiovascular or cerebrovascular disease or conditions that predispose patients to orthostatic hypotension, hypothermia or hyperthermia, previous diagnosis of breast cancer or prolactin-dependent tumours, renal insufficiency, hepatic insufficiency, Lewy body dementia or Parkinson's disease, seizure history, pathologic changes in blood count, dysphagia, elderly patients, hypotension, hypovolaemia, dehydration, agents prolonging QT, risk of aspiration pneumonia. Known cardiovascular disease, dosage should be gradually titrated as recommended, a dose reduction should be considered when hypotension occurs. Epilepsy, pregnancy ad lactation. May affect ability to drive or operate machinery Adverse Reactions : Somnolence, dizziness, hyperkinesia, nausea, extrapyramidal effects, constipation, anxiety, headache, rhinitis, rash, dyspepsia, tachycardia, dry mouth, weight gain, sexual dysfunction, hyperprolactinaemia, menstrual irregularities, severe hypotension, tardive dyskinesia, neuroleptic malignant syndrome and hyperglycaemia Contraindications : Hyperprolactinaemia, hypersensitivity to risperidone products, prolonged QT interval Interactions : Tramadol, increased risk of seizures. Carbamazepine, increased risperidone clearance. Levodopa, loss of levodopa efficacy. Clozapine, decreased risperidone clearance. Amphotericin, Class Ia and III antiarrhythmics, acetalozamide, central alpha2 agonists, systemic corticosteroids, diuretics, tricyclic antidepressants -------------------------------------------------------------------------------------------------------------------------Sulpiride 200 mg Tablet Trade Name : Dogmatil Indication : Acute and chronic schizophrenia, chronic delusional psychoses Dosage : 200-400 mg twice daily; 800 mg daily in predominantly negative symptoms and 2.4 g daily in mainly positive symptoms. Elderly, lower initial dose; increased gradually according to response. Child under 14 years not recommended B Precautions : Cardiovascular disease, manic or hypomanic patients, renal insufficiency, neuroleptic malignant syndrome, hyperthyroidism, pulmonary disease, urinary retention, previous hypersensitivity to other benzamide derivatives eg. metoclopramide, elderly patients. Pregnancy, lactation, Parkinson's disease. May be exacerbated by the presence of bradycardia, hypokalaemia, a long QT which is either congential or acquired (due to combination with a medicinal product increasing the QT interval). Do not use in the event of congential galactosaemia, glucose/galactose malabsorption syndrome or lactase deficiency and children less than 6 year. Parkinson's disease, renal impairment, epileptic patients. Avoid alcohol Adverse Reactions : Extrapyramidal syndrome, drowsiness, dry mouth, urinary retention, tachycardia, postural hypotension, dizziness, galactorrhoea, gynaecomastia, amenorrhoea, sedation, somnolence. Early 120 dyskinesia, tardive dyskinesia, sedation or drowsiness, transient hyperprolactinemia, weight gain, QT interval prolongation, orthostatic hypotension, neuroleptic malignant syndrome Contraindications : Hypersensitivity to sulpiride, phaeochromocytoma, prolactin dependent tumour, in combination with sultopride and dopamine agonists apart from in patients with Parkinson's disease, lactation, levodopa, class Ia and III antiarrhythmics, certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, pimozide, haloperidol, droperidol), bepridil, cisapride, diphemanil, erythromycin, mizolastine, vincamine, halofantrine, pentamidine, sparfloxacin, moxifloxacin Interactions : Tramadol, increased risk of seizures. Other central nervous system depressants, alcohol, levodopa. Dopamine agonists, sultopride, halofantrine, pentamidine, sparfloxacin, moxifloxacin, bradycardiac agents, hypokalaemic agents, antihypertensives, if treatment with neuroleptics is necessary in patients with Parkinson's disease receiving treatment with dopamine agonists, the latter must be gradually reduced and then discontinued -------------------------------------------------------------------------------------------------------------------------Trifluoperazine HCI 5 mg Tablet B Trade Name : Stelazine Indication : Psychotic disorder Dosage : ADULT: Initially 5 mg twice daily, increase by 5 mg after 1 week, then at 3-day intervals. Maximum 40 mg/day. CHILD up to 12 years: Initially up to 5 mg daily in divided doses adjusted to response, age and body weight Precautions : Tardive dyskinesias may develop, concomitant lithium therapy (encephalopathic syndrome), may increase anginal pain, neuroleptic malignant syndrome, glaucoma or retinopathy. If affected by drowsiness do not drive or operate machinery. cardiovascular or respiratory disease, phaeochromocytoma, parkinsonism, epilepsy, renal or hepatic impairment, pregnancy and lactation Adverse Reactions : Seizures, extrapyramidal effects, blood dyscrasias, agranulocytosis, neuroleptic malignant syndrome, dry mouth, constipation, orthostatic hypotension, blurred vision, tardive dyskinesia, urinary retention, photosensitivity, rash, nausea, tachycardia, dizziness, fatigue, headache, weight gain, jaundice, dystonic reaction in children, sensitivity reactions eg agranulocytosis, leucopenia, leucocytosis and haemolytic anaemia Contraindications : Coma, bone marrow depression, hypersensitivity to trifluoperazine products and other phenothiazines, pre-existing liver damage, central nervous system depression Interactions : Tramadol, increased risk of seizures. Lithium, weakness, dyskinesias, increased extrapyramidal symptoms, encephalopathy and brain damage. Procyclidine, decreased phenothiazine serum concentrations and effectiveness, enhanced anticholinergic effects (ileus, hyperpyrexia, sedation, dry mouth). Phenytoin, increased or decresed phenytoin levels and possibly reduced phenothiazine levels. Ethanol, increased central nervous system depression and an increased risk of extrapyramidal reactions. Amphotericins, class Ia and III antiarrhythmics, beta2 agonists, acetazolamide, central alpha2 agonists, systemic corticosteroids, diuretics, MAOIs, tricyclic antidepressants -------------------------------------------------------------------------------------------------------------------------- 121 Zuclopenthixol Acetate 50 mg/ml Injection A* Trade Name : Clopixol - Acuphase Indication : Only for treatment of agitated and violent patients suffering from schizophrenia who are not responding to the available standard drugs Dosage : 50 - 150 mg repeated after 2 - 3 days if necessary. Additional dose may be needed 1 - 2 days after the first injection. Maximum cumulative dose 400 mg per course and maximum 4 injections; maximum duration of treatment 2 weeks. Change to oral dose 2 - 3 days after the last injection. Child not recommended Precautions : Previous hypersensitivity to other neuroleptic agents, particularly thioxanthenes, fluphenazine and perphenazine. Hepatic or renal disease or cardiovascular disease, pregnancy, breastfeeding, epileptic or parkinsonian patients or organic brain syndrome. Patients on long-term therapy should be monitored carefully. May affect ability to drive or operate machinery Adverse Reactions : Extrapyramidal syndrome, drowsines, anticholinergic effect, tachycardia, postural hypotension, dizziness, tardive dyskinesia, urinary retention, disturbed accommodation, tachycardia Contraindications : Severe central nervous system depression, coma, blood dyscrasias, phaeocromocytoma. Previous hypersensitivity to zuclopenthixol or clopenthixol. Comatose states, acute alcohol, barbiturate and opiate intoxication. Pregnancy Interactions : Alcohol, barbiturates and central nervous system depressant, tricyclic antidepressant, metoclopramide - increased effect -------------------------------------------------------------------------------------------------------------------------Zuclopenthixol Decanoate 200 mg/ml Injection A* Trade Name : Clopixol Depot Indication : Only for treatment of agitated and violent patients suffering from schizophrenia who are not responding to the available standard drugs Dosage : By deep IM injection test dose 100 mg followed after 7 - 28 days by 100 - 200 mg or more followed by 200 - 400 mg at intervals of 2 - 4 weeks adjusted according to response. Maximum 600 mg weekly. Child not recommended Precautions : Previous hypersensitivity to other neuroleptic agents, particularly thioxanthenes, fluphenazine and perphenazine, Hepatic or renal disease or cardiovascular disease, pregnancy, breastfeeding, epileptic or parkinsonian patients or organic brain syndrome. Patients on long-term therapy should be monitored carefully. May affect ability to drive or operate machinery Adverse Reactions : Extrapyramidal syndrome, drowsines, anticholinergic effect, tachycardia, postural hypotension, dizziness, tardive dyskinesia, urinary retention, disturbed accommodation Contraindications : Severe central nervous system depression, blood dyscrasias, phaeocromocytoma. Previous hypersensitivity to zuclopenthixol or clopenthixol. Comatose states, acute alcohol, barbiturate and opiate intoxication. Pregnancy 122 Interactions : Alcohol, barbiturates and central nervous system depressant, tricyclic antidepressant, metoclopramide - increased effect -------------------------------------------------------------------------------------------------------------------------Paliperidone 3mg Extended Release Tablet A* Paliperidone 6mg Extended Release Tablet A* Trade Name : Invega Indication : Second or third line treatment of schizophrenia Dosage : ADULT 6 mg once daily in the morning, adjusted if necessary; usual range 3 -12 mg daily. Renal impairment (creatinine clearance between 10-50 mL/min) 3 mg once daily. Avoid if creatinine clearance less than 10mL/min Precautions : Neuroleptic malignant syndrome, tardive dyskinesia (discontinue use), diabetes mellitus, cerebrovascular disease or conditions predisposing to hypotension, seizure, Parkinson's disease, conditions that contribute to core body temperature elevation or dehydration, pregnancy, adolescent and children. May impair ability to drive or operate machinery Adverse Reactions : Headache, tachycardia, akathisia, sinus tachycardia, extrapyramidal disorder, somnolence, dizziness, sedation, tremor, hypertonia, dystonia, orthostatic hypotension & dry mouth. Menstrual disturbances, erectile dysfunction, galactorrhoea and gynaecomastia Contraindications : Lactation, hypersensitivity to Paliperidone, Risperidone or to any product component Interactions : Centrally acting drugs, alcohol, levodopa, dopamine agonists, itraconazole ---------------------------------------------------------------------------------------------------------------Ziprasidone 20mg/ml Injection A* Trade Name : Zeldox Indication : Acute agitation in schizophrenia Dosage : ADULT: Initially 10 mg (every 2 hour) or 20 mg (every 4 hour). Maximum: 40 mg/day. IM administration more than 3 days has not been studied Adverse Reactions : Injection site pain, asthenia, headache, hypertension, postural hypertension, diarrhoea, nausea, somnolence, dizziness, akathisia Contraindications : QT-interval prolongation, recent myocardial infarction, uncompensated heart failure, cardiac arrhythmias requiring treatment with Class IA and III antiarrhythmic drugs, drugs that prolong QT interval Interactions : Class IA and III antiarrhythmics, drugs that prolong QT interval, central nervous system drugs/alcohol ---------------------------------------------------------------------------------------------------------------- 123 Amitriptyline HCl 25 mg Tablet B Trade Name : Laroxyl Indication : Depression Dosage : Initially 75 mg. ADULT and ELDERLY : 30 - 75 mg daily in divided doses or as a single dose at bedtime, increase gradually as necessary to 150 - 200 mg. CHILD under 16 years are not recommended Precautions : Cardiac disease, hyperthyroidism, impaired hepatic and renal function, urinary retention, history of seizures, glaucoma, suicide risk, pregnancy, lactation, elderly, phaeochromocytoma, history of mania, phychoses, angle-closure glaucoma, concurrent anticonvulsive therapy, anaesthesia Adverse Reactions : Dry mouth, constipation, nausea, vomiting, urinary retention, blurred vision, drowsiness, dizziness, tachycardia, increased appetite, confusion, seizures, myocardial infarction, stroke, agranulocytosis, thrombocytopenia, rash and hypersensitivity reactions, blood sugar changes, endocrine side effects, impotence, menstrual irregularities, bone marrow depression Contraindications : Hypersensitivity to drug/class. Immediate recovery phase after myocardial infarction, heart block, mania. MAOI use within the last 14 days Interactions : Barbiturate, phenytoin, carbamazepine, cimetidine, amphetamines, antiarrhythmics, class Ia and III, anticholinergics, antihistamines, beta 2 agonists, benzodiazepines, systemic carbonic anhydrase inhibitors, central alpha 2 agonists, cholinergic agents, clozapine, intranasal decongestants, flumazenil, halothane, lithium, MAOIs, methylphenidate, metoclopramide, muscle relaxants, nitrates, opiates, antipsychotics, phenytoin, protease inhibitors, sedatives/hypnotics, SSRIs, indirect/mixed sympathomimetics, cimetidine, fluoxetine, clonidine -------------------------------------------------------------------------------------------------------------------------Dothiepin HCl 75 mg Tablet A Trade Name : Prothiaden Indication : Depression of any aetiology Dosage : Initially 75 mg (ELDERLY 50-75 mg) daily in divided doses or single dose at bedtime, increased gradually as necessary to 150 mg daily (ELDERLY 75 mg may be sufficient), up to 225 mg daily in some circumstances. CHILD is not recommended Precautions : May activate latent schizophrenia, exaggerate paranoid delusions, renal or hepatic impairment, Pregnancy, lactation and children less than 16 years Adverse Reactions : Drowsiness, extrapyramidal symptoms, tremor, confusional state, disorientation, dizziness, anticholinergic effects, paraesthesia, hypotension, tachycardia, palpitations, arrhythmias, conduction defects, libido changes, nausea, vomiting, constipation, rash, pharyngitis, impotence, anemia Contraindications : Concomitant use of MAOIs, recovery phase of myocardial infarction, hepatic failure, epilepsy 124 Interactions : Alcohol, barbiturate, tranquilliser, MAOIs, anticholinergic, antihistamine, sympathomimetics, 5 HT agonist, benzodiazepines, carbamazepine, clozapine, cyclosporine, digoxin, haloperidol, phenytoin, linezolid, metoclopramide, ritonavir, tramadol, lithium, NSAIs, thioridazine, warfarin -------------------------------------------------------------------------------------------------------------------------Duloxetine 30 mg Capsule A* Duloxetine 60 mg Capsule A* Trade Name : Cymbalta Indication : Major depressive disorder, diabetic peripheral neuropathic pain Dosage : ADULT: 60 mg once daily up to a maximum dose of 120mg/day (in divided doses) CHILD and ADOLESCENT under 18 years not recommended Precautions : History of mania/hypomania, seizures, renal impairment, elderly, liver transaminase elevations, pregnancy and lactation, suicidal ideation and behavior or worsening depression, controlled narrowangle glaucoma, diabetes; may worsen glycemic control, hepatic impairment; increased risk of liver injury and aggravation of pre-existing liver disease, hepatic insufficiency; risk of drug toxicity Adverse Reactions : Gastrointestinal disorders, excessive sweating, CNS disorders (eg dizziness, fatigue, insomnia, somnolence, blurred vision, dysuria), hepatotoxicity, suicidal thought, increased urinary frequency, increased libido, palpitation Contraindications : Concomitant use with MAOIs, potent CYP1A2 inhibitors, hepatic or severe renal impairment, uncontrolled narrow-angle glaucoma, hypersensitivity to duloxetine or any other component of the product Interactions : Drugs metabolised by CYP2D6 (eg flecainide, vinblastine, carbamazepine, tricyclic antidepressants), potent CYP1A2 inhibitors/inducers, CNS-active drugs (eg diazepam, imipramine, phenytoin, haloperidol, alcohol) -------------------------------------------------------------------------------------------------------------------------Escitalopram 10 mg Tablet A* Trade Name : Lexapro Indication : i) Treatment of major depressive episodes ii) Treatment of panic disorder with or without agoraphobia Dosage : i) 10 mg once daily; may be increased to max 20 mg daily. ii) Panic disorder with or without agoraphobia :Initially 5 mg for the first week, thereafter increased to 10 mg daily. May be further increased up to max 20 mg daily, dependent on individual patient response. ELDERLY initially half adult dose, lower maintenance dose may be sufficient. CHILD and ADOLESCENT under 18 years not recommended Precautions : Paradoxical anxiety, seizures, mania, diabetes, suicidal tendencies, hyponatraemia, haemorrhage, electroconvulsive therapy, reversible selective MAO-A inhibitors, serotonin syndrome, St John's Wort, lactation, renal and hepatic function impairment, abnormal bleeding, avoid abrupt discontinuation, may activate hypomania or mania, concomitant use of NSAIDs 125 Adverse Reactions : Dizziness, headache, nausea, sweating, somnolence, insomnia, constipation, diarrhoea, decreased appetite, sexual dysfunction, fatigue, pyrexia, sinusitis, yawning, rash, Steven Johnson Syndrome, rhinitis, blurred vision, nasal congestion, prolactinemia, dry mouth, decrease prothrombin, hepatic failure, hypoglycemia, hypokalemia, suicidal ideation, diaphoresis, Syndrome of inappropriate antidiuretic hormone secretion(SIADH) Contraindications : Concurrent use of MAOIs or within 14 days of discontinuing MAOS treatment Interactions : MAOI, selegiline, lithium, tryptophan, agents that may lower seizure threshold, St John's Wort, omeprazole, high doses of cimetidine, drugs metabolised by CYP2D6 and CYP2C19 enzymes, alcohol, aspirin, NSAIDs, warfarin, carbamazepine, ketoconazole, linezolid, tramadol, metoprolol, 5 HT agonist, gingko, lamotrigine -------------------------------------------------------------------------------------------------------------------------Fluoxetine HCl 20 mg Capsule A Trade Name : Prozac Indication : i) Depressive illness ii) Obsessive-compulsive disorder Dosage : i) 20 mg once daily increased after 3 weeks if necessary, usual dose 20 - 60 mg (ELDERLY 20 - 40 mg) once daily max 80 mg once daily (ELDERLY max 60 mg once daily). ii) Initially 20 mg once daily increased after 2 weeks if necessary, usual dose 20 - 60 mg (ELDERLY 20 - 40 mg) once daily, max 80 mg (ELDERLY max 60 mg) once daily, discontinue if no improvement within 10 weeks. CHILD and ADOLESCENT under 18 years are not recommended Precautions : History of seizure, elderly, volume depletion, diabetes, pregnancy and breastfeeding, impaired renal/liver function, abnormal bleeding, anxiety and insomnia, hyponatremia, rash, avoid abrupt withdrawal Adverse Reactions : Tremor, asthenia, gastrointestinal disorder, inappropriate secretion of adrenocortical hormone, nervousness, insomnia, headache, anorexia, anxiety, dry mouth, decreased libido, delayed ejaculation, anorgasmia, sweating and serotonin syndrome Contraindications : Present or recent treatment with MAOIs, hypersensitivity to fluoxetine Interactions : Drugs metabolised by cytochrome P450, CNS active drugs, drugs highly bound to protein plasma. Benzodiazepines, caffeine, ergotamine, clozapine, lithium, MAOIs, phenytoin, antipsychotics, propranolol, warfarin. -------------------------------------------------------------------------------------------------------------------------Fluvoxamine 100 mg Tablet B Fluvoxamine 50 mg Tablet B Trade Name : Luvox Indication : Depressive disorder Dosage : For depression, initially 50 - 100 mg daily in the evening, increased if necessary to 300 mg daily (over 150 mg in divided doses); usual maintenance dose 100 mg daily. CHILD and ADOLESCENT under 18 years not recommended 126 Precautions : Concomitant use with MAOIs, hepatic insufficiency, children, epilepticus, pregnancy, lactation, cardiovascular disease, avoid abrupt withdrawal, elderly, abnormal bleeding, hyponatremia, may activate mania or hypomania, history of seizure, suicidal ideation, worsening depression Adverse Reactions : Blurred vision, dry mouth, tremor, gastrointestinal disturbances, somnolence, constipation, headache, insomnia, vomiting, dizziness, agitation, extrapyramidal effects, bradycardia, seizures, hepatotoxicity, withdrawal syndrome, Steven Johnson Syndrome, anphylactic reaction, abnormal ejaculation, hepatitis, asthenia, abnormal bleeding, hyponatremia, seizure, serotonin syndrome, worsening depression, hypomania, mania (rare), suicidal thoughts Contraindications : Use of MAOI within 14 days, coadministration of terfenadine, astemizole or cisapride, may cause increased plasma concentrations of these drugs and an increased incidence of side effects, hypersensitivity to fluvoxamine Interactions : Warfarin, phenytoin, theophyline, propanolol, lithium, benzodiazepines, caffeine, ergotamine, MAOIs, sildenafil, statins, heparin, NSAIDs, aspirin, carbamazepin, clozapin, haloperidol, proton pump inhibitor, tricyclic antidepressants, grapefruit, St. John wort, dilatiazem, metoclopramide, serotonergic drugs, linezolid, tramadol, celecoxib -------------------------------------------------------------------------------------------------------------------------Mirtazapine 15 mg Orodispersible Tablet A* Mirtazapine 30 mg Orodispersible Tablet A* Indication : Episodes of major depression Dosage : Initially 15 mg daily at bedtime increased according to response up to 45 mg daily as a single dose at bedtime or in 2 divided doses. CHILD and ADOLESCENT under 18 years not recommended Precautions : Heart disease, hypotension, epilepsy, hepatic and renal impairment, pregnancy, mania and hypomania, hypersensitivity to other anti-depressant, suicidal ideation and behavior or worsening depression; increased risk in children and adolescents Adverse Reactions : Agranulocytopenia, neutropenia, mania, dizziness, increase appetite, constipation, somnolence. Patients should be advised to report any fever, sore throat, stomatitis or other signs of infection during treatment. Blood count should be performed and the drug stopped immediately if blood dyscrasia suspected, increased appetite, raised serum cholesterol and serum triglycerides, raised ALT (SGPT) level, asthenia, dizziness, dream disorder, agranulocytosis, neutropenia, seizure, worsening depression, suicidal ideation Contraindications : Hypersensitivity to mirtazapine or component of formulation, MAOIs, procarbazine, selegiline Interactions : Clonidine, monoamine oxidase inhibitors, ethanol, warfarin, carbamazepine, phenytoin, ketoconazole, cimetidine, methadone, rifampicin, antivirals, St. John's wort, diazepam, fluoxetine, fluvoxamine, linezolid, olanzapine, tramadol, venlafaxine -------------------------------------------------------------------------------------------------------------------------- 127 Moclobemide 150 mg Tablet A* Trade Name : Aurorix Indication : Treatment of depressive syndrome Dosage : Initially 300 mg daily in divided doses. Gradually to increase up to 600 mg daily in divided doses depending on response. Usual range 150 - 600 mg daily. Not recommended in children Precautions : Avoid in excited and agitated patient, thyorotoxicosis, hepatic impairment, pregnancy, lactation, hypertensive, avoid ingestion of excessive amounts of tyramine-rich foods, occipital headache, palpitations, neck stiffness, tachycardia or bradycardia, coadministration with dextromethorphan resulted in vertigo, tremor, nausea and vomiting Adverse Reactions : Sleep disturbance, dizziness, gastrointestinal disturbance, restlessness, agitation, blurred vision, dry mouth, headache, constipation, possible hyponatraemia, diaphoresis, rash, increase libido, abdominal pain, hepatotoxicity, oedema, orthostatic hypotension, tremor Contraindications : Acute confusional state, hypersensitivity to moclobemide, concomitant use with selective serotonin reuptake inhibitors, conventional MAOIs or tricyclic antidepressants, concomitant use of narcotics Interactions : Tricyclic antidepressants, beta-2 agonist, carbamazepine -------------------------------------------------------------------------------------------------------------------------Sertraline HCI 50 mg Tablet B Trade Name : Zoloft Indication : Major depression, obsessive-compulsive disorder (OCD), panic disorder Dosage : Depression, obsessive-compulsive disorder: 50 mg/day. Panic disorder: Initially 25 mg/day. After 1 week, increase dose to 50 mg/day. All dose changes should be made at intervals of more than 1 week, max: 200 mg/day Precautions : Concomitant use with tryptophan and fenfluramine, impaired hepatic function, electroconvulsive therapy, abnormal bleeding, avoid abrupt discontinuation, hyponatraemia, history of seizures, MAO inhibitors, uricosuric effect Adverse Reactions : Male sexual dysfunction, gastrointestinal complain, tremor, dizziness, insomnia, headache, dry mouth, somnolence, ejaculatory dysfunction, dyspepsia, decreased libido, sweating, anorexia, agitation, visual disturbances, serotonin syndrome, withdrawal syndrome, rash, pharyngitis, purpura, agranulocytosis, elevated liver enzyme, antidepressants increase the risk of suicidal Contraindications : Concurrent use or recent use of MAOIs, hypersensitivity to sertraline products Interactions : MAO inhibitors, serotonergic drugs, caffeine/ergotamine, cimetidine, lithium, metoprolol, phenytoin, propranolol, warfarin, alcohol, central nervous system depressants, carbamezepine, clozapine, cyclosporine, NSAIDs, aspirin, erythromycin, metoclopramide, tramadol, St. John's wort, tolbutamide, tricyclic antidepressants, zolpidem -------------------------------------------------------------------------------------------------------------------------- 128 Venlafaxine HCl 75 mg Extended Release Capsule A* Trade Name : Efexor XR Indication : i) Depression ii) Generalized anxiety disorder iii) Social anxiety disorder (social phobia) iv) Panic disorder Dosage : i), ii) & iii) ADULT: 75 mg once daily. May increase dose by 75 mg/day every 4 days to a maximum dose of 225 mg/day iv) 37.5 mg/day for the first 4-7 days after which the dose should be increased to 75 mg once daily. CHILD and ADOLESCENT under 18 years not recommended Precautions : Activation of mania/hypomania, changes in appetite or weight, glaucoma, history of seizure, hyponatraemia, syndrome of inappropriate antidiuretic hormone syndrome (SIADH), patients with recent myocardial infarction or unstable heart disease, sustained hypertension, suicidal ideation, lactation, elderly, renal and liver function impairment, avoid abrupt discontinuation Adverse Reactions : Abnormal ejaculation, anorgasmia, impotence, anorexia, constipation, weight loss, diarrhoea, dyspepsia, anxiety, dizziness, insomnia, nervousness, somnolence, tremor, asthenia, abnormal bleeding, activation of mania, suicide ideation, hepatitis, hypertension, hyponatraemia, seizures, sweating symptom, nausea, dream disorder, headache, blurred vision Contraindications : Recent or concomitant use of MAOIs, risk of potentially life-threatening serotonin syndrome hypersensitivity to venlafaxine hydrochloride or any other component of the product Interactions : Clozapine, dexfenfluramine, droperidol, fenfluramine, haloperidol, linezolid, lithium, metoclopramide, moclobemide, NSAIDs, procarbazine, selegiline, thioridazine, tramadol, trifluoperazine, amoxicillin, aspirin, celecoxib ,diclofenac, etoricoxib, ginkgo, NSAIDs, jujube ,ketoprofen, ketorolac, mefenamic acid, meloxicam, mirtazapine, phenylbutazone, procarbazine, sulindac, zolpidem -------------------------------------------------------------------------------------------------------------------------Methylphenidate HCl 10 mg Tablet Trade Name : Ritalin Indication : Hyperkinetic disorder (attention deficit hyperactivity disorder) Dosage : CHILD over 6 years, initially 5 mg 1 - 2 times daily, increased if necessary at weekly intervals by 5 - 10 mg daily to maximum of 60 mg daily in divided doses; discontinue if no response after 1 month, also suspend periodically to assess child's condition (usually finally discontinued during or after puberty) A Precautions : May exacerbate behavioral disturbance and thought disorder in psychotic patients. Not for severe depression. Chronic abuse can lead to marked tolerance and psychic dependence. Epilepsy and hypertension. Monitor blood count during long-term treatment. Careful supervision during drug withdrawal. Children less than 6 years. Pregnancy and lactation. Caution in road/machinery users. Cardiovascular disease, alcohol/drug abuse, hyperthyroidism Adverse Reactions : Nervousness, insomnia, decreased appetite. Ocassionally headache, drowsiness, dizziness, dry mouth, tachycardia, palpitations, arrhythmias, changes in blood pressure and heart rate. Gastrointestinal disturbances, skin reactions, fever, arthralgia. Rare: blurred vision, moderately reduced weight gain and minor growth retardation in children. Seizures, dependency, leucopenia 129 Contraindications : Anxiety and tension states, agitation, tics, tics in siblings, familial history or diagnosis of Tourette's syndrome, glaucoma, hyperthyrodism, cardiac arrythmias, severe angina pectoris, hypersensitivity to drug/class, children less than 6 years of age, MAOIs use within 14 days Interactions : Pressor agents, MAOIs, anticoagulants, anticonvulsants, tricyclic antidepressants, phenylbutazone, guanethidine -------------------------------------------------------------------------------------------------------------------------- 130 7. NEUROLOGY Antimigraine drugs Antiepileptics Drugs used in Parkinsonism and related disorders Drugs used in substance dependence Drugs used for dementia Central nervous system stimulants Miscellaneous neurology 131 Flunarizine HCl 5 mg Capsule B Trade Name : Sibelium Indication : i) Migraine prophylaxis ii) Maintenance treatment of vestibular disturbances and of cerebral and peripheral disorders Dosage : i) ADULT: 5 - 10 mg daily preferably at night. ELDERLY more than 65 years: 5 mg at night. Maintenance 5-day treatment at the same daily dose ii) 5 - 10 mg at night. If no improvement after 1 month, discontinue treatment Precautions : Narrow-angle glaucoma, obesity, urinary retention. May affect ability to drive and operate machinery. Pregnancy, breast feeding. Dosage reduction may be necessary in renal impairment, prostatic hyperplasia, pyloroduodenal obstruction, epilepsy, hepatic impairment, elderly, young children. Pregnancy, lactation Adverse Reactions : Sedation, dizziness, dry mouth and constipation. Increased appetite, sedation, nausea, fatigue. Rarely, hypersensitivity reactions, face oedema, rash, central nervous system stimulation, hallucinations, seizures, depression, drowsiness, headache, palpitation, arrhythmias, gastrointestinal disturbance, palpitations, blood disorders, convulsions, sweating, myalgia, paraesthesias, extrapyramidal effects, sleep disturbances, confusion, tinnitus, tremor, hypotension, hair loss Contraindications : Hypersensitivity to the drug. Children less than 2 years. Postural giddiness Interactions : Central effects of sedatives, hypnotics, antihistamines, including certain common cold preparations and alcohol may be enhanced. Antagonised hypotensive effect of adrenergic neuron blockers. May mask warning signs of damage caused by ototoxic drugs eg. aminoglycosides ---------------------------------------------------------------------------------------------------------------Pizotifen 0.5 mg Tablet B Trade Name : Sandomigran Indication : Prophylactic treatment of vascular headache Dosage : ADULT: 0.5 mg in the evening for first 2 days, then 0.5 mg mid-day and evening for next 2 days, then 0.5 mg 3 times daily. CHILD: Up to 1.5 mg daily in divided doses Precautions : Narrow-angle glaucoma, obesity, urinary retention. May affect ability to drive and operate machinery. Pregnancy, breast feeding. Dosage reduction may be necessary in renal impairment, prostatic hyperplasia, pyloroduodenal obstruction, epilepsy, hepatic impairment, elderly, young children. Pregnancy, lactation Adverse Reactions : Sedation, dizziness, dry mouth and constipation. Increased appetite, sedation, nausea, fatigue. Rarely, hypersensitivity reactions, face oedema, rash, central nervous system stimulation, hallucinations, seizures, depression, drowsiness, headache, palpitation, arrhythmias, gastrointestinal disturbance, palpitations, blood disorders, convulsions, sweating, myalgia, paraesthesias, extrapyramidal effects, sleep disturbances, confusion, tinnitus, tremor, hypotension, hair loss Contraindications : Hypersensitivity to the drug. Children less than 2 years. Postural giddiness 132 Interactions : Central effects of sedatives, hypnotics, antihistamines, including certain common cold preparations and alcohol may be enhanced. Antagonised hypotensive effect of adrenergic neuron blockers. May mask warning signs of damage caused by ototoxic drugs eg. aminoglycosides ---------------------------------------------------------------------------------------------------------------Carbamazepine 100 mg/5 ml (2% w/v) Syrup A Trade Name : Tegretol Indication : Epilepsy Dosage : ADULT: Initially, 100-200 mg once or twice daily gradually increased by increments of 100-200 mg every 2 week. Maintenance: 0.8-1.2 g daily in divided doses. CHILD: 10-15 years: 0.6-1 g daily; 5-10 years: 400-600 mg daily; 1-5 years: 200-400 mg daily; less than or equal to 1 year: 100-200 mg daily. Alternatively, 10-20 mg/kg body weight daily in divided doses. Max: Adult: 1.6 g daily Precautions : Breast feeding, pregnancy, liver or kidney dysfunction, increased intraocular pressure, history of cardiac damage, elderly patients, glaucoma, may exacerbate certain types of idiopathic epilepsy. Avoid abrupt discontinuation. Neonatal withdrawal syndrome. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Rash, Stevens-Johnson Syndrome, nausea, drowsiness, dizziness, ataxia, blood dyscrasias, confusion, agitation, visual disturbance, constipation or diarrhoea, anorexia, leukopenia, blood disorders, Syndrome of inappropriate ADH (SIADH), cardiac conduction abnormalities, gynaecomastia. Allergic skin reactions, leukopenia, vomiting, accommodation disorders, diplopia, raised liver enzymes, thrombocytopenia and hyponatraemia, exfoliative dermatitis Contraindications : Hypersensitivity to carbamazepine products or tricyclic compounds, bone marrow suppression, porphyria. Concomitant MAOIs, pregnancy Interactions : Plasma level is increased by erythromycin, diltiazem, isoniazid, verapamil, fluoxetine, cimetidine and decreased by other antiepileptics and theophylline. May reduce alcohol tolerance and antagonise the effects of non-depolarising muscle relaxants. Cytochrome P450 3A4 inducers or inhibitors, oral contraceptive ---------------------------------------------------------------------------------------------------------------Carbamazepine 200 mg CR Tablet A Trade Name : Tegretol CR Indication : Epilepsy Dosage : ADULT: Initial, 200 mg twice daily for the first week, may increase dosage by 200 mg/day at weekly intervals until optimal response is obtained. Maximum 1.6 g/day. CHILD: usual maximum dosage 1000 mg/day in children 12-15 years of age, 1200 mg/day in patients above 15 years of age Precautions : Breast feeding, pregnancy, liver or kidney dysfunction, increased intraocular pressure, history of cardiac damage, elderly patients, glaucoma, may exacerbate certain types of idiopathic epilepsy. Initial and periodic complete blood counts, liver function tests and urinalysis. Monitor plasma levels. History haematological reactions. Road/machinery users. Increased intraocular pressure, latent 133 psychosis, confusion, agitation. Mixed seizure disorders. Elderly. Avoid abrupt discontinuation. Neonatal withdrawal syndrome. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Rash, Stevens-Johnson Syndrome, nausea, drowsiness, dizziness, ataxia, blood dyscrasias, confusion, agitation, visual disturbance, constipation or diarrhoea, anorexia, leukopenia, blood disorders, Syndrome of Inappropriate ADH (SIADH), cardiac conduction abnormalities, gynaecomastia. Allergic skin reactions, leukopenia, vomiting, accommodation disorders, diplopia, raised liver enzymes, thrombocytopenia and hyponatraemia, exfoliative dermatitis Contraindications : Hypersensitivity to carbamazepine products or tricyclic compounds, bone marrow suppression, porphyria. Concomitant MAOIs, pregnancy Interactions : Plasma level is increased by erythromycin, diltiazem, isoniazid, verapamil, fluoxetine, cimetidine and decreased by other antiepileptics and theophylline. May reduce alcohol tolerance and antagonise the effects of non-depolarising muscle relaxants. Cytochrome P450 3A4 inducers or inhibitors, oral contraceptive ---------------------------------------------------------------------------------------------------------------Carbamazepine 200 mg Tablet B Trade Name : Tegretol Indication : i) Epilepsy ii) Trigeminal neuralgia Dosage : i) ADULT: 100 - 200 mg 1 - 3 times daily increased gradually to usual dose of 0.8 - 1.2 g daily in divided doses. CHILD: Up to 1 year: 100 - 200 mg daily; 1 - 5 yrs: 200 - 400 mg daily; 5 - 10 years: 400 - 600 mg daily; 10 - 15 years: 0.6 - 1 g daily ii) ADULT: Initially, 100 mg once or twice daily gradually increased as necessary. Maintenance: 400-800 mg daily in 2-4 divided doses. Max: 1.2 g daily Precautions : Breast feeding, pregnancy, liver or kidney dysfunction, increased intraocular pressure, history of cardiac damage, elderly patients, glaucoma, may exacerbate certain types of idiopathic epilepsy. Avoid abrupt discontinuation. Neonatal withdrawal syndrome. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Rash, Stevens-Johnson Syndrome, nausea, drowsiness, dizziness, ataxia, blood dyscrasias, confusion, agitation, visual disturbance, constipation or diarrhoea, anorexia, leukopenia, blood disorders, Syndrome of Inappropriate ADH (SIADH), cardiac conduction abnormalities, gynaecomastia. Allergic skin reactions, leukopenia, vomiting, accommodation disorders, diplopia, raised liver enzymes, thrombocytopenia and hyponatraemia, exfoliative dermatitis Contraindications : Hypersensitivity to carbamazepine products or tricyclic compounds, bone marrow suppression, porphyria. Concomitant MAOIs, pregnancy Interactions : Plasma level is increased by erythromycin, diltiazem, isoniazid, verapamil, fluoxetine, cimetidine and decreased by other antiepileptics and theophylline. May reduce alcohol tolerance and antagonise the effects of non-depolarising muscle relaxants. Cytochrome P450 3A4 inducers or inhibitors, oral contraceptive ---------------------------------------------------------------------------------------------------------------- 134 Clonazepam 2 mg Tablet B Trade Name : Rivotril Indication : i) Epilepsy ii) Non-epileptic myoclonus Dosage : i) ADULT: Initially, 1 mg given at night for 4 nights, gradually increased over 2-4 week. Elderly: 500 mcg. Maintenance: 4-8 mg daily. Maximum dosage: 20 mg/day. CHILD: 5-12 years: Initially, 0.5 mg daily; 1-5 years: 0.25 mg daily. Maintenance (given in 2-4 divided doses): 5-12 years: 3-6 mg daily; 15 years: 1-3 mg daily; infants: 0.5-1 mg daily. Maximum 200 mcg/kg/day. ii) ADULT: Initially, 250 mcg twice daily, increased after 3 days up to 1 mg daily. Max: 4 mg daily Precautions : Avoid abrupt withdrawal, renal insufficiency, respiratory disease, acute intermittent porphyria, uncontrolled open angle glaucoma, elderly, pregnancy, lactation, may exacerbate tonic seizures. Patients with spinal or cerebellar ataxia, acute alcohol or drug intoxification, severe liver damage, sleep apnoea, renal and hepatic diseases. History of depression and or suicide attempts. Simultaneous use of other anti-epileptics. Avoid driving and operating machinery Adverse Reactions : Drowsiness, ataxia, aggravation of seizure, fatigue, dizziness. Tiredness, sleepiness, lassitude, muscular hypotonia, muscle weakness, light-headedness, ataxia, slowed reaction, poor concentration, restlessness, confusion, agitation, excitability, irritability, disorientation, anterograde amnesia, depression. Increased production of saliva or bronchial secretions in infants and young children, coordination disturbances, vertigo, anorexia, visual disturbances, libido changes Contraindications : Hypersensitivity to clonazepam products and benzodiazepines, severe liver disease, narrow angle glaucoma, respiratory depression, acute pulmonary insufficiency Interactions : Alcohol may reduce the efficacy of treatment or produce unexpected side effects. Increases phenytoin or primidone concentrations. Combination with valproate may cause petit mal status epilepticus. Amiodarone, carbamazepine, theophylline. Barbiturates, hydantoins, carbamazepine, other centrally-acting drugs, alcohol ---------------------------------------------------------------------------------------------------------------Diazepam 10 mg/2 ml Injection B Trade Name : Valium Indication : i) Status epilepticus ii) Skeletal muscle spasm iii) Anxiety disorders Dosage : i) Status epilepticus, by slow IV: 5-10 every 10-15 minute (rate not more than 5 mg/min), to a total dose of 30 mg, may repeat in 2 hour if needed. Infants 30 days to 5 years, 0.05-0.3 mg/kg/dose given over 2-3 minutes, every 15-30 minutes to a total dose of 5 mg, repeat in 2-4 hours if necessary. CHILD more than 5 years, 1 mg by slow IV, every 2-5 minutes, maximum 10 mg, repeat in 2-4 hours if necessary ii) Skeletal muscle spasm, by slow IV or IM, 5-10 mg repeated if necessary in 3-4 hours. CHILD (tetanus): 30 days - 5 years, 1-2 mg IM or IV slowly every 3-4 hours as needed. 5 years and above, 5-10 mg IM or IV slowly every 3-4 hours if needed iii) Anxiety disorders, 2-10 mg by slow IV (not more than 5 mg/min). Repeat if necessary every 3-4 hours Precautions : Respiratory disease, history of drug or alcohol abuse, drug dependence, pregnancy, breast feeding, renal and hepatic impairment and avoid operating vehicles or machinery Adverse Reactions : Drowsiness, dizziness, vertigo, hallucinations, blurred vision, confusion, muscle weakness, fatigue, incontinence or urinary retention, constipation, rashes, changes in libido, leukopenia and 135 gastrointestinal, hypotension, ataxia, respiratory depression, sedation, depression, headache, nausea, tremor, withdrawal syndrome, neutropenia, hepatotoxicity, pancytopenia, thrombocytopenia, blood dyscrasias, bradycardia, dependence/abuse. Paradoxical reactions in children and elderly Contraindications : Respiratory depression, acute pulmonary insufficiency, severe hepatic impairment, acute narrow angle glaucoma, myasthenia gravis, hypersensitivity to diazepam products, patients less than 6 months old, alcohol intoxication, central nervous system depression Interactions : Central nervous system depressants, barbiturates, alcohol, isoniazid, rifampicin, phenytoin, ritonavir, omeprazole, cimetidine, theophylline, digoxin, erythromycin, itraconazole ---------------------------------------------------------------------------------------------------------------Diazepam 5 mg Rectal Solution Trade Name : Stesolid Indication : Status epilepticus, skeletal muscle spasm Dosage : Status epilepticus - ADULT: 0.5 mg/kg repeated after 12 hours if necessary. CHILD (febrile convulsions, prolonged or recurrent): 0.5 mg/kg (maximum 10 mg), repeated if necessary. Not recommended for children below 2 years C Precautions : Respiratory disease, history of drug or alcohol abuse, drug dependence, pregnancy, breast feeding, renal and hepatic impairment and avoid operating vehicles or machinery Adverse Reactions : Drowsiness, dizziness, vertigo, hallucinations, blurred vision, confusion, muscle weakness, fatigue, incontinence or urinary retention, constipation, rashes, changes in libido, leukopenia and gastrointestinal disturbances. Paradoxical reactions in children and elderly Contraindications : Respiratory depression, acute pulmonary insufficiency, severe hepatic impairment, acute narrow angle glaucoma, myasthenia gravis Interactions : Central nervosu system depressants, alcohol, barbiturates, antibacterials, antivirals, omeprazole ---------------------------------------------------------------------------------------------------------------Gabapentin 300 mg Capsule A* Gabapentin 600 mg Tablet A* Trade Name : Neurontin Indication : i) Add-on therapy for intractable partial epilepsy, refractory to standard anti-epileptic drugs ii) Treatment of various types of neuropathic pain, both peripheral (which includes diabetic neuropathy, post-herpetic neuralgia, trigeminal neuralgia) in adult more than 18 years Dosage : i) ADULT: 900 - 1800 mg/day in 3 divided doses. CHILD: 10-40 mg/kg/day in 3 divided doses ii) ADULT: 900 mg/day in 3 equally divided doses, maximum: 3600 mg/day. Initiate therapy with 300 mg once on Day 1, 300 mg twice daily on Day 2, 300 mg three times daily on Day 3. Thereafter, the dose may be increased in 3 equally divided doses up to maximum 3600 mg/day Precautions : Renal insufficiency, patients less than 12 years old, diabetes, pregnancy, lactation, elderly, renal impairment, haemodialysis, absence seizures. Avoid abrupt withdrawal. Discontinuation of gabapentin and or addition or substitution of alternative therapy should be gradual, over a minimum 136 of 1 week. May affect ability to drive or operate machinery. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Somnolence, dizziness, ataxia, weight gain, fatigue, nystagmus, tremor, diplopia, amnesia, dyspepsia, asthenia, leukopenia, headache, myalgia Contraindications : Hypersensitivity to gabapentin Interactions : Antacid like Maalox reduced the bioavailability of gabapentin ---------------------------------------------------------------------------------------------------------------Lamotrigine 100 mg Tablet A Lamotrigine 50 mg Tablet A Trade Name : Lamictal Indication : i) Adjunctive or monotherapy for partial seizures and generalised tonic-clonic seizures not satisfactorily controlled with other antiepileptic drugs ii) Prevention of mood episodes in adult 18 years and above with bipolar disorder, predominately by preventing depressive episodes Dosage : i) Up to 200 mg daily in single or divided dosage ii) 25- 200 mg daily Precautions : Concomitant use of other antiepileptics, discontinue therapy at the first sign of rash, renal, hepatic or cardiac impairment, pregnancy, lactation. Closely monitor and consider withdrawal if hypersensitivity syndrome develops. Avoid abrupt withdrawal (reduce dosage stepwise over a period of 2 week) unless serious skin reaction occurs. Significant hepatic or renal impairment. Monitor and adjust dose if necessary in women who are starting or stopping hormonal contraceptives during Lamictal therapy. Close supervision of patients at high risk of suicide in bipolar disorder. Potential of an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Dizziness, fatigue, headache, hypersensitivity reactions, rashes, malaise, leukopenia, thrombocytopenia, photosensitivity, blurred vision, conjunctivitis, drowsiness, insomnia, ataxia, nausea. Irritability, drowsiness, insomnia, tremor, nystagmus, ataxia, diplopia, blurred vision, gastrointestinal disturbances, arthralgia, pain including back pain. Rarely, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis Contraindications : Hypersensitivity to lamotrigine products, hepatic impairment Interactions : Metabolism is increased by carbamazepine, phenobarbital, phenytoin and primidone, decreased by valproate. Central nervous system events occur with carbamazepine. Rifampicin, ethinyloestradiol/levonorgestrel combination enhances the metabolism of lamotrigine. Sodium valproate reduces the metabolism of lamotrigine. Possible interference with folate metabolism during long-term therapy ---------------------------------------------------------------------------------------------------------------Levetiracetam 500 mg Tablet A* Trade Name : Keppra Indication : i) Monotherapy therapy in the treatment of partial onset seizures with or without secondary generalization in patients from age 16 years of age with newly diagnosed epilepsy ii) Adjunctive treatment in partial onset seizures with or without secondary generalization in adults and children 137 from 4 years of age with epilepsy; juvenile myoclonic epilepsy and idiopathic generalized tonic clonic epilepsy from 12 years of age Dosage : i) Monotherapy ADULTS and ADOLESCENT (from 16 years) : Starting dose: 250 mg twice daily, Increase dose to 500 mg twice daily after 2 week. Dose can be further increased by 250 mg twice daily every 2 week depending upon the clinical response. Max: 1500 mg twice daily. ii) ADULT more than 18 years and ADOLESCENT (12-17 years) more than or equal to 50 kg: Initially 500 mg twice daily may be increased up to 1500 mg twice daily. Dose changes can be made in 500 mg twice daily increments or decrements 2-4 weekly. CHILD (4-11 years) and ADOLESCENT (12-17 years) less than 50 kg : Initially 10 mg/kg twice daily, may be increased up to 30 mg/kg twice daily. Dose changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks. CHILD more than or equal to 50 kg: Adult dose Precautions : Avoid abrupt discontinuation, renal impairment, severe hepatic impairment, pregnancy, lactation, elderly. May affect ability to drive or operate machinery. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Asthenia, somnolence, dizziness, anorexia, diarrhoea, nausea, dyspepsia, rash, diplopia Contraindications : Hypersensitivity to levetiracetam products Interactions : Evening primrose, ginkgo ---------------------------------------------------------------------------------------------------------------Phenobarbitone 30 mg Tablet Trade Name : Luminal Indication : Epilepsy Dosage : ADULT: 60 - 180 mg daily on. CHILD: Up to 8 mg/kg daily B Precautions : Depression, renal impairment, pulmonary insufficiency, elderly, avoid abrupt discontinuation, pregnancy, breast feeding, porphyria, hyperactivity in children Adverse Reactions : Hypersensitivity, rash, hypotension, drowsiness, ataxia, respiratory depression, dyskinesias Contraindications : Hypersensitivity to phenobarbital products, porphyria Interactions : Alcohol, antibacterial, warfarin, antidepressants, other antiepileptics, antipsychotics, antiviral, ciclosporin ---------------------------------------------------------------------------------------------------------------Phenobarbitone Sodium 200 mg/ml Injection B Trade Name : Gardenal Indication : Status Epilepticus Dosage : ADULT: 10 mg/kg IV at a rate of not faster than 100 mg/minute. Initial maximum dose does not exceeding 1 gm. Daily maintenance of 1 - 4 mg/kg/day. CHILD: 10 - 20 mg/kg/dose loading dose, followed by repeated doses at 10 mg/kg/dose (strictly in ICU setting). Maintenance 5 - 8 mg/kg/day 138 Precautions : Depression, renal impairment, pulmonary insufficiency, elderly, avoid abrupt discontinuation, pregnancy, breast feeding, porphyria, hyperactivity in children Adverse Reactions : Hypersensitivity, rash, hypotension, drowsiness, ataxia, respiratory depression, dyskinesias Contraindications : Hypersensitivity to phenobarbital products, porphyria Interactions : Alcohol, antibacterial, warfarin, antidepressants, other antiepileptics, antipsychotics, antiviral, ciclosporin ---------------------------------------------------------------------------------------------------------------Phenytoin Sodium 30mg Capsule B Phenytoin Sodium 100 mg Capsule B Trade Name : Dilantin Indication : Epilepsy Dosage : ADULT and CHILD more than 6 years: 300-400 mg/day in 3 - 4 divided doses before meals. Maximum: 600 mg/day. CHILD: Initially 5 mg/kg/day in 2 - 3 divided doses. Maintenance: 4 - 8 mg/kg/day. Maximum: 300 mg/day Precautions : Avoid abrupt withdrawal, liver insufficiency, porphyria, discontinue if skin rash occurs, diabetes, elderly, pregnancy, breast feeding. Severe myocardial insufficiency. Pregnancy. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Nystagmus, ataxia, lethargy, blood dyscrasias, cardiovascular toxicity, nausea, vomiting, headache, tremor, insomnia, gingival hypertrophy, acne, lupus erythematosus, Stevens-Johnson syndrome, leukopenia, megaloblastic anaemia, hirsutism, hepatitis. Slurred speech, decreased coordination, mental confusion, constipation, toxic hepatitis, liver damage, hematopoietic complications, dermatological manifestations, agranulocytosis, bullous dermatosis, granulocytopenic disorder, liver damage, nephrotoxicity, pancytopenia, purpuric rash, scaling eczema, thrombocytopenia, toxic epidermal necrolysis Contraindications : Hypersensitivity to phenytoin or hydantoin products, sinus bradycardia, SA block, second and third degree AV block and Adams-Stokes syndrome (intravenous phenytoin only) Interactions : Chloramphenicol, anticoagulants, diazepam, oestrogen, cimetidine, fluconazole etc may increase serum levels. Methotrexate, folic acid, carbamazepine, theophylline, etc may decrease serum levels. Increased phenytoin serum levels with alcohol (acute intake), disulfiram, omeprazole, ticlopidine, salicylates, SSRIs, benzodiazepines, antifungal agents, calcium channel blockers. Decreased phenytoin serum levels with alcohol (acute intake), rifampicin, ciprofloxacin, vigabatrin, sucralfate, theophylline, reserpine, diazoxide, anticonvulsants, antineoplastics ---------------------------------------------------------------------------------------------------------------Phenytoin Sodium 125 mg/5ml Suspension Trade Name : Dilantin Indication : Epilepsy B 139 Dosage : ADULT and CHILD more than 6 years: 300-400 mg/day in 3 - 4 divided doses before meals. Maximum: 600 mg/day. CHILD: Initially 5 mg/kg/day in 2 - 3 divided doses. Maintenance: 4 - 8 mg/kg/day. Maximum: 300 mg/day Precautions : Avoid abrupt withdrawal, liver insufficiency, porphyria, discontinue if skin rash occurs, diabetes, elderly, pregnancy, breast feeding. Severe myocardial insufficiency. Pregnancy. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Nystagmus, ataxia, lethargy, blood dyscrasias, cardiovascular toxicity, nausea, vomiting, headache, tremor, insomnia, gingival hypertrophy, acne, lupus erythematosus, Stevens-Johnson syndrome, leukopenia, megaloblastic anaemia, hirsutism, hepatitis. Slurred speech, decreased coordination, mental confusion, constipation, toxic hepatitis, liver damage, hematopoietic complications, dermatological manifestations, agranulocytosis, bullous dermatosis, granulocytopenic disorder, liver damage, nephrotoxicity, pancytopenia, purpuric rash, scaling eczema, thrombocytopenia, toxic epidermal necrolysis Contraindications : Hypersensitivity to phenytoin or hydantoin products, sinus bradycardia, SA block, second and third degree AV block and Adams-Stokes syndrome (intravenous phenytoin only) Interactions : Chloramphenicol, anticoagulants, diazepam, oestrogen, cimetidine, fluconazole etc may increase serum levels. Methotrexate, folic acid, carbamazepine, theophylline, etc may decrease serum levels. Increased phenytoin serum levels with alcohol (acute intake), disulfiram, omeprazole, ticlopidine, salicylates, SSRIs, benzodiazepines, antifungal agents, calcium channel blockers. Decreased phenytoin serum levels with alcohol (acute intake), rifampicin, ciprofloxacin, vigabatrin, sucralfate, theophylline, reserpine, diazoxide, anticonvulsants, antineoplastics ---------------------------------------------------------------------------------------------------------------Phenytoin Sodium 250 mg/5ml Injection B Trade Name : Dilantin Indication : Status epilepticus Dosage : i) Status epilepticus: ADULT 10 - 15 mg/kg by slow IV. Maximum 50 mg/minute. Maintenance: 100 mg orally/IV every 6 - 8 hours. CHILD 15 - 20 mg/kg by slow IV. Maximum: 1 - 3 mg/kg/minute ii) Neurosurgery 100 - 200 mg IM approximately at 4 hourly interval Precautions : Avoid abrupt withdrawal, liver insufficiency, porphyria, discontinue if skin rash occurs, diabetes, elderly, pregnancy, breast feeding. Severe myocardial insufficiency. Pregnancy. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Nystagmus, ataxia, lethargy, blood dyscrasias, cardiovascular toxicity, nausea, vomiting, headache, tremor, insomnia, gingival hypertrophy, acne, lupus erythematosus, Stevens-Johnson syndrome, leukopenia, megaloblastic anaemia, hirsutism, hepatitis. Slurred speech, decreased coordination, mental confusion, constipation, toxic hepatitis, liver damage, hematopoietic complications, dermatological manifestations, agranulocytosis, bullous dermatosis, granulocytopenic disorder, liver damage, nephrotoxicity, pancytopenia, purpuric rash, scaling eczema, thrombocytopenia, toxic epidermal necrolysis 140 Contraindications : Hypersensitivity to phenytoin or hydantoin products, sinus bradycardia, SA block, second and third degree AV block and Adams-Stokes syndrome (intravenous phenytoin only) Interactions : Chloramphenicol, anticoagulants, diazepam, oestrogen, cimetidine, fluconazole etc may increase serum levels. Methotrexate, folic acid, carbamazepine, theophylline, etc may decrease serum levels. Increased phenytoin serum levels with alcohol (acute intake), disulfiram, omeprazole, ticlopidine, salicylates, SSRIs, benzodiazepines, antifungal agents, calcium channel blockers. Decreased phenytoin serum levels with alcohol (acute intake), rifampicin, ciprofloxacin, vigabatrin, sucralfate, theophylline, reserpine, diazoxide, anticonvulsants, antineoplastics ---------------------------------------------------------------------------------------------------------------Sodium Valproate 200 mg Tablet B Trade Name : Epilim Indication : Epilepsy Dosage : ADULT: Initially 600 mg/day in 2 - 3 divided doses, dose may be increased by 200 mg at 3-day intervals to max 2.5 g/day. Usual maintenance dose: 1-2 g/day (20-30 mg/kg/day). CHILD: More than 20 kg. Initially 400 mg/day with spaced increases until control is achieved (usually 20-30 mg/kg/day), dose may be increased to 35 mg/kg/day. Less than 20 kg 20 mg/kg/day, in severe cases the dose may be increased provided plasma concentration can be monitored Precautions : Monitor liver function, avoid sudden withdrawal, certain metabolic disorders, fatigue, loss of appetite, vomiting. Pregnancy and lactation. Avoid concomitant use of salicylates in children less than 3 years due to risk of liver toxicity, use of salicylates in children less than 16 years is also not recommended. Monitor liver function before therapy and during first 6 months. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Nausea, vomiting, headache, dizziness, ataxia, tremor, weight gain, transient hair loss, oedema, thrombocytopenia, leukopenia. Liver dysfunction, gastrointestinal disorders Contraindications : Hepatic disease or significant hepatic dysfunction, hypersensitivity to valproate sodium, valproic acid or divalproex sodium, porphyria Interactions : Increases phenobarbital, primidone and phenytoin plasma concentrations. Potentiates toxic effect of carbamazepine. Risk of rash may be increased by coadministration with lamotrigine. May potentiate the effect of neuroleptics, MAOIs, antidepressants and benzodiazepines. Potentiate effects of MAOIs. Monitor prothrombin time when used with anticoagulants. Caution when used with newer anti-epileptics whose pharmacodynamics are not well-established ---------------------------------------------------------------------------------------------------------------Sodium Valproate 200 mg/5 ml Syrup B Trade Name : Epilim Indication : Epilepsy Dosage : CHILD: More than 20 kg. Initially 400 mg/day with spaced increases until control is achieved (usually 20-30 mg/kg/day), dose may be increased to 35 mg/kg/day. Less than 20 kg, 20 mg/kg/day. Severe cases: 50 mg/kg daily 141 Precautions : Monitor liver function, avoid sudden withdrawal, certain metabolic disorders, fatigue, loss of appetite, vomiting. Pregnancy, lactation, Avoid concomitant use of salicylates in children less than 3 years due to risk of liver toxicity, use of salicylates in children less than 16 years is also not recommended. Monitor liver function before therapy and during first 6 months. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Nausea, vomiting, headache, dizziness, ataxia, tremor, weight gain, transient hair loss, oedema, thrombocytopenia (dose related), leukopenia. Gastrointestinal disorders, liver failure, children under the age of two years are at increased risk, pancreatitis Contraindications : Hepatic disease or significant hepatic dysfunction, hypersensitivity to valproate sodium, valproic acid or divalproex sodium, porphyria Interactions : Increases phenobarbital, primidone and phenytoin plasma concentrations. Potentiates toxic effect of carbamazepine. Risk of rash may be increased by coadministration with lamotrigine. May potentiate the effect of neuroleptics, MAOIs, antidepressants and benzodiazepines. Monitor prothrombin time when used with anticoagulants. Caution when used with newer anti-epileptics whose pharmacodynamics are not well-established ---------------------------------------------------------------------------------------------------------------Sodium Valproate 400 mg Injection B Trade Name : Epilim Indication : Status epilepticus Dosage : ADULT and CHILD above 10 years: 10 to 15 mg/kg/day IV, may increase 5 to 10 mg/kg/week to achieve optimal clinical response (Maximum 60 mg/kg/day or less with a therapeutic range of 50 to 100 mcg/mL) Precautions : Monitor liver function, avoid sudden withdrawal, certain metabolic disorders, fatigue, loss of appetite, vomiting. Pregnancy, lactation, Avoid concomitant use of salicylates in children less than 3 years due to risk of liver toxicity, use of salicylates in children less than 16 years is also not recommended. Monitor liver function before therapy and during first 6 months. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Nausea, vomiting, headache, dizziness, ataxia, tremor, weight gain, transient hair loss, oedema, thrombocytopenia (dose related), leukopenia. Gastrointestinal disorders, liver failure, children under the age of two years are at increased risk, pancreatitis Contraindications : Hepatic disease or significant hepatic dysfunction, hypersensitivity to valproate sodium, valproic acid or divalproex sodium, porphyria Interactions : Increases phenobarbital, primidone and phenytoin plasma concentrations. Potentiates toxic effect of carbamazepine. Risk of rash may be increased by coadministration with lamotrigine. May potentiate the effect of neuroleptics, MAOIs, antidepressants and benzodiazepines. Monitor prothrombin time when used with anticoagulants. Caution when used with newer anti-epileptics whose pharmacodynamics are not well-established ---------------------------------------------------------------------------------------------------------------142 Topiramate 15 mg Capsule Sprinkle A* Trade Name : Topamax Indication : Add-on therapy for intractable partial epilepsy Dosage : ADULT: 200 - 400 mg/day in 2 divided doses. Maximum 1600 mg/day. CHILD: initial 25 mg (1-3 mg/kg/day), then titrated by 1-3 mg/kg/1-2 weeks in 2 divided doses. Maintenance 5-9 mg/kg/day in 2 divided doses Precautions : Avoid abrupt withdrawal, hepatic or renal impairment, behavioral disorders or cognitive deficit, paraesthesia, predisposition to or history of nephrolithiasis, pregnancy, lactation. Ensure adequate hydration. May impair ability to drive or operate machinery. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Cognitive dysfunction, sedation, diarrhoea, weight loss, dizziness, abdominal pain, nausea, anorexia, confusion, impaired speech, ataxia, drowsiness, fatigue, asthenia, visual disturbances, nystagmus, taste disorder, leucopenia, renal calculi, somnolence and paraesthesia Contraindications : Hypersensitivity to topiramate, breast feeding Interactions : Plasma concentration decreased by phenytoin and carbamazepine. Metabolism of oral contraceptive (oestrogens and progestogens) accelerated (reduced contraceptive effect) ---------------------------------------------------------------------------------------------------------------Topiramate 25 mg Tablet A* Topiramate 50 mg Tablet A* Trade Name : Topamax Indication : Add-on therapy for intractable partial epilepsy Dosage : ADULT: 200 - 400 mg/day in 2 divided doses. Maximum 1600 mg/day. CHILD: initial 25 mg (1-3 mg/kg/day), then titrated by 1-3 mg/kg/1-2 weeks in 2 divided doses. Maintenance 5-9 mg/kg/day in 2 divided doses Precautions : Avoid abrupt withdrawal, hepatic or renal impairment, behavioral disorders or cognitive deficit, paraesthesia, predisposition to or history of nephrolithiasis, pregnancy, lactation. Ensure adequate hydration. May impair ability to drive or operate machinery. Potential for an increase in risk of suicidal thoughts or behaviours Adverse Reactions : Cognitive dysfunction, sedation, diarrhoea, weight loss, dizziness, abdominal pain, nausea, anorexia, confusion, impaired speech, ataxia, drowsiness, fatigue, asthenia, visual disturbances, nystagmus, taste disorder, leucopenia, renal calculi, somnolence and paraesthesia Contraindications : Hypersensitivity to topiramate, breast feeding Interactions : Plasma concentration decreased by phenytoin and carbamazepine. Metabolism of oral contraceptive (oestrogens and progestogens) accelerated (reduced contraceptive effect) ---------------------------------------------------------------------------------------------------------------- 143 Amantadine HCl 100 mg Capsule B Trade Name : Symmetrel Indication : Parkinson's disease Dosage : Initial dose: 100 mg daily and is increased to 100 mg twice daily (not later than 4 p.m.) after a week. Elderly over 65 years: less than 100 mg or 100 mg at intervals of more than 1 day Precautions : Seizure disorder, psychiatry disorder, recurrent eczema, gastric ulceration. Patients with cardiovascular or liver disease, impaired renal function. Elderly. Withdrawal of the drug should be gradual Adverse Reactions : Oedema of ankles, livedo reticularis, depression, hallucination, nausea, vomiting, dizziness, insomnia, blurred vision, dry mouth. Seizures, psychosis, confusion, ataxia, heart failure, depression, orthostatic hypotension, blood dyscrasias, urinary retention, irritability, gastrointestinal disturbances Contraindications : Hypersensitivity to amantadine products, pregnancy, lactation, epilepsy, history of gastric ulceration, severe renal impairment Interactions : Alcohol, methyldopa, metoclopramide, domperidone, antipsychotic, antimuscarinics. Enhances the adverse effects of antimuscarinics and levodopa. Central nervous system stimulants, drugs that raise urinary pH ---------------------------------------------------------------------------------------------------------------Benzhexol 2 mg Tablet B Trade Name : Artane Indication : i) Parkinson's disease ii) Drug induced parkinsonism iii) Dystonias Dosage : ADULT: Initially 1 mg daily. Maintenance: 5 - 15 mg daily in 3 - 4 divided doses. CHILD: 0.02 mg/kg/dose 8 hourly, gradually increasing to 0.1 - 0.3 mg/kg/dose Precautions : Autonomic neuropathy, heart disease, hepatic or renal disease, hyperthyroidism, paediatric, elderly, potential for abuse, prostatic hypertrophy, glaucoma, obstructive disease of gastrointestinal or genitourinary, pregnancy and lactation. Use with caution in patients with ileostomy or colostomy. Avoid driving or hazardous activities. Monitor intraocular pressure Adverse Reactions : Severe mental disturbances, confusion, drowsiness, restlessness, hallucinations, excitement, nausea and vomiting, dry mouth, blurring of vision, constipation, urinary retention, glaucoma Contraindications : Children under 3 years, narrow-angle glaucoma, closed-angle glaucoma, tardive dyskinesias, prostatic enlargement, paralytic ileus, chronic pulmonary disease, sick sinus syndrome, thyrotoxicosis, cardiac failure with tachycardia, lactation Interactions : Alcohol and central nervous system depressants may increase the sedative effect of benzhexol. Delayed absorption of other oral drugs ---------------------------------------------------------------------------------------------------------------- 144 Entacapone 200 mg Tablet A Trade Name : Comtan Indication : Parkinson's Disease. An adjunct to standard levodopa/benserazide or levodopa/carbidopa for use in patients with parkinson's disease and end of dose motor fluctuations, who cannot be stabilised on those combinations Dosage : 200 mg to be taken with each daily dose of levodopa/dopa-decarboxylase inhibitor. May be taken with or without food Precautions : Levodopa-induced orthostatic hypotension may be aggravated. Abrupt withdrawal Adverse Reactions : Nausea, vomiting, abdominal pain, constipation, diarrhoea, urine may be coloured reddish-brown, dry mouth, dyskinesia, dizziness, anaemia, rarely elevated liver enzymes, gastrointestinal symptoms, insomnia, hallucinations, confusion, paroniria, aggravated parkinsonism, dizziness, dystonia, hyperkinesia, fatigue, increased sweating, fall. Extremely rare (potentially serious adverse reactions): Hepatitis, sudden sleep onset episodes, neuroleptic malignant syndrome, rhabdomyolysis Contraindications : Pregnancy and breast-feeding, hepatic impairment, phaeochromocytoma, history of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis. Concomitant use with selective and nonselective MAO-A and MAO-B inhibitors Interactions : Entacapone and ferrous product should be taken at least 2 - 3 hours apart. Dosage of levodopa and other antiparkinson drugs may need to be adjusted when initiating entacapone. Effects of medicinal products metabolised by catechol-O-methyl transferase (COMT) may be potentiated. MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors, medicinal products metabolized by COMT, selegiline, warfarin ---------------------------------------------------------------------------------------------------------------Levodopa 100 mg, Benserazide 25 mg HBS capsule B Trade Name : Madopar HBS Indication : Parkinson's Disease Dosage : Initial: 100/25 mg 1-2 times/day, increase every 3-4 days until therapeutic effect, optimal dosage: 400/100 mg to 800/200 mg/day divided into 4-6 doses. Dose: 200/50 mg used only when maintenance therapy is reached and not to exceed levodopa 1000-1200 mg/benserazide 250-300 mg per day Precautions : Open-angle glaucoma, depression, diabetes, severe cardiovascular disease, bronchial asthma, renal, hepatic or endocrine disease, history of psychoses or convulsion. Lactation. Perform liver function and blood count tests during treatment. Discontinue 12-48 hours before surgery requiring general anaesthesia. If patient must undergo surgery without Madopar having been withdrawn, avoid anaesthesia with cyclopropane or halothane Adverse Reactions : Anorexia, nausea and vomiting, diarrhoea, insomnia, agitation, cardiac arrhythmias, postural hypotension (rarely labile hypertension), dizziness, tachycardia, arrhythmias, reddish discoloration of urine and other body fluid, rarely hypersensitivity, abnormal involuntary movement. Lost or change of taste. Abnormal involuntary movements. Rarely, skin reactions, haemolytic anaemia, mild, transient leukopenia and thrombocytopenia. Agitation, anxiety, insomnia, hallucination, delusion and temporal disorientation in the elderly 145 Contraindications : Hypersensitivity to this drug. Patient on MAOIs therapy with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases or closed-angle glaucoma. Pregnancy. Patients less than 25 years. Lactation. Combination with MAOIs (except selegiline) Interactions : Hypertensive crisis with MAOIs, increased hypotensive effect with antihypertensives, antagonism effect of antipsychotic, reduced absorption by iron, plasma concentration increased by metoclopramide. Tricylic antidepressant, phenothiazines, phenytoin, pyridoxine. Potentiates effects of sympathomimetics. Neuroleptics, opioids, antihypertensives containing reserpine, antacid, protein-rich meal ---------------------------------------------------------------------------------------------------------------Levodopa 200 mg, Benserazide 50 mg Tablet B Trade Name : Madopar Indication : Parkinson's Disease Dosage : Initial: 100/25 mg 1-2 times/day, increase every 3-4 days until therapeutic effect, optimal dosage: 400/100 mg to 800/200 mg/day divided into 4-6 doses. Dose: 200/50 mg used only when maintenance therapy is reached and not to exceed levodopa 1000-1200 mg/benserazide 250-300 mg per day Precautions : Open-angle glaucoma, depression, diabetes, severe cardiovascular disease, bronchial asthma, renal, hepatic or endocrine disease, history of psychoses or convulsion. Lactation. Perform liver function and blood count tests during treatment. Discontinue 12-48 hours before surgery requiring general anaesthesia. If patient must undergo surgery without Madopar having been withdrawn, avoid anaesthesia with cyclopropane or halothane Adverse Reactions : Anorexia, nausea and vomiting, diarrhoea, insomnia, agitation, cardiac arrhythmias, postural hypotension (rarely labile hypertension), dizziness, tachycardia, arrhythmias, reddish discoloration of urine and other body fluid, rarely hypersensitivity, abnormal involuntary movement. Lost or change of taste. Abnormal involuntary movements. Rarely, skin reactions, haemolytic anaemia, mild, transient leukopenia and thrombocytopenia. Agitation, anxiety, insomnia, hallucination, delusion and temporal disorientation in the elderly Contraindications : Hypersensitivity to this drug. Patient on MAOIs therapy with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases or closed-angle glaucoma. Pregnancy. Patients less than 25 years. Lactation. Combination with MAOIs (except selegiline) Interactions : Hypertensive crisis with MAOIs, increased hypotensive effect with antihypertensives, antagonism effect of antipsychotic, reduced absorption by iron, plasma concentration increased by metoclopramide. Tricylic antidepressant, phenothiazines, phenytoin, pyridoxine. Potentiates effects of sympathomimetics. Neuroleptics, opioids, antihypertensives containing reserpine, antacid, protein-rich meal ---------------------------------------------------------------------------------------------------------------- 146 Levodopa 250 mg and Carbidopa 25 mg Tablet Levodopa 100 mg and Carbidopa 25 mg Tablet Trade Name : Sinemet Indication : Parkinson's disease Dosage : Patients not receiving Levodopa before, initially 100 - 125 mg 3 - 4 times daily adjusted according to response. Maintenance: 0.75 - 2 g in divided doses. In patients previously treated with Levodopa the dose should be about 20 - 25% of the dose previous being taken B B Precautions : Not recommended for treatment of drug-induced extrapyramidal reactions. The occurrence of dyskinesias in patients previously treated with levodopa alone may require dosage reduction. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Cardiovascular disease or pulmonary disease, bronchial asthma. Hepatic impairment, renal impairment, endocrine disease, chronic wide-angle glaucoma. Observe carefully when the dosage is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. Pregnancy, women of childbearing potential. Not recommended in patients less than 18 years Adverse Reactions : Central nervous system: Anxiety, confusion, nervousness, mental depression, psychotic symptoms. Anorexia, nausea and vomiting, diarrhoea, insomnia, agitation, postural hypotension, dizziness, chest pain, tachycardia, arrhythmias, reddish discoloration of urine and other body fluid. Dyskinesia, muscle twitching and blepharospasm may be taken as early signs to consider dosage reduction. Gastrointestinal bleeding, development of duodenal ulcer, dark saliva, leukopenia, hemolytic and non-hemolytic anemia, thrombocytopenia, agranulocytosis, angioedema, urticaria, pruritus, paresthesia, increased libido, dyspnea, alopecia, rash, dark sweat, dark urine Contraindications : Hypersensitivity to this drug. Patient on MAOIs therapy or 2 weeks prior to initiating therapy. May be administered concomitantly with or an MAOI with or selectivity for MAO type B (eg selegiline HCl). Narrow-angle glaucoma with compensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases or closed-angle glaucoma, undiagnosed skin lesion, melanoma, pregnancy Interactions : Hypertensive crisis with MAOIs, increased hypotensive effect with antihypertensives, antagonism effect of antipsychotic, reduced absorption by iron, plasma concentration increased by metoclopramide. Linezolid, clonidine, anticholinergics, tricylic antidepressant, phenothiazines, phenytoin, papaverine, selegiline and high protein diet ---------------------------------------------------------------------------------------------------------------Piracetam 1.2 g Tablet Trade Name : Nootropil Indication : Mild cognitive impairment, post concussional head syndrome, head injury disorder, chronic vertigo and myoclonus Dosage : Initially 7.2 g daily in 2 - 3 divided doses, increased according to response by 4.8 g daily every 3 - 4 days to maximum of 20 g daily. CHILD under 16 years not recommended Precautions : Renal insufficiency (possible need for dose adjustments), elderly patients with multiple diseases Adverse Reactions : 147 A* Nervousness, agitation, irritability, anxiety and sleep disturbances, fatigue or drowsiness, gastrointestinal disturbances Contraindications : Previous hypersensitivity to piracetam. Huntington's chorea Interactions : Warfarin: an increased risk of bleeding ---------------------------------------------------------------------------------------------------------------Piribedil 50 mg Tablet A* Trade Name : Trivastal Retard Indication : Parkinson disease Dosage : As monotherapy: 150 - 250 mg as 3 - 5 divided doses daily. As combination with L-dopa therapy: 50 150 mg daily (50 mg per 250 mg of L-dopa) Precautions : Hepatic dysfunction, elderly, psychosis, parkinsonism, mania, thyroid disorder Adverse Reactions : Drowsiness, confusion, anxiety, dizziness, delusions, hallucinations, hypotension, tachycardia, extrapyramidal effects, dyskinesias, mania, gastric discomfort, nystagmus, changes in liver function, gastrointestinal disorders (nausea, vomiting, flatulence), orthostatic hypotension, drowsiness Contraindications : Hypersensitivity to piribedil, cardiogenic shock, acute phase of myocardial infaction Interactions : Dopaminergic antagonists ---------------------------------------------------------------------------------------------------------------Pramipexole Dihydrochloride 0.125 mg Tablet A* Trade Name : Sifrol Indication : Treatment for signs and symptoms of advanced idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa Dosage : Dose escalation: 0.125 mg 3 times daily on week 1 then 0.25 mg 3 times daily week 2 then 0.5 mg 3 times daily on week 3. Increase by 0.75 mg at weekly intervals if needed up to maximum of 4.5 mg/day. Patient on levodopa: Reduced dose. Renal impairment: creatinine clearance: 20 - 50 ml/minute: initially 0.125 mg twice daily, creatinine clearance less than 20 ml/minute initially 0.25 mg daily as a single dose, maximum dose: 1.5 mg twice daily Precautions : Renal impairment, severe cardiovascular disease. Avoid abrupt withdrawal. Pregnancy and lactation. May impair ability to drive or operate machinery Adverse Reactions : Nausea, constipation, somnolence, hallucination, confusion, dizziness, dyskinesia, amnesia, asthenia, dream disorder, extrapyramidal movements, insomnia, orthostatic hypotension Contraindications : Hypersensitivity to pramipexole or to any of the excipients Interactions : Cimetidine, amantadine, antipsychotics (typical), central nervous system depressants. Avoid alcohol ---------------------------------------------------------------------------------------------------------------- 148 Procyclidine HCl 10 mg/2 ml Injection B Trade Name : Kemadrin Indication : i) All forms of Parkinson's disease (idiopathic paralysis agitants), post-encephalitis and arteriosclerosis ii) To control troublesome extrapyramidal symptoms induced by neuroleptic drugs including pseudoparkinsonism, acute dystonic reactions and akathisia Dosage : By IM injection 5 - 10 mg repeated if necessary after 20 minutes. Maximum 20 mg daily. By IV injection 5 - 10 mg Precautions : Hypotension, severe psychoses, prostatic hypertrophy, tachycardia, urinary retention, hepatic or rena impairment, lactation, pregnancy, children, elderly Adverse Reactions : Excitability, dizziness, hallucinations (seen on abuse), dry mouth, constipation, urinary retention, agitation, restlessness, convulsions Contraindications : Closed-angle glaucoma, narrow-angle glaucoma, hypersensitivity to procyclidine products, gastrointestinal tract or urinary outflow obstruction, prostatic hypertrophy, tardive dyskinesia in patients on neuroleptic drugs Interactions : Anticholinergic-like drugs, chlorpromazine, haloperidol, promethazine, thioridazine, trifluoperazine and prochlorperazine. Reduced peristaltic movement affects absorption of erythromycin, penicillin ---------------------------------------------------------------------------------------------------------------Ropinirole HCl 0.25 mg Tablet A* Trade Name : Requip Indication : Parkinson disease in younger patients and patients with dyskinesias, especially peak dose dyskinesias Dosage : 0.25 mg 3 times daily gradually increasing till adequate response obtained up to a maximum of 24 mg/day. Most patients need 3-9 mg/day Precautions : Several renal or hepatic failure, concomitant use of alcohol, others central nervous system depressants and neuroleptics. Pregnancy. May impair ability to drive or operate machinery. Withdrawal should be gradual Adverse Reactions : Dizziness, headache, somnolence, nausea, vomiting, dyskinesia, hallucinations (dose related), sleep attacks, postural hypotension, syncope, abdominal pain Contraindications : Hypersensitivity to ropinirole, pregnancy and lactation, hepatic or severe renal impairment Interactions : Neuroleptics and other centrally active dopamine antagonist, other dopamine agonists, ciprofloxacin, high dose oestrogen, hormone replacement therapy, antiarrhythmias, inhibitors of CYP1A2 eg, cimetidine, erythromycin, fluvoxamine, isoniazid, ritonavir and zileuton may increase serum concentrations of ropinirole. Ethanol, kava kava, gotu kola, valerian and St John's wort may increase central nervous system depression ---------------------------------------------------------------------------------------------------------------149 Selegiline HCl 5 mg Tablet Trade Name : Jumex Indication : Only for treatment of late stage Parkinsonism with on and off phenomenon Dosage : 5 mg twice daily at breakfast and lunch. Maximum 10 mg/day A* Precautions : History of peptic ulcer, pregnancy and lactation, elderly, concurrent use of tricyclic antidepressants, uncontrolled hypertension. Suicidal ideation and behavior or worsening depression, increased risk during the first few months of therapy or following changes in dosage (particularly in children, adolescents and young adults with major depressive disorder) Adverse Reactions : Hypotension, nausea, confusion, agitation, hallucination, dyskinesia, sleep disturbances, psychosis, constipation, dry mouth, headache, tremor, dizziness Contraindications : Extrapyramidal symptoms not related to dopamine deficiency, thyrotoxicosis, narrow angle glaucoma agitated psychosis, hypersensitivity to selegiline products. Pregnancy Interactions : Hyperpyrexia and central nervous system toxicity with pethidine. Hypertension and central nervous system excitation with fluoxetine and sertraline. Hypotension with MAOIs. Carbamazepine, amitriptyline, amphetamine ---------------------------------------------------------------------------------------------------------------Methadone 5mg/ml Syrup A Indication : Detoxification treatment of narcotic addiction Dosage : 10 - 40 mg orally once daily. Increased by up to 10 mg daily (maximum increase 30 mg weekly) until no signs of withdrawal or intoxication, usual dose range 60 - 120 mg daily. CHILD not recommended Precautions : May cause dependence on prolonged use. Avoid alcoholic beverages, effects on ability to drive or operate machine. Methadone, even in low doses is a special hazard for children, non-dependent adults are also at risk of toxicity and dependent adults are at risk if tolerance is incorrectly asessed during induction Adverse Reactions : Constipation, nausea, vomiting, asthenia, dizziness, somnolence, cardiac arrest, disease of cardiovascular system, shock, respiratory arrest, respiratory depression, diaphoresis, constipation, sedation Contraindications : Hypersensitivity to methadone, severe hepatic impairment, respiratory depression, obstructive airways disease, ulcerative colitis, concomitant administration with monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuation Interactions : Buprenorphine, didanosine, efavirenz, fluconazole, fluvoxamine, naltrexone, nevirapine, rifampin, risperidone, ritonavir, voriconazole, zidovudine ---------------------------------------------------------------------------------------------------------------- 150 Donepezil HCl 5 mg Tablet A Donepezil HCl 10 mg Tablet A Trade Name : Aricept Indication : Treatment of mild to moderate dementia in Alzheimer's disease, as well as in patients with severe Alzheimer's disease. [psychiatrists and neurologists only] Dosage : 5 - 10 mg once daily at bedtime. Maximum 10 mg daily Precautions : Gastrointestinal disease or history of ulcer disease, asthma or obstructive pulmonary disease or seizures or those receiving concurrent NSAIDs, pregnancy, cardiac conduction abnormalities, anaesthesia with succinylcholine Adverse Reactions : Diarrhoea, muscle cramps, nausea, vomiting, insomnia, fatigue, dizziness, hallucination, agitation, loss of appetite Contraindications : Hypersensitivity to donepezil hydrochloride and piperidine derivatives. Pregnancy and lactation Interactions : Has the potential for synergistic activity with concurrent succinylcholine, other neuromuscular blocking agents or cholinergic agonist. Has the potential to interfere with drugs having anticholinergic activity. Muscle relaxants drugs, suxamethonium ---------------------------------------------------------------------------------------------------------------Rivastigmine 1.5 mg Capsule A* Trade Name : Exelon Indication : For psychiatrists and neurologists only. Mild to moderately severe dementia associated with Alzheimer's or Parkinson's disease Dosage : Initial dose 1.5 mg 2 times daily, may increase by 1.5 mg 2 times daily every 2 weeks to maximum of 6 mg 2 times daily. If treatment is interrupted for several days, should be reinitiated at the lowest daily dose Precautions : History of toxicity (especially excessive cholinergic responses) related to other cholinesterase inhibitors (e.g: tacrine), diabetes, cardiovascular/pulmonary disease, gastrointestinal disorders, concurrent use of agents with anticholinergic activity, urogenital tract obstruction, parkinsonism, pregnancy, renal or hepatic insufficiency, high incidence of nausea and vomiting, concurrent NSAIDs, asthma or obstructive pulmonary disease, anorexia, weight loss, neurological conditions resulting in seizures, extrapyramidal symptoms, tremor Adverse Reactions : Nausea, vomiting, anorexia, dizziness, diarrhoea, abdominal pain, loss of appetite, dyspepsia and headache Contraindications : Known hypersensitivity to the drug, other carbamate derivatives, severe liver impairment Interactions : Cholinomimetic drugs, anticholinergic medications, succinylcholine-type muscle relaxants during anaesthesia, diazepam, digoxin, fluoxetine and warfarin ---------------------------------------------------------------------------------------------------------------- 151 Rivastigmine 4.6mg/24hr Transdermal Patch A* Rivastigmine 9.5 mg/24hr Transdermal Patch A* Trade Name : Exelon® patch 5, Exelon®patch 10 Indication : Mild to moderately severe dementia associated with Alzheimer's or Parkinson's disease Dosage : Initial, 4.6 mg/24 hr patch TOPICALLY once daily; after a minimum of 4 weeks and good tolerability, increase the dose to 9.5 mg/24 hr patch once daily Precautions : Sick-sinus syndrome, conduction defects, urinary obstruction, seizures in predisposed patients, asthma or obstructive pulmonary disease. Pregnancy and lactation. Hepatic impairment, renal impairment, anesthesia, low body weight, nicotine use. May impair ability to drive or operate machinery Adverse Reactions : Vomiting, nausea, anorexia, decreased appetite, anxiety, depression, insomnia, dizziness, headache, diarrhoea, dyspepsia, abdominal pain, application site reaction Contraindications : Hypersensitivity to rivastigmine, other carbamate derivatives and other components of the product Interactions : Cholinomimetic drugs, anticholinergic medications, succinylcholine-type muscle relaxants during anaesthesia ---------------------------------------------------------------------------------------------------------------Atomoxetine HCl 10 mg Capsule A* Atomoxetine HCl 18 mg Capsule A* Trade Name : Strattera Indication : Attention deficit hyperactivity disorder (ADHD) in children 6 years and older who do not respond to methylphenidate or who have intolerable effects or have tics. Diagnosis should be made according to DSM IV criteria or the guidelines in ICD-10 Dosage : CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 mg/kg/day for at least 7 days, then increased according to response. Maintenance: 1.2 mg/kg/day. ADULTS and ADOLESCENTS more than 70 kg: Initially 40 mg/day for at least 7 days then increased according to response. Maintenance: 80 mg/day. Max 100 mg/ day Precautions : Hypotension, cardiovascular or cerebrovascular disease. Hypertension tachycardia. Urinary retention or bladder dysfunction. Monitor growth in children, QT interval prolongation, history of seizures, susceptibility to angle-closure glaucoma, hepatic impairment, suicidal ideation. Pregnancy and lactation Adverse Reactions : Gastrointestinal disorder or cardiovascular disorders, weight loss, decreased appetite, weight loss. Nervous system disorders such as dizziness, headache, insomnia, somnolence, mood swings, urinary retention, dysmenorrhea, ejaculation disorder. Orthostatic hypotension and syncope, psychiatric disorders such as irritability, suicidal thought Contraindications : Concomitant use with MAOIs. Narrow-angle glaucoma, liver injury, jaundice 152 Interactions : MAOIs, CYP2D6 inhibitors (fluoxetine, paroxetine), salbutamol, pressor agents, drugs that affect noradrenaline ---------------------------------------------------------------------------------------------------------------Piracetam 1 g Injection A* Trade Name : Nootropil Indication : Treatment of cerebral functional impairment and ischaemic stroke Dosage : 30 - 160 mg/kg/day orally or parenterally 2 times daily or 3 to 4 times daily. Maximum: 24 g/day Precautions : Renal insufficiency (possible need for dose adjustments), elderly patients with multiple diseases Adverse Reactions : Nervousness, agitation, irritability, anxiety and sleep disturbances, fatigue or drowsiness, gastrointestinal disturbances Contraindications : Previous hypersensitivity to piracetam. Huntington's chorea Interactions : Warfarin: an increased risk of bleeding ---------------------------------------------------------------------------------------------------------------Betahistine Dihydrochloride 24 mg Tablet Trade Name : Betaserc® Indication : Vertigo, tinnitus and hearing loss associated with Meniere's disease Dosage : 24 mg twice daily A* Precautions : Betahistine should not be given to patients with phaeochromocytoma. It should be given with care to patients with asthma, peptic ulcer disease or a history of peptic ulcer disease. Antihistamines may block some or all of intended effects of betahistine. Liver disease, pregnancy, lactation Adverse Reactions : Nausea, vomiting, skin rash, pruritus Contraindications : Hypersensitivity, phaeochromocytoma Interactions : Selegiline ---------------------------------------------------------------------------------------------------------------Baclofen 10 mg Tablet Trade Name : Lioresal Indication : Spasticity of the skeletal muscle Dosage : ADULT: 5 mg 3 times daily. Max: 80 mg daily. CHILD: 0.75 - 2 mg/kg daily (more than 10 years, maximum: 2.5 mg/kg daily) B Precautions : Pregnancy, patients suffering not only from spasticity but also from psychotic disorders, schizophrenia or confusional states, epilepsy, cerebrovascular or respiratory insufficiency. Central 153 nervous system depressants, antihypertensives, levodopa. Caution in road users. Avoid abrupt discontinuation Adverse Reactions : Daytime sedation, drowsiness, nausea and other central nervous system disorders, gastrointestinal disturbances, dysuria, frequency of micturition, enuresis or retention of urine, respiratory depression Contraindications : Epilepsy and other convulsive conditions, corticol or subcorticol brain damage, peptic ulceration, known hypersensitivity to baclofen Interactions : Tricyclics and lithium enhance muscle relaxant effect, ACE inhibitor, diuretics and antihypertensives enhance hypotensive effect. Sedative effect enhanced with alcohol, anxiolytics and hypnotics. Excretion reduced by ibuprofen and possibly other NSAIDs ---------------------------------------------------------------------------------------------------------------Clostridium Botulinum Toxin Type A 100 units Clostridium Botulinum Toxin Type A 500 units Trade Name : Botox Indication : i) Focal dystonias ii) Hemifacial spasm iii) Spasticity including cerebral palsy Dosage : 20 - 200 units 3 months once A* A* Precautions : Anaphylaxis and corneal exposure.Subclinical or clinical evidence of marked defective neuromuscular transmission Adverse Reactions : Misplaced injections may paralyse nearby muscle groups and excessive doses may paralyse distant muscle, influenza-like syndrome. Exacerbation of existing eyelid abnormalities, ptosis, diplopia, spread of the paralytic effect to mid-facial muscles, keratitis, dry eyes, minor bruising, lid swelling, burning sensation, dysphagia Contraindications : Generalised disorders of muscle activity eg. myasthenia gravis, bleeding disorders, pregnancy and breast feeding Interactions : Effects enhanced by aminoglycosides and non-depolarizing muscle relaxant ---------------------------------------------------------------------------------------------------------------Diazepam 5 mg Tablet B Trade Name : Valium Indication : i) Muscle spasm of varied aetiology, including tetanus ii) Anxiety disorders Dosage : i) ADULT: 2-10 mg 3-4 times daily. CHILD 6 months and older: 0.12 - 0.8 mg/kg daily in divided doses, every 6-8 hours ii) ADULT : 2 mg 3 times daily, increased in severe anxiety to 15 - 30 mg daily in divided doses. ELDERLY (or delibitated) half adult dose. CHILD (night terrors), 1 - 5 mg at bedtime Precautions : Respiratory disease, history of drug or alcohol abuse, drug dependence, pregnancy, breast feeding, renal and hepatic impairment and avoid operating vehicles or machinery. Safety and effectiveness not established in children less than 6 months of age 154 Adverse Reactions : Drowsiness, dizziness, vertigo, hallucinations, blurred vision, confusion, muscle weakness, fatigue, incontinence or urinary retention, constipation, rashes, changes in libido, leukopenia and gastrointestinal, hypotension, ataxia, respiratory depression, sedation, depression, headache, nausea, tremor, withdrawal syndrome, neutropenia, hepatotoxicity, pancytopenia, thrombocytopenia, blood dyscrasias, bradycardia, dependence/abuse. Paradoxical reactions in children and elderly Contraindications : Respiratory depression, acute pulmonary insufficiency, severe hepatic impairment, acute narrow angle glaucoma and untreated open angle glaucoma, myasthenia gravis, hypersensitivity to diazepam products, patients less than 6 months old, alcohol intoxication and central nervous system depression. Pregnancy and lactation Interactions : Erythromycin, clarithromycin, isoniazid, fentanyl, alfentanil, itraconazole, ketoconazole, digoxin, phenytoin, rifampicin, ethanol, carbamazepine, phenobarbital, levodopa, lithium, amitriptyline, codeine, fluvoxamine, ginkgo, morphine, primidone, St John's Wort, theophylline, thiopental ---------------------------------------------------------------------------------------------------------------Mecobalamin 500 mcg Tablet B Trade Name : Methylcobal Indication : Peripheral neuropathies Dosage : 1 tablet 3 times daily. The dosage should be adjusted according to age of patient and severity of symptoms Precautions : Discontinue medication if there is no response after taking orally for several months Adverse Reactions : Anorexia, nausea, diarrhoea, pain and induration at IM injection site. Headache, sweating or hot sensation Contraindications : Not known Interactions : Not known ---------------------------------------------------------------------------------------------------------------Neostigmine Methylsulphate 2.5 mg/ml Injection B Trade Name : Prostigmine Indication : i) Myasthenia gravis ii) Reversal of non-depolarising neuromuscular blockade Dosage : i) ADULT: 1 - 2.5 mg at suitable intervals by SC, IM or IV. Usual total daily dose 5 - 20 mg. CHILD: 200 500 mcg at suitable intervals throughout the day. NEONATE: 50 - 250 mcg every 4 hours ii) By IV injection over 1 minute, 50 - 70 mcg/kg (maximum 5 mg) after or with atropine sulphate 0.6 - 1.2 mg Precautions : Bronchial asthma (extreme caution), bronchitis, bradycardia, peptic ulcer, epilepsy, parkinsonism, pregnancy and lactation 155 Adverse Reactions : Allergic reactions, salivation, gastrointestinal upsets, diaphoresis, diarrhea, flatulence, increased peristalsis, nausea and vomiting, cardiac dysrhythmia, anaphylaxis, seizure, bronchospasm, respiratory arrest, respiratory depression Contraindications : Mechanical intestinal or urinary obstruction, peritonitis Interactions : Antagonism effect by lithium, antimuscarinics, aminoglycoside, clindamycin, procainamide, quinidine, propranolol. Enhanced effect of suxamethonium. Chloroquine have potential to increase symptoms of myasthenia gravis. Cyclopropane or halothane ---------------------------------------------------------------------------------------------------------------Pyridostigmine Bromide 60 mg Tablet B Trade Name : Mestinon Indication : Myasthenia gravis Dosage : ADULT: 30 - 120 mg at suitable intervals throughout the day, total daily dose 0.3 - 1.2 g. CHILD up to 6 years initially 30 mg, 6 - 12 years initially 60 mg, usual total daily dose 30 - 360 mg Precautions : Bronchial asthma (extreme caution) or bronchitis, renal disease, cardiac dysrhythmias, cholinergic crisis Adverse Reactions : Abdominal cramps, excessive sweating, bronchoconstriction, lacrimation, bradycardia, asystole, diaphoresis, diarrhoea, nausea, vomiting, cramp, muscle fasciculation, asthenia, miosis Contraindications : Intestinal or urinary obstruction Interactions : Potentiates actions of morphine derivatives and barbiturates, succinylcholine -------------------------------------------------------------------------------------------------------------------------- 156 8. ANTIINFECTIVES Antibacterials Antifungals Antivirals Antiprotozoals Anthelmintics 157 Amikacin 250 mg/2 ml Injection A Amikacin 500 mg/2 ml Injection A Trade Name : Amikin Indication : Infections due to susceptible organisms Dosage : ADULT: (IM or IV): 15 mg/kg/day 8 - 12 hourly for 7 - 10 days. Maximum: 1.5 g/day. CHILD: 15 mg/kg/day 8 - 12 hourly. Maximum: 1.5 g/day. Neonates: Initial loading dose of 10 mg/kg followed by 7.5 mg/kg/day 12 hourly. Maximum 15mg/kg/day Precautions : Myasthenia gravis, renal impairment, pregnancy and lactation. Tinnitus or vertigo may be indications of vestibular injury and impending bilateral irreversible damage Adverse Reactions : Ototoxicity and nephrotoxicity, rarely skin rash, fever, paraesthesia, athralgia, anaemia, hypotension Contraindications : Hypersensitivity to aminoglycosides Interactions : Potentiation of toxicity in combination with loop diuretics, cephalothin, vancomycin, cyclosporin. Prolongs action of neuromuscular blockers. Increased risk of respiratory depression with either halothane, methoxyflurane & neuromuscular blockers ---------------------------------------------------------------------------------------------------------------Amoxicillin & Clavulanate 228 mg/5 ml Syrup A/KK Trade Name : Augmentin Indication : Infections caused by susceptible organisms Dosage : Moderate infections: CHILD 7 - 12 year: 10 ml, 2 - 6 year: 5 ml. Severe infections: 2 6 year: 10 ml Precautions : Renal impairment, severe hepatic dysfunction Adverse Reactions : Diarrhoea, pseudomembraneous colitis, indigestion, GI upsets, increased liver enzyme Contraindications : Hypersensitivity to penicillins, possible cross sensitivity with other β-lactams. History of penicillinassociated cholestatic jaundice or hepatic dysfunction Interactions : Aminoglycosides, anti-coagulants, oral contraceptives, methotrexate ---------------------------------------------------------------------------------------------------------------Amoxicillin 1 g & Clavulanate 200 mg Injection A Trade Name : Augmentin Indication : Infections caused by susceptible organisms. Respiratory tract, skin, soft tissue, GUT infection, septicaemia, peritonitis, post-operative infection & osteomyelitis Dosage : CHILD less than 3 months: 30mg/kg 12 hourly. 3 months - 12 years: 30mg/kg 6 - 8 hourly. ADULT: 1.2 g by IV or intermittent infusion 6 - 8 hourly Precautions : Pregnancy, breast-feeding, renal or liver failure, pseudomembranous colitis 158 Adverse Reactions : Diarrhoea, pseudomembraneous colitis, GI upsets, increased liver enzyme, urticaria and erythematous multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, transient leucopenia, thrombocytopenia, haemolytic anaemia Contraindications : Hypersensitivity to penicillins, possible cross sensitivity with other â-lactams. History of penicillinassociated cholestatic jaundice or hepatic dysfunction Interactions : Aminoglycosides, anti-coagulants, oral contraceptives, methotrexate -------------------------------------------------------------------------------------------------------------------------Amoxicillin 500 mg & Clavulanate 125 mg Tablet A/KK Trade Name : Augmentin Indication : Infections due to beta-lactamase producing strain where amoxicillin alone is not appropriate. Respiratory tract, skin, soft tissue, GUT infection, septicaemia, peritonitis, post-operative infection & osteomyelitis Dosage : ADULT & CHILD more than 12 years: Mild to moderate infections: 625 mg twice daily. Severe infections: 1 g twice daily Precautions : Renal or hepatic impairment, pregnancy Adverse Reactions : Diarrhoea, indigestion, nausea, vomiting, candidiasis, rash, pseudomembranous colitis, hepatitis, cholestatic jaundice, crystalluria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, reversible leucopaenia, thrombocytopaenia, haemolytic anaemia, CNS disturbances Contraindications : Hypersensitivity to penicillins, possible cross sensitivity with other β-lactams. History of penicillinassociated cholestatic jaundice/hepatic dysfunction Interactions : Aminoglycosides, anticoagulants, oral contraceptives, methotrexate -------------------------------------------------------------------------------------------------------------------------Amoxicillin 250 mg Capsule Indication : Infections caused by susceptible strains of gram positive and gram negative organisms Dosage : ADULT: 250 - 500 mg 3 times daily. CHILD: 20 - 40 mg/kg/day in divided doses 8 hourly Precautions : Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection Adverse Reactions : Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice Contraindications : Hypersensitivity to penicillins Interactions : Aminoglycosides, oral contraceptives B ---------------------------------------------------------------------------------------------------------------- 159 Amoxicillin Trihydrate 125 mg/5 ml Syrup B Indication : Infections caused by susceptible strains of gram positive and gram negative organisms Dosage : CHILD less than 10 years: 125 - 250 mg 8 hourly. CHILD less than 20 kg: 20 - 40 mg/kg/day in 3 - 4 divided doses Precautions : Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection Adverse Reactions : Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice Contraindications : Hypersensitivity to penicillins Interactions : Aminoglycosides, oral contraceptives -------------------------------------------------------------------------------------------------------------------------Ampicillin Sodium 1g & Sulbactam Sodium 500mg Injection A Trade Name : Unasyn 1.5g Indication : Treatment of susceptible bacterial infections Dosage : ADULT: 1.5 - 12 g/day in divided doses 6 - 8 hourly. Maximum: 4 g Sulbactam per day. CHILD: 150300mg/kg/day 6 - 8 hourly. Prophylaxis: 1.5 -3 g at induction of anaesthesia. May be repeated 6 - 8 hourly Precautions : Overgrowth of non-susceptible organism. Check periodically for organ system dysfunction during prolong therapy Adverse Reactions : GI disturbances, phlebitis, skin rashes, itching, blood disorders, anaphylaxis and superinfection Contraindications : History of allergic reaction to any penicillins Interactions : Concurrent use with oral contraceptives may result in decreased contraceptive effectiveness -------------------------------------------------------------------------------------------------------------------------Ampicillin Sodium 500 mg Injection B Trade Name : Penbritin Indication : Treatment of susceptible bacterial infections (non beta-lactamase-producing organisms); meningitis Dosage : 250 - 500 mg IM/IV every 4 - 6 hours. Maximum: 400 mg/kg/day. Meningitis: 2 g 6 hourly. CHILD: 150 mg/kg/daily IV in divided doses. Usual children dose less than 10 years, half adult dose Precautions : Hypersensitivity to cephalosporins. Chronic treatment requires assessment of renal, hepatic& haematopoietic functions. Renal impairment, lymphatic leukaemia Adverse Reactions : GI disturbances, skin rashes, pruritis, urticartia, fever, anaphylaxis, blood disorders, superinfection Contraindications : Hypersensitivity to penicillins 160 Interactions : Excretion impaired by probenecid. Increased risk of skin rashes with allopurinol. May decrease effectiveness of oral contraceptives and atenolol ---------------------------------------------------------------------------------------------------------------Ampicillin Trihydrate 125 mg/5 ml Suspension B Trade Name : Penbritin Indication : Treatment of susceptible bacterial infections (non beta-lactamase-producing organisms) Dosage : CHILD: 50 - 100 mg/kg/day 4 times daily. Under 1 year: 62.5 - 125 mg 4 times daily, 1 - 10 years: 125 - 250 mg 4 times daily Precautions : Hypersensitivity to cephalosporins. Severe renal dysfunction Adverse Reactions : Diarrhoea, indigestion, nausea, vomiting, occasionally rashes Contraindications : Hypersensitivity to penicillins Interactions : Bacteriostatic drugs, anticoagulants -------------------------------------------------------------------------------------------------------------------------Azithromycin 250 mg Tablet A* Trade Name : Zithromax Indication : i) Treatment of complicated respiratory tract infection not responding to standard macrolides ii) Adult treatment of uncomplicated genital infections due to Chlamydia trichomatis or susceptible Neisseria gonorrhoea iii) Prophylaxis against Mycobacterium avium complex in patients with advanced HIV Dosage : i) 500 mg daily for 3 days ii) 1 g as a single dose iii) 1 g weekly Precautions : Moderate or severe renal impairment, liver impairment, pregnancy & lactation Adverse Reactions : Nausea, abdominal discomfort, vomiting, flatulence, diarrhoea & loose stools. Hearing impairment, interstitial nephritis, acute renal failure, abnormal liver function, dizziness & vertigo, convulsions, headache, somnolence Contraindications : Known hypersensitivity to azithromycin or any of the macrolides Interactions : Antacids, ergot derivatives. Monitor patients on concurrent warfarin, digoxin or cIclosporin ---------------------------------------------------------------------------------------------------------------Azithromycin 500 mg Injection A* Trade Name : Zithromax Indication : Only for treatment of severe atypical pneumonia Dosage : 500 mg IV as a single daily dose for a minimum of two days followed by 500 mg oral dose as a single daily dose to complete a 7 - 10 days course 161 Precautions : Moderate or severe renal impairment, sever liver impairment, pregnancy & lactation Adverse Reactions : Nausea, abdominal discomfort, vomiting, flatulence, diarrhoea& loose stools. Hearing impairment, interstitial nephritis, acute renal failure, abnormal liver function, dizziness& vertigo, convulsions, headache, somnolence Contraindications : Known hypersensitivity to azithromycin or any of the macrolides Interactions : Antacids, ergot derivatives. Monitor patients on concurrent warfarin, digoxin or ciclosporin. Increase levels of tacrolimus, phenytoin, bromocriptine, disopyramide ---------------------------------------------------------------------------------------------------------------Bacampicillin 400 mg Tablet B Trade Name : Penglobe Indication : Infections caused by ampicillin-sensitive gram positive& gram negative microorganisms Dosage : ADULT: 400 mg twice daily. Severe infection: 800 mg twice daily. CHILD more than 25 kg: 12.5 - 25 mg/kg 12 hourly Precautions : Hypersensitivity to cephalosporins, renal or hepatic impairment, superinfection Adverse Reactions : Diarrhoea, indigestion, urticarial or erythematous rash, hepatitis, cholestatic jaundice Contraindications : Hypersensitivity to penicillins Interactions : Aminoglycosides, oral contraceptives -------------------------------------------------------------------------------------------------------------------------Benzathine Penicillin 2.4 mega units Injection (1.8 g) B Trade Name : Penadur L.A. Indication : i) Treatment of mild to moderately severe infections due to Penicillin G-sensitive organisms ii) Treatment of syphillis Dosage : i) ADULT: 1.2 mega units IM ii) For syphillis: 2.4 mega units weekly for 1 - 3 weeks Precautions : Diabetes. Not for SC, IV or intralumbarly or into body cavities. Impaired renal function, infants, elderly, hypersensitivity to cephalosporins Adverse Reactions : Allergic reactions, glossitis, stomatitis, haemolytic anaemia, leucopenia, thrombocytopenia, agranulocytosis, neuropathy, nephropathy, Jarisch-Herxheimer reactions secondary to bacteriolysis Contraindications : Hypersensitivity to penicillins& cephalosporins. Severe pneumonia, empyema, sepsis, pericarditis, meningitis, peritonitis or arthritis requiring high dose of penicillin levels, bronchial asthma Interactions : Bacteriostatic antibiotics, anti-inflammatory, antirheumatics, antipyretics, probenecids, oral contraceptives ---------------------------------------------------------------------------------------------------------------162 Benzylpenicillin 1 mega unit (600 mg) Injection B Benzylpenicillin 5 mega units (3 g) Injection B Indication : i) Infections caused by susceptible organisms ii) Infective endocarditis Dosage : i) ADULT: 600 - 1200 mg IM 4 times daily, increased if necessary in more serious infections. CHILD: 50 - 100 mg/kg body weight daily IV in 2 - 4 divided doses ii) ADULT: 7.2 g daily by slow IV infusion in 6 divided doses Precautions : History of anaphylaxis, accelerated (e.g. hives) or serum sickness reaction to previous penicillin administration Adverse Reactions : Hypersensitivity reactions, GI disturbances, eosinophilia, haemolytic anaemia, leucopenia, agranulocytosis. Convulsions in the presence of severely reduced renal function, epilepsy, meningitis or cerebral oedema or during cardiopulmonary bypass procedure Contraindications : History of anaphylaxis, accelerated (e.g. hives) or serum sickness reaction to previous penicillin administration Interactions : Bacteriostatic antibiotics, anti-inflammatory, antirheumatics, antipyretics, probenecids, oral contraceptives ---------------------------------------------------------------------------------------------------------------Cefazolin Sodium 1 g Injection A Trade Name : Cefazolin Sandoz Indication : Infection caused by cefazolin-sensitive microorganism, infection of the respiratory tract, urogenital tract, skin and soft tissue, bile duct, bones and joint, endocarditis, systemic septic infection, perioperative/ surgical prophylaxis Dosage : ADULT: Uncomplicated infections: 500 - 1000 mg 2 - 3 times daily. Moderately severe and severe infections: 500 - 1000 mg 3 - 4 times daily. Severe life-threatening infections: 1 - 1.5 g 4 times daily. Rarely, dose up to 12 g daily Precautions : Allergic, diathesis with bronchial asthma or hay fever, history of GI disease, renal impairment, pregnancy and lactation Adverse Reactions : Drug induced fever, reddening of skin with heat sensation, angioneurotic edema, itch, Steven Johnson Syndrome, urticaria, eosinophilia, allergic nephritis, GI disturbances, anaphylactic reactions. Pseudomembranous enterocolitis, leukopenia, thrombocytopenia, neutropenia and hepatotoxicity Contraindications : Hypersensitivity to cephalosporins Interactions : Warfarin, probenecid ---------------------------------------------------------------------------------------------------------------Cefepime 1 g Injection A* Trade Name : Maxipime Indication : Febrile neutropenia, septicaemia, lower respiratory tract infection, urinary tract infection, skin and skin structure infections, gynaecologic and intra-abdominal infections 163 Dosage : ADULT: 1 - 2 g twice daily for most infections. For severe infections including febrile neutropenia: 2 g 3 times daily. CHILD: 25 - 50 mg/kg 3 times daily Precautions : Hypensensitivity, pseudomembranous colitis& superinfection may occur. Discontinue therapy if allergic reaction occurs. Pregnancy, lactation Adverse Reactions : GI disturbances (diarrhoea, nausea, vomiting), history of colitis, hypersensitivity, respiratory and CNS disorders including headache, vaginitis Contraindications : Hypersensitivity to cephalosporins, penicillins or other beta-lactam antibiotics Interactions : Typhoid vaccine ---------------------------------------------------------------------------------------------------------------Cefoperazone Sodium 1 g Injection A Trade Name : Cefobid Indication : Infections due to gram-negative bacteria Dosage : ADULT: 1 - 2 g twice daily IM or IV. By IV, adult dose may be doubled. Maximum: 16 g daily in divided doses. CHILD & INFANT: 50 - 200 mg/kg/day in 2 - 4 divided doses. NEONATE less than 8 days: 50 200 mg/kg/day 12 hourly Precautions : Penicillin-sensitive patients, severe biliary obstruction, severe hepatic disease or coexisting renal dysfunction Adverse Reactions : Hypersensitivity reactions eg. rash, urticaria, fever, neutropenia (reversible), hypothrombinaemia, GI effects & local reactions, vitamin K deficiency Contraindications : Hypersensitvity to cephalosporins Interactions : Heparin, typhoid vaccine, warfarin ---------------------------------------------------------------------------------------------------------------Cefoperazone Sodium 500 mg & Sulbactam Sodium 500 mg Injection A Trade Name : Sulperazon Indication : i) Treatment of infections due to multi-drug resistance pathogens producing B-lactamase ii) Treatment of infections caused by Acinetobacter species Dosage : ADULT: 1 - 2 g twice daily. CHILD: 40 - 80 mg/kg/day Precautions : Hepatic dysfunction& concomitant renal impairment, ingestion of alcoholic beverages; overgrowth of nonsusceptible organisms Adverse Reactions : Diarrhoea, nausea, vomiting, maculopapular rash, urticaria; eosinophilia; drug fever Contraindications : Known allergy to penicillins, sulbactam or cephalosporins 164 Interactions : Heparin, typhoid vaccine, warfarin ---------------------------------------------------------------------------------------------------------------Cefotaxime 1 g Injection A Trade Name : Claforan Indication : Infections due to gram-negative bacteria Dosage : ADULT: 1 g 12 hourly (up to 12 g/day in severe cases). CHILD: 50 - 180 mg/kg/day in 4 - 6 divided doses Precautions : Hypersensitivity to penicillins, history of gastrointestinal disease especially colitis, pregnancy & lactation dverse Reactions : Rash, pruritus, diarrhoea, nausea, vomiting, colitis, thrombocytopenia, eosinophilia, leucopenia, hypersensitivity reactions, GI effects, anaphylactic shock(rare) Contraindications : Hypersensitivity to cephalosporins Interactions : Aminoglycosides, probenecid, typhoid vaccine ---------------------------------------------------------------------------------------------------------------Ceftazidime 1 g Injection A Ceftazidime 2 g Injection A Trade Name : Fortum Indication : Severe gram negative bacterial infections Dosage : ADULT: 1 g 8 hourly or 2 g 12 hourly. In severe infections: 2 g 8 hourly. CHILD: 25 - 150 mg/kg/day in 2 - 3 divided doses Precautions : Hypersensitivity to penicillins, renal impairment Adverse Reactions : GI upsets, CNS effects, phlebitis or thrombophlebitis at the IV injection site, pain and/or inflammation after IM injection, very rarely hypersensitivity reactions. Transient haematologicals changes Contraindications : Hypersensitivity to cephalosporins Interactions : Aminoglycosides, probenecid, chloramphenicol, live typhoid vaccine ---------------------------------------------------------------------------------------------------------------Ceftriaxone 0.25g Injection Trade Name : Rocephin Indication : i.Gonorrhea ii. Chancroid Dosage : i.250mg by deep IM injection 100mg/kg/day A ii. Single IM injection 250mg only. For severe infection up to 165 Precautions : Previous hypersensitivity to penicillins, anaphylactic shock, severe renal& hepatic failure, pregnancy. Ceftriaxone and calcium -containing solutions may be administered sequentially to one another if the infusion lines are thoroughly flushed between infusions with compatible fluid. Diluents containing calcium (Ringer's / Hartmann's solution) are not to be used to reconstitute ceftriaxonevials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Ceftriaxone must not be administered simultaneously with calcium- containing intravenous solutions, including continous calcium -containing infusions such as parenteral nutrition via a Y-site, because precipaitation of ceftriaxone-calcium can occur Adverse Reactions : GI upsets, haematological changes, skin reactions, coagulation disorders, phlebitis, agranulocytosis, renal precipitations Contraindications : Hypersensitivity to cephalosporins. Neonates aged less than or 28 days if they require treatment with calcium-containing intravenous solutions, including calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium Interactions : Ciclosporin, typhoid vaccine ---------------------------------------------------------------------------------------------------------------Ceftriaxone 1g Injection A Trade Name : Rocephin Indication : Infections caused by susceptible organisms Dosage : ADULT: 1 - 2 g once daily. Severe infection: 4 g daily at 12 hour intervals. INFANT & CHILD, 3 weeks 12 years: 20 - 80 mg/kg body weight daily. CHILD with body weight 50 kg or more: adult dose. NEONATE up to 2 weeks: 20 - 50 mg/kg body weight daily, not to exceed 50 mg/kg Precautions : Previous hypersensitivity to penicillins, anaphylactic shock, severe renal& hepatic failure, pregnancy. Ceftriaxone and calcium -containing solutions may be administered sequentially to one another if the infusion lines are thoroughly flushed between infusions with compatible fluid. Diluents containing calcium (Ringer's / Hartmann's solution) are not to be used to reconstitute ceftriaxonevials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Ceftriaxone must not be administered simultaneously with calcium- containing intravenous solutions, including continous calcium -containing infusions such as parenteral nutrition via a Y-site, because precipaitation of ceftriaxone-calcium can occur Adverse Reactions : GI upsets, haematological changes, skin reactions, coagulation disorders, phlebitis, agranulocytosis, renal precipitations Contraindications : Hypersensitivity to cephalosporins. Neonates aged less than or 28 days if they require treatment with calcium-containing intravenous solutions, including calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium Interactions : Ciclosporin, typhoid vaccine ---------------------------------------------------------------------------------------------------------------- 166 Cefuroxime Axetil 125 mg Tablet A/KK Trade Name : Zinnat Indication : Upper respiratory tract, GUT, skin & soft tissue infections, urinary tract infection (UTI), pyelonephritis Dosage : ADULT: 250 mg twice daily ;UTI: 125 mg twice daily. CHILD:125 mg twice daily. Maximum 250 mg/day Precautions : Anaphylactic reaction to penicillins Adverse Reactions : GI disturbances occasionally pseudomembraneous colitis, hypersensitivity reactions, eosinophilia, headache, superinfection Contraindications : Hypersensitivity to cephalosporins Interactions : Aminoglycosides, typhoid vaccine ---------------------------------------------------------------------------------------------------------------Cefuroxime Axetil 125 mg/5 ml Suspension A Trade Name : Zinnat Indication : Infections caused by susceptible organisms Dosage : 30 mg/kg/day in 2 divided doses Precautions : Anaphylactic reaction to penicillins Adverse Reactions : GI disturbances occasionally pseudomembraneous colitis, hypersensitivity reactions, eosinophilia, headache, superinfection Contraindications : Hypersensitivity to cephalosporins Interactions : Aminoglycosides, typhoid vaccine ---------------------------------------------------------------------------------------------------------------Cefuroxime Sodium 1.5 g Injection A Cefuroxime Sodium 750 mg Injection A Trade Name : Zinacef Indication : Infections caused by susceptible organisms, surgical prophylaxis Dosage : ADULT: 750 mg 6 - 8 hours IM or IV. Severe infections: 1.5 g three times to four times daily IV. CHILD: 30 - 100 mg/kg/day in 3 - 4 divided doses. Surgical prophylaxis: 1.5 g IV Precautions : Anaphylactic reaction to penicillins Adverse Reactions : GI disturbances occasionally pseudomembraneous colitis, hypersensitivity reactions, eosinophilia, headache, superinfection 167 Contraindications : Hypersensitivity to cephalosporins Interactions : Aminoglycosides, typhoid vaccine ---------------------------------------------------------------------------------------------------------------Cephalexin Monohydrate 125 mg/5 ml Syrup B Trade Name : Ceporex Indication : Respiratory tract infections, ear, nose and throat infections, urinary tract infections, obstetric and gynaecologic infections Dosage : CHILD: 25 - 100 mg/kg/day every 6 hourly. Maximum: 4 g daily Precautions : Hypersensitivity to penicillins, renal impairment, superinfection Adverse Reactions : GI disturbances, overgrowth of non-susceptible organisms, hypersensitivity reactions, reversible neutropenia Contraindications : Hypersensitivity to cephalosporins Interactions : Concurrent treatment with high doses of cephalosporins& aminoglycosides or potent diuretics may adversely affect renal function. Probenecid may increase or prolong plasma level& toxicity of cephalosporins ---------------------------------------------------------------------------------------------------------------Cephalexin Monohydrate 250 mg Capsule B Trade Name : Ceporex Indication : i) Respiratory tract infection, urinary tract infection ii) Complicated, recurrent or chronic infections, bronchitis iii) Pneumonia Dosage : i) 250 mg 6 hourly ii) 250 - 500 mg 6 hourly iii) 1 - 1.5 g 3 times daily or 4 times daily. Maximum: 6 g/day Precautions : Concurrent treatment with high doses of cephalosporins& aminoglycosides or potent diuretics may adversely affect renal function. Probenecid may increase or prolong plasma level& toxicity of cephalosporins Adverse Reactions : GI disturbances, overgrowth of non-susceptible organisms, hypersensitivity reactions, reversible neutropenia Contraindications : Hypersensitivity to cephalosporins Interactions : Concurrent treatment with high doses of cephalosporins& aminoglycosides or potent diuretics may adversely affect renal function. Probenecid may increase or prolong plasma level& toxicity of cephalosporins ---------------------------------------------------------------------------------------------------------------- 168 Chloramphenicol Sodium Succinate 1 g Injection B Trade Name : Chloromycetin Indication : Treatment of typhoid, paratyphoid fevers, bronchopneumonia and enteric infection Dosage : ADULT: 1.5 - 3 g daily in divided doses every 6 hourly. CHILD: 25 -100 mg/kg/day in divided doses every 6 hourly Precautions : Repeated courses& chronic treatment, infants, impaired liver or kidney function. Frequent haematological examination is recommended Adverse Reactions : Depression of bone marrow leading to agranulocytosis, thrombocytopenia purpura, leucopenia and aplastic anaemia. Peripheral& optic neuritis, erythema multiforme, GI disorders, urticaria, dry mouth and blurred vision Contraindications : Hypersensitivity, pregnancy and lactation, anaemia, porphyria Interactions : Phenobarbitone& rifampicin may reduce the plasma concentration. Drugs which potentially depress bone marrow function. May potentiate actions of phenytoin, sulfonylureas& anticoagulants ---------------------------------------------------------------------------------------------------------------Ciprofloxacin 100 mg/50 ml Injection A Trade Name : Ciprobay Indication : Treatment of infections due to susceptible bacterial strains Dosage : ADULT uncomplicated infections:200 mg/day; acute gonorrhoea and acute uncomplicated cystitis in women can be treated with a single infusion of 100 mg.Other infections: 400-800 mg/day Precautions : Epilepsy, CNS disorder, liver damage, renal impairment. Avoid prolonged exposure to sunlight Adverse Reactions : Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, flatulence, anorexia, dizziness, headache, tiredness, agitation, trembling, insomnia, peripheral paralgesia, sweating, unsteady gait, convulsions, increase in intracranial pressure, anxiety states, nightmares, confusion, depression, hallucinations, impaired taste and smell, visual disturbances, tinnitus, transitory impairment of hearing, especially at high frequencies, skin reactions Contraindications : Hypersensitivity to ciprofloxacin or other quinolones. Children, adolescents, pregnancy and lactation Interactions : Theophylline, iron, magnesium, aluminium, calcium, sulcralfate, antacids, probenecid, NSAIDs, antineoplastics, immunosuppressants, cyclosporin, warfarin, glibenclamide, metoclopramide and other prokinetic drugs ---------------------------------------------------------------------------------------------------------------Ciprofloxacin 250 mg Tablet Trade Name : Ciprobay Indication : Treatment of infections due to susceptible bacterial strains Dosage : ADULT: 125-750 mg twice daily. Acute gonorrhoea: a single dose of 250 mg 169 A Precautions : Epilepsy, CNS disorder, liver damage, renal impairment. Avoid prolonged exposure to sunlight Adverse Reactions : Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, flatulence, anorexia, dizziness, headache, tiredness, agitation, trembling, insomnia, peripheral paralgesia, sweating, unsteady gait, convulsions, increase in intracranial pressure, anxiety states, nightmares, confusion, depression, hallucinations, impaired taste and smell, visual disturbances, tinnitus, transitory impairment of hearing, especially at high frequencies, skin reactions Contraindications : Hypersensitivity to ciprofloxacin or other quinolones. Children, adolescents, pregnancy and lactation Interactions : Theophylline, iron, magnesium, aluminium, calcium, sulcralfate, antacids, probenecid, NSAIDs, antineoplastics, immunosuppressants, cyclosporin, warfarin, glibenclamide, metoclopramide and other prokinetic drugs ---------------------------------------------------------------------------------------------------------------Clarithromycin 250 mg Tablet A* Trade Name : Klacid Indication : Only for i) treatment of complicated respiratory tract infection not responding to standard macrolides ii) eradication of Helicobacter pylori infection Dosage : i) 250 - 500 mg twice daily. Up to 6 - 14 days ii) 500 mg twice daily with omeprazole & amoxicillin. Up to 2 weeks Precautions : Impaired hepatic function & moderate to severe renal impairment Adverse Reactions : Nausea, dyspepsia, abdominal pain & diarrhoea. Headache & skin rash. Reversible hearing loss. Alteration of sense of smell with taste perversion. Glossitis, stomatitis, oral monilia, tongue discoloration, tooth discoloration (reversible) Contraindications : Known hypersensitivity to macrolides. Patients receiving terfenadine therapy with pre-existing cardiac abnormalities or electrolyte disturbances Interactions : Modest increase of circulating theophylline or carbamazepine levels. May potentiate effects of warfarin or digoxin. May alter metabolism of terfenadine resulting in increased levels of terfenadine. Inhibition of metabolism with ritonavir ---------------------------------------------------------------------------------------------------------------Clindamycin HCl 300 mg Capsule A* Trade Name : Lincocin Indication : i) Skin and soft tissue infections, bone& joint infections ii) Cerebral toxoplasmosis iii) Children less than 8 years old:Treatment and prophylaxis of malaria in combination with quinine, as an alternative to doxycline Dosage : i) ADULT: 150 - 300 mg every 6 hours; up to 450 mg every 6 hours in severe infections; CHILD: 3 - 6 mg/kg every 6 hours ii) 600 mg 6 hourly for 6 weeks iii) 10mg/kg twice a day, in combination with quinine. The combination to be given for 7 days 170 Precautions : History of GI disease, especially colitis. Renal or hepatic impairment. Perform periodic liver and kidney function tests with prolonged therapy and in neonates and infants. Discontinue immediately if diarrhoea or colitis develops. Pregnancy and lactation Adverse Reactions : Diarrhoea occasionally with acute colitis (discontinue), abdominal pain, GI upsets, skin reactions, jaundice, hematopoietic changes, pseudomembranous enterocolitis, pruritus, vaginitis Contraindications : Hypersensitivity to clindamycin or lincomycin Interactions : Neuromuscular blockers, erythromycin ---------------------------------------------------------------------------------------------------------------Cloxacillin Sodium 125 mg/5 ml Suspension B Trade Name : Orbenin Indication : Treatment of susceptible bacterial infections, notably penicillinase-producing staphylococci Dosage : CHILD 2 - 10 years: 250 mg 6 hourly, less than 2 years: 125 mg 6 hourly Precautions : Renal impairment. Neonates born to mothers hypersensitive to penicillin. Hypersensitivity to cephalosporins Adverse Reactions : Occasional rashes, GI upsets, anaphylaxis Contraindications : Hypersensitivity to cloxacillin products/penicillins Interactions : Probenecid impairs renal excretion. Decreases anticoagulant effect ---------------------------------------------------------------------------------------------------------------Cloxacillin Sodium 250 mg Capsule B Trade Name : Orbenin Indication : Treatment of susceptible bacterial infections, notably penicillinase-producing staphylococci Dosage : ADULT: 250 - 500 mg every 6 hours. CHILD: 2 - 10 years: 250 mg 4 times daily; less than 2 years: 125 mg 4 times daily Precautions : Renal impairment. Neonates born to mothers hypersensitive to penicillin. Hypersensitivity to cephalosporins Adverse Reactions : Occasional rashes, GI upsets, anaphylaxis Contraindications : Hypersensitivity to cloxacillin products/penicillins Interactions : Probenecid impairs renal excretion. Decreases anticoagulant effect ---------------------------------------------------------------------------------------------------------------- 171 Cloxacillin Sodium 250 mg Injection B Cloxacillin Sodium 500 mg Injection B Trade Name : Orbenin Indication : Treatment of susceptible bacterial infections, notably penicillinase-producing staphylococci infections Dosage : ADULT: 250 to 500 mg every 6 hours depending on type and severity of infection. CHILD less than 20 kg: 25 to 50 mg/kg/day in equally divided doses every 6 hours Precautions : History of asthma or allergic-type reactions to other medications, overgrowth of nonsusceptible organisms Adverse Reactions : Fever, rash, nausea, vomiting, diarrhoea, hepatotoxicity, anaphylaxis Contraindications : Hypersensitivity to cloxacillin products/penicillins Interactions : Allopurinol, chloramphenicol. Probenecid impairs renal excretion. Anticoagulant effect is decreased. Tetracycline, oestrogen-containing oral contraceptives ---------------------------------------------------------------------------------------------------------------Dapsone 100 mg Tablet B Indication : i)Leprosy ii) Dermatitis herpetiformis Dosage : i) ADULT: 6 - 10 mg/kg weekly (around 50 - 100 mg daily). CHILD: 1 - 2 mg/kg/day. Maximum: 100 mg/day ii) ADULT: 50 - 300 mg daily Precautions : Cardiac, pulmonary, hepatic or renal disease, pregnancy, lactation Adverse Reactions : Nausea, vomiting, anorexia; fever, malaise, headache; dizziness, tachycardia, nervousness, insomnia, skin disorders, agranulocytosis, peripheral neuritis, psychosis, haemolysis, methaemoglobinemia; hypersensitivity reactions Contraindications : Hypersensitivity to dapsone products, severe anaemia, G6PD deficiency Interactions : Rifampicin increases plasma clearance of dapsone. Excretion decreased by probenecid. Pyrimethamine may increase the likelihood of haematologic reactions ---------------------------------------------------------------------------------------------------------------Doxycycline 100 mg Capsule Trade Name : Vibramycin Indication : Infections due to susceptible organisms Dosage : ADULT: 200 mg on the first day followed by 100 mg daily. Severe infections: 200 mg daily Precautions : Lactation, myasthenia gravis, hepatic or renal impairment Adverse Reactions : GI distress, anorexia, maculopapular and erythematous rash, tooth discolouration in children 172 B Contraindications : Hypersensitivity to tetracyclines/doxycycline, porphyria, pregnancy, lactation, children less than 12 years Interactions : Anticoagulants, penicillin, antacids, ferum, acitretin, isotretinoin, methotrexate -------------------------------------------------------------------------------------------------------------------------Erythromycin Stearate 250mg Tablet B Indication: Infections due to susceptible organism Dosage : ADULT: 250 - 500 mg 6 hourly. CHILD: 30 - 50 mg/kg/day in 4 divided doses Precautions : Hypersensitivity, porphyria Adverse Reactions : Abdominal discomfort, mild allergic reaction; liver dysfunction with or without jaundice; reversible hearing loss, prolonged Q-T interval, ventricular arrhythmias, GI disturbances Contraindications : Hepatic& renal impairment, myasthenia gravis Interactions : Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or astemizole ---------------------------------------------------------------------------------------------------------------Erythromycin Ethylsuccinate 200 mg/5 ml Suspension B Trade Name : Erythrocin Indication : Treatment of susceptible bacterial infections Dosage : CHILD: mild to moderate infection: 30 - 50 mg/kg/day in equally divided doses every 6 hours. For more severe infection this dose may be doubled. Doses may be given 2 - 3 times a day Precautions : Hepatic& renal impairment, myasthenia gravis Adverse Reactions : Abdominal discomfort, mild allergic reaction; liver dysfunction with or without jaundice; reversible hearing loss, prolonged Q-T interval, ventricular arrhythmias, GI disturbances Contraindications : Hypersensitivity, porphyria Interactions : Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or astemizole ---------------------------------------------------------------------------------------------------------------Erythromycin Ethylsuccinate 400 mg Tablet Trade Name : EES Indication : Treatment of susceptible bacterial infections B 173 Dosage : ADULT: 400 mg 6 hourly or 800 mg 12 hourly. Maximum 4 g/day. CHILD: 30 - 50 mg/kg/day in 2 - 4 divided doses Precautions : Hepatic& renal impairment, myasthenia gravis Adverse Reactions : Abdominal discomfort, mild allergic reaction; liver dysfunction with or without jaundice; reversible hearing loss, prolonged Q-T interval, ventricular arrhythmias, GI disturbances Contraindications : Hypersensitivity, porphyria Interactions : Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or astemizole ---------------------------------------------------------------------------------------------------------------Erythromycin Lactobionate 500 mg Injection A* Trade Name : Erythrocin Indication : Only for treatment of i) certain forms of meningitis ii) septicaemia not responding to usual antibiotics iii) mycoplasma pneumonia iv) infection with gram-positive organisms (e.g. tetanus, streptococcal infection) associated with Penicillin allergy, only when oral erythromycin cannot be given Dosage : ADULT& CHILD: 15 - 20 mg/kg/day in divided doses by IV infusion or intermittently by slow IV over 1 hour at intervals not more than 6 hourly. Maximum: 4 g/day Precautions : Hepatic& renal impairment, myasthenia gravis Adverse Reactions : Phlebitis; mild allergic reaction; liver dysfunction with or without jaundice, reversible hearing loss, prolonged Q-T interval, ventricular arrhythmias, GI disturbances Contraindications : Hypersensitivity, porphyria. Systemic: concomitant use with ergot derivatives or cisapride Interactions : Can increase plasma concentration of warfarin, theophylline, carbamazepine, cyclosporin, possibly phenytoin. Combination with ergotamine increases risk of peripheral ischaemia. Caution when taken with terfenadine or astemizole -------------------------------------------------------------------------------------------------------------------------Ethambutol HCl 400 mg Tablet B Trade Name : Myambutol Indication : Tuberculosis Dosage : ADULT & CHILD more than 13 years: Initial treatment: 15 mg/kg as a single daily dose 24 hourly. Retreatment: 25 mg/kg/day as a single dose 24 hourly. Concurrent anti-TB drug required. After 60 days, decrease to 15 mg/kg body weight as single dose 24 hourly Precautions : Reduced visual acuity. Reduced dosage in impaired renal function. May precipitate attack of gout. Ocular examination is recommended 174 Adverse Reactions : Generally well tolerated but may provoke reversible retrobulbar neuritis with a reduction of visual acuity, central scotoma& green-red colour blindness, allergic rashes, GI disturbances, jaundice, peripheral neuritis, confusion, hallucinations, joint pain, fever, malaise, headache, dizziness, anorexia& abdominal pain Contraindications : Optic neuritis; history of previous adverse effects with ethambutol Interactions : Aluminium hydroxide, ethionamide -------------------------------------------------------------------------------------------------------------------------Fusidic Acid 500 mg Injection A* Trade Name : Fucidin Indication : Treatment of severe staphylococcal infections especially Methicillin Resistant Staphylococcus aureus (MRSA). To be used in combination therapy only Dosage : ADULT : 500 mg 3 times daily diluted to 250 - 500 ml infused slowly over 2 hours. Maximum : 2 g daily. CHILD and INFANT : 20 mg/kg/day divided into 3 equal doses infused slowly over 2 - 4 hours Precautions : Hepatic insufficiency, pregnancy and lactation Adverse Reactions : Reversible jaundice, thrombophlebitis Contraindications : Hypersensitivity to fusidic acid and or its salts Interactions : Hepatotoxicity and increased plasma concentrations of fusidic acid and ritonavir. An increased risk of myopathy or rhabdomyolysis with simvastatin ---------------------------------------------------------------------------------------------------------------Gentamicin Sulphate 80 mg/2 ml Injection B Trade Name : Garamycin Indication : Infections due to susceptible organisms Dosage : ADULT: 3 - 5 mg/kg/day 8 hourly IM or IV. CHILD up to 2 weeks: 3mg/kg every 12 hours; 2 weeks - 12 years: 2 mg/kg 8 hourly Precautions : Pregnancy. Patients with reduced renal function, myasthenia gravis or Parkinson Adverse Reactions : Vestibular& auditory toxicity, renal toxicity, neuromuscular blockade, superinfection, nausea, vomitting, rash, blood disorders Contraindications : Known hypersensitivity. Patients with pre-existent vestibular& or cochlear disease. Administration of other ototoxic and/or nephrotoxic antibiotics. Pregnancy and lactation Interactions : Concurrent or sequestial administration with potent antidiuretics, anaesthetics, neuromuscular blockers, other aminoglycosides, polymyxin, amphotericin B, mannitol, cephalosporins ---------------------------------------------------------------------------------------------------------------- 175 Imipenem 500 mg and Cilastatin 500 mg Injection A* Trade Name : Tienam Indication : Severe infections caused by susceptible pathogens especially useful in infections involving ESBL organisms. Not to be used for prophylaxis Dosage : Based on type or severity of infection, susceptibility of pathogen(s) and patient condition including body weight and renal function. ADULT: 1 - 2 g/day in 3 - 4 divided doses. Maximum: 4 g/day or 50 mg/kg/day. Infusion rate: less than 500 mg dose: over 20 - 30 minutes, more than 500 mg: dose over 40 - 60 minutes. CHILD: 15 - 30 mg/kg/dose, infusion at 6 - 12 hourly intervals depending on age. Maximum: 2 g/day Precautions : Hypersensitivity to penicillins, cephalosporins and other beta lactams. History of GI disease. Caution in patients with CNS disorders and or compromised renal function in whom accumulation of drug could occur. If CNS symptoms occur, dosage should be decreased or discontinued. Usage during pregnancy, lactation and children less than 3 months or paediatrics patients with impaired renal function Adverse Reactions : Thrombophlebitis, pain, erythema & tenderness following injection. Rash, urticaria, pruritus, GI disturbances, pseudomembranous colitis, haematological disturbances, increase in liver enzymes, taste perversion. Myoclonic activity, seizures, psychic disturbances, confusional states Contraindications : Hypersensitivity to local anaesthetics of the amide-type and in patients with severe shock or heart block Interactions : Ganciclovir -------------------------------------------------------------------------------------------------------------------------Isoniazid 100 mg Tablet B Isoniazid 400 mg Tablet B Indication : i) Tuberculosis ii)Tuberculous meningitis Dosage : i) ADULT and CHILD 5 mg/kg (4-6 mg/kg) daily,maximum 300 mg daily) or 10 mg/kg 3 times weekly ii) 15 - 20 mg/kg daily Precautions : Increased risk of hepatitis in severe renal dysfunction, chronic liver disease, daily users of alcohol, increased risk of fatal hepatitis in females Adverse Reactions : Peripheral neuropathy and hepatotoxicity, psychiatric sign or symptom, agranulocytosis, anaemia, megaloblastic anaemia, thrombocytopenia, systemic lupus erythematosus, seizure Contraindications : Acute liver disease, hypersensitivity to isoniazid Interactions : Inhibits metabolism of antiepileptics (carbamazepine, ethosuximide and phenytoin) and diazepam, reduced plasma concentration of ketoconazole and increased theophylline plasma concentration -------------------------------------------------------------------------------------------------------------------------- 176 Levofloxacin 500 mg Tablet A* Trade Name : Loxof, Cravit Indication : Community acquired pneumonia Dosage : 500 mg daily for 7 - 14 days Precautions : Renal impairment (CrCl less than 50 mL/minute), CNS disorders, predisposition to seizures, lowered convulsion threshold, diabetes mellitus, conditions predisposing to torsade de pointes, significant bradycardia, cardiomyopathy, G6PD deficiency. Ensure adequate hydration. Avoid excessive sun exposure. May affect ability to drive or operate machinery Adverse Reactions : Diarrhoea, nausea, headache, blurred vision, hypoglycemia, tendinitis, anaphylactic reactions, Stevens-Johnson syndrome Contraindications : Hypersensitivity to quinolones, pregnancy & lactation. Children and growing adolescents less than 18 years old Interactions : Antacids, sucralfate, divalent cations, multivitamin, theophylline, warfarin, NSAIDS, antidiabetic agents, amiodarone, chlorpromazine, cortisone, dexamethasone, diclofenac, disopyramide, ibuprofen, indomethacin, iron, ketoprofen, ketorolac, mefenamic acid, meloxicam, naproxen, phenylbutazone, piroxicam, prednisolone, prochlorperazine, quinidine ---------------------------------------------------------------------------------------------------------------Linezolid 2mg/ml Injection A* Trade Name : Zyvox Indication : MRSA patient with severe sepsis requiring intensive care and not clinically responding to vancomycin Dosage : ADULT: 600 mg twice daily for 10 - 14 days. CHILD: 10 mg/kg 3 times daily. PREMATURE NEONATES less than 7 days: 10 mg/kg twice daily Precautions : Monitor Full Blood Count (FBC) in patients with pre-existing myelosuppression, increased bleeding risk or who receive medications that may decrease haemoglobin levels, platelet count or function, or who received linezolid for more than 2 weeks. Pregnancy Adverse Reactions : Headache, insomnia, thrombocytopenia, myelosuppression, optic nerve disorder, peripheral neuropathy, diarrhoea, nausea, myelosuppression, vomiting, constipation, rash, dizziness, fever Contraindications : Hypersensitivity to linezolid Interactions : Citalopram, dopamine, epinephrine, escitalopram, fluoxetine, fluvoxamine, sertraline, venlafaxine, pseudoephedrine, tramadol ---------------------------------------------------------------------------------------------------------------- 177 Meropenem 1 g Injection A* Meropenem 500 mg Injection A* Trade Name : Meronem Indication : i. Emperical treatment for presume infections in patients (adult and children) with febrile neutropenia, used as monotherapy or in combination with anti-virals or antifungal agent ii. Septicaemia iii. Serious infections in renal impaired patients Dosage : ADULT: 0.5 - 1g 3 times daily, CHILD: 10 - 20 mg/kg 3 times daily (except meningitis 40 mg/kg) Precautions : History of hypersensitivity to carbapenems or other beta-lactam antibiotics, penicillins and cephalosporins. Monitor transaminase and bilirubin levels when used in hepatic disease. Not recommended for MRSA infections. Consider diagnosis of pseudomembranous colitis in patients who develop diarrhoea. Critically ill patients with Pseudomonas aeruginosa infection. Pregnancy and lactation Adverse Reactions : Local injection site reactions, rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhoea, headache, paraesthesia, oral and vaginal candidiasis, reversible thrombocytopenia, leucopenia, eosinophilia, thrombocytopenia, neutropenia Contraindications : Hypersensitivity to meronem, carbapenems, penicillins or other beta-lactam antibiotics Interactions : Probenecid, valproic acid, typhoid vaccine ---------------------------------------------------------------------------------------------------------------Metronidazole 200 mg Tablet B Trade Name : Flagyl Indication : Anaerobic infection Dosage : 800 mg initially followed by 400 mg 8 hourly. CHILD: 7.5 mg/kg every 8 hours Precautions : Caution in patient with active disease of CNS except for brain abscess or hepatic encephalopathy. Pregnancy and lactation Adverse Reactions : Unpleasant taste in mouth, furry tongue, gastrointestinal disturbances, urticaria, angioedema, drowsiness, dizziness, headache, ataxia, skin rashes, pruritus, darkening of urine, peripheral neuropathy or transient epileptiform seizures, leucopenia, nausea, vomiting, erythema multiforme, hepatitis, jaundice, thrombocytopenia, aplastic anaemia, myalgia, arthralgia Contraindications : Hypersensitivity to metronidazole. Chronic alcohol dependence Interactions : Alcohol, warfarin, phenobarbitone, lithium, phenytoin, cimetidine, amiodarone, busulfan, carbamazepine, cholestyramine, cyclosporine, dihydroergotamine, disulfiram, ergotamine, fluorouracil, tacrolimus ---------------------------------------------------------------------------------------------------------------Metronidazole 500 mg/100 ml Injection Trade Name : Metrogyl Indication : Anaerobic infections A 178 Dosage : ADULT: 500 mg IV infusion 8 hourly. CHILD: 7.5 mg/kg body weight every 8 hours Precautions : If administered for more than 10 days, haematological tests are recommended. Re-administer immediately after haemodialysis. Caution in patient with active disease of CNS except for brain abscess or hepatic encephalopathy. Pregnancy & lactation Adverse Reactions : GI disturbances, urticaria, angioedema, drowsiness, dizziness, headache, ataxia, skin rashes, pruritus, darkening of urine, peripheral neuropathy or transient epileptiform seizures, leucopenia, anaphylaxis Contraindications : Hypersensitivity to metronidazole Interactions : Alcohol, warfarin, phenobarbitone, lithium, phenytoin, cimetidine, amiodarone, busulfan, carbamazepine, cholestyramine, cyclosporine, dihydroergotamine, disulfiram, ergotamine, fluorouracil, tacrolimus ---------------------------------------------------------------------------------------------------------------Netilmicin Sulphate 150mg/2ml Injection A Trade Name : Netromycin Indications : Systemic infections Dosage : ADULT: 4 - 6.5 mg/kg/day IM or IV in 2 - 3 equally divided doses for 7 - 14 days. Maximum: 7.5 mg/kg/day. CHILD: 5 - 7.5 mg/kg/day 8 - 12 hourly depending on gestation and age. Maximum: 7.5 mg/kg/day Precautions : Renal impairment; neuromuscular disorder eg myasthenia gravis or Parkinson, hypocalcaemia. Pregnancy & lactation. Good hydration during treatment required Adverse Reactions : Nephrotoxicity, neurotoxicity (auditory & vestibular toxicity); local reactions; GI effects, fever; blood coagulation abnormalities Contraindications : Known allergy to netilmicin products/aminoglycosides Interactions : Lysine, tacrolimus, neuromuscular blockers such as alcuronium, pancuronium, rocuronium, vecuronium ---------------------------------------------------------------------------------------------------------------Nitrofurantoin 100 mg Tablet B Trade Name : Furadantin Indication : Uncomplicated lower urinary tract infections Dosage : i) Acute uncomplicated infections: ADULT: 50 mg every 6 hours or 100 mg every 12 hours with food for 7 days. CHILD more than 3 months: 3mg/kg/day in 4 divided doses ii) Severe chronic recurrent infection: ADULT: 100 mg every 6 hours with food for 7 days (dose reduced or discontinued if severe nausea) iii) Prophylaxis: 50 - 100 mg at night. CHILD over 3 months: 1 mg/kg at night Precautions : Pulmonary disorders or hepatic impairment, neurological or allergic disorders, anaemia, diabetes mellitus, elderly and debilitated, monitor lung and liver function on long-term therapy 179 Adverse Reactions : Anorexia, nausea, vomiting, diarhoea, acute and chronic pulmonary reactions, peripheral neuropathy, hypersensitivity reactions, hepatic reaction (hepatic necrosis, hepatic failure, hepatitis, jaundice) Contraindications : Impaired renal function, infants less than 3 months old, glucose-6-phosphate deficiency (G6PD) including breast-feeding of affected infants, pregnancy at term and porphyria Interactions : Concurrent use with norfloxacin may result in antagonism of antibacterial effect of norfloxacin. Fluconazole may increased risk of hepatic or pulmonary toxicity. Probenecid, antacids ---------------------------------------------------------------------------------------------------------------Ofloxacin 100 mg Tablet A Trade Name : Tarivid Indication : i) As second-line treatment of leprosy ii) As second-line treatment for tuberculosis and multidrug resistant tuberculosis (MDR-TB) iii) Sequential therapy for UTI and pyelonephritis Dosage : i) 400 mg/day ii) 400 mg twice daily iii) 200 mg twice daily Precautions : CNS disorders or other risk factors that may predispose to seizures or lower the seizure threshold. Renal or hepatic impairment, diabetes. Avoid exposure to direct sunlight. Children less than 18 years Adverse Reactions : Rash, GI discomfort, insomnia, dizziness, rash, pruritus, headache, photosensitivity, diarrhoea, nausea, vomiting, cardiac dysrhythmia, QT prolongation, immune hypersensitivity reaction, traumatic or non-traumatic rupture of tendon, peripheral neuropathy, seizure Contraindications : Hypersensitivity to quinolones. Pregnancy, lactation Interactions : Antacids, sucralfate, oral antidiabetics, warfarin, theophylline, probenecid, aminoglycosides, betalactam antibiotics -------------------------------------------------------------------------------------------------------------------------------------Phenoxymethyl Penicillin 125 mg Tablet C Trade Name : Penicillin V Indication : i) Treatment or prophylaxis of infections caused by susceptible organisms ii) Prophylactic, rheumatic fever Dosage : i) ADULT: 500 - 750 mg 6 hourly.CHILD; up to 1 year: 62.5 mg, 1 - 5 years: 125 mg, 6 - 12 years: 250 mg 6 hourly ii) ADULT: 125 - 250 mg twice daily. CHILD: 25 - 50 mg/kg in divided doses every 6 - 8 hours. Maximum: 3 g/day Precautions : Use cautiously in patients with penicillin or cephalosporin. Hypersensitivity reactions or asthma. Haematological& renal function test required on long-term treatment. Not for trivial infection. Renal or hepatic impairment Adverse Reactions : Skin rashes, anaphylaxis, urticaria, fever, joint pain. Haemolytic anaemia, blood disorders, gastrointestinal distress& superinfection 180 Contraindications : Hypersensitivity to penicillin Interactions : Antirheumatics& antipyretics inhibit excretion. Neomycin may cause malabsorption -------------------------------------------------------------------------------------------------------------------------------------Piperacillin 4 g & Tazobactam 500 mg Injection A* Trade Name : Tazocin 4.5 g Indication : Febrile neutropenia, lower respiratory tract infection and severe sepsis Dosage : - Adult and children more than 12 years: 4.5 g 8 hourly - Renal insufficiency: CrCL 20 - 80 ml/minute: 4.5 g 8 hourly. CrCL less than 20ml/minute: 4.5 g 12 hourly - Neutropenia adult and children more than 12 years, more than 50 kg: 4.5 g 6 hourly in combination with aminoglycosides - Children with normal renal function & less than 50kg: 90 mg/kg 6 hourly in combination with aminoglycosides Precautions : Bleeding manifestations, neuromuscular excitability in renal impairment, increased risk of fever and rash in cystic fibrosis, patients requiring sodium restriction. Not to use in children who do not have neutropenia Adverse Reactions : Allergic reaction, diarrhoea, nausea and vomiting, headache, injection site reactions, rash, pruritus, anaphylaxis Contraindications : Hypersensitivity to penicillins, cephalosporins or beta-lactamase inhibitors Interactions : Methotrexate, probenecid, typhoid vaccine, vecuronium ---------------------------------------------------------------------------------------------------------------Procaine Benzylpenicillin Aqueous 4 mega units (4 g) Injection B Indication : Treatment of infections due to Penicillin G-sensitive organisms Dosage : ADULT: 300,000 - 900,000 units (300 - 900 mg) IM daily. CHILD: Up to 1 year: 150 mg IM daily. 1 - 5 years: 300 mg IM daily. 6 - 12 years: 600 mg IM daily Precautions : History of penicillin or cephalosporin. Hypersensitivity reactions. Histories of significant allergies and or asthma. Inadvertent intra-arterial administration or injection into or near major peripheral nerves or blood vessels Adverse Reactions : Hypersensitivity reactions, especially skin rashes, diarrhoea, nausea, anaphylaxis, haemolytic anaemia and neutropenia, prolongation of bleeding time and defective platelet function, convulsions and other signs of CNS toxicity (encephalopathy has followed intrathecal administration and can be fatal) and electrolyte disturbances Contraindications : History of anaphylactic, accelerated allergic (eg, hives) or serum sickness reactions to previous penicillin administration. Hypersensitivity to procaine Interactions : Probenecid, bacteriostatic antibacterials such as chloramphenicol and tetracyclines, anticoagulants, methotrexate and oral contraceptives ---------------------------------------------------------------------------------------------------------------181 Pyrazinamide 500 mg Tablet B Indication : Tuberculosis Dosage : ADULT & CHILD : 25 mg/kg daily or 35 mg/kg 3 times weekly Precautions : Slightly impaired liver function, hyperuricaemia, arthralgia, renal insufficiency, diabetes mellitus Adverse Reactions : Liver toxicity depending on treatment duration & concomitant therapy. Transient increase in serum transminase levels, acute atrophy of the liver. Nausea, vomiting, anorexia, diarrhoea, abdominal pain. Hyperuricaemia may occur with dosages more than 2 g/day Contraindications : Porphyria, severe liver damage, acute liver disease, pregnancy, lactation Interactions : Concurrent use of pyrazinamide and zidovudine may result in decreased efficacy of pyrazinamide. Cyclosporin, ethionamide ---------------------------------------------------------------------------------------------------------------Rifampicin 150 mg Capsule B Rifampicin 300 mg Capsule B Trade Name : Rifadin Indication : i) Tuberculosis ii) Leprosy iii) Prophylaxis for meningococcal meningitis Dosage : i) ADULT: 450 - 600 mg as a single morning dose. CHILD: 10 - 20 mg/kg body weight daily in 1 - 2 doses. Directly observed therapy (DOT): 10 mg/kg twice weekly or 3 times/week. Maximum: 600 mg ii) 600 mg/day iii) 600 mg twice daily for 2 days Precautions : Alcoholism, patients with impaired liver function, pregnancy, lactation Adverse Reactions : Flushing, itching, gastrointestinal reactions, pseudomembranous colitis, hepatitis, thrombocytopenia, muscle weakness. Flu syndrome may occur with intermittent dosage regimens. May produce a reddish brown discoloration of body fluids Contraindications : Hypersensitivity and jaundice patient Interactions : May reduce the activity of anticoagulant, corticosteroids, cyclosporin, digitalis, oral contraceptives, oral hypoglycaemics ---------------------------------------------------------------------------------------------------------------Streptomycin Sulphate 1 g Injection B Indication : Tuberculosis Dosage : 0.5 - 1 g IM of Streptomycin base daily or at longer intervals, cumulative dose should not exceed 100 g Precautions : Renal and hepatic impairment. Elderly, poor oral and parenteral nutrition. Pregnancy and lactation Adverse Reactions : Ototoxicity, nephrotoxicity, shock, vitamin K and vitamin B deficiency, Steven-Johnson syndrome 182 Contraindications : Hypersensitivity to other aminoglycosides Interactions : Used with blood substitutes and diuretics intensify nephrotoxicity and ototoxicity. Possible inhibition of respiration with anaesthetics or muscle relaxants ---------------------------------------------------------------------------------------------------------------Sulphamethoxazole 200 mg & Trimethoprim 40 mg/5ml Suspension B Trade Name : Bactrim Indication : Infections caused by susceptible pathogens Dosage : CHILD less than 12 years: Trimethoprim 6 mg & Sulphamethoxazole 30 mg/kg/day, divided into 2 equal doses. CHILD more than 12 years: Standard dose: 10 ml diluted and infused twice daily. Severe infections: 15 ml diluted and infused twice daily Precautions : Haematological disorders, elderly, pregnancy, lactation, G6PD deficiency, folate deficiency, impaired renal function Adverse Reactions : Gastrointestinal upsets, stomatitis, glossitis and skin rashes, tinnitus, erythema multiforme, StevensJohnson syndrome, Lyell's syndrome, leucopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anaemia, pancytopenia or purpura, hyperkalaemia Contraindications : Marked liver parenchymal damage, blood dyscrasias, severe renal impairment, pregnancy, hypersensitivity. Use with caution in premature babies or full-term infants in the neonatal period Interactions : Increased risk of thrombocytopenia with thiazide diuretics in elderly. May require dosage reduction of warfarin and phenytoin. May displace methotrexate from plasma protein binding sites. Increased risk of venticular arrhythmias with amiodarone ---------------------------------------------------------------------------------------------------------------Sulphamethoxazole 400 mg & Trimethoprim 80 mg Injection A Trade Name : Bactrim Indication : i) Severe or complicated infections when oral therapy is not feasible ii) Treatment and prophylaxis of pneumocystis carinii pneumonia (PCP) in immunocompromised patients Dosage : i) ADULT: 960 mg twice daily increased to 1.44 g twice daily in severe infections. CHILD: 36 mg/kg daily in 2 divided doses increased to 54 mg/kg/day in severe infections ii) Treatment: ADULT & CHILD over 4 weeks: 120 mg/kg/day PO/IV infusion in 2 - 4 divided doses for 14 days. Prophylaxis: ADULT: 960 mg once daily or 960 mg on alternate days (3 times a week) or 960 mg twice daily on alternate days (3 times a week). CHILD 6 weeks - 5 months: 120 mg twice daily on 3 consecutive days or 7 days per week; 6 months - 5 years: 240 mg; 6 - 12 years: 480 mg Precautions : Haematological disorders, elderly, pregnancy, lactation, G6PD deficiency, folate deficiency, impaired renal function Adverse Reactions : Gastrointestinal upsets, stomatitis, glossitis and skin rashes, tinnitus, erythema multiforme, StevensJohnson syndrome, Lyell's syndrome, leucopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anaemia, pancytopenia or purpura, hyperkalaemia 183 Contraindications : Marked liver parenchymal damage, blood dyscrasias, severe renal impairment, pregnancy, hypersensitivity. Use with caution in premature babies or full-term infants in the neonatal period Interactions : Increased risk of thrombocytopenia with thiazide diuretics in elderly. May require dosage reduction of warfarin and phenytoin. May displace methotrexate from plasma protein binding sites. Increased risk of venticular arrhythmias with amiodarone ---------------------------------------------------------------------------------------------------------------Sulphamethoxazole 400 mg & Trimethoprim 80 mg Tablet B Trade Name : Bactrim Indication : i) Severe or complicated infections due to susceptible infection ii) Treatment and prophylaxis of pneumocystis carinii pneumonia (PCP) in immunocompromised patients Dosage : i) ADULT: 1 - 3 tablets twice daily ii) Treatment: ADULT & CHILD over 4 weeks: 120 mg/kg/day in 2 - 4 divided doses for 14 days. Prophylaxis: ADULT: 960 mg once daily or 960 mg on alternate days (3 times a week) or 960 mg twice daily on alternate days (3 times a week). CHILD; 6 weeks - 5 months: 120 mg twice daily on 3 consecutive days or 7 days per week; 6 months - 5 years: 240 mg; 6 - 12 years: 480 mg Precautions : Haematological disorders, elderly, pregnancy, lactation, G6PD deficiency, folate deficiency, impaired renal function Adverse Reactions : Gastrointestinal upsets, stomatitis, glossitis and skin rashes, tinnitus, erythema multiforme, StevensJohnson syndrome, Lyell's syndrome, leucopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anaemia, pancytopenia or purpura, hyperkalaemia Contraindications : Marked liver parenchymal damage, blood dyscrasias, severe renal impairment, pregnancy, hypersensitivity. Use with caution in premature babies or full-term infants in the neonatal period Interactions : Increased risk of thrombocytopenia with thiazide diuretics in elderly. May require dosage reduction of warfarin and phenytoin. May displace methotrexate from plasma protein binding sites. Increased risk of venticular arrhythmias with amiodarone ---------------------------------------------------------------------------------------------------------------Trimethoprim 300 mg Tablet B Trade Name : Alprim Indication : Treatment of urinary tract infections due to susceptible pathogens Dosage : ADULT: 200 mg daily in 1 or 2 divided doses or 300 mg daily as a single dose. Acute infection: 200 mg twice daily. CHILD: 6 - 12 years: 100 mg twice daily; 6 months - 5 years: 50 mg twice daily. 6 weeks 5 months: 25mg twice daily Precautions : Renal/hepatic impairment, folate deficiency, elderly and malnourished patients or with possible folate deficiency Adverse Reactions : Rash, pruritus, exfoliative dermatitis, nausea, vomiting, anorexia, and infrequent hematologic reactions (thrombocytopenia, leucopenia and megaloblastic anaemia) with chronic high dose 184 Contraindications : Hypersensitivity to trimethoprim or any component, megaloblastic anaemia due to folate deficiency Interactions : Increased effect, toxicity or levels of phenytoin, increased myelosuppression with methotrexate, may increase levels of digoxin ---------------------------------------------------------------------------------------------------------------Vancomycin HCL 500mg Injection A* Trade Name : Vancocin Indication : Only for the treatment of MRSA and CAPD peritonitis Dosage: Slow IV infusion, ADULT: 500 mg over at least 60 minutes every 6 hours or 1 g over at least 100 minutes every 12 hours. NEONATE up to 1 week, 15 mg/kg initially, then 10 mg/kg every 12 hours. INFANT 1 - 4 weeks, 15 mg/kg initially then 10 mg/kg every 8 hours. CHILD over 1 month, 10 mg/kg every 6 hours Precautions : Rapid infusion-related reactions. Hearing loss, renal impairment, pregnancy and lactation Adverse Reactions : Thrombophlebitis, febrile reactions with rigor during administration, nephrotoxicity, ototoxicity, nausea and vomiting Contraindications : Known hypersensitivity to this antibiotic Interactions : Increased risk of ototoxicity with loop diuretics, aminoglycosides. Increased risk of nephrotoxicity with aminoglycosides and cephalosporins ---------------------------------------------------------------------------------------------------------------Amphotericin B 50 mg Injection A Trade Name : Fungizone Indication : Systemic fungal infections Dosage : ADULT: 0.25 mg/kg/day by IV infusion, gradually increase if tolerated to 1 mg/kg/day. Maximum in severe cases: 1.5 mg/kg daily or on alternate days. For neonates, lower doses are recommended Precautions : Avoid rapid infusion, renal impairment. Hepatic & renal function tests, blood count & plasma electrolyte monitoring are required. Pregnancy, lactation Adverse Reactions : Fever, headache, anorexia, weight loss, GI disturbances, malaise, epigastric pain, dyspepsia, generalized pain, anaemia, abnormal renal function. Rarely cardiovascular toxicity, haematologic reactions, neurologic reactions, liver failure Contraindications : Hypersensitivity Interactions : Corticosteroids, nephrotoxic antibiotics and antineoplastics ---------------------------------------------------------------------------------------------------------------- 185 Caspofungin Acetate 50 mg Injection A* Caspofungin Acetate 70 mg Injection A* Trade Name : Cancidas Indication : Confirmed systemic fungal infection in patients who are refractory or intolerant to other fungal therapies Dosage : Invasive aspergillosis & invasive candidiasis: ADULT: Initially, 70 mg infused over 1 hour followed by subsequent doses of 50 mg/day. Oesophageal candidiasis: ADULT: 50 mg by slow IV infusion over approximately 1 hour Precautions : Concomitant ciclosporine; use only if benefits outweigh risk of possible hepatic toxicity, liver impairment, myelosuppression, pregnancy, lactation, renal insufficiency Adverse Reactions : Fever, nausea, vomiting, flushing, rash, dyspnoea, dystonia, facial swelling, pruritus, increased liver enzymes, complication of infusion, thrombophlebitis, headache Contraindications : Hypersensitivity to caspofungin acetate Interactions : Tacrolimus, cyclosporine, inducer of drug clearance (e.g. efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, carbamazepine) ---------------------------------------------------------------------------------------------------------------Clotrimazole 1% Ear Drop Trade Name : Candid Ear Drops Indication : Otomycosis; concomitant therapy with antibiotics and corticosteroid ear drops Dosage : 4 to 5 drops 3 to 4 times daily Precautions : Perforated eardrums, otitis media, pegnancy and lactation Adverse Reactions : local irritation Contraindications : Hypersensitive to clotrimazole Interactions : Not known B ---------------------------------------------------------------------------------------------------------------Fluconazole 100 mg Capsule A Trade Name : Diflucan Indication : i) Oropharyngeal candidiasis, atrophic oral candidiasis associated with dentures, other candidal infections of mucosa ii) Tinea pedis, corporis, cruris, versicolor and dermal candidiasis iii) Invasive candidal & cryptococcal infections (including meningitis) iv) Prevention of relapse of cryptococcal meningitis in AIDS patients after completion of primary therapy v) Prevention of fungal infections in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant 186 Dosage : i) Oropharyngeal candidiasis: 50 - 100 mg daily for 7 - 14 days (Maximum 14 days) except in severely immunocompromised patients, treatment can be continued for longer periods. Atrophic oral candidiasis associated with dentures: 50 mg daily for 14 days. Other candidal infections of mucosa: 50 - 100 mg daily for 14 - 30 days. CHILD: 3 - 6 mg/kg on first day then 3 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 - 4 weeks old) ii) 50 mg daily for 2 - 4 weeks, maximum 6 weeks iii) 400 mg initially then 200 - 400 mg daily for 6 - 8 weeks. CHILD: 6 - 12 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 -4 weeks old) iv) 100 - 200 mg daily v) 50 - 400 mg daily. CHILD: 3 - 12 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 - 4 weeks old) Precautions : Pregnancy, lactation, renal impairment Adverse Reactions : Nausea, abdominal pain, diarrhoea, flatulence; rash, headache Contraindications : Known hypersensitivity to fluconazole or to related azole compounds, co-administration of terfenadine Interactions : Warfarin, oral sulfonylureas, phenytoin, rifampicin, cyclosporin, theophylline, cisapride ---------------------------------------------------------------------------------------------------------------Fluconazole 2 mg/ml Injection A Trade Name : Diflucan Indication : i) Oropharyngeal candidiasis, atrophic oral candidiasis associated with dentures, other candidal infections of mucosa ii) Tinea pedis, corporis, cruris, versicolor and dermal candidiasis iii) Invasive candidal& cryptococcal infections (including meningitis) iv) Prevention of relapse of cryptococcal meningitis in AIDS patients after completion of primary therapy v) Prevention of fungal infections in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant Dosage : i) 50 - 100 mg daily for 7 - 14 days (Maximum 14 days) except in severely immunocompromised patients, treatment can be continued for longer periods. Atrophic oral candidiasis associated with dentures: 50 mg daily for 14 days. Other candidal infections of mucosa: 50 - 100 mg daily for 14 - 30 days. CHILD: 3 - 6 mg/kg on first day then 3 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 - 4 weeks old) ii) 50 mg daily for 2 - 4 weeks, maximum 6 weeks iii) 400 mg initially then 200 - 400 mg daily for 6 - 8 weeks. CHILD: 6-12 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 - 4 weeks old) iv) 100 - 200 mg daily v) 50 - 400 mg daily. CHILD: 3 - 12 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 - 4 weeks old) Precautions : Pregnancy, lactation, renal impairment Adverse Reactions : Nausea, abdominal pain, diarrhoea, flatulence; rash, headache Contraindications : Known hypersensitivity to fluconazole or to related azole compounds, co-administration of terfenadine Interactions : Warfarin, oral sulfonylureas, phenytoin, rifampicin, cyclosporin, theophylline, cisapride ---------------------------------------------------------------------------------------------------------------187 Griseofulvin (Ultramicrosize 125 mg = 250 mg Microsize) Tablet B Trade Name : Fulcin Indication : Dermatophyte infections of the skin, scalp, hair and nails, where topical therapy has failed or inappropriate Dosage : ADULT: 500 mg daily up to 1 g daily in divided doses, CHILD: 10 mg/kg daily in divided doses or as a single dose Precautions : Ability to drive and operate machinery may be impaired. Lactation. May damage sperm cells - male should not father children within 6 month of treatment Adverse Reactions : Oral thrush, gastrointestinal distress, taste perversion, dizziness, confusion, headache, depression, insomnia, fatigue, peripheral neuritis, photosensitivity, skin rashes, urticaria, erythema multiforme, leucopaenia, proteinuria Contraindications : Established porphyria, hepatocellular failure, SLE and related conditions, pregnancy Interactions : Absorption reduced by barbiturates. Effectiveness reduced by liver enzyme inducing drugs. Decreases anticoagulant effect of warfarin. Reduces effectiveness of oral contraceptive. Enhancement of effects of alcohol ---------------------------------------------------------------------------------------------------------------Itraconazole 10 mg/ml Oral Solution A* Trade Name : Sporanox Indication : Treatment of: i) oral and/or oesophageal candidiasis ii) fluconazole resistant and/or oesophageal candidiasis Dosage : i) 200 mg daily in 2 intakes, or in 1 intake, for 1 week. If no response after 1 week, continue treatment for another week ii) 100 - 200 mg twice daily for 2 weeks. If no response after 2 weeks, continue treatment for another 2 weeks. The 400 mg daily dose should not be used for more than 14 days Precautions : Lactation, history of liver or renal disease, children, decreased gastric acidity. Patients with risk factors for congestive heart failure such as ischaemic and valvular cardiac disease Adverse Reactions : Rash, hypokalemia, diarrhoea, nausea and vomiting, Stevens-Johnson syndrome, neutropenic disorder, hepatotoxicity, anaphylaxis Contraindications : Pregnancy, hypersensitivity to itraconazole Interactions : Rifampicin& phenytoin reduce oral bioavailability of itraconazole. Inhibits metabolism of warfarin, digoxin, terfenadine, cyclosporin A, astemizole, cisapride, oral midazolam ---------------------------------------------------------------------------------------------------------------- 188 Itraconazole 100 mg Capsule A* Trade Name : Sporanox Indication : i) Dermatomycosis including pityriasis versicolor ii) Oral candidiasis iii) Palmar tinea manus and plantar tinea pedis iv) Fingernail onychomycosis v) Toenail onychomycosis vi) Vulvovaginal candidiasis Dosage : i) 200 mg once daily for 7 days ii) 100 mg daily for 15 days iii) 200 mg twice daily for 7 days iv) 200 mg twice daly for 1 week/month v) 200 mg twice daily for 1 week/month for 3 months vi) 200 mg morning and evening for 1 day or 200 mg once daily for 3 days Precautions : Lactation, history of liver or renal disease, children, decreased gastric acidity. Patients with risk factors for congestive heart failure such as ischaemic and valvular cardiac disease Adverse Reactions : Rash, hypokalemia, diarrhoea, nausea and vomiting, Stevens-Johnson syndrome, neutropenic disorder, hepatotoxicity, anaphylaxis Contraindications : Pregnancy, hypersensitivity to itraconazole Interactions : Rifampicin& phenytoin reduce oral bioavailability of itraconazole. Inhibits metabolism of warfarin, digoxin, terfenadine, cyclosporin A, astemizole, cisapride, oral midazolam ---------------------------------------------------------------------------------------------------------------Ketoconazole 200 mg Tablet A/KK Trade Name : Nizoral Indication : i) Pityriasis versicolor ii) Systemic mycosis (other skin mycoses) iii) Nail infections Dosage : i) 200 mg with meal once daily for 10 days ii) 200 - 400 mg daily for 4 weeks - 6 months iii) 200 - 400 mg daily for 6 - 12 months. Maximum 400 mg daily Precautions : Adrenal insufficiency or borderline adrenal function, prolonged periods of stress, pregnancy & lactation Adverse Reactions : GI disturbances; pruritus; elevated liver function tests. Rarely, acute allergic reactions, hepatitis, gynaecomastia, photophobia, alopecia Contraindications : Liver disease, recovery phase of hepatitis, known hypersensitivity Interactions : Antacids, H2 receptor antagonist, antimuscarinic agents, alcohol, warfarin, prednisolone, quinidine, cyclosporin, phenytoin, rifampicin, oral contraceptives ---------------------------------------------------------------------------------------------------------------Nystatin 100,000 units/ml Suspension B Trade Name : Mycostatin Indication : Prevention and treatment of candidiasis of the skin and mucous membranes, protection against candidas overgrowth during antimicrobial /corticosteroid therapy and as selective decontamination regimens 189 Dosage : NEWBORN: 50,000-100,000 units daily. CHILD up to 5 years: 100,000 -500,000 units 6 hourly. CHILD up to 6-12 years and ADULT: 500,000-1,000,000 units 3 to 4 times daily Precautions : Not intended to treat systemic mycoses. If hypersensitivity develops, discontinue use Adverse Reactions : GI disturbances, rash, urticaria , Steven Johnson Syndrome, oral irritation Contraindications : Hypersensitivity to nystatin Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Terbinafine HCl 250 mg Tablet A* Trade Name : Lamisil Indication : Fungal infections especially onchomycosis caused by dermatophytes Dosage : 250 mg once daily for 6 weeks for fingernails: 12 weeks for toenails Precautions : Severe liver or renal dysfunction (creatinine clearance less than 50 ml/min or serum creatinine of more than 300 µmol/L) should receive a lower dose. Pregnancy and lactation Adverse Reactions : Gastrointestinal symptoms, skin reactions, headache, dizziness, vertigo, lymphocytopenia, and visual disturbance Contraindications : Hypersensitivity to terbinafine Interactions : Induce metabolism (eg, rifampicin) and may be inhibited by drugs which inhibit cytochrome P-450 (eg, cimetidine) ---------------------------------------------------------------------------------------------------------------Acyclovir 200 mg Tablet A/KK Acyclovir 800 mg Tablet A/KK Trade Name : Zovirax Indication : i) Mucocutaneous Herpes Simplex infection in immunocompromised and AIDS patients ii) Primary and recurrent Varicella Zoster infection in immunocompromised and AIDS patients iii) Severe Kaposi Varicella Eruption (Eczema herpeticum) iv) Severe primary HSV infections (eg. Neonatal herpes, encephalitis, eczema herpeticum, genital herpes, gingival stomatitis, vaginal delivery with maternal vulva herpes) v) Severe and complicated varicella infection (eg. Encephalitis, purpura fulminans) vi) Severe zoster infection in paediatrics (eg. Encephalitis, purpura fulminans, immunocompromised patients and facial, sacral and motor zoster) Dosage : i) ADULT: initially 400 mg 5 times daily for 7 - 14 days. CHILD less than 2 years: 200 mg 4 times daily, CHILD more than 2 years: 400 mg 4 times daily ii), iii) and iv) ADULT: 200 - 400 mg 4 times daily. CHILD: less than 2 years, half adult dose; more than 2 years, adult dose v) ADULT: 800 mg 5 times daily for 7 days vi) ADULT: 20 mg/kg (maximum: 800 mg) four times daily for 5 days, CHILD 6 years: 800 mg four times daily. CHILD less than 2 years; 400mg 4 times daily, more than 2 years; 800mg 4 times daily 190 Precautions : Patients with pre-existing neurologic, renal, or hepatic impairment, dehydrated patient, elderly and lactation Adverse Reactions : Skin rashes; GI effects; fatigue Contraindications : Patients known to be hypersensitivity to acyclovir Interactions : Increased mean half-life & plasma concentration with probenecid ---------------------------------------------------------------------------------------------------------------Acyclovir 250 mg Injection A* Trade Name : Zovirax Indication : Treatment and prophylaxis of herpes simplex in immunocompromised, severe initial genital herpes and Varicella -Zoster Dosage : ADULT: 5 mg/kg by IV infusion 8 hourly for 5 days, doubled to 10mg/kg every 8 hourly in varicellazoster in the immunocompromised and in simplex encephalitis (usually given for at least 10 days in encephalitis; possibly for 14 - 21 days). NEONATE & INFANT up to 3 months with disseminated herpes simplex: 20mg/kg every 8 hourly for 14 days (21 days in CNS involvement), varicellazoster 1020mg/kg every 8 hourly usually for 7 days. CHILD, 3 months - 12 years: Herpes simplex or Varicella Zoster: 250 mg/m2 8 hourly for 5 days, doubled to 500 mg/m2 8 hourly for varicella-zoster in the immunocompromised and in simplex encephalitis (usually given for 10 days in encephalitis) Precautions : In patients receiving Zovirax IV at higher doses, specific care regarding renal function should be taken, particularly when patients are dehydrated or have any renal impairment Adverse Reactions : Skin rashes; GI effects, neurological reactions (IV infusion) Contraindications : Patients known to be hypersensitivity to acyclovir Interactions : Increased mean half-life & plasma concentration with probenecid -------------------------------------------------------------------------------------------------------------------------------------Didanosine 100 mg Tablet (ddI) A* Trade Name : Videx Indication : HIV infection, in combination with other antiretrovirals Dosage : ADULT less than 60 kg: 125 mg twice daily or 250 mg once daily; more than 60 kg: 400 mg once daily or 200 mg twice daily. CHILD more than 8 months: 120 mg/m2 twice daily, 2 weeks - 8 months: 100 mg/m2 twice daily Precautions : Peripheral neuropathy, history of pancreatitis, lactic acidosis, renal impairment, phenylketonuria, pregnancy & lactation Adverse Reactions : Pancreatitis, peripheral neuropathy, hepatomegaly, lactic acidosis, optic neuritis, retinal disorder, steatosis of liver, rash, pruritis, asthenia, headache, nausea, vomiting, abdominal pain, diarrhoea, chills, fever, pain, retinal depigmentation, optic neuritis, anorexia, dyspepsia, flatulence, parotid gland enlargement, arthralgia, myopathy 191 Contraindications : Hypersensitivity to didanosine Interactions : Allopurinol, ketoconazole, itraconazole, dapsone, ganciclovir/ valganciclovir, hydroxyurea, methadone, quinolone antibiotics, ribavirin, stavudine, tenofovir, ethanol ---------------------------------------------------------------------------------------------------------------Didanosine 2 g Oral Solution (ddI) A* Trade Name : Videx Indication : HIV infection, in combination with other antiretrovirals Dosage : ADULT less than 60 kg: 125 mg twice daily or 250 mg once daily; more than 60 kg: 400 mg once daily or 200 mg twice daily. CHILD more than 8 months: 120 mg/m2 twice daily, 2 weeks - 8 months: 100 mg/m2 twice daily Precautions : Peripheral neuropathy, history of pancreatitis, lactic acidosis, renal impairment, phenylketonuria, pregnancy & lactation Adverse Reactions : Pancreatitis, peripheral neuropathy, rash, pruritis, asthenia, headache, nausea/vomiting, abdominal pain, diarrhoea, chills, fever, pain, retinal depigmentation, optic neuritis, anorexia, dyspepsia, flatulence, parotid gland enlargement, anthralgia, myopathy, hypoglycaemia & hyperglycaemia, rhabdomyolysis Contraindications : Hypersensitivity to didanosine Interactions : Allopurinol, ketoconazole, itraconazole, dapsone, ganciclovir / valganciclovir, hydroxyurea, methadone, quinolone antibiotics, ribavirin, stavudine, tenofovir, ethanol ---------------------------------------------------------------------------------------------------------------Efavirenz 600 mg Tablet A* Trade Name : Stocrin Indication : Combination therapy for HIV infections with a protease inhibitor and or Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Dosage : ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: 400 mg once daily, 25 - less than 32.5 kg: 350 mg once daily, 20 - less than 25 kg: 300 mg once daily, 15 - less than 20 kg: 250 mg once daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Tablet formulation unsuitable for children less than 40 kg Precautions : Pregnancy, lactation and renal impairment Adverse Reactions : Dizziness, nausea, headache, fatigue, rash including erythema multiforme & Stevens-Johnson Syndrome, allergic reaction, abnormal coordination, ataxia, confusion, stupor, vertigo, vomiting, diarrhoea, hepatitis, impaired concentration, insomnia, anxiety, abnormal dreams, somnolence, depression, abnormal thinking, agitation, amnesia, delirium, emotional liability, euphoria, hallucination and psychosis Contraindications : Hypersensitivity, concomitant terfenadine, cisapride, midazolam, triazolam and ergot derivatives 192 Interactions : Amprenavir, indinavir, ritonavir, saquinavir, rifamycins, clarithromycin, oral contraceptives, anticonvulsants, methadone, St. John's wort, sertraline, cetirizine, lorazepam. Other compounds that are substrates of CYP3A4 may have decreased plasma concentration when coadministered with efavirenz -------------------------------------------------------------------------------------------------------------------------------------Entecavir 0.5 mg Tablet A* Trade Name : Baraclude Indication : First line treatment of Chronic Hepatitis B in patients who satisfy the criteria for treatment and require long-term therapy or have a very high baseline viral load Dosage : 0.5 mg once daily Precautions : Monitor hepatic function after treatment discontinuation. Patient with renal impairment. Liver transplant recipients. Pregnancy and lactation Adverse Reactions : Swelling, erythema, pruritus, rash, stinging of skin, burning sensation Contraindications : Hypersensitivity to entecavir or to any component of the product Interactions : Drugs that reduce renal function or compete for active tubular secretion may increase serum concentration of either entecavir or co-administered drug ---------------------------------------------------------------------------------------------------------------Indinavir Sulfate 400 mg Capsule A* Trade Name : Crixivan Indication : i) Post-exposure prophylaxis (PEP) among healthcare workers in high-risk HIV occupational exposure ii) For therapy as part of combination antiretroviral treatment on adult HIV patients ie Highly Active Anti-Retroviral Therapy (HAART) Dosage : ADULT: 800 mg every 8 hours. CHILD (investigational): 500 mg/m2 every 8 hours (patients with smaller body surface area (BSA) may require lower doses of 300 - 400 mg/m2 every 8 hours) Precautions : Nephrolithiasis, acute haemolytic anaemia, hyperglycaemia, pregnancy, lactation, hyperlipidaemia Adverse Reactions : Asthenia/fatigue, abdominal pain, dry mouth, flatulence, lymphadenopathy Contraindications : Breast feeding, known hypersensitivity to this compound Interactions : Ketoconazole, rifampicin, cisapride, astemizole, phenobarbitone, phenytoin, carbamazepine, dexamethasone, sildenafil, St. John's Wort ---------------------------------------------------------------------------------------------------------------Lamivudine 10 mg/ml Oral Solution Trade Name : 3TC Indication : HIV infection in combination with other antiretroviral agents 193 A* Dosage : ADULT: 150 mg twice daily or 300 mg once daily. INFANT under 1 month: 2 mg/kg twice daily. CHILD 1 month or over: 4 mg/kg twice daily. Maximum 300 mg daily Precautions : Moderate to severe renal impairment, advanced cirrhotic liver disease, pregnancy, lactation, chronic hepatitis B or C, hepatic disease Adverse Reactions : Nausea, vomiting, diarrhoea, abdominal pain, cough, headache, fatigue, insomnia, malaise, fever, rash, alopecia, muscle disorders, peripheral neuropathy, pancreatitis, neutropenia, anaemia, thrombocytopenia and red-cell aplasia, lactic acidosis, raised liver enzymes and serum amylase, hepatomegaly Contraindications : Hypersensitivity to lamivudine, abnormally low neutrophil counts or abnormally low haemoglobin levels Interactions : Trimethoprim, interferon alfa, ribavirin, sulfamethoxazole, zalcitabine ---------------------------------------------------------------------------------------------------------------Lamivudine 100 mg Tablet A* Lamivudine 150 mg Tablet A* Trade Name : Zeffix Indication : Management of chronic hepatitis B infection associated with evidence of hepatitis B viral replication and active liver inflammation Dosage : ADOLESCENTS more than 16 years and ADULTS: 100 mg/dose once daily Precautions : Moderate to severe renal impairment, advanced cirrhotic liver disease, pregnancy, lactation, chronic hepatitis B or C, hepatic disease Adverse Reactions : Nausea, vomiting, diarrhoea, abdominal pain, cough; headache, fatigue, insomnia, malaise, fever, rash, alopecia, muscle disorders, peripheral neuropathy, pancreatitis, neutropenia, anaemia, thrombocytopenia and red-cell aplasia, lactic acidosis, raised liver enzymes and serum amylase, hepatomegaly Contraindications : Hypersensitivity to lamivudine, abnormally low neutrophil counts or abnormally low haemoglobin levels Interactions : Trimethoprim, interferon alfa, ribavirin, sulfamethoxazole, zalcitabine ---------------------------------------------------------------------------------------------------------------Lopinavir 200 mg and Ritonavir 50 mg Tablet A* Trade Name : Kaletra Indication : As second line protease inhibitor if intolerant to indinavir/ ritonavir as part of HAART regimen Dosage : ADULT and CHILD with BSA greater than 1.4 m2 or body weight 40kg and over: 2 tablets twice daily Precautions : Hepatic impairment, renal impairment, haemophilia, pregnancy, diabetes, pancreatitis 194 Adverse Reactions : Dyslipidemia, hyperglycaemia, hypercholesterolemia, increased triglycerides, diarrhoea, nausea, headache, pain, insomnia Contraindications : Hypersensitivity to lopinavir or ritonavir, concomitant use with drugs that are highly dependent on CYP3A or CYP2D6 for clearance Interactions : Antiarrhythmias, anticonvulsant, antihistamines, benzodiazepines, calcium channel blockers, cisapride, clarithromycin, dexamethasone, disulfiram, didanosine ---------------------------------------------------------------------------------------------------------------Lopinavir/Ritonavir Oral Solution A Trade Name : Kaletra Indication : Management of patients with asymptomatic and symptomatic (early or advanced) HIV Infection with CD4 cell counts Dosage : 12 mg/kg twice daily for those 7 - 15 kg and 10mg/kg twice daily for those 15 - 40 kg taken with food, up to a maximum dose of 533 mg Lopinavir/13.3mg Ritonavir in children greater than 45 kg (5 ml) twice daily Precautions : Hepatic impaiment, renal impairment, haemophilia, pregnancy, diabetes, pancreatitis Adverse Reactions : Dyslipidaemia, hyperglycaemia, hypercholesterolemia, increased triglycerides, diarrhoea, nausea, headache, pain, insomnia Contraindications : Hypersensitivity to lopinavir or ritonavir, concomitant use with drugs that are highly dependent on CYP3A or CYP2D6 for clearance Interactions : Antiarrhythmias, anticonvulsant, antihistamines, benzodiazepines, calcium channel blockers, cisapride, clarithromycin, dexamethasone, disulfiram, didanosine ---------------------------------------------------------------------------------------------------------------Nevirapine 200 mg Tablet A* Indication : Treatment of HIV-1 infection in combination with other antiretroviral agents Dosage : 200 mg once daily for first 14 days then 200 mg twice daily Precautions : Hepatic impairment, history of chronic hepatitis, hepatic disease, pregnancy. Avoid use in patients with CD4 cell counts more than 250 cells/mm3 in adult women and 400 cells/mm3 in adult men Adverse Reactions : Hepatitis, hepatic failure (life threatening), hepatotoxicity, severe skin reaction, headache, fatique, diarrhoea, nausea, rash Contraindications : Hypersensitivity to nevirapine or any component of the formulation, breast feeding, severe hepatic impairment Interactions : Methadone, rifampicin, ketoconazole, other antivirals such as saquinaxir, indinavir, St. John's wort, warfarin ---------------------------------------------------------------------------------------------------------------195 Palivizumab 100mg Injection A* Trade Name : Synagis Indication : For the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in paediatric patients at high risk of RSV disease Dosage : 15 mg/kg IM once a month during season of RSV risk Precautions : Should be given with caution to patients with thrombocytopenia or any coagulation disorder. Injection should be given within 6 hours after reconstitution Adverse Reactions : Fever, nervousness, diarrhoea, vomiting, rhinitis, cough, wheeze, pain, rash, leucopenia, abnormal liver function tests Contraindications : Hypersensitivity to humanised monoclonal antibodies Interactions : Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed ---------------------------------------------------------------------------------------------------------------Ritonavir 100 mg Capsule A* Trade Name : Norvir Indication : Progressive or advanced HIV infection in combination with other antiretroviral agents. Criteria for use: a) Clinical AIDS b) CD4 less than 350 cells or c) Viral load more than 10,000 copies/ml Dosage : ADULT: initially 300 mg twice daily, increase by 100 mg twice daily increments to 600 mg twice daily. For older child who can swallow soft gelatin capsule; 250 mg/m2 twice daily for 2 days, if tolerate 400 mg/m2 twice daily onwards Precautions : Hepatic impairment Adverse Reactions : Asthenia, gastrointestinal and neurological disturbances, anorexia, taste perversion, dyslipidemia, pancreatitis, hepatitis, Stevens-Johnson syndrome Contraindications : Hypersensitivity, lactation, severe hepatic impairment Interactions : Decreased plasma concentration with phenobarbital, carbamazepine, dexamethasone, phenytoin, rifampicin. Risk of myopathy with concurrent use of lovastatin, simvastatin ---------------------------------------------------------------------------------------------------------------Stavudine 30 mg Capsule A* Trade Name : Zerit Indication : HIV infection, in combination with other antiretrovirals Dosage : ADULT more than 60 kg: 40 mg twice daily; less than 60 kg: 30 mg twice daily. CHILD more than 30 kg: 30 mg twice daily; less than 30 kg: 15 mg twice daily Precautions : Renal and hepatic impairment, peripheral neuropathy, elderly, pregnancy and lactation 196 Adverse Reactions : Headache, rash, gastrointestinal effects, peripheral neuropathy, abdominal pain, allergic reaction, anaemia, anorexia, chills, diabetes mellitus, fever, hepatic failure, hepatitis, hepatomegaly, hyperglycaemia, hyperlactatemia, insomnia, lactic acidosis, leukopenia, macrocytosis, motor weakness, myalgia, pancreatitis, redistribution /accumulation of body fat, thrombocytopenia Contraindications : Hypersensitivity to stavudine Interactions : Zidovudine, doxorubicin, ribavirin, didanosine ---------------------------------------------------------------------------------------------------------------Stavudine 30 mg, Lamivudine 150 mg & Nevirapine 200 mg Tablet A* Trade Name : SLN 30 Indication : Fixed dose triple therapy for treatment of HIV infection in adults once patients have been stabilized on the maintenance regimen of nevirapine 200 mg twice daily and have demonstrated adequate tolerability to nevirapine Dosage : One tablet twice daily for patients weighing less than 60 kg Precautions : Hepatitis B or C. Discontinue immediately if severe life-threatening skin reactions occur and do not rechallenge. Avoid concomitant prednisone. Perform baseline and periodic liver function tests. Pregnancy and lactation Adverse Reactions : Peripheral neuropathy, pancreatitis, chills, fever, malaise, diarrhoea, constipation, dyspepsia, asthenia, anorexia, nausea/vomiting, chest, abdominal and back pain, depression, anxiety, flu syndrome, sweating, dizziness, dyspnoea, rash, pruritus. Stevens-Johnson syndrome, toxic epidermal necrolysis, serious hepatitis, hepatic failure, hypersensitivity reactions characterised by rash with constitutional symptoms and visceral involvement, gastrointestinal disturbances, fatigue, somnolence, myalgia Contraindications : Patients who are just initiating therapy with nevirapine. These patients require a lead-in dose of nevirapine 200 mg daily, whereas this formulation contains the maintenance dose of nevirapine 200 mg twice daily Interactions : Trimethoprim and sulphamethoxazole, rifampicin, ketoconazole, oral contraceptives, methadone ---------------------------------------------------------------------------------------------------------------Telbivudine 600 mg Tablet A* Trade Name : Sebivo Indication : Treatment of chronic hepatitis B in patients with evidence of viral replication and active liver inflammation Dosage : ADULT and CHILD over 16 years: 600 mg once daily. Moderate to severe renal impairment: CrCL 3049ml/minute, 600 mg every 48 hours. CrCL Precautions : Renal impairment: Use caution in patients with moderate-to-severe renal dysfunction and end stage renal disease (ESRD); dosing adjustment required (ClCr 197 Adverse Reactions : Dizziness, headache, increased blood amylase and lipase, diarrhoea, nausea, elevated ALT, rash, increased blood creatinine phosphokinase, fatigue, abdominal pain, dyspepsia. Increased AST, myopathy, arthralgia, myalgia, malaise Contraindications : Hypersensitivity to telbivudine or any component of the product Interactions : Increased risk of peripheral neuropathy when telbivudine given with interferon alfa ---------------------------------------------------------------------------------------------------------------Zidovudine 1% Injection A Trade Name : Retrovir Indication : To reduce the rate of maternal-foetal transmission of HIV in: i) HIV-positive pregnant women over 14 weeks of gestation ii) Their newborn infants Dosage : i) 200 mg 3 times/day or 300 mg twice daily until start of labor. During labour, by IV infusion initially 2 mg/kg over 1 hour followed by continuous IV infusion at 1 mg/kg/hr until delivery ii) 2 mg/kg orally every 6 hours within 12 hours after birth. If unable to receive oral dose: FULL TERM: 1.5 mg/kg/dose every 6 hours, INFANTS 30 weeks and less than 35 weeks gestation at birth: 1.5 mg/kg/dose every 12 hours; at 2 weeks of age, advance to 1.5 mg/kg/dose every 8 hours, INFANTS less than 30 weeks gestation at birth: 1.5 mg/kg/dose every 12 hours; at 4 weeks of age, advance to 1.5 mg/kg/dose every 8 hours Precautions : Monitor carefully haematological parameters. If anaemia or myelosuppression occurs dose adjustments are suggested. Patients with pre-existing bone marrow compromise. Pregnancy and lactation Adverse Reactions : Anaemia, neutropenia, leucopenia, nausea, headache, rash, abdominal pain, fever, myalgia, paraesthesia, vomiting, insomnia and anorexia. Asthenia, malaise, somnolence, diarrhoea, dizziness, sweating, dyspnoea, dyspepsia, flatulence, bad taste, chest pain, loss of mental acuity, anxiety, urinary frequency, depression, generalised pain, chills, cough, urticaria, pruritus and flu-like syndrome Contraindications : Abnormally low neutrophil cell count (less than 0.75 x 109L) or abnormally low Hb levels (less than 7.5 g/dL) Interactions : Chronic paracetamol use, potentially nephrotoxic or myelosuppressive drugs, probenecid ---------------------------------------------------------------------------------------------------------------Zidovudine 10 mg/ml Syrup A* Trade Name : Retrovir Indication : i) Management of patients with asymptomatic and symptomatic (early or advanced) HIV infections with CD4 cell counts less than 500 cu. mm. ii) Neonatal prophylaxis Dosage : i) ADULT: 500 - 600 mg/day in 2 - 3 divided doses. CHILD more than 3 months: 360 - 480 mg/m2 daily in 3 - 4 divided doses; maximum 200 mg every 6 hours ii) 2 mg/kg 6 hourly within 12 hours after birth up to 6 weeks 198 Precautions : Monitor carefully haematological parameters. If anaemia or myelosuppression occurs dose adjustments are suggested. Patients with pre-existing bone marrow compromise. Pregnancy and lactation Adverse Reactions : Anaemia, neutropenia, leucopenia, nausea, headache, rash, abdominal pain, fever, myalgia, paraesthesia, vomiting, insomnia and anorexia. Asthenia, malaise, somnolence, diarrhoea, dizziness, sweating, dyspnoea, dyspepsia, flatulence, bad taste, chest pain, loss of mental acuity, anxiety, urinary frequency, depression, generalised pain, chills, cough, urticaria, pruritus and flu-like syndrome Contraindications : Abnormally low neutrophil cell count (less than 0.75 x 109/L) or abnormally low Hb levels (less than 7.5 g/dL) Interactions : Chronic paracetamol use, potentially nephrotoxic or myelosuppressive drugs, probenecid ---------------------------------------------------------------------------------------------------------------Zidovudine 100 mg Capsule A* Trade Name : Retrovir Indication : i) Management of patients with asymptomatic and symptomatic (early or advanced) HIV infections with CD4 cell counts less than 500 cu. mm ii) Neonatal prophylaxis Dosage : i) Adult: 500 - 600 mg/day in 2 - 3 divided doses. Child more than 3 months: 360 - 480 mg/m2 daily in 3 - 4 divided doses; maximum 200 mg every 6 hours ii) 2 mg/kg 6 hourly within 12 hours after birth up to 6 weeks Precautions : Monitor carefully haematological parameters. If anaemia or myelosuppression occurs dose adjustments are suggested. Patients with pre-existing bone marrow compromise. Pregnancy and lactation Adverse Reactions : Anaemia, neutropenia, leucopenia, nausea, headache, rash, abdominal pain, fever, myalgia, paraesthesia, vomiting, insomnia and anorexia, asthenia, malaise, somnolence, diarrhoea, dizziness, sweating, dyspnoea, dyspepsia, flatulence, bad taste, chest pain, loss of mental acuity, anxiety, urinary frequency, depression, generalised pain, chills, cough, urticaria, pruritus and flu-like syndrome Contraindications : Abnormally low neutrophil cell count (less than 0.75 x 109/L) or abnormally low Hb levels (less than 7.5 g/dL) Interactions : Chronic paracetamol use, potentially nephrotoxic or myelosuppressive drugs, probenecid ---------------------------------------------------------------------------------------------------------------Zidovudine 300 mg & Lamivudine 150 mg Tablet Trade Name : Combivir Indication : HIV infection in combination with at least one other antiretroviral drug Dosage : ADULT and CHILD over 12 years: 1 tablet twice daily 199 A* Precautions : Advanced cirrhotic liver disease due to chronic hepatitis B infection. Severe hepatic or renal impairment. Monitor haematological parameters Adverse Reactions : Headache, malaise, fatigue, gastrointestinal effects, upper abdominal pain, fever, rash, pancreatitis, peripheral neuropathy, leucopenia, neutropenia, anaemia, thrombocytopenia Contraindications : Hypersensitivity, patients with abnormally low neutrophil counts or abnormally low haemoglobin levels Interactions : Trimethoprim, phenytoin, paracetamol, aspirin, codeine, morphine, indomethacin, ketoprofen, naproxen, oxazepam, lorazepam, cimetidine, clofibrate, dapsone and isoprinosine, potentially nephrotoxic or myelosuppressive drugs, ribavirin ---------------------------------------------------------------------------------------------------------------Chloroquine Phosphate 250 mg Tablet (150 mg Chloroquine base) C Indication : Treatment of malaria - acute attack Dosage : ADULT 600 mg base stat, 300 mg 6 - 8 hours later and a further 300 mg on each of 2 following days. CHILD 3 - 4 years : 150 mg base stat, 75 mg 6 hours later, then 75 mg daily for 2 days. CHILD 5 - 8 years : 300 mg stat, 150 mg 6 hours later, then 150 mg daily for 2 days Precautions : May exacerbate psoriasis or trigger an acute attack of hepatic porphyria (metabolic abnormality). Pre-existing kidney damage, first trimester of pregnancy Adverse Reactions : Loss of appetite, nausea, pressure over the stomach, visual disturbances Contraindications : G6PD deficiency, diseases of haematopoietic organs or CNS, retinopathy Interactions : Simultaneous use of corticosteroids can accentuate possible myopathies and cardiomyopathies ---------------------------------------------------------------------------------------------------------------Primaquine 7.5 mg base Tablet B Indication : i) Treatment of malaria ii) Prophylaxis together with a schizonticide such as chloroquine Dosage : i) ADULT: 15 mg daily for 14 days. CHILD: 0.3 mg/kg body weight daily for 14 days ii) ADULT: 30 mg once weekly. CHILD: 0.5 mg once weekly Precautions : Use with caution in patients with a deficiency in G6PD (may cause acute haemolytic anaemia) and patients with a nicotinamide-adenine dinucleotide hydroxide (NADH) methaemoglobin-reductase deficiency (at risk of developing methaemoglobinaemia and cyanosis) Adverse Reactions : Anaemia, leucocytosis, abdominal pain, methaemoglobinaemia Contraindications : Concomitant medications which cause bone marrow suppression, rheumatoid arthritis, lupus erythematosus, glucose-6-phosphate dehydrogenase (G6PD) deficiency, pregnancy 200 Interactions : Artemether/ lumefantrine ---------------------------------------------------------------------------------------------------------------Quinine Sulphate 300 mg Tablet B Indication : Suppression or treatment of chloroquine-resistant Plasmodium Falciparum malaria in conjunction with other antimalarial agents Dosage : 300 - 600 mg daily. Treatment : 1.2 - 2 g daily in divided doses. CHILDS less than 1 year : 100 - 200 mg daily, 1 - 3 years : 200 - 300 mg daily, 4 - 6 years: up to 500 mg daily, more than 7 years : up to 1 g daily. All above doses are given for 7 days in 2 - 3 divided doses Precautions : Atrial fibrillation or other serious heart disease, myasthenia gravis, history of asthma, optic neuritis, tinnitus, hypoglycaemia Adverse Reactions : Headache, fever, vomiting, muscle weakness, excitement, confusion, blindness, deafness, loss of consciousness, fall in blood pressure, rash, hypoglycaemia, dysphagia, epigastric pain, nausea, vomiting, disseminated intravascular coagulation, thrombocytopenia, hepatotoxicity, ototoxicity (rare), hemolytic uremic syndrome, interstitial nephritis Contraindications : Presence of haemoglobinuria during malaria or of optic neuritis, glucose-6-phosphate dehydrogenase deficiency, hypersensitivity to quinine, myasthenia gravis Interactions : Amiodarone, terfenadine, thioridazine, digoxin, cimetidine, astemizole, cyclosporine, droperidol, mefloquine, methadone, pancuronium, rifapentine ---------------------------------------------------------------------------------------------------------------Quinine Dihydrochloride 600 mg/2 ml Injection B Indication : Suppression or treatment of chloroquine-resistant Plasmodium Falciparum malaria in conjunction with other antimalarial agents Dosage : By slow intravenous infusion (over 4 hours). ADULT : 20 mg/kg followed by 10 mg/kg every 8 hours. CHILD : 20 mg/kg followed by 10 mg/kg every 12 hours, initial dose should be half in patients who have received quinine, quinidine or mefloquine during the previous 12 or 24 hours Precautions : Atrial fibrillation or other serious heart disease, myasthenia gravis, history of asthma, optic neuritis, tinnitus, hypoglycaemia Adverse Reactions : Headache, fever, vomiting, muscle weakness, excitement, confusion, blindness, deafness, loss of consciousness, fall in blood pressure, rash, hypoglycaemia, dysphagia, epigastric pain, nausea, vomiting, disseminated intravascular coagulation, thrombocytopenia, hepatotoxicity, ototoxicity (rare), haemolytic uremic syndrome, interstitial nephritis Contraindications : Presence of haemoglobinuria during malaria or of optic neuritis, glucose-6-phosphate dehydrogenase deficiency, hypersensitivity to quinine, myasthenia gravis Interactions : Amiodarone, terfenadine, thioridazine, digoxin, cimetidine, astemizole, cyclosporine, droperidol, mefloquine, methadone, pancuronium, rifapentine -------------------------------------------------------------------------------------------201 Sulfadoxine 500 mg and Pyrimethamine 25 mg Tablet B Trade Name : Fansidar Indication : Treatment of Plasmodium falciparum malaria in patients in whom chloroquine resistance is suspected and malaria prophylaxis for travellers to areas where chloroquine-resistant malaria is endemic Dosage : Treatment as single dose. ADULT : 2 - 3 tablet. CHILD more than 45 kg : 3 tablets, 45 to 31 kg : 2 tablets, 30 to 21 kg : 1 and half tablets, 20 to 11 kg : 1 tablet, 5 to 10 kg : one-half tablet Precautions : Discontinue if skin reactions occur. Avoid excessive exposure to sunlight. Analysis for crystalluria during prolonged prophylaxis therapy is recommended, impaired renal or hepatic function, periodic blood counts are recommended, possible folate deficiency, severe allergic or bronchial asthma Adverse Reactions : Rash, pruritus, contact dermatitis, urticaria, nausea and feeling of fullness, headache. Rarely, StevenJohnson and Lyell's syndromes, blood dyscrasias, liver cell damage, agranulocytosis, aplastic anaemia, thrombocytopenia, hepatitis, nephrotoxicity Contraindications : Hypersensitivity to sulfonamides. Premature or newborn infants, pregnancy, prophylactic (prolonged) use in patients with renal/hepatic failure and with blood dyscrasias Interactions : Methotrexate, sulfamethoxsazole, trimethoprim, zidovudine, lorazepam -------------------------------------------------------------------------------------------------------------------------------------Albendazole 200 mg Tablet C Trade Name : Zentel Indication : i) Single or mixed infestations of intestinal parasites ii) Strongyloides infection Dosage : i) ADULT and CHILD over 2 years : 400 mg as a single dose ii) 400 mg as a single dose for 3 consecutive days. CHILD 12 - 24 months : half adult dose Precautions : Discontinue therapy if liver function test elevations are significant, retinal lesions, cerebral hypertensive episodes, pregnancy, hepatic disease, retinal lesions Adverse Reactions : Gastrointestinal discomfort, dizziness, headache, erythema multiforme, Stevens-Johnson syndrome, agranulocytosis, aplastic anemia, leukopenia, pancytopenia, thrombocytopenia, hepatotoxicity Contraindications : Patients with hypersensitivity to albendazole or to the benzimidazole drug class, pregnancy (avoid pregnancy for at least one month following therapy) Interactions : Concurrent use with dexamethasone may result in an increased risk of albendazole adverse effects. ---------------------------------------------------------------------------------------------------------------Albendazole 200 mg/5 ml Suspension C Trade Name : Zentel Indication : i) Single or mixed infestations of intestinal parasites ii) Strongyloides infection Dosage : i) ADULT and CHILD over 2 years : 400 mg as a single dose ii) 400 mg as a single dose for 3 consecutive days. CHILD 12 - 24 months : half adult dose 202 Precautions : Discontinue therapy if liver function test elevations are significant, retinal lesions, cerebral hypertensive episodes, pregnancy, hepatic disease, retinal lesions Adverse Reactions : Gastrointestinal discomfort, dizziness, headache, erythema multiforme, Stevens-Johnson syndrome, agranulocytosis, aplastic anemia, leukopenia, pancytopenia, thrombocytopenia, hepatotoxicity Contraindications : Patients with hypersensitivity to albendazole or to the benzimidazole drug class, pregnancy (avoid pregnancy for at least one month following therapy) Interactions : Concurrent use with dexamethasone may result in an increased risk of albendazole adverse effects. ---------------------------------------------------------------------------------------------------------------- 203 9. ENDOCRINE Drugs used in diabetes Thyroid and antithyroid drugs Corticosteroids Sex hormones Hypothalamic and pituitary hormones and anti-estrogens Drugs affecting bone metabolism Miscellaneous endocrine 204 Acarbose 50 mg Tablet A/KK Trade Name : Glucobay Indication : Only for treatment of: i) Non insulin dependent diabetes mellitus (NIDDM) when diet therapy is insufficient ii) Non insulin dependent diabetes mellitus (NIDDM) in combination with existing conventional oral therapy where glycaemic control is inadequate Dosage : Initially 50 mg daily, increase to 3 times daily up to 100 mg 3 times daily. Max 200 mg 3 times daily Precautions : Asymptomatic liver enzyme elevations especially at higher dosages. Monitor liver enzyme during 6 12 months of treatment Adverse Reactions : Flatulence and bowel sounds, diarrhoea and abdominal pain Contraindications : Patients less than 18 years, chronic intestinal disorders associated with distinct disturbances of digestion and absorption, conditions which may deteriorate as a result of increased intestinal gas formation, pregnancy, lactation, severe renal impairment Interactions : Thiazide and other diuretic, corticosteriod, thyroid product, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympatomimetic, calcium channel blocker, isoniazid, cholestyramine, intestinal absorbents, digestive enzymes -------------------------------------------------------------------------------------------------------------------------------------Dextrose Powder B Indication : Use as a diagnostic agent for diabetes Dosage : 75 g stat Precautions : Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischemic insult, patients at risk for cerebral ischemia, acute stroke, impending cardiac arrest, or severe hypotension unless hypoglycaemia is suggested or until glucose is determined. Adverse Reactions : Thrombophlebitis, rebound hypoglycaemia, hypokalaemia. Contraindications : Do not use concentrated solutions of dextrose in patients with anuria, diabetic coma and hyperglycaemia, intracranial or intraspinal haemorrhage, delirium tremens in dehydrated patients and glucose-galactose malabsorption syndrome. Interactions : Not known. ---------------------------------------------------------------------------------------------------------------------------------Glibenclamide 5 mg Tablet B Trade Name : Daonil Indication : Diabetes mellitus type 2 Dosage : Range: 2.5 - 15 mg daily (with or immediately after breakfast). Initially 2.5 mg daily increasing by 2.5 mg required for metabolic control. Max: 15 mg daily 205 Precautions : Elderly, mild and moderate hepatic and renal impairment. Cross-sensitivity to sulphonamides and its derivatives Adverse Reactions : Gastrointestinal disturbance, blood dyscrasia, increase appetite, weight gain, skin rashes, pruritus, hypersensitivity reaction. Contraindications : Diabetes mellitus type 1, diabetic coma, severe renal or renal impairment, pregnancy Interactions : Alcohol, beta blockers, biguanides, MAOIs, sulphonamides, thyroid hormone, ACE inhibitor, analgesic --------------------------------------------------------------------------------------------------------------------------------Gliclazide 30 mg Modified Release Tablet B Trade Name : Diamicron MR Indication : Diabetes mellitus type 2 Dosage : 30 mg daily, adjust according to response every 4 weeks, max 120 mg daily Precautions : Hepatic and or renal impairment. Hypoglycaemia may occur with reduced dietary intake or too high doses Adverse Reactions : Nausea, headache, rashes and gastrointestinal disturbances. Rarely, haematological disorders Contraindications : Diabetes type 1. Severe renal or hepatic insufficiency, diabetic ketoacidosis, diabetic precoma. Pregnancy and lactation. Avoid concomitant treatment with miconazole preparation Interactions : Potentiates hyperglycaemia with danazol, chlorpromazine, glucocorticoids, progestogens, beta 2 agonist. Potentiated hypoglycaemic effect with sulfonamides, salicylates, phenylbutazone, betablockers, alcohol, H2 antagonists, NSAIDs, ACE inhibitors, MAOIs, fluconazole, ketoconazole and miconazole. Diminished hypoglycaemic effect with thiazide diuretics, corticosteroids and oestrogens. ---------------------------------------------------------------------------------------------------------------------------------Gliclazide 80 mg Tablet B Trade Name : Diamicron Indication : Diabetes mellitus type 2 Dosage : Initially 40-80 mg daily. Total daily dose may vary from 80- 320 mg orally. Adjust dose according to patient's individual response Precautions : Hepatic and or renal impairment. Hypoglycaemia may occur with reduced dietary intake or too high doses Adverse Reactions : Nausea, headache, rashes and gastrointestinal disturbances. Rarely, haematological disorders Contraindications : Children with epiphyseal fusion. Active neoplasia, progression or recurrence of underlying intracranial lesion, critically ill patient, proliferative or pre-proliferative diabetic retinopathy 206 Interactions : Potentiates hyperglycaemia with danazol, chlorpromazine, glucocorticoids, progestogens, beta2 agonist. Potentiated hypoglycaemic effect with sulfonamides, salicylates, phenylbutazone, betablockers, alcohol, H2 antagonists, NSAIDs, ACE inhibitors, MAOIs, fluconazole, ketoconazole and miconazole. Diminished hypoglycaemic effect with thiazide diuretics, corticosteroids and oestrogens. -------------------------------------------------------------------------------------------------------------------------------Glucagon (Lyophilised) 1 mg/ml Injection B Trade Name : Glucagen Indication : Management of hypoglycaemia Dosage : ADULT: 1 mg by SC, IM or IV. Repeat in 20 minutes if necessary. CHILD less than 20 kg: 0.02 to 0.03 mg/kg/dose or 0.5mg dose SC, IM or IV. Maximum: 1mg/dose. CHILD greater than 20 kg: 1mg SC, IM or IV Precautions : Patients with marked depletion of liver glycogen stores Adverse Reactions : Gastrointestinal upset, hypersensitivity Contraindications : Glucagonoma, insulinoma, phaeochromocytoma Interactions : Not known --------------------------------------------------------------------------------------------------------------------------------Insulin Aspart 100 IU/ml Injection A* Trade Name : Novorapid Indication : Diabetic Type 1 and 2 in patients that still experienced hypoglycaemia with use of human insulin Dosage : Dose to be individualised. The average daily insulin requirement is between 0.5 to 1.0 units/kg body weight Precautions : Decreased insulin requirements due to hepatic or renal impairment, malabsorption, diarrhoea, nausea/vomiting, hypothyroidism hypokalaemia, stress due to fever, infection, surgery, trauma, systemic allergic reactions Adverse Reactions : Transient oedema, local reactions and fat hypertrophy at injection site, hypoglycaemia, hypokalaemia, generalized hypersensitivity Contraindications : Hypersensitivity to insulin aspart and its components, hypoglycaemia Interactions : Oral hypoglycaemic agents, ocreotide, MAOIs, alcohol, lithium, non selective beta blocker, ACE inhibitor, salicylates, anabolic steroids, glucocorticoids, oral contraceptives, sulphonamides, disopyramides, diuretics fibrates, fluoxetine, propoxyphene, thyroid hormone, symphatomimetics, danazol, niacin, isonazide, guanethidine, reserpine, clonidine, phenothiazine ------------------------------------------------------------------------------------------------------------------------------- 207 Insulin Glargine 300 IU/3ml Injection A* Trade Name : Lantus Indication : i) Diabetes mellitus type I in adults and child over 6 years ii) Diabetes mellitus type II in adult Dosage : ADULT and CHILD over 6 years: individualised dose given by SC, once daily at the same time every day Precautions : Insulin dose adjustment may be needed with renal or hepatic impairment, illness, stress, emotional disturbances or in elderly patients, may impair ability to drive and operate machinery Adverse Reactions : Severe hypoglycemic episodes, lipodystrophy, rash, diabetic ketoacidosis, allergic skin reactions Contraindications : Hypersensitivity, intravenous administration Interactions : ACE inhibitors, aspirin, beta- blockers, fibrates, fluoxetine, fenfluramine, fluoroquinolones, ginseng, MAOIs, oestrogen and progestogens, somatropin, lithium, clonidine, sulphonamide antibiotic, pentoxifylline. -------------------------------------------------------------------------------------------------------------------------------Insulin Recombinant Neutral Human short-acting 100 IU/ml Injection in 10ml vial B Trade Name : Actrapid/Humulin Indication : Insulin dependent diabetes mellitus, non insulin dependent diabetes unresponsive to treatment to diet or oral hypoglycaemics. hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition Dosage : Dose to be individualised. The average daily insulin requirement is between 0.5-1.0 units/kg body weight Precautions : Psychic stress, infection, pregnancy Adverse Reactions : Rare incidence of allergy and lipoatrophy Contraindications : Hypoglyacemia, insulinoma Interactions : MAOIs, alcohol, corticosteroid, oral contraceptives, beta-blocker, thyroid hormone, diuretic --------------------------------------------------------------------------------------------------------------------------------Insulin Recombinant Synthetic Human, intermediate-acting 100 IU/ml Penfill and Refill B Trade Name : Insulatard Indication : Insulin dependent diabetes mellitus, non insulin dependent diabetes unresponsive to treatment to diet or oral hypoglycaemics, hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition Dosage : Dose to be individualised. The average daily insulin requirement is between 0.5-1.0 units/kg body weight Precautions : Psychic stress, infection, pregnancy 208 Adverse Reactions : Rare incidence of allergy and lipoatrophy Contraindications : Hypoglyacemia, insulinoma Interactions : MAOIs, alcohol, corticosteroid, oral contraceptives, beta-blocker, thyroid hormone, diuretic -------------------------------------------------------------------------------------------------------------------------------------Insulin Recombinant Synthetic Human, pre-mixed 100 IU/ml Penfill and Refill B Trade Name : Mixtard Indication : Insulin dependent diabetes mellitus, non insulin dependent diabetes unresponsive to treatment to diet or oral hypoglycaemics, hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition Dosage : Dose to be individualised. The average daily insulin requirement is between 0.5-1.0 units/kg body weight Precautions : Psychic stress, infection, pregnancy Adverse Reactions : Rare incidence of allergy and lipoatrophy Contraindications : Hypoglyacemia, insulinoma Interactions : MAOIs, alcohol, corticosteroid, oral contraceptives, beta- blocker, thyroid hormone, diuretic. -------------------------------------------------------------------------------------------------------------------------------------Insulin Recombinant Synthetic Human, short-acting 100 IU/ml Penfill and Refill B Trade Name : Actrapid Indication : Insulin dependent diabetes mellitus, non insulin dependent diabetes unresponsive to treatment to diet or oral hypoglycaemics, hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition Dosage : Dose to be individualised. The average daily insulin requirement is between 0.5-1.0 units/kg body weight Precautions : Psychic stress, infection, pregnancy Adverse Reactions : Rare incidence of allergy and lipoatrophy Contraindications : Hypoglyacemia, insulinoma Interactions : MAOIs, alcohol, corticosteroid, oral contraceptives, beta-blocker, thyroid hormone, diuretic ------------------------------------------------------------------------------------------------------------------------------- 209 Metformin 500 mg and Glibenclamide 2.5 mg Tablet A/KK Metformin 500 mg and Glibenclamide 5 mg Tablet A/KK Trade Name : Glucovance Indication : As second-line therapy when diet, exercise and initial treatment with sulphonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes mellitus Dosage : One tablet twice daily, titrate up to a maximum daily dose of 2000 mg metformin/20 mg glibenclamide Precautions : Adrenal or pituitary insufficiency elderly, debilitated or malnourished patients, excessive alcohol intake, hypoxic states due to shock, acute chronic heart failure or acute myocardial infarction, lactic acidosis, severe metabolic complication due to accumulation of metformin, liver or renal disease, peripheral vascular disease, pulmonary disease, pregnancy or lactation, stress caused by infection, fever, trauma or surgery Adverse Reactions : Hypoglycemia, lactic acidosis, cobalamin deficiency, abdominal pain, diarrhoea, nausea and vomiting, dizziness Contraindications : Renal disease or renal dysfunction, chronic heart failure requiring pharmacologic treatment, acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, hypersensitivity to metformin or glibenclamide Interactions : Cationic drugs that are eliminated by renal tubular secretion. Thiazide and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers and isoniazid may produce hyperglycaemia and lead to loss of glycaemic control. The hypoglycaemic action of sulphonylureas may be potentiated by NSAIDs and other highly protein-bound drugs, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, MAOIs, β-blockers, ciprofloxacin, oral miconazole. -------------------------------------------------------------------------------------------------------------------------------Metformin HCl 500 mg Extended Release Tablet A/KK Trade Name : Glucophage XR Indication : Diabetes mellitus who experienced gastrointestinal side effects with normal metformin Dosage : 500 mg once daily. Maximum dose 2000 mg once daily with evening meal Precautions : Dehydration, serious infection or trauma, patients undergoing surgery, pregnancy, lactation, children. Monitor serum B12 levels annually. Adverse Reactions : Metallic taste, epigastric discomfort, nausea, vomiting, decreased vitamin B12 absorption. Rarely, diarrhoea, anorexia. Contraindications : Diabetic pre-coma, ketoacidosis, renal impairment, chronic liver disease, cardiac failure, hypoxaemia, history of lactic acidosis, acute alcohol intoxication, hypoxia. Interactions : Alcohol, sulfonylureas, cimetidine, anticoagulants. ------------------------------------------------------------------------------------------------------------------------------ 210 Metformin HCl 500 mg Tablet B Trade Name : Glucophage Indication : Diabetes mellitus Dosage : 500 mg 3 times daily or 850 mg twice daily with food, maximum: 3 g daily in 3 divided doses Precautions : Dehydration, serious infection or trauma, patients undergoing surgery, pregnancy, lactation, children. Monitor serum B12 levels annually Adverse Reactions : Anorexia, nausea, vomiting, diarrhoea (usually transient), abdominal pain, metalic taste, rarely lactic acidosis (withdraw treatment), decreased vitamin-B12 absoption, erythema Contraindications : Diabetic pre-coma, ketoacidosis, renal impairment, chronic liver disease, cardiac failure, hypoxaemia, history of lactic acidosis, acute alcohol intoxication, hypoxia Interactions : Alcohol, sulfonylureas, cimetidine, anticoagulants. -------------------------------------------------------------------------------------------------------------------------------Repaglinide 2 mg Tablet A* Trade Name : Novonorm Indication : Type 2 diabetes mellitus (as monotherapy or in combination with metformin when metformin alone is inadequate) Dosage : 0.5 mg within 30 minutes before main meal. If patients are transferred from another oral hypoglycaemic agent. Start dose with 1 mg before each main meal. Max single dose: 4 mg before each main meal. Max 16 mg/day Precautions : Patients more than 75 years, debilitated or malnourished patients, renal impairment. Adverse Reactions : Hypoglycaemia, transient visual disturbances, gastrointestinal disturbances, hypersensitivity reactions of skin, arthralgia. Contraindications : Type 1 diabetes, diabetic ketoacidosis with or without coma. Pregnancy, lactation. Children less than 12 years. Severe hepatic impairment, concomitant therapy with medicinal products which are CYP3A4 inhibitors or inducers. Interactions : Type 1 diabetes, diabetic ketoacidosis with or without coma. Pregnancy, lactation. Children less than 12 years. Severe hepatic impairment, concomitant therapy with medicinal products which are CYP3A4 inhibitors or inducers. ------------------------------------------------------------------------------------------------------------------------------Rosiglitazone 8 mg Tablet A* Trade Name : Avandia Indication : Diabetes mellitus with insulin resistant features, combined with sulphonylureas, metformin, acarbose and or insulin, delays introduction of insulin in type 2 diabetes mellitus already on maximal doses of two or more oral hypoglycaemic agents 211 Dosage : 4 mg once daily or in 2 divided doses, may be increased to 8 mg/day in 1-2 divided doses after 12 week Precautions : Increased risk of myocardial ischeamia, exacerbate heart failure. Increased risk of fracture, especially in women. Active liver disease, alanine transaminase level more than 2.5 times upper limit of normal, type 1 diabetes, oedema (especially when used in combination with insulin), lack of adequate contraception in premenopausal anovulatory women Adverse Reactions : Headache, anaemia, hepatotoxicity, weight gain, oedema. Contraindications : Patients with cardiac failure (NYHA Class I-IV) or history of cardiac failure, known ischeamic heart disease, hepatic impairment, pregnancy and breastfeeding, diabetic ketoacidosis, hypersensitivity to rosiglitazone product. Interactions : Gemfibrozil, rifampicin. ----------------------------------------------------------------------------------------------------------------------------Sitagliptin 100 mg Tablet A* Trade Name : Januvia Indication : Management of diabetes in patients with renal failure where metformin is contraindicated and elderly with multiple co morbidities that always experience hypoglycemia with other antidiabetic.. Not to be used in diabetic patient whose sugar control, HBA1c is more than 9% Dosage : ADULT over 18 years, 100 mg once daily. Dosage in renal failure: 50 mg once daily if creatinine clearance equal or more than 30 to equal or less than 50 mL/min. 25 mg orally once if creatinine clearance less than 30 mL/min or with end stage renal disease requiring hemodialysis, may be administered without regard to the timing of hemodialysis Precautions : Should not be used in patient with type 1 diabetes or for the treatment of diabetic ketoacidosis, pregnancy, lactation. Dosage adjustments are needed in patients with moderate or severe renal function impairment Adverse Reactions : Gastrointestinal disturbances, peripheral oedema, upper respiratory tract infection, nasopharyngitis, pain, osteoarthritis, less commonly anorexia, headache, drowsiness, dizziness, hypoglycaemia, osteoarthritis Contraindications : Ketoacidosis; pregnancy; breast-feeding; History of a serious hypersensitivity reaction to Sitagliptin, such as anaphylaxis or angioedema Interactions : Ciclosporine: Sitagliptin mean peak plasma concentrations may be increased modestly (approximately 68%), which is not expected to be clinically important. Digoxin: Digoxin mean peak plasma levels may be increased slightly (approximately 18%); no dosage adjustment is recommended. Ketoconazole ------------------------------------------------------------------------------------------------------------------------------Carbimazole 5 mg Tablet Trade Name : Neo-mercazole Indication : Hyperthyroidism B 212 Dosage : ADULT: Initially 10 - 60 mg daily in divided doses. Maintenance: 5 - 20 mg daily Precautions : Liver disorders, pregnancy, breast feeding. Adverse Reactions : Nausea, mild gastrointestinal disturbance, rashes, bone marrow supression Contraindications : May be given to pregnant women. Treatment should be discontinued 3 - 4 weeks before delivery. Infants should not breast fed by mothers taking carbimazole. Interactions : Concurrent use of digoxin and carbimazole may result in decreased peak serum levels of digoxin. Antithyroid drugs, by reducing the extent of hyperthyroidism, decrease the metabolism of clotting factors and thus reduce the effects of oral anticoagulants. -------------------------------------------------------------------------------------------------------------------------------------Iodine and Potassium Iodide Solution B Trade Name : Lugol's Solution Indication : i) Pre-operative treatment of thyrotoxicosis ii) Thyrotoxicosis crisis Dosage : i) 1 ml daily in divided doses ii) 2 - 3 ml daily Precautions : Should not be used for long term treatment. Pregnancy, lactation, children Adverse Reactions : Hypersensitivity reactions, headache, lacrimation. Contraindications : Breast feeding Interactions : Concomitant use with lithium may result in hypothyroidism and decrease the effects of oral anticoagulants. -----------------------------------------------------------------------------------------------------------------------------------Levothyroxine Sodium 100 mcg Tablet B Trade Name : Oroxine Indication : Hypothyroidism Dosage : ADULT: 1.7 mcg/kg/day orally in a single daily dose (usual maintenance dose is 100 - 125 mcg/day 70 kg adult). CHILD; 0 - 3 months: 10 - 15 mcg/kg/day; 3 - 6 months: 8 - 10 mcg/kg/day; 6 - 12 months: 6 - 8 mcg/kg/day; 1 - 5 years: 5 - 6 mcg/kg/day; 6 - 12 years: 4 - 5 mcg/kg/day; more than 12 years: 2 3 mcg/kg/day Precautions : Angina, heart failure, diabetes mellitus, diabetes insipidus, elderly, long-standing hypothyroidism, adrenal insufficiency, myxoedema. Do not use for treatment of obesity or for weight loss. Pregnancy, lactation Adverse Reactions : Nervousness, excitability, tremor, muscle weakness, cramps, sweating, flushing, heat intolerance, headache, insomnia, tachycardia, palpitations, angina pectoris, excessive weight loss, menstrual irregularities, diarrhoea, vomiting, convulsions, cardiac arrhythmia, heart failure, coma, myocardial infarction, osteopenia, pseudotumor cerebri, seizure 213 Contraindications : Untreated hyperthyroidism; uncorrected adrenal failure; recent myocardial infarction Interactions : Reduced absorption with iron, cholestyramine, colestipol, aluminium- and magnesium-containing antacids, calcium carbonate, simethicone, sucralfate. May alter requirements of antidiabetic drugs. Reduced efficacy of thyroid replacement therapy with imatinib. Reduced tri-iodothyronine serum levels with amiodarone. Reduced serum levels of thyroxine with carbamazepine, phenytoin, phenobarbital, rifampicin, oestrogens. May change hypoprothrombinaemic response to warfarin and other oral anticoagulants. Increased risk of significant hypertension and tachycardia with ketamine ------------------------------------------------------------------------------------------------------------------------------Levothyroxine Sodium 25 mcg Tablet B Trade Name : Euthyrox Indication : Hypothyroidism Dosage : ADULT:1.7 mcg/kg/day ORALLY in a single daily dose (usual maintenance dose is 100-125 mcg/day 70 kg adult) CHILD; 0-3 months: 10-15 mcg/kg/day; 3-6 months: 8-10 mcg/kg/day; 6-12 months: 6-8 mcg/kg/day; 1-5 years: 5-6 mcg/kg/day; 6-12 years: 4-5 mcg/kg/day; more than 12 years: 2-3 mcg/kg/day Precautions : Angina, heart failure; diabetes mellitus; diabetes insipidus; elderly; long-standing hypothyroidism; adrenal insufficiency; myxoedema. Do not use for treatment of obesity or for weight loss. Pregnancy, lactation Adverse Reactions : Nervousness, excitability, tremor, muscle weakness, cramps; sweating, flushing, heat intolerance, headache, insomnia, tachycardia, palpitations, angina pectoris, excessive weight loss; menstrual irregularities; diarrhoea, vomiting, convulsions, cardiac arrhythmia, heart failure, coma,myocardial infarction, osteopenia, pseudotumor cerebri, seizure. Contraindications : Untreated hyperthyroidism; uncorrected adrenal failure; recent myocardial infarction. Interactions : Reduced absorption with iron, colestyramine, colestipol, aluminium- and magnesium-containing antacids, calcium carbonate, simethicone, sucralfate. May alter requirements of antidiabetic drugs. Reduced efficacy of thyroid replacement therapy with imatinib. Reduced tri-iodothyronine serum levels with amiodarone. Reduced serum levels of thyroxine with carbamazepine, phenytoin, phenobarbital, rifampicin, oestrogens. May change hypoprothrombinaemic response to warfarin and other oral anticoagulants. Increased risk of significant hypertension and tachycardia with ketamine. ------------------------------------------------------------------------------------------------------------------------------Propylthiouracil 50 mg Tablet B Indication : Palliative treatment of hypothyroidism as an adjunct to ameliorate hyperthyrodism in preparation for surgical treatment or radioactive iodine therapy and in the management of thyrotoxicosis crisis Dosage : CHILD: Initial 5 - 7 mg/kg/day in divided doses every 8 hours. Maintenance: 1/3 to 2/3 of the initial dose in divided doses every 6 - 8 hours. ADULT: Initial dose: 300 - 450 mg daily in divided doses every 8 hours. Maintenance: 100 - 150 mg daily in divided doses every 8 - 12 hours 214 Precautions : Renal impairment Adverse Reactions : Gastric distress, headache, nausea, skin rash Contraindications : Pregnancy, lactation, bleeding disorders or easy bruising Interactions : Dicumarol, warfarin, carbimazole ---------------------------------------------------------------------------------------------------------------------------------Dexamethasone 0.5 mg Tablet A Trade Name : Decadron Indication : Croup, septic shock, cerebral oedema and respiratory distress syndrome including status asthmaticus Dosage : 0.5 - 9 mg daily, depending upon the disease being treated. Up to 15 mg daily in severe disease Precautions : Discontinue treatment by reducing the dosage gradually. Adverse Reactions : Fluid and electrolyte disturbances, muscle weakness, peptic ulcer. Contraindications : Hypersensitivity, systemic fungal infection. Interactions : Barbiturates, phenytoin, rifampin may decreases dexamethasone effects; dexamethasone decreases effect of salicylates, vaccines, toxoids. Increased effect: Salmeterol: The addition of salmeterol has been demonstrated to improve response. ------------------------------------------------------------------------------------------------------------------------------Dexamethasone Sodium Phosphate 8 mg/2 ml Injection B Trade Name : Decadron Indication : Croup, septic shock, cerebral oedema and respiratory distress syndrome including status asthmaticus Dosage : Initially 0.5 - 9 mg IM, IV or infusion daily, depending upon the disease being treated Precautions : During periods of stress. Mask the signs of infection and decrease resistance to infection. Discontinue treatment by reducing the dosage gradually. Adverse Reactions : Fluid and electrolyte disturbances, muscle weakness, peptic ulcer. Contraindications : Hypersensitivity. systemic fungal infections. Interactions : Barbiturates, phenytoin, rifampicin may decrease dexamethasone effects; dexamethasone decreases effect of salicylates, vaccines, toxoids. Increased effect: Salmeterol: The addition of salmeterol has been demonstrated to improve response. ------------------------------------------------------------------------------------------------------------------------------- 215 Hydrocortisone 10 mg Tablet B Indication : Glucocorticoid replacement therapy in primary or secondary adrenal insufficiencies and long term management of congenital adrenal hyperplasia in children Dosage : ADULT: 20 - 30 mg daily in divided doses. CHILD: 10 - 30 mg daily in divided doses Precautions : Discontinue treatment by reducing the dosage gradually. Adverse Reactions : Fluid and electrolyte disturbances, muscle weakness, peptic ulcer. Contraindications : Hypersensitivity, systemic fungal infection. Interactions : Concurrent use of barbiturates, carbamazepine, phenytoin, primidone or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroids. Oral contraceptives or ritonavir may increase plasma concentrations of corticosteroids. -------------------------------------------------------------------------------------------------------------------------------------Hydrocortisone Sodium Succinate 100 mg Injection C Trade Name : Solu-Cortef Indication : Conditions responsive to systemic or local glucocorticoid injection therapy especially in emergencies Dosage : Initially 100 - 500 mg IV over 30 seconds to more than 10 minutes. Dose may be repeated at intervals of 2, 4 or 6 hours Precautions : Discontinue treatment by reducing the dosage gradually. Adverse Reactions : Fluid and electrolyte disturbances, muscle weakness, peptic ulcer. Contraindications : Hypersensitivity, systemic fungal infection. Interactions : Concurrent use of barbiturates, carbamazepine, phenytoin, primidone or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroids. Oral contraceptives or ritonavir may increase plasma concentrations of corticosteroids. -----------------------------------------------------------------------------------------------------------------------------Methylprednisolone Sodium Succinate 0.5 g Injection A Trade Name : Solu-Medrol Indication : Suppression of inflammatory and allergic disorders, cerebral oedema, immunosuppression treatment of haematological and oncological disorders, treatment of shock states and endocrine disorders Dosage : 15 - 30 mg/kg daily. Large doses may be repeated 4 - 6 hourly for up to 48 hours Precautions : Discontinue treatment by reducing the dosage gradually. Adverse Reactions : Fluid and electrolyte disturbances, muscle weakness, peptic ulcer, osteoporosis, abdominal distention, nausea and vomiting. 216 Contraindications : Hypersensitivity, systemic fungal infection. Interactions : Decreased effect: Phenytoin, phenobarbital, rifampicin increases clearance of methylprednisolone. Potassium depleting diuretics enhance potassium depletion. Increased toxicity: Skin test antigens, immunizations decrease response of methylprednisolone. -------------------------------------------------------------------------------------------------------------------------------------Prednisolone 3 mg/5 ml Syrup B Trade Name : Prednisone Indication : i) Replacement therapy for primary and secondary adrenocortical insufficiency ii) Adrenogenital syndrome iii) Other therapy Dosage : i) 5 - 25 mg daily in divided doses ii) 10 - 20 mg/m2 body surface daily in divided doses iii) ADULT: 5 60 mg daily. CHILD: 0.5 - 2 mg/kg/day in divided doses every 6 - 8 hours or as a single daily Precautions : Discontinue treatment by reducing the dosage gradually. Adverse Reactions : Fluid and electrolyte disturbances, muscle weakness and peptic ulcer, osteoporosis, abdominal distention, nausea and vomiting. Contraindications : Hypersensitivity and systemic fungal infection. Interactions : Phenytoin, phenobarbital, rifampin increase clearance of methylprednisolone. Potassium depleting diuretics enhance potassium depletion. Skin test antigens and immunizations decrease response. Increase circulating glucose level and may need adjustment of insulin or oral hypoglycaemics. ------------------------------------------------------------------------------------------------------------------------------Prednisolone 5 mg Tablet B Trade Name : Prednisone Indication : i) Replacement therapy for primary and secondary adrenocortical insufficiency ii) Adrenogenital syndrome iii) Other therapy Dosage : i) 5 - 25 mg daily in divided doses ii) 10 - 20 mg/m2 body surface daily in divided doses iii) ADULT: 5 60 mg daily. CHILD: 0.5 - 2 mg/kg/day in divided doses every 6 - 8 hours or as a single daily Precautions : Discontinue treatment by reducing the dosage gradually. Adverse Reactions : Fluid and electrolyte disturbances, muscle weakness and peptic ulcer, osteoporosis, abdominal distention, nausea and vomiting. Contraindications : Hypersensitivity and systemic fungal infection. Interactions : Phenytoin, phenobarbital, rifampin increase clearance of methylprednisolone. Potassium depleting diuretics enhance potassium depletion. Skin test antigens and immunizations decrease response. Increase circulating glucose level and may need adjustment of insulin or oral hypoglycaemics. ------------------------------------------------------------------------------------------------------------------------------- 217 Triamcinolone Acetonide 40 mg/ml Injection A/KK Trade Name : Kenacort-A Indication : Allergies, dermatoses, rheumatoid arthritis and opthalmic diseases Dosage : 40-80 mg deep into the gluteal muscle Precautions : Intercurrent infection, hypothyroidism, cirrhosis, active or latent tuberculosis, renal insufficiency, cardiac failure, diabetes, glaucoma, myasthenia gravis, pregnancy. Adverse Reactions : Local atrophy, post injection flare, pigmentation changes, sodium and fluid retention, peptic ulcer, impaired wound healing, purpura, striae, increased ocular/intracranial pressure with cushingnoid state, growth retardation. Contraindications : Systemic fungal infection, unstable or infected joints, lactation. Interactions : Phenytoin, phenobarbitone, rifampicin, carbamazepine, hypoglycaemics, diuretics, anticholinesterases, salicylates. ------------------------------------------------------------------------------------------------------------------------------Progesterone 8% Vaginal Gel A* Trade Name : Crinone Indication : Treatment of infertility due to inadequate luteal phase Dosage : 90 mg intravaginally daily from day of egg retrieval till pregnancy established Precautions : Severe hepatic impairment. Discontinue use if thrombophlebitis, cerebrovascular disorders, pulmonary embolism and retinal thrombosis occur. History of psychic depression, diabetic patients. May affect ability to drive or operate machinery. Adverse Reactions : Constipation, dizziness, headache, mood swings, cerebrovascular accident, cerebrovascular disease, myocardial infarction, thrombosis of retinal artery, venous thromboembolism, dementia, ectopic pregnancy, pulmonary embolism, gastrointestinal disturbances, joint pain, decreased libido, nervousness, breast tenderness and pain, dyspareunia, nocturia, allergy, cramps, fatigue, pain, genital moniliasis and pruritus, aggressive reaction, vaginal dryness, cystitis, urinary tract infection, vaginal discharge. Contraindications : Undiagnosed vaginal bleeding, breast or genital organ malignancy, acute porphyria, thrombophlebitis, thromboembolic disorder, cerebral apoplexy, missed abortion, lactation. Interactions : Should not be used concurrently with other local intravaginal therapy. -----------------------------------------------------------------------------------------------------------------------------Testosterone 250 mg/ml Injection A* Trade Name : Testoviron-Depot Indication : Only for treatment of male infertility, protein deficiency during convalescence after surgery and wasting disorder. In women, supplementary therapy of progressive mammary carcinoma 218 Dosage : By IM only. Hypogonadism 250 mg every 2-3 weeks. To maintain an adequate androgenic effect 250 mg every 3-6 weeks. Potency disorders 250 mg every 4 weeks. Male climateric disorders: 250 mg every 3-4 weeks. Repeated 6-8 weeks courses at 2-3 months interval Precautions : Geriatric patient, healthy males with delayed puberty, benign prostatic hyperthrophy, priapism and or excessive sexual stimulation may develop, oligospermia may occur with prolonged administration or excessive dosage. If severe upper abdominal complaints, liver enlargement or signs of intra abdominal haemorrhage, a liver tumour should be taken into consideration. Development of hypercalcaemia in female patients (stop treatment). Adverse Reactions : Oedema, signs of virilisation in women, inhibition of spermatogenesis. Contraindications : Hypersensitivity to testosterone, males with breast carcinoma, androderm therapy has not been evaluated in women and must not be used in women. Testosterone may cause foetal harm. Extensive cardiac, hepatic or renal disease. History of or existing hepatic tumour. Interactions : An increased risk of cyclosporin toxicity (renal dysfunction, cholestasis, paraesthesias), concurrent use with dicumarol may result in bleeding. ----------------------------------------------------------------------------------------------------------------------------Desmopressin 0.1 mg Tablet A Desmopressin 0.2 mg Tablet A Trade Name : Minirin Indication : i)Central diabetes insipidus ii)Primary nocturnal enuresis iii)Treatment of nocturia associated with nocturnal polyuria in adult Dosage : i)ADULT and CHILD: 0.1 mg 3 times daily. Maintenance: 0.3-0.6 mg daily ii)ADULT and CHILD over 5 years, 0.2 mg at bed time; withdraw for 1 week for assessment after 3 months iii)Initially 0.1 mg at night. May be increased to 0.2 mg and then to 0.4 mg by means of weekly increase Precautions : Avoid fluid overload in the very young & the elderly, conditions characterised by fluid & or electrolyte imbalance & those at risk for increased intracranial pressure. Caution in renal concentration capacity testing for children less than 1 year. Adverse Reactions : Nausea, hypertension, hypotension, palpitation, anaphylaxis, transient headache, stomach pain, epistaxis , fatigue, transient fall in BP with reflex tachycardia and facial flushing. Contraindications : Hypersensitivity to desmopressin; hyponatremia or a history of hyponatremia; moderate-to-severe renal impairment. Interactions : Chlorpropamide, fludrocortisone, lithium, carbamazepine , chloropromazine, indomethacin. ---------------------------------------------------------------------------------------------------------------------------------Desmopressin 100 mcg/ml Nasal Spray Trade Name : Minirin Indication : i) Diabetes Insipidus ii) Primary nocturnal enuresis Dosage : i) ADULT : 10 - 20 mcg 1-2 times daily. CHILD: 5 - 10mcg 1-2 times daily ii) 10-40 mcg 219 A Precautions : Avoid fluid overload in the very young and the elderly, conditions characterized by fluid and or electrolyte imbalance and those at risk for increased intracranial pressure. Caution in renal concentration capacity testing for infant less than 1 year. Adverse Reactions : Nausea, hypertension, hypotension, palpitation, anaphylaxis, transient headache, stomach pain, epistaxis and fatigue, transient fall in blood pressure with reflex tachycardia and facial flushing. Contraindications : Hypersensitivity to desmopressin, hyponatremia or a history of hyponatremia, moderate-to-severe renal impairment , unstable angina pectoris, decompensated cardiac insufficiency and von Willebrand's disease type IIB. Interactions : Chlorpropamide, fludrocortisone, lithium, carbamazepine, chloropromazine, indomethacin. -------------------------------------------------------------------------------------------------------------------------------------Desmopressin Acetate 4 mcg/ml Injection A Trade Name : Minirin Indication : i) Diabetes insipidus ii) Haemostasis in peri-operative situations Dosage : i) ADULT : 1 - 4 mcg IV daily. CHILD :0.4 mcg daily ii) 0.3 mcg/kg IV Precautions : Avoid fluid overload in the very young and the elderly, conditions characterized by fluid and or electrolyte imbalance and those at risk for increased intracranial pressure. Caution in renal concentration capacity testing for infant less than 1 year. Adverse Reactions : Nausea, hypertension, hypotension, palpitation, anaphylaxis, transient headache, stomach pain, epistaxis and fatigue, transient fall in blood pressure with reflex tachycardia and facial flushing. Contraindications : Hypersensitivity to desmopressin, hyponatremia or a history of hyponatremia, moderate-to-severe renal impairment , unstable angina pectoris, decompensated cardiac insufficiency and von Willebrand's disease type IIB. Interactions : Chlorpropamide, fludrocortisone, lithium, carbamazepine, chloropromazine, indomethacin. ------------------------------------------------------------------------------------------------------------------------------Octreotide 0.1 mg/ml Injection A Trade Name : Sandostatin Indication : i) Acromegaly ii) Treatment of patients with symptoms associated with gastro-entero-pancreatic endocrine tumours iii) Carcinoid tumours with features of the carcinoid syndrome, VIPomas, glucagonomas, gastrinomas/Zollinger-Ellison syndrome, GRFomas, insulinomas iv) Prevention of complications following pancreatic surgery v) Emergency management of bleeding gastroeosophageal varices in patients with cirrhosis Dosage : i, ii and iii) Initially 0.005 - 0.1 mg SC 1 - 2 times daily, increase gradually up to 0.1 - 0.2 mg 3 times daily iv) 0.1 mg 3 times daily for 7 consecutive days, starting on the day of operation, at least 1 hour before laparotomy v) 25 mcg/hour for 5 days by continous IV infusion Precautions : Growth hormone secreting pituitary tumours (can expand and cause space occupying effects), insulinomas (exaggerate hypoglycaemia), diabetes, pregnancy and lactation. 220 Adverse Reactions : Local reaction and discomfort at injection site. Anorexia, nausea, vomiting, crampy abdominal pain, abdominal bloating, flatulence, loose stools, diarrhoea, steatorrhea, rarely progressive abdominal distension, severe epigastric pain, abdominal tenderness, guarding, acute pancreatitis. Impairment of post-prandial glucose tolerance, hyperglycaemia, hypoglycemia, isolated case of hepatic dysfunction, bradycardia, anaphylactic reactions. Long-term treatment: gallstones. Contraindications : Hypersensitivity to octreotide. Interactions : Reduces absorption of cyclosporin, cimetidine. Increases bioavailability of bromocriptine. ---------------------------------------------------------------------------------------------------------------------------------Synthetic ACTH (Tetracosactrin Acetate) 250 mcg/ml Injection A Trade Name : Synacthen Indication : Diagnostic test to differentiate primary adrenal from secondary (pituitary) adrenocortical insufficiency Dosage : Adrenocortical insufficiency: IM, IV (over 2 minutes): Peak plasma cortisol concentrations usually occur 45-60 minutes after administration CHILD less than 2 years: 0.125 mg, CHILD more than 2 years and ADULTS: 0.25-0.75 mg, when greater cortisol stimulation is needed, an IV infusion may be used: CHILD more than 2 years and ADULTS: 0.25 mg administered at 0.04 mg/hour over 6 hours Precautions : Due to side effects or potentially fatal allergic reactions, therefore, patients should be monitored for at least one hour after administration in a controlled setting. Discontinue treatment by reducing the dosage gradually. Adverse Reactions : Bradycardia, hypertension, peripheral oedema, tachycardia, rash, whealing with redness at the injection site, anaphylaxis, hypersensitivity reaction. Contraindications : Hypersensitivity to natural ACTH. avoid injections containing benzyl alcohol in neonates. Interactions : Decreased effect: Spironolactone, hydrocortisone, cortisone. -----------------------------------------------------------------------------------------------------------------------------------Terlipressin 1 mg Injection A* Trade Name : Glypressin Indication : Acute oesophageal variceal bleeding Dosage : 2 mg IV bolus over 1 minute. Maintenance: 1 - 2 mg IV bolus 4 - 6 hourly until bleeding is controlled, up to 24 - 36 hours Precautions : Asthma, hypertension, advanced arteriosclerosis, coronary insufficiency, cardiac arrhythmias, renal insufficiency. Adverse Reactions : Fibrinolysis, bradycardia, facial pallor, increased blood pressure and ECG changes, peripheral vasoconstriction, increased intestinal peristalsis, stool urgency and possible stool incontinence, uterine contractions, bronchial constriction. Contraindications : Pregnancy. 221 Interactions : Not known. ---------------------------------------------------------------------------------------------------------------------------------Vasopressin 20 units/ml Injection A Trade Name : Pitressin Indication : i) Pituitary diabetes insipidus ii) Oesophageal variceal bleeding Dosage : i) 5 - 20 units SC or IM every 4 hours ii) 20 units in 100 - 200 ml 5% dextrose saline over 15 minutes as infusion which may be repeated after at intervals of 1 - 2 hours. Maximum: 4 doses Precautions : Heart failure, migraine, epilepsy, asthma or other conditions which might be exacerbated by fluid retention, renal impairment. Avoid fluid overload. Adverse Reactions : Pallor, nausea, belching, abdominal cramps, hypersensitivity reaction, sweating, urticaria, gangrene, arrhythmias, angina and bronchoconstriction, anaphylaxis, cardiac arrest or shock. Contraindications : Hypersensitivity to vasopressin, vascular disease especially coronary artery disease, chronic nephritis and pregnancy (3rd trimester). Interactions : Carbamazepine, chlorpropamide, clofibrate, urea, fludrocortisone, tricyclic antidepressants, noradrenaline, lithium, heparin and alcohol. ------------------------------------------------------------------------------------------------------------------------------Alendronate Sodium 70mg and Cholecalciferol 2800 IU Tablet A* Trade Name : Fosamax Plus Indication : Osteoporosis in post menopausal women with a history of vertebral fracture and whom oestrogen replacement therapy is contraindicated Dosage : 1 tablet once weekly [contains cholecalciferol 2800 units in a weekly dose, equivalent to 400 units daily]. Swallow the tablet whole with a full glass of plain water only on an empty stomach at least 30 minutes before breakfast (and any other oral medication); stand or sit upright for at least 30 min and do not lie down until after eating breakfast Precautions : Discontinue in case of dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. Active upper gastrointestinal problems (dysphagia, esophageal diseases, gastritis, duodenitis or ulcers). CrCl less 35 ml/min. Correct hypocalcemia and other disorders affecting mineral metabolism (eg vit D deficiency) before starting therapy. Monitor serum Calcium and urine. Children, pregnancy and lactation. Adverse Reactions : Urticaria, myalgia, malaise; nausea, vomiting, esophageal stricture/perforation, oropharyngeal ulceration; esophagitis, esophageal erosions, esophageal ulcers; localized osteonecrosis of the jaw; bone, joint and or muscle pain; rash, pruritus, angioedema, fever, hypocalcemia, gastric or duodenal ulcers, Stevens-Johnson syndrome, toxic epidermal necrolysis, ocular inflammations (uveitis, iritis, scleritis). Contraindications : Esophageal abnormalities which inhibit esophageal emptying (ie, achalasia, stricture), increased risk for adverse esophageal effects, hypocalcemia; decreases in serum calcium and phosphate have 222 occurred during therapy, resolve hypocalcemia prior to beginning therapy, inability to sit or stand in an upright position for at least 30 minutes. Interactions : Calcium supplements, antacids. Hormone replacement therapy. Olestra, mineral oils, orlistat, cholestyramine, colestipol. Anticonvulsants, cimetidine, thiazides ------------------------------------------------------------------------------------------------------------------------------Calcitonin (synthetic Salmon) 100 IU Injection A* Trade Name : Miacalcic Indication : Acute hypercalcaemia Dosage : 5 - 10 IU/kg/day SC/IM (in 1 - 2 divided doses) to 400 units every 6 - 8 hours adjusted according to clinical and biochemical response (no additional benefit with over 8 units/kg every 6 hours. 5 - 10 units/kg slow IV over at least 6 hours Precautions : Pregnancy, lactation, caution when driving vehicles or operating machinery. Adverse Reactions : Nausea, vomiting, flushing, chills, dizziness, polyuria. Rarely, local hypersensitivity reactions, anaphylactoid-like reactions. Contraindications : Hypersensitivity to calcitonin. Interactions : Ketoprofen inhibit the calciuric and uricosuric effects of calcitonin. Calcitonin cause a significant decrease in the mean values of lithium plasma levels. -----------------------------------------------------------------------------------------------------------------------------Calcitonin (Synthetic Salmon) 200 IU Nasal Spray A* Trade Name : Miacalcic Indication : Osteoporosis Dosage : 200 units daily Precautions : Pregnancy, lactation, caution when driving vehicles or operating machine. Should not be given to children more than a few weeks. Possibility of systemic allergic reaction exists. Adverse Reactions : Rhinitis, ulcerative rhinitis, sinusitis, epitaxis, flushing, dizziness, headache, gastrointestinal disturbances, musculoskeletal pain, pharyngitis, fatigue, dysgeusia. Rarely, hypertension, vomiting, arthralgia, cough, oedema, flu-like symptoms, abnormal vision. Contraindications : Hypersensitivity to calcitonin. Interactions : Ketoprofen inhibit the calciuric and uricosuric effects of calcitonin. Calcitonin cause a significant decrease in the mean values of lithium plasma levels. ------------------------------------------------------------------------------------------------------------------------------------Ibandronic Acid 150 mg Tablet Trade Name : Bonviva Indication : Treatment of postmenopausal osteoporosis to reduce the risk of fracture 223 A* Dosage : 150 mg once monthly Precautions : Concurrent therapies with corticosteroids, chemotherapy, radiotherapy; increased risk for osteonecrosis especially in the jaw. Creatinine clearance less than 35 ml/minute, vitamin D and mineral deficiencies to be corrected before initiating therapy. Adverse Reactions : Rash, abdominal pain, diarrhoea, indigestion, nausea, arthralgia, back pain, myalgia, headache, bronchitis, dyspepsia, nausea, flu-like symptoms. Contraindications : Hypersensitivity to ibandronate or to any of its excipients. Inability to stand or sit upright for 60 minutes. Uncorrected hypocalcaemia, hypocalcaemia, esophageal reactions. Interactions : Concurrent use with calcium and antacids may result in reduced alendronate absorption. ---------------------------------------------------------------------------------------------------------------------------------Pamidronate Disodium 30 mg Injection A* Trade Name : Aredia Indication : Hypercalcaemia of malignancy (tumour -induced hypercalcaemia) Dosage : Dose depends on the initial serum calcium levels. Doses range from a single infusion of 30 - 90 mg Precautions : Risk of hypocalcaemia especially in patients with Paget's disease, monitor if pre-existing anaemia, leucopenia, or thrombocytopenia are present, follow complete blood count during the first 2 weeks of treatment, history of hypoparathyroidism. Do not administer as a bolus injection or with other bisphosphonates or Calcium-containing IV infusions. Monitor serum electrolytes, Calcium, phosphates, renal function (at the start of treatment and prior to each further dose). Renal impairment, cardiac disease. Caution in road/machinery users. Pregnancy, lactation. Children. Severe hepatic impairment. Patients should be advised to inform their dentist while under treatment or if dental surgery is planned. Adverse Reactions : Myelosuppression, hypertension, hypotension, thrombophlebitis, malaise, nausea, vomiting, fever, anorexia, hypomagnesaemia, hypokalaemia, hyperkalaemia, hypernatraemia, hypocalcaemia, hypophosphataemia, anaemia, thrombocytopenia, lymphocytopenia, headache, insomnia, somnolence, conjunctivitis, hypertension, gastrointestinal disturbances, rash, transient musculoskeletal pain, reactions at infusion site, deterioration of preexisting renal disease, acute renal failure, increased serum creatinine increased serum urea. Uncommon: allergic reactions, seizures, agitation, dizziness, lethargy, uveitis, dyspepsia, pruritus, muscle cramps, abnormal liver function tests. Rare: focal segmental glomerulosclerosis, nephrotic syndrome, anaphylactic shock, reactivation of herpes simplex and zoster, leukopenia, confusion, visual hallucinations, scleritis, episcleritis, xanthopsia, left ventricular failure, chronic heart failure, haematuria. Contraindications : Hypersensitivity to biphosphonates. Interactions : Caution when coadministration with potentially nephrotoxic drugs. Combination with thalidomide may increase risk of renal dysfunction. ------------------------------------------------------------------------------------------------------------------------------ 224 Zoledronic Acid 4 mg Injection A* Trade Name : Zometa Indication : i) Treatment of hypercalcaemia of malignancy ii) Prevention of skeletal related events in patients with multiple myeloma involving multiple bone lesions Dosage : 4 mg reconstituted and should be given as a 15 minutes IV infusion every 3-4 weeks Precautions : Assess hydration status prior to administration. Monitor serum electrolytes and creatinine. Evaluate serum creatinine prior to each administration. If renal function has deteriorated, the dose should be withheld. Not recomended in patients with bone metastases with severe renal impairment (serum creatinine greater than 3.0 mg/dl) Severe renal or hepatic impairment. Patients should be advised to inform the dentist during treatment and if dental surgery is foreseen. Caution is advised when bisphosphonates are administered with aminoglycosides or other potentially nephrotoxic drugs, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required. Adverse Reactions : Alopecia, dermatitis, hypokalaemia, hyperkalaemia, hypernatremia, hypocalcemia, hypomagnesemia, hypophosphatemia, shivering, abdominal pain, diarrhoea, nausea, vomiting, arthralgia, bone pain, myalgia, headache, paraesthesia, upper tract infection, cough, dyspnoea, upper respiratory infection, anemia, neutropenia, thrombocytopenia, nephrotoxicity, aseptic necrosis of bone and jaw , pleural effusion. Rise in body temp, flu-like syndrome, elevation of serum creatinine, renal impairment, conjunctivitis. Hypersensitivity reactions, hypertension, shortness of breath, dizziness, sleeping disturbances, gastrointestinal reactions, loss of appetite, local reactions at infusion site, rash, pruritus. Contraindications : Hypersensitivity to zoledronic acid or other bisphosphonates, pregnancy, lactation. Interactions : Aminoglycosides, other potentially nephrotoxic drugs, thalidomide. ----------------------------------------------------------------------------------------------------------------------------------Bromocriptine Mesilate 2.5 mg Tablet A/KK Trade Name : Parlodel Indication : i) Hypogonadism or Galactorrhoea ii) Acromegaly Dosage : i) Initially 1 - 1.25 mg at bedtime increased gradually, usual dose: 7.5 mg daily in divided doses. Max 30 mg daily ii) 1.25 - 2.5 mg at bedtime for 3 days and may be increased by 1.25 - 2.5 mg every 3 - 7 days up to 30 mg a day in divided doses Precautions : Nursing mothers, children under 15 years old, peptic ulcer disease, postpartum, puerperal women with high blood pressure, coronary artery disease, psychic disorders, concomitant use of other ergot alkaloid. Fertility may be restored (contraception needed), malignancy excluded before use for benign breast disease, acromegalic patients with history of peptic ulceration. Adverse Reactions : Hypotension, peripheral vasoconstriction, dyskinesias, fatigue, nausea, vomiting, constipation, drowsiness, confusion, psychomotor excitation, hallucinations, dyskinesias, dryness of the mouth, leg cramps, allergic skin reactions. On prolonged treatment, reversible pallor of fingers and toes. Contraindications : Hypersensitivity to bromocriptine products, toxaemia of pregnancy, hypertension in postpartum and during puerperium. 225 Interactions : Clarithromycin - elevations in serum levels of bromocriptine. Inhibit ciclosporin metabolism. Erythromycin - significantly increase the bioavailability of bromocriptine. Bromocriptine, may decrease the metabolism of sirolimus, tacrolimus . Alcohol reduces tolerance to bromocriptine and vice-versa. Effects of antihypertensives may be potentiated. Avoid concurrent psychotropics. ------------------------------------------------------------------------------------------------------------------------------Cabergoline 0.5 mg Tablet A* Trade Name : Dostinex Indication : i) Treatment of hyperprolactinaemic disorders ii) Prevention of puerperal lactation and suppression of lactation in HIV infected mothers only Dosage : i) Hyperprolactinaemia: 0.25 mg 1-2 times per week ii) HIV mothers only: Prevent lactation 2 tab first day after delivery. Interruption of lactation: 0.25 mg 12 hourly for 2 days Precautions : Eclampsia, pre-eclampsia or pregnancy induced hypertension. Do not administer dopamine D2 receptor antagonists concurrently. High initial doses (1mg), especially with concurrent antihypertensive regimens, liver disease. Adverse Reactions : Orthostatic hypotension, valvular regurgitation, abdominal pain, vertigo, pleural effusion, pulmonary fibrosis, constipation, nausea, dizziness, headache, somnolence, depression, fatigue, sleeplessness, dyspepsia, gastritis, weakness, fatigue, constipation, vomiting, breast pain, hot flushes, depression, tingling. Contraindications : Hypersensitivity to cabergoline or potent inhibitors of CYP3A4 (includes protease inhibitors, azole antifungals and some macrolide antibiotics), uncontrolled hypertension. Interactions : Activity and tolerability may be affected by antiemetics, antihypertensives, psychotropics and macrolide antibiotics. -------------------------------------------------------------------------------------------------------------------------------Danazol 200 mg Capsule A/KK Trade Name : Ladogal Indication : i)Endometriosis and gynaecomastia ii)Menorrhagia iii)Prophylaxis of hereditary angioedema Dosage : i)200 - 800 mg daily for max of 9 months ii)200 mg daily for 12 weeks ii)400 mg daily. Reduce to 200 mg daily after 2 months attack free period Precautions : Haemophilia, epilepsy, migraine or cardiac or renal dysfunction, require careful observation. Periodic liver function tests should be performed, exacerbation of acute intermittent porphyria. Adverse Reactions : Hepatic dysfunction, weight gain, acne, menstrual disturbances. Contraindications : Undiagnosed abnormal vaginal bleeding, hepatic or renal or cardiac dysfunction. Interactions : Co-administration of oral anticoagulants has resulted in a prolonged prothrombin time and haemorrhages. Carbamazepine : significant increases in carbamazepine levels which resulted in toxicity. Clomifene : result in inhibition of response to clomifene. Cyclosporin : increased cyclosporin 226 blood levels and toxicity. Sirolimus, Tacrolimus : decrease the metabolism, causing increased plasma concentrations of sirolimus and tacrolimus. ----------------------------------------------------------------------------------------------------------------------------------Goserelin 3.6 mg Depot Injection A Trade Name : Zoladex Indication : Prostate cancer,endometriosis,leiomyoma uteri and assissted reproduction,breast cancer in premenopausal and perimenopausal women suitable for hormonal manipulation Dosage : mg depot injection every 28 days Precautions : Initially may increase bone pain, increase serum testosterone levels, and worsen symptoms of prostatic cancer.Isolated cases of spinal cord compression and renal impairment from ureteral obstruction have occurred.History of prior treatment that may have resulted in bone mineral density loss or patients with increased risk factors for decreased bone mineral density. Adverse Reactions : Bone pain, hot flashes, gynecomastia, impotence, breakthrough bleeding, deep venous thrombosis, depression, imsomnia. Contraindications : Pregnancy, lactation, hypersensitivity to goserelin products, leutenizing hormone-releasing hormon (LHRH) or LHRH analogues. Depot injection of 10.8 mg is contraindicated in women. Interactions : Not Known. -------------------------------------------------------------------------------------------------------------------------------- 227 10. OBSTETRICS & GYNAECOLOGY Hormone replacement therapy Infertility Prostaglandin and oxytocics Treatment of vaginal and vulval conditions Contraceptices Miscellaneous Obstetrics and Gynaecology 228 Conjugated Oestrogens 0.625 mg & Medroxyprogesterone Acetate 2.5 mg Tablet A Trade Name : Premelle 2.5 Indication : Management of moderate to severe vasomotor symptoms associated with menopause, prevention and management of postmenopausal osteoporosis, atropic vaginitis and atropic urethritis in post menopausal woman with intact uterus Dosage : 1 tablet daily Precautions : Myocardia infarction, stroke, breast, endometrial and ovarian cancer, pregnancy, gallbladder disease, retinal vascular thrombosis, proptosis, diplopia, migraine, hypercalcaemia, fluid retention, hypertriglyceridemia, hepatic impairment, past history of cholestatic jaundice, elevated blood pressure, asthma, epilepsy, hypocalcaemia, hypothyroidism, abnormal uterine bleeding, depression Adverse effects : Breast pain, breakthrough bleeding, dysmenorrhea, spotting, breast tenderness or enlargement, discharge, arthralgias, leg cramp, depression, vaginitis, weight changes. Contraindications : Pregnancy, known or suspected cancer of the breast and estrogen dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis or thromboembolic disorders, liver dysfunction or disease. Active or recent arterial thromboembolic disease. Interactions : Rifampin may reduce effectiveness. -------------------------------------------------------------------------------------------------------------------------------------Conjugated Oestrogens 0.625 mg Tablet A Trade Name : Premarin Indication : i) Osteoporosis ii) Female hypoestrogenism iii) Vasomotor symptoms or atrophic vaginitis and urethritis Dosage : i) 0.625 mg daily ii) 0.3 - 1.25 mg daily iii) 0.3 - 1.25 mg daily Precautions : Familial hyperlipoproteinaemia, uterine bleeding and mastodynia, uterine fibroids, impaired liver function, fluid retention, hypocalcaemia and renal insufficiency, addition of a progesterone for seven or more days of a cycle of oestrogen administration have reported a lowered incidence of endometrial hyperplasia, gall bladder disease, patient who have been treated for endometrial carcinoma, endometriosis, patient with pre-existing hypertension, fibrocystic disease of the breast, migraine headache, uterine leiomyoma. Adverse effects : Nausea, endometrial cancer (postmenopausal), oedema, weight changes, breast changes, headache migraine, steepening of corneal curvature, changes in libido, change in menstrual flow, vomiting, aggravation of porphyria, cholestatic jaundice, alopecia, breakthrough bleeding, spotting, amenorrhoea, bloating, dizziness. Contraindications : Oestrogen-dependent neoplasia, known or suspected pregnancy, undiagnosed abnormal vaginal bleeding. Interactions : Rifampicin may reduce effectiveness. -------------------------------------------------------------------------------------------------------------------------------------- 229 Dydrogesterone 10 mg Tablet A/KK Trade Name : Duphaston Indication : i) Dysmenorrhoea ii) Endometriosis iii) Dysfunctional uterine bleeding (to arrest and to prevent bleeding) iv) Threatened abortion v) Habitual abortion vi) Post menopausal complaints (hormone replacement therapy in combination with oestrogen) Dosage : i) 10 mg bd from day 5 - 25 of cycle ii) 10 mg bd - tds from day 5 - 25 of the cycle or continuously iii) To arrest bleeding :10 mg bd with an oestrogen once daily for 5 - 7 days, To prevent bleeding : 10 mg bd with an oestrogen once daily from day 11 - 25 of the cycle iv) 40 mg at once, then 10mg 8hrly until symptoms remit v) 10 mg bd until 20th week of pregnancy vi) 10-20 mg daily during last 12-14 days of each cycle. Precautions : Pregnancy. Adverse effects : Breakthrough bleeding, altered liver function, angioedema, haemolytic anaemia. Contraindications : Breast and genital cancers, abnormal vaginal bleeding. Interactions : Enzyme inducing drugs such as carbamazepine, griseofulvin, phenobarbitone, phenytoin and rifampicin may enhance the clearance of progesterone. Progesterone may inhibit ciclosporin metabolism leading to increased plasma-ciclosporin. ------------------------------------------------------------------------------------------------------------------------------Estradiol 1 mg (14 tablet) & Estradiol 1 mg with Dydrogesterone 10 mg (14 tablet) A* Trade Name : Femoston 1/10 Indication : Hormone Replacement Therapy for women with disorders due to natural or surgically induced menopause with intact uteri Dosage : One tablet daily without pill-free interval, starting with 1 mg of Estradiol for first 14 days, followed by 1mg Estradiol with 10 mg Dydrogestrone daily for the next 14 days Precautions : Periodic general and gynaecological exam and mammogram should be instituted. Patients in the perimenopausal phase are advised to take non-hormonal contraceptive precautions. Interruption of HRT 1 month before surgery should be considered. Epilepsy, migraine, cardiac failure, hypertension, porphyria, haemoglobinopathies, otosclerosis, uterine leiomyomata, endometriosis, lactation. Adverse effects : Breast tenderness, nausea, headache, oedema, breakthrough bleedings, skin reactions. Contraindications : Known or suspected carcinoma of the breast, endometrial carcinoma or other hormone dependent neoplasia. Acute or chronic liver disease. History of liver disease where the liver function tests have not returned to normal. History of venous thromboembolic diseases (e.g. deep venous thrombosis or pulmonary embolism). Abnormal genital bleeding. Known or suspected pregnancy. Interactions : Barbiturates, phenytoin, rifampicin, carbamazepine. -------------------------------------------------------------------------------------------------------------------------------------- 230 Estradiol 1 mg with Dydrogesterone 5 mg Tablet A* Trade Name : Femoston Conti Indication : i) Hormone replacement therapy for the relief of symptoms due to oestrogen deficiency ii) Prevention of postmenopausal osteoporosis in women with a uterus Dosage : One tablet daily, taken continuously without interruption. Should be used only in postmenopausal women more than 12 month after menopause Precautions : Periodic general and gynaecological exam and mammogram should be instituted. Patients in the perimenopausal phase are advised to take non-hormonal contraceptive precautions. Interruption of HRT 1 month before surgery should be considered. Epilepsy, migraine, cardiac failure, hypertension, porphyria, haemoglobinopathies, otosclerosis, uterine leiomyomata, endometriosis, lactation. Adverse effects : Breast tenderness, nausea, headache, oedema, breakthrough bleedings, skin reactions. Contraindications : Known or suspected carcinoma of the breast, endometrial carcinoma or other hormone dependent neoplasia. Acute or chronic liver disease. History of liver disease where the liver function tests have not returned to normal. History of venous thromboembolic diseases (e.g. deep venous thrombosis or pulmonary embolism). Abnormal genital bleeding. Known or suspected pregnancy. Interactions : Barbiturates, phenytoin, rifampicin, carbamazepine. ------------------------------------------------------------------------------------------------------------------------------Estradiol Valerate 1 mg Tablet A* Trade Name : Progynova Indication : Oestrogen replacement therapy - only those who cannot tolerate Premarin Dosage : 1 mg daily continuously or 21 day regimen with 1 week of tablet free interval Precautions : Associated with adverse lipoprotein metabolism, impairment of glucose tolerance, possible enhancement of mitotic activity in breast epithelial tissue. Hypercoagulability, familial hyperlipoproteinaemia, fluid retention, uterine bleeding and mastodynia, impaired liver function and aspirin hypersensitivity (tartazine dye). Adverse effects : Headache, nausea, hypertension, myocardia infarction, thromboembolism, vaginal bleeding, breast tension, increase in body weight. Contraindications : Severe liver disease, breast cancer (except metatastic disease), oestrogen dependent neoplasia, known or suspected pregnancy, undiagnosed abnormal vaginal bleeding, thromboembolic disorders. Interactions : Barbiturates, phenylbutazone, hydantoins, rifamcipin and ampicillin may impair action of the drug. Requirements for oral antidiabetics and insulin can change. --------------------------------------------------------------------------------------------------------------------------------Estradiol Valerate 2 mg and Norgestrel 500 mcg with Estradiol Valerate 2 mg Tablet B Trade Name : Progyluton Indication : Pre and post menopausal syndrome, primary and secondary amenorrhea, menstrual irregularities. Deficiency symptoms after oophorectomy or radiological castration for noncarcinomatous disease 231 Dosage : Start on the 5th day of menstrual cycle - 1 tab daily for 21 days then stop for 7 days. If patient forgets dose at usual time, it should be taken within following 12 hours Precautions : Asthma, epilepsy, migraine, hypertension, cardiac or renal dysfunction, endometrial hyperplasia, metabolic bone diseases, endometrial cancer, breast cancer, gall bladder disease, pancreatitis, lactation, surgery, liver disorders, enlargement of uterine fibromyomata. Adverse effects : Changes in vaginal bleeding pattern, change in amount of cervical secretion, premenstrual-likesyndrome, cystitis-like-syndrome, increase in size of uterine leiomyomata, vaginal candidiasis, amenorrhoea, changes in cervical erosion, nausea, cholestatic jaundice, changes in appetite, vomiting, abdominal cramps, bloating, increased incidence of gall bladder disease, pancreatitis. Headache, dizziness, mental depression, nervousness, migraine. Increase or decrease in weight, oedema, changes in libido, fatigue, backache, reduced carbohydrate tolerance, aggravation of porphyria, pyrexia, anaphylactoid reactions. Contraindications : Known or suspected pregnancy, including use for missed abortion or as a diagnostic test for pregnancy. Oestrogen or progestin may cause foetal harm when administered to a pregnant woman. Known or suspected cancer of the breast. Known or suspected oestrogen -dependent neoplasm, severe liver dysfunction, jaundice or severe pruritus during a previous pregnancy, previous or existing liver tumours, existing or suspected hormone-dependent tumours of uterus or mammae. Severe diabetes with vascular changes, previous or existing thromboembolic processes, endometriosis, disturbances of lipometabolism, a history of herpes gestationis, otosclerosis with deterioration during previous pregnancies, Dubin-Johnson syndrome, Rotor syndrome, sickle-cell anemia. Interactions : Rifampicin, barbiturates, phenytoin, rifampicin, phenylbutazone, ampicillin. Requirements for oral antidiabetics and insulin can change. -----------------------------------------------------------------------------------------------------------------------------Medroxyprogesterone Acetate 5 mg Tablet B Trade Name : Provera/Farlutal Indication : i) Secondary amenorrhoea ii) Abnormal uterine bleeding due to hormonal imbalance Dosage : i) 5-10 mg daily for 5-10 days. To produce optimum secretory transformation 10 mg daily for 10 days ii) 5-10 mg daily for 5-10 days on day 15-21 of menstrual cycle. Optimum secretory transformation 10 mg daily for 10 days from day 15 of the cycle Precautions : Depressions, diabetes, epilepsy, migraine, asthma. Adverse effects : Gastrointestinal distress, oedema, menstrual disorders, dermatologic effects, nausea, fatique, depression, acne, hirsutism, breast tenderness, thromboembolic phenomena, galactorrhoea, decreased glucose tolerance, anaphylaxis, corticoid like reaction (high doses). Contraindications : Thromboembolic disorders, liver disease, known or suspected malignancy of breast or genital organs, undiagnosed abnormal vaginal bleeding, known or suspected pregnancy, hypersensitivity to medroxyprogesterone products. Interactions : Aminoglutethimide, rifampicin. ------------------------------------------------------------------------------------------------------------------------------- 232 Tibolone 2.5 mg Tablet A* Trade Name : Livial Indication : Complaints resulting from natural or surgical menopause and in cases at high risk for breast carcinomas where general hormone replacement therapy is contraindicated Dosage : 2.5 - 5mg daily Precautions : Women with hormone dependent tumours, cardiovascular or cerebrovascular disorders including thrombophlebitis, thromboembolic processes or a history of these conditions, undiagnosed vaginal bleeding and severe liver disorders. Liver disease. Patients with hypercholesterolaemia and impaired glucose tolerance. Stop tibolone 4 weeks before elective surgery when prolonged immobilisation after surgery is likely. Adverse effects : Endometrial hyperplasia and endometrial carcinoma (rare), change in body weight, vaginal bleeding, gastrointestinal upsets, changes in liver parameters, increased facial hair growth and pretibial oedema. Contraindications : Hypersensitivity to tibolone, breast cancer (known or suspected), oestrogen-dependent neoplasms, cerebrovascular disease, history of stroke, arterial disease, thromboembolic disorders, history of cholestatic jaundice, hepatic tumours (benign or malignant), abnormal vaginal bleeding. Interactions : Phenytoin, carbamazepine and rifampicin may enchance the metabolism of tibolone and thus reduce its activity. -------------------------------------------------------------------------------------------------------------------------------Chorionic Gonadotrophin Human (HCG) 5000 IU Injection * Trade Name : Pregnyl Indication : Treatment of infertile women to induce ovulation and as a luteal support in controlled ovarian hyperstimulation cycles Dosage : Induction of ovulation: 5000 - 10,000 units one day following last dose of menotropin. Up to 3 repeat injections of 5000 units each may be given within the following 9 days to prevent insufficiency corpus luteum Precautions : Use of human gonadotrophin either to induce ovulation or as a luteal support, may increase the risk of ovarian hyperstimulation syndrome (OHSS). Adverse effects : Thromboembolism, oedema, headache, irritability, restlessness, depression and tiredness, salt and fluid retention, pain at injection site, skin rashes. Contraindications : Androgen dependent neoplasia prior allergic reaction to chorionic gonadotrophin, active thrombophlebitis. Interactions : When used with gonadotrophins (Follicle Stimulating Hormone), ovarian hyperstimulation syndrome, enlargement of ovarian cysts or rupture of ovarian cysts and multiple births may occur. --------------------------------------------------------------------------------------------------------------------------------- 233 Clomifene Citrate 50 mg Tablet Trade Name : Clomid Indication : Anovulatory infertility Dosage : 50 mg daily from 2nd - 6th or 5th - 9th day of menstrual cycle. Increase dose gradually by increments of 50 mg if there is no response until a dosage of 200 mg daily is achieved Precautions : Pelvic examination prior to initial treatment, ophthalmological evaluation in patients developing visual symptoms, multiple pregnancies can occur, ovarian hyperstimulation syndrome and abnormal ovarian enlargement may occur. Adverse effects : Blurred vision, vasomotor flushing, abdominal pain and ovarian enlargement (which may be part of the ovarian hyperstimulation syndrome). Contraindications : Pregnancy, uncontrolled thyroid or adrenal dysfunction, liver disease, abnormal uterine bleeding, ovarian cysts, organic intracranial lesion. Interactions : Danazol can results in inhibition of response to clomifene. Ethinyl estradiol can results in suppression of response to ethinyl estradiol. When used concomitantly with gonadorelin acetate gonadotrophins (FSH), it may increase the risk of ovarian hyperstimulation syndrome (OHSS). --------------------------------------------------------------------------------------------------------------------------------Follitropin Alpha (Recombinant Human FSH) 75 IU Injection A* Trade Name : Gonal F Indication : i) Infertility treatment in anovulatory women who have been unresponsive to treatment with clomiphene citrate ii) Stimulation of follicular development for intra-uterine cycles iii) Stimulation of follicular development in assisted reproductive technology in the management of infertility Dosage : i) 75 - 150 IU daily, should commence within the first 7 days of the menstrual cycle and increased by 37.5 IU or 75 IU at 7 or 14 days interval. Max daily dose 225 IU ii) 150 - 225 IU daily commencing on days 2 or 3 of the cycle. Max daily dose 450 IU Precautions : Evaluate patient for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia and pituitary or hypothalamic tumours before starting therapy. Adverse effects : Fever, arthralgia, pain in lower abdominal region, nausea, vomiting and weight gain, ovarian hyperstimulation syndrome (OHSS), multiple pregnancy. Contraindications : Pregnancy, lactation, ovarian enlargement or cyst not due to polycystic ovarian disease, gynaecological haemorrhages of unknown aetiology, ovarian, uterine or mammary carcinoma tumours of the hypothalamus and pituitary gland. Interactions : Other ovulation stimulation agents may potentiate the follicular response whereas concurrent use in GnRH agonist- induced pituitary desensitization may increase the dosage of Gonal-F needed to elicit an adequate ovarian response. ------------------------------------------------------------------------------------------------------------------------------- 234 Carboprost Tromethamine 250 mcg Injection A* Trade Name : Hemabate Indication : Postpartum haemorrhage refractory to oxytocin Dosage : ADULT: by deep IM injection; 250 mcg, may repeat at 15-90 minute, intervals to a total dose of 2 mg (8 doses), followed by subsequent doses of 250 mcg at intervals of 1.5 to 3.5 hours. Dosage may be increased to 500 mcg/dose if contractility is inadequate Precautions : Glaucoma, elevated intraocular pressure, asthma or history of asthma. Cephalopevic relationships carefully evaluated prior to use. During use, uterine activity, foetal status and the progression of cervical dilation evaluated at frequent intervals. In patients with history of hypertonic uterine contractility or tetanic uterine contractions, recommended that uterine activity and state of foetus be monitored throughout labour. Possible uterine rupture where high tone myometrical contractions are sustained. Adverse effects : Nausea, vomiting and diarrhoea, paraesthesia, fever or chills, dystonia, breast tenderness, hyperthermia and flushing, bronchospasm, cardiovascular collapse. Contraindications : Hypersensitivity to prostagladin, acute pelvic inflammatory disease, cardiac, renal, pulmonary or hepatic disease. Interactions : Not known. ------------------------------------------------------------------------------------------------------------------------------Dinoprostone (Prostagladine E2) 3 mg Vaginal Tablet A Trade Name : Prostin E2 Indication : Induction of labour by vagina Dosage : 3 mg vaginal tablet to be inserted high into the posterior formix. A second 3 mg tablet may be inserted after 6-8 hours if labour is not established. Max 6 mg Precautions : Glaucoma elevated intraocular pressure, asthma or history of asthma. Cephalopelvic relationships carefully evaluated prior to use. During use, uterine activity, fetal status and progression of cervical dilatation evaluated at frequent intervals. In patients with history of hypertonic uterine. Adverse effects : Gastrointestinal upsets, uterine hypercontractility with or without fetal bradycardia, rapid cervical dilatation with low Apgar score, headache. Contraindications : Hypersensitivity to dinosprostone, pelvic inflammatory disease, extrauterine pregnancy, cephalopelvic disproportion, fetal distress, placenta previa, hypertonic or hyperactive uterine patterns, unexplained vaginal bleeding during current pregnancy. Interactions : Oxytocin: an increased risk of oxytocic toxicity (uterine hyperstimulation). Wait at least 30 minutes after removal of vaginal insert before initiating oxytocin. ------------------------------------------------------------------------------------------------------------------------------ 235 Ergometrine Maleate 0.5 mg/ml Injection C+ Indication : Prevention and treatment of postpartum and postabortal haemorrhage due to uterine atony Dosage : IM 200 - 1000 mcg and IV 250 - 500 mcg Precautions : Exacerbations of porphyria. Not recommended for routine use prior to delivery of the placenta. Patients with heart disease, hepatic dysfunction, hypertension, mitral valve stenosis, obliterative vascular disease, renal impairment, sepsis or venoarterial shunts. Hyperstimulation of the uterus during labor. Patients with calcium deficiency. Adverse effects : Nausea and vomiting, abdominal pain, diarrhoea, headache, dizziness, tinnitus, chest pain , palpitations, bradycardia, dyspnoea, hypertension, hypersensitivity reactions and ergotism has been reported. Cardiovascular effects, including arrhythmias and myocardial infarction and bronchospasm. Contraindications : Induction of labour, in cases of threatened spontaneous abortion, and in patients with a history of hypersensitivity or idiosyncratic reactions. Interactions : Combined use of delavirdine and ergometrine may cause elevated ergometrine serum concentration. Avoid concomitant use with antivirals like indinavir,saquinavir etc. -------------------------------------------------------------------------------------------------------------------------------------Gemeprost (Prostagladin E1 Synthetic Analogue) 1 mg Pessary A Trade Name : Cervagem Indication : Inducing abortion in the first trimester Dosage : Cervical dilatation: 1 pessary 3 hourly before surgery to a max of 5 pessaries over 24 hours Precautions : Obstructive airway disease, elevated intraocular pressure, cervicitis or vaginitis, ulcerative colitis, cardiovascular disease, renal or hepatic disease. Patients with hypertension or hypotension. Adverse effects : Vaginal bleeding, mild uterine pain, gastrointestinal disturbances, headache, muscle weakness, dizziness, flushing, chills, backache, dyspnoea, chest pain, palpitations and mild pyrexia. Anapylactic reactions (rare). Contraindications : Hypersensitivity to gemeprost or other prostagladin derivatives. Acute pelvic inflammatory disease and uterine scars Induction of labour or cervical softening at term. Interactions : Not known. ------------------------------------------------------------------------------------------------------------------------------Oxytocin 10 units/ml Injection B Trade Name : Pitocin Indication : Induction of labour Dosage : IV: 0.5 - 1 milliunits/minute; gradually increase dose in increments of 1 - 2 milliunits/minute until desired contraction pattern is established; dose may be decreased after desired frequency of contractions is reached and labor has progressed to 5 - 6 cm dilation 236 Precautions : For induction or enhancement only as IV infusion, careful monitoring of fetal heart rate and uterine contractions are required. Adverse effects : Gastrointestinal upsets, water intoxication resulting from large amounts of solution or too rapid infusion, cardiac arrhythmias. Contraindications : Hypersensitivity to oxytocin, significant cephalopelvic disproportion, unfavorable fetal positions, fetal distress, hypertonic or hyperactive uterus, contraindicated vaginal delivery. Interactions : Prostaglandins, inhalation anaesthetics, vasoconstrictor agents. ------------------------------------------------------------------------------------------------------------------------------Oxytocin 5 units & Ergometrine Maleate 0.5 mg/ml Injection C+ Trade Name : Syntometrine Indication : i) Prevention and treatment of post partum haemorrhage ii) Management of third stage of labour Dosage : i) 1 ml IM, may be repeated after 2 hours. Should not exceed 3 ml within 24 hours ii) For routine management of third stage of labour, 1 ml IM following delivery of the anterior shoulder or immediately after delivery of the child Precautions : Hypertension, cardiac, hepatic or renal disease. Should not be given until after delivery of child & in multiple births not until the last child has been delivered. Adverse effects : Gastrointestinal upsets, abdominal pain, headache, dizziness, skin rashes. Rarely hypertension, bradycardia, cardiac arrthymias, chest pain, anaphylactoid reactions. Contraindications : Pregnancy, labour (except second stage following delivery of the anterior shoulder), severe hypertension, pre-eclampsia, eclampsia, severe disorders of cardiac, hepatic or renal function, occlusive vascular disease, sepsis and in patients with a history of hypersensitivity. Interactions : Vasoconstrictors, prostaglandins, halothane anaesthesia. -------------------------------------------------------------------------------------------------------------------------------Clotrimazole 500 mg Vaginal Tablet B Indication : Vaginal candidiasis Dosage : 500 mg as a single one-time dose Precautions : Monitor hepatic function in patients with pre-existing hepatic impairment, not for ophthalmic use and vaginal use in pregnant patients should be supervised by a physician. Adverse effects : Local irritation or skin reaction and mild burning, nausea, vomiting, troches, increased liver enzymes. Contraindications : Hypersensitivity to clotrimazole. 237 Interactions : Concurrent use with betamethasone may result in increased susceptibility to skin infection or enhanced organism growth. Concurrent use with tacrolimus may increase plasma concentration of tacrolimus and cause toxicity (nephrotoxicity, hyperglycaemia, hyperkalaemia), fentanyl. ------------------------------------------------------------------------------------------------------------------------------Conjugated Oestrogens 0.625 mg/g Cream A Trade Name : Premarin Indication : Atrophic vaginitis and post menopausal atrophic urethritis Dosage : Intravaginally or topically 2 - 4 g daily depending on severity of condition. Total dose not exceeding 4 g. Administration should be cyclic, with 3 weeks on conjugated oestrogens and one week off. Oestrogens should be used for the shortest duration possible when treating atrophic vaginitis. Every 3 to 6 months attempts should be made to taper or discontinue therapy and conjugated oestrogens should be titrated to give the lowest possible dosage to control symptoms Precautions : Systemic absorption may occur. Precautions as for oral premarin should be considered. Adverse effects : Nausea, abdominal cramp, oedema, rash. Contraindications : Oestrogen dependent neoplasia, known or suspected pregnancy, undiagnosed abnormal vaginal bleeding, thromboembolic disorders, neuro-ophthalmologic vascular disease, breast cancer (except metastatic disease therapy). Interactions : Not known. ------------------------------------------------------------------------------------------------------------------------------Cyproterone Acetate 2 mg & Ethinyloestradiol 0.035 mg Tablet A* Trade Name: Diane 35 Indication: Androgen dependent diseases in women Dosage : 1 tablet daily for 21 days from the first day of the cycle, followed by 7 tab free days Precautions : Diabetes, hypertension, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor, history of phlebitis. Benign and rarely, malignant liver tumours which may lead to life threatening intra abdominal haemorrhage have been observed. If severe upper abdominal complaints, liver enlargement or signs of intra abdominal haemorrhage occur, a liver tumour should be taken into consideration Adverse Effects : Hepatotoxicity, anaemia, myocardial ischaemia, oedema, thromboembolic disease, headache, gastric upsets, nausea, breast tension, changes in body weight and libido, intermenstrual bleeding, depressive mood, chloasma, fluid retention Contraindications : Pregnancy, lactation, severe disturbances of liver function, history of idiopathic jaundice or severe pruritus during pregnancy, previous or existing liver tumours, malignant diseases (not prostatic carcinoma), thromboembolic disorders, acute liver disease, hypersensitivity 238 Interactions: Barbiturates, phenylbutazone, hydantoins, rifampicin and ampicillin may impair the action of the drug. Requirements for oral antidiabetics and insulin can change -------------------------------------------------------------------------------------------------------------------------------------Desogestrol 150 mcg & Ethinyloestradiol 30 mcg Tablet C Trade Name: Marvelon Indication: Contraception Dosage : 1 tablet daily for 21 days, subsequent courses repeated after 7 day interval (during which withdrawal bleeding occurs) Precautions : Gastrointestinal disease (impaired absorption of oral contraceptive steroids in the small bowel due to inflammatory disease, diarrhoea, ileostomy or jejunoileal bypass may result in contraceptive failure). Severe varicose veins, hepatic cell adenoma, latent or overt cardiac failure, renal dysfunction, epilepsy, migraine, hypertension, diabetes, smoking, surgery or prolonged immobilization Adverse Effects : Thromboembolic disease, hypertension, gall bladder disease, nausea, vomiting, migraine Contraindications : Thromboembolic disorders, coronary artery disease, breast or endometrial cancer, oestrogen dependent neoplasia, undiagnosed abnormal vaginal bleeding, cholestatic jaundice of pregnancy, hepatic adenomas or carcinomas, known or suspected pregnancy Interactions: Irregular bleeding and reduced efficacy with anticonvulsant, barbiturates, tetracyclines, rifampicin, activated charcoal, certain laxatives, antidiabetic drugs. Monitor patients receiving alprazolam therapy for an increased response to the benzodiazepine -------------------------------------------------------------------------------------------------------------------------------------Levonorgestrel 1.5mg Tablet A* Trade Name : Escapelle Indication : Emergency contraception within 72 hours of unprotected sexual intercourse for the female victim of sexual violence to prevent unwanted pregnancy Dosage : 1.5 mg as a single dose as soon as possible after coitus [preferably within 12 hours but no later than after 72 hours] Precautions : Not effective in terminating an existing pregnancy, not recommended for routine use as a contraceptive and in patients with severe hepatic dysfunction Adverse Effects : Acne, weight gain, abdominal pain, nausea, dizziness, headache, depression, breast tenderness, cyst of ovary, fatigue pelvic inflammatory disease, sepsis, menstrual irregularities Contraindications : Genital bleeding of unknown etiology, pregnancy Interactions : Effectiveness is reduced by enzyme inducing drugs such as barbiturates, phenytoin, carbamazepine, St. John's Wort, rifampicin, ritonavir and griseofulvin -------------------------------------------------------------------------------------------------------------------------------------- 239 Levonorgestrel Releasing Intrauterine System A* Trade Name : Mirena Indication : Contraception (Initial release rate of 20 mcg/24 hours) Dosage : One unit intrauterine device to be inserted into the uterine cavity within 7 days of the onset of menstruation or immediately after first trimester abortion. Postpartum insertion should be postponed until 6 weeks after delivery. One unit IUD is effective for 5 years Precautions : Discontinue treatment if crescendo migraine or other symptoms indicating transient cerebral ischaemia, exceptionally severe headache, jaundice, marked increase of blood pressure, unexplained loss of vision or other symptoms of retinal thrombosis occurs. Hormone dependent neoplasia including breast cancer, malignancies affecting the blood or leukaemias, severe arterial disease eg stroke or myocardia infarction. Diabetics. In recurrent endometriosis, pelvic infections or if an acute infection does not respond to treatment within a few days, perforation, accidental pregnancy. Not a contraceptive of choice during lactation Adverse Effects : Menstrual changes, lower abdominal pain, acne or other skin problems, backpain, mastalgia, headache, vaginal discharge, mood changes, nausea, oedema, weight gain, decreased libido, sweating, hair loss, greasy hair, ectopic pregnancy, pelvic inflammatory disease (PID), perforation of uterine wall, enlarged follicles may develop Contraindications : Active hepatic disease, active thrombophlebitis or thromboembolic disorders, haemorrhagic diathesis, carcinoma of the breast, pregnancy, undiagnosed abnormal uterine bleeding, undiagnosed abnormal genital bleeding, history of idiopathic intracranial hypertension, hypersensitivity Interactions : Not known -------------------------------------------------------------------------------------------------------- Medroxyprogesterone Acetate 150 mg/3 ml Injection B Trade Name : Provera/Farlutal Indication : Prevention of pregnancy and to provide long term contraception Dosage : To be administered every 3 month Precautions : Depression, epilepsy, migraine, asthma, diabetes, cardiac or renal dysfunction, fluid retention, thromboembolic disorders, cerebral apoplexy. Adverse effects : Gastrointestinal distress, oedema, menstrual disorders, dermatologic effects. Contraindications : Thromboembolic disorders, liver disease, breast or genital cancer, undiagnosed abnormal vaginal bleeding, known or suspected pregnancy, hypersensitivity to medroxyprogesterone products. Interactions : Concurrent use with aminoglutethimide may result in decreased medroxyprogesterone efficacy. Concurrent use with nevirapine may result in loss of contraceptive efficacy. Concurrent use with succinylcholine may result in prolongation of neuromuscular blockade. ------------------------------------------------------------------------------------------------------------------------------- 240 Norethisterone 0.35mg Tablet C Trade name : Noriday Indication : Contraception Dosage : 1 tablet daily starting on the first day of the menstrual bleeding Precautions : Gastrointestinal disease (impaired absorption of oral contraceptive steroids in the small bowel due to inflammatory disease, diarrhoea, ileostomy or jejunoileal bypass may result in contraceptive failure) Adverse Effects : Gastrointestinal distress, oedema, menstrual disorders, dermatologic effects, nausea, fatique, depression, acne, hirsutism, breast tenderness, thromboembolic phenomena, galactorrhoea, decreased glucose tolerance, anaphylaxis, corticoid like reaction (high doses) Contraindications : Hypersensitivity, breast carcinoma, liver disease or dysfunction, pregnancy, incomplete abortion, abnormal and undiagnosed vaginal bleeding, active or history of thromboembolic disease, thrombophlebitis, hypercoagulable state. Cerebral vascular or coronary artery diseases Interactions : Effectiveness may be reduced by antibiotics, phenytoin, carbamazepine, barbiturates, rifampicin -------------------------------------------------------------------------------------------------------------------------------------Norethisterone Enanthate 200 mg/ml Injection B Trade name : Noristerat Indication : Contraception Dosage : By deep IM injection only. First injection is within first 5 days of the cycle. The next 3 injections are given at 8 weeks interval after which the injection interval should be extended to 12 weeks Precautions : Benign and rarely malignant liver tumours which may lead to life threatening intra abdominal haemorrhage have been observed. If severe upper abdominal complaints, liver enlargement or signs of intra abdominal haemorrhage occur, a liver tumour should be considered. Porphyria, diabetes, smoking, age, sickle cell anaemia, history of phlebitis or thromboembolic diseases, impaired liver function, history of extrauterine pregnancy if one tube is missing Adverse Effects : Nausea, headache, dizziness, depressive moods, spotting, breakthrough bleeding, amenorrhoea, rarely weight gain Contraindications : Pregnancy, thromboembolic diseases, hypertension, acute and severe chronic liver disease, existing or treated breast or uterine cancers, severe diabetes with vascular changes, history of or existing liver tumours, disturbances of lipid metabolism, history of extrauterine pregnancy if one tube is missing Interactions : Action may be impaired by barbiturates, phenylbutazone, hydantoins, rifampicin and ampicillin -------------------------------------------------------------------------------------------------------------------------------------- 241 Raloxifene HCl 60 mg Tablet A* Trade Name : Evista Indication : Prevention and treatment of post menopausal osteoporosis Dosage : 1 tablet daily Precautions : Elderly, excessive exercise, hypoglycaemia, breast cancer. Adverse effects : Has been associated with increased risk of thromboembolism (deep vein thrombosis, pulmonary embolism) and superficial thrombophlebitis. Hot flushes and leg cramps. Contraindications : Women with child bearing potential, active thromboembolic disorder, pregnancy. Interactions : Ampicillin and cholestyramine decrease raloxifene absorption. ------------------------------------------------------------------------------------------------------------------------------Salbutamol 5 mg/5 ml Injection A* Trade Name : Ventolin Indication : Prevention of uncomplicated premature labour only Dosage : Infusions containing 5 mg in 500ml (10 mcg/ml) at the rate of 10 - 45 mcg/min increased at intervals of 10 minutes until evidence of patient response as shown by reduction of strength, frequency or duration of contractions; maintain rate for 1 hour after contractions have stopped, then gradually reduce by 50% every 6 hours Precautions : Potential for paradoxical bronchospasm, patients with cardiovascular disorders, hyperthyroidism, diabetes mellitus, phaeochromocytoma, patients with history of aneurysm and patients who are usually responsive to sympathomimetic amines. Labour and delivery may be complicated. Thyrotoxicosis, pregnancy and lactation. Adverse effects : Haemorrhage, thrombocytopenia, tachycardia and palpitations, erythema, ventricular ectopic beats, myocardial ischaemia and infarction have been reported following IV administration. Fine tremors (particularly in the hands), nervous tension, headache, peripheral dilatation and palpitations, tachycardia, arrhythmias. Muscle cramps and hypersensitivity reactions including paradoxical bronchospasm, urticaria and angioedema. Contraindications : Hypersensitivity, hyperthyroidism or thyrotoxicosis, tachycardia or tachycardic arrthymias, subvalvular aortic stenosis. Interactions : Hypertensive crisis and other adverse effects occur frenquently with the concurrent use of indirectacting sympathomimetics. Concomitant administration of salbutamol and other beta-2 agonists with corticosteroids, diuretics or xanthines increases the risk of toxicity. ------------------------------------------------------------------------------------------------------------------------------- 242 11. GENITOURINARY Drugs for urinary retention Drugs for urinary frequency, enuresis and continence Miscellaneous genitourinary 243 Doxazosin Mesilate 4 mg CR Tablet A* Trade Name : Cardura XL Indication : Benign Prostatic Hyperplasia Dosage : 4 mg once daily Precautions: Gastrointestinal disorders, pregnancy, lactation, history of gastrointestinal obstruction, oesophageal obstruction Adverse Reactions: Postural hypotension, vertigo, headache, fatigue, dizziness, oedema and asthenia Contraindications: Hypersensitivity to doxazosin and other quinazolines Interactions: In patients currently on beta blockers, the first dose response (marked initial drop in blood pressure, particularly on standing) to an alpha-1 adrenergic blocking drug may be exaggerated, tadalafil, sildenafil, vardenafil -------------------------------------------------------------------------------------------------------------------------------------Dutasteride 0.5 mg Capsule A* Trade Name : Avodart Indication : Benign prostatic hyperplasia in men with an enlarged prostate gland Dosage : 0.5 mg daily Precautions: Concurrent use of CYP3A4 enzyme inhibitors (e.g. ritonavir), capsules should not be handled by women who are pregnant or who may become pregnant due to the possibility of absorption of dutasteride through the skin and the potential risk of a fetal anomaly Adverse Reactions: Impotence, decrease libido, ejaculation disorders, gynaecomastia, breast tenderness, allergic reactions including rash, prutitus, urticaria and localized edema. Contraindications: Severe hepatic impairment, women, child and adolescent Interactions: Verapamil, diltiazem, cimetidine, ciprofloxacin, ketoconazole, ritonavir -------------------------------------------------------------------------------------------------------------------------------------Finasteride 5 mg Tablet A* Trade Name : Proscar Indication : Treatment and control of benign prostatic hyperplasia Dosage : 5 mg a day as a single dose. Clinical responses occur within 12 weeks - 6 months of initiation of therapy. Long-term administration is recommended for maximal response Precautions: Patients should be screened for prostatic carcinoma, hepatic dysfunction, patients with a large residual urinary volume or a severely diminished urinary flow rate should be monitored for obstructive uropathy and may not be candidates for finasteride therapy, crushed tablets should not be handled by a woman when she is pregnant or may potentially be pregnant because of the possibility of absorption and the subsequent potential risk to the male foetus 244 Adverse Reactions: Sexual dysfunction, breast tenderness or enlargement Contraindications: Hypersensitivity to finasteride products, known or suspected pregnancy Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Terazosin HCl 1 mg Tablet A Terazosin HCl 2 mg Tablet A Trade Name : Hytrin Indication : Only for treatment of Benign Prostatic Hyperplasia. Not to be used for treatment of hypertension Dosage : Initially 1 mg at night, increased in a stepwise fashion to 2 mg, 5 mg or 10 mg once daily Precautions: Carcinoma of the prostate and benign prostatic hyperplasia may cause the same symptoms. Prostate cancer should be ruled out prior to treatment. Dizziness, lightheadedness, orthostatic hypotension, syncope (first-dose effect) Adverse Reactions: Tachycardia, dizziness, syncope, headache and asthenia Contraindications: Hypersensitivity to terazosin products or other quinazolines Interactions: In patients currently on beta blockers, the first dose response (marked initial drop in blood pressure, particularly on standing) to an alpha-1 adrenergic blocking drug may be exaggerated. Concomitant therapy with ibuprofen and antihypertensive agents has been reported to result in increases in blood pressure and interference with blood pressure control -------------------------------------------------------------------------------------------------------------------------------------Tamsulosin HCl 400 mcg Extended Release Tablet A* Trade Name : Harnal® OCAS Indication : Second line treatment of functional symptoms of benign prostatic hyperplasia (BPH) in patients who do not tolerate first line drugs or when first line drugs are inappropriate or contraindicated Dosage : 400 mcg once daily Precautions: Patients receiving antihypertensive treatment, elderly patients, hepatic and renal impairment, during cataract surgery (risk of intra-operative floppy iris syndrome) Adverse Reactions: Abnormal ejaculation, reduced libido, priapism, intra-operative floppy iris syndrome (IFIS), dizziness, syncope, palpitations, postural hypotension, rhinitis, vomiting, constipation, diarrhoea, rash, angioedema, asthenia, drowsiness, blurred vision Contraindications: History of orthostatic hypotension, severe hepatic insufficiency, hypersensitivity to Tamsulosin HCl or any other component of the product 245 Interactions: Drugs which may reduce blood pressure, cimetidine, fluoxetine, ketoconazole, sildenafil -------------------------------------------------------------------------------------------------------------------------------------Tolterodine Tartrate ER 2 mg Capsule A* Trade Name : Detrusitol SR Indication : Treatment of overactive bladder with symptoms of urinary, frequency or urge incontinence Dosage : 4 mg once daily. May decrease to 2 mg once daily depending on response and tolerability Precautions: Significant bladder outlet obstruction, gastrointestinal obstruction disorders, renal disease, hepatic disease, autonomic neuropathy, hiatus hernia, concomitant treatment with CYP3A4 inhibitors Adverse Reactions: Mild to moderate antimuscarinic effects, dryness of mouth, dyspepsia, reduced lacrimation Contraindications: Urinary retention, uncontrolled narrow angle glaucoma, toxic megacolon, myasthenia gravis. Pregnancy and lactation Interactions: Erythromycin, clarithromycin, metoclopramide, cisapride -------------------------------------------------------------------------------------------------------------------------------------Flavoxate HCl 100 mg Tablet A Trade Name : Urispas Indication : Urinary frequency and incontinence, dysuria, urgency, bladder spasm due to catheterisation Dosage : ADULT: 200 mg 3 times daily. CHILD under 12 years not recommended Precautions: Pregnancy and lactation, suspected glaucoma. May affect ability to drive or operate machinery Adverse Reactions: Gastrointestinal disturbances, vertigo, headache, mental confusion especially in elderly, drowsiness, fatigue and nervousness, tachycardia and palpitations, urticaria, eosinophilia and hyperpyrexia Contraindications: Pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal haemorrhage, obstructive uropathies of the lower urinary tract, children less than 12 years Interactions: Other antimuscarinic drugs -------------------------------------------------------------------------------------------------------------------------------------Potassium Citrate 3 g/10 ml and Citric Acid Mixture Indication : For systemic or urine alkalinization Dosage : ADULT: 10 ml 3 times daily well diluted with water. CHILD up to 1 year: 2.5 ml 3 times daily; 1 - 5 years: 5 ml 3 times daily; 6 - 12 years: 10 ml 3 times daily. To be taken well diluted with water 246 C Precautions: Congestive heart failure, hypertension, pulmonary or peripheral oedema, toxaemia of pregnancy, monitor serum electrolytes especially bicarbonate in patients with renal disease, decreased urinary output, especially in the presence of hypocalcaemia Adverse Reactions: Hyperkalaemia, metabolic alkalosis, nausea, vomiting, diarrhoea, mild diuresis Contraindications: Severe renal impairment with oliguria, azotemia or anuria, Addison's disease, adynamic episodica hereditaria, acute dehydration, heat cramps, severe myocardial damage, potassium citrate in patients with hyperkalemia, sodium citrate for patients on sodium restriction Interactions: Concurrent administration of potassium citrate with potassium- containing medications, angiotensin-converting enzyme inhibitors or cardiac glycosides, concurrent administration with aluminum-based gels -------------------------------------------------------------------------------------------------------------------------------------Sodium Bicarbonate, Citric Acid, Sodium Citrate and Tartaric Acid - 4 g per sachet B Trade Name : Ural Indication : For relieving of discomfort in mild urinary tract infection, symptomatic relief of dysuria to enchance the action to certain antibiotics especially some sulphonamides. In gout as urinary alkalinizers to prevent cystallisation of urates Dosage : 4- 8 g (1- 2 sachets) dissolved in a glass of cold water 4 times daily as prescribed Precautions: Patients on sodium restricted diet Adverse Reactions: Mild laxative effect, systemic alkalosis or hyperthermia with prolonged or excessive usage Contraindications: Renal failure or hyperthermia Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------- 247 12. DRUGS AFFECTING IMMUNE RESPONSE Immunosuppressants Immunomodulators 248 Antilymphocyte/Antithymocyte Immunoglobulin (from Horse) Injection A* Trade Name : Atgam Indication : i) To be used when conventional anti-rejection therapy is not successful ii) Treatment of aplastic anaemia not responding to oxymethalone after 3 months, in which there is persistent pancytopenia with repeated attacks of septicaemia and bleeding. iii) Severe aplastic anaemia with the following parameters: a) Granulocyte less than 0.5x109/L b) Platelet less than 20x109/L c) Reticulocyte less than 20x109/L iv) As a conditioning regime prior to transplant. v) Graft-versus-host disease treatment Dosage : 10 - 30 mg/kg body weight daily. Slow IV infusion (over at least 4 hours) diluted in 250 - 500 ml Normal Saline. For Graft versus host disease treatment:40 mg/kg/day Precautions: Perform test dose, prophylactic platelet transfusion before and after infusion. Sodium and fluid overload. Monitor for allergic reactions and serum sickness Monitor for signs of leukopenia, thrombocytopenia or concurrent infection. Perform skin testing Adverse Reaction: Severe and unremitting thrombocytopenia or leucopenia, generalized rash, tachycardia, dyspnoea, hypotension, anaphylaxis. Contraindications: Hypersensitivity, acute viral illness. Interactions: Live vaccines, increased risk of infection. -------------------------------------------------------------------------------------------------------------------------------------Azathioprine 50 mg Tablet A Trade Name : Imuran Indication : i)Acute leukaemia ii)Immunosuppressive agent Dosage : i) 1-4 mg/kg/day ii) 1.5-2 mg/kg/day Precautions: Chronic immunosuppression , increases risk of neoplasm, hematologic toxicity, mutagenicity. Bleeding or bruising or signs of infection, bone marrow suppression. Monitor FBC weekly during first 8 week of therapy especially with high dose or severe renal/hepatic impairment. Inherited deficiency of thiopurine methyltransferase enzyme. Avoid excessive sun/UV exposure. Pregnancy, lactation and elderly Adverse Reaction: Gastrointestinal disturbances, myelosuppression, pancreatitis, fever. Opportunistic infections especially in transplant patients receiving concomitant other immunosuppressants. Bone marrow depression, leucopenia, thrombocytopenia, nausea. Uncommonly, anaemia, hypersensitivity reactions, cholestasis, pancreatitis Contraindications: Hypersensitivity, pregnancy, previous alkylating agents such as cyclophosphamide, chlorambucil, melphalan (risk of neoplasms) Interactions: ACEI, Angiotensin II Antagonist, warfarin, allopurinol, live vaccines, antibacterial. Reduces the neuromuscular blockade of curare, tubocurarine but potentiates that of succinylcholine -------------------------------------------------------------------------------------------------------------------------------------- 249 Mycophenolate Sodium 360mg Tablet A* Trade Name : Myfortic Indication : Prophylaxis of acute transplant rejection in adult patients receiving allogenic renal transplant in combination with ciclosporin and corticosteroids Dosage : 720 mg twice daily Precautions: Avoid in patients with rare hereditary deficiency of hypoxanthine-guanine hosphoribosyl-transferase (HGPRT) (eg, Lesch-Nyhan and Kelley-Seegmiller syndrome). Associated with an increased risk of congenital malformations and spontaneous abortions when used during pregnancy. CellCept and myfortic dosage forms should not be used interchangeably due to differences in absorption. Increased risk of developing lymphomas & other malignancies particularly of the skin. Oversuppression of the immune system with increased susceptibility to infection. Active serious digestive system disease. Bone marrow depression. Perform regular complete blood counts for monitoring neutropenia. Effective contraception must be used. Lactation. Severe chronic renal impairment. Avoid live attenuated vaccines. Increased risk for opportunistic infections such as activation of latent viral infections including BK virus -associated nephropathy Adverse Reaction: Leucopenia, neutropenia, lymphomas and skin malignancies. Increased risk of infections, constipation, insomnia, increased risk of first trimester pregnancy loss and increased risk of structural abnormalities in the infants born to mothers receiving mycophenolate during pregnancy. Diarrhoea, viral, bacterial & fungal infections, anaemia, thrombocytopenia, headache, cough, abdominal distension, abdominal pain, abdominal tenderness, dyspepsia, flatulence, gastritis, loose stools, nausea, vomiting, fatigue, pyrexia, abnormal hepatic function tests, increased blood creatinine Contraindications: Hypersensitivity, pregnancy, hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil or any other component of the product Interactions: Azathioprine, live vaccines, aciclovir, antacids with aluminium and magnesium hydroxides, cholestyramine and drugs that interfere with enterohepatic circulation, ganciclovir, tacrolimus, oral contraceptives and cyclosporin -------------------------------------------------------------------------------------------------------------------------------------Tacrolimus 0.5 mg Capsule A* Tacrolimus 1 mg Capsule A* Trade Name : Prograf Indication : i) Primary immunosuppressant agent for all solid organ transplantation ii) Rescue therapy for rejection Dosage : i) 0.2 mg/kg/day in 2 divided doses ii) 0.3 mg/kg/day in 2 divided doses Precautions: Renal or hepatic insufficiency, monitor blood glucose levels, increased risk of infections and possibly lymphoma, hyperkalaemia, hypertension, myocardial hypertrophy and neurotoxicity. Monitor blood pressure, ECG, visual status, electrolytes (especially K), haematology parameters. Children less than 2 year who are Epstein-Barr virus sero-negative. Patients with allergenic disposition. May impair ability to drive or operate machinery. Continuous IV therapy should not be continued for more than 7 days. Avoid excessive exposure to sun or UV light. Increased risk for opportunistic infections such as activation of latent viral infections including BK virus -associated nephropathy 250 Adverse Reaction: Hypertension, angina, tachycardia, pleural and pericardial effusion, hypotension, arrhythmias, ventricular or septal hypertrophy, cardiomyopathy, gastrointestinal disturbances, headache, tremor, dizziness, anxiety, confusion and infection Contraindications: Hypersensitivity to tacrolimus products, macrolides, polyoxyethylated castor oil (parenteral formulation) or structurally related compounds, pregnancy and lactation Interactions: Aminoglycosides, cisplatin, amphotericin B, additive or synergistic renal function impairment. Spironolactone, hyperkalaemia. NSAIDs, acute renal failure. Live vaccines, risk of infection in immunocompromised hosts, reduced effectiveness of vaccine. Fluconazole, nifedipine, diltiazem, clarithromycin, erythromycin, chloramphenicol, increased risk of tacrolimus toxicity (nephrotoxicity, hyperglycaemia, hyperkalaemia) -------------------------------------------------------------------------------------------------------------------------------------Ciclosporin 25 mg Capsule Microemulsion A* Trade Name : Sandimmun Neoral Indication : Only for: i) Patients in whom donor specific transplantation cannot be carried out and in young children to minimise side-effects of steroids ii) Follow-up cases of bone marrow transplant iii) Patients with severe rheumatoid arthritis not responding to other second line drugs iv) Patients with idiopathic nephrotic syndrome who are steroid toxic or poor response to cyclophosphamide v) Severe aplastic anemia, pure red cell aplasia vi) Cases of recalcitrant psoriasis and atopic eczema vii) Treatment of chronic ocular inflammatory disorders/uveitis Dosage : i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 months before being tapered off to zero by 1 year of transplantation iii) 3 mg/kg/day in 2 divided doses for first 6 weeks. May increased gradually to maximum 5 mg/kg. Treatment withdrawn if no response after 3 months iv) ADULT: 5 mg/kg/day in 2 divided doses. CHILD: 6 mg/kg/day in 2 divided doses. Patients with permitted levels of kidney failure, the starting dose must not more than 2.5 mg/kg/day v) 12 mg/kg/day vi) 2.5 mg/kg/day in 2 divided doses increasing if there is no improvement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5 mg/kg/day vii) 5 mg/kg/day in 2 divided doses, may increase to 7 mg/kg/day in resistant cases. Maintenance: Less than 5 mg/kg/day especially during remission Precautions: History of allergic reactions, pregnancy, monitor BP, serum electrolytes, renal and hepatic function, hypertension & malignancies. Neoral and Sandimmun are not bioequivalent - dosage adjustments and increased monitoring needed. Increased risk for opportunistic infections such as activation of latent viral infections including BK virus -associated nephropathy Adverse Reaction: Nephrotoxicity, hepatotoxicity, gum hyperplasia, hypertension, neurotoxicity, convulsions, increased malignancy risk, tremor, paraesthesia, hypertrichosis, facial oedema, acne, gingival hypertrophy, hyperkalaemia, fluid retention, increased susceptibility to infections, gastrointestinal symptoms Contraindications: Hypersensitivity to ciclosporin or any other component, rheumatoid arthritis or psoriasis patients with abnormal renal function, uncontrolled hypertension, malignancies, uncontrolled infections in rheumatoid arthritis patients, primary or secondary immunodeficiency in rheumatoid arthritis patients, psoriasis patients receiving PUVA (psoralen plus ultraviolet A) or UVB (ultraviolet B) therapy, methotrexate or other immunosuppressants, coal tar, radiation therapy & lactation 251 Interactions: Etoposide, statins, vaccines, immunosuppressive drugs except corticosteroids, live vaccines, nephrotoxic drugs, NSAIDs, hepatic enzyme inducers. Increased ciclosporin level by diltiazem, doxycycline, erythromycin, ketoconazole, nicardipine, verapamil, oral contraceptives. Drugs which reduce ciclosporin level are carbamazepine, isoniazid, phenobarbitone, phenytoin and rifampicin. Increased risk of convulsion when used concurrently with high-dose methylprednisolone -----------------------------------------------------------------------------------------------------------------------------------Ciclosporin 100 mg/ml Drink Solution A* Trade Name : Sandimmum Neoral Indications: Only for : i) Patients in whom donor specific transplantation cannot be carried out and in young children to minimise side-effects of steroids ii) Follow-up cases of bone marrow transplant iii) Patients with severe Rheumatoid arthritis not responding to other second line drugs iv) Patients with idiopathic nephrotic syndrome who are steroid toxic or poor response to cyclophosphamide v) Severe aplastic anaemia, pure red cell aplasia vi) Cases of recalcitrant psoriasis and atopic eczema Dosage : i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 months before being tapered off to zero by 1 year of transplantation iii) 3 mg/kg/day in 2 divided doses for first 6 weeks. May increased gradually to maximum 5 mg/kg. Treatment withdrawn if no response after 3 months iv) ADULT: 5 mg/kg/day in 2 divided doses. CHILD: 6 mg/kg/day in 2 divided doses. Patients with permitted levels of kidney failure, the starting dose must not more than 2.5 mg/kg/day v) 12 mg/kg/day vi) 2.5 mg/kg/day in 2 divided doses increasing if there is no improvement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5 mg/kg/day Precautions : History of allergic reactions, pregnancy; monitor BP, serum electrolytes, renal and hepatic function, hypertension & malignancies. Neoral and Sandimmun are not bioequivalent - dosage adjustments and increased monitoring needed. Increased risk for opportunistic infections such as activation of latent viral infections including BK virus -associated nephropathy Adverse Reactions : Nephrotoxicity, hepatotoxicity, gum hyperplasia, hypertension, neurotoxicity, convulsions, increased malignancy risk, tremor, paraesthesia, hypertrichosis, facial oedema, acne, gingival hypertrophy; hyperkalaemia, fluid retention, increased susceptibility to infections, gastrointestinal symptoms Contraindications : Hypersensitivity to ciclosporin, or any other component. Rheumatoid arthritis or psoriasis patients with abnormal renal function, uncontrolled hypertension, malignancies, uncontrolled infections in rheumatoid arthritis patients, primary or secondary immunodeficiency in rheumatoid arthritis patients, psoriasis patients receiving PUVA (psoralen plus ultraviolet A) or UVB (ultraviolet B) therapy, methotrexate or other immunosuppressants, coal tar, radiation therapy, lactation 252 Interactions : Etoposide, statins,vaccines, immunosuppressive drugs except corticosteroids, live vaccines, nephrotoxic drugs, NSAIDs, hepatic enzyme inducers. Increased ciclosporin level by diltiazem, doxycycline, erythromycin, ketoconazole, nicardipine, verapamil, oral contraceptives. Drugs which reduce ciclosporin level are carbamazepine, isoniazid, phenobarbitone, phenytoin and rifampicin. Increased risk of convulsion when used concurrently with high-dose methylprednisolone ---------------------------------------------------------------------------------------------------------------Mycophenolate Mofetil 250 mg tablet A* Mycophenolate Mofetil 500 mg tablet A* Trade Name : Cellcept Indication : i) Prophylaxis of acute organ rejection in patients receiving allogenic renal, cardiac and hepatic transplant ii) Used with steroids for induction and maintenance of severe lupus nephritis resistant or intolerant to cyclophosphamide therapy Dosage : i) Renal transplant rejection: ADULT: 1 g twice daily. CHILD (3 months and older): 600 mg/m(2)/dose, twice daily; maximum daily dose, 2 g/10 mL. Cardiac transplant rejection: 1.5 g twice daily. Hepatic transplant rejection: 1.5 g twice daily ii) Induction phase: 2 - 3 g/day for up to 6 months. Maintenance phase: dose gradually tapers to 1 g/day Precautions: Full blood count weekly for 4 weeks, then twice a month for 2 months, then monthly in the first year. Elderly, active serious gastro-intestinal disease, delayed graft function. Avoid exposure to sunlight. Bone marrow suppression, monitor neutrophil count. If neutropenia develops, stop treatment or reduce dose. Perform relevant diagnostic tests as necessary & complete blood counts weekly. Severe active digestive diseases, severe chronic renal failure. Pregnancy & lactation. Increased risk for opportunistic infections such as activation of latent viral infections including BK virus -associated nephropathy Adverse Reaction: Myelosuppression, hypertension, infection, diarrhoea, nausea and vomiting, constipation, abdominal pain, dyspepsia, dizziness, insomnia, headache, tremor, leucopenia, anaemia, thrombocytopenia, leucocytosis, polycythaemia, electrolyte imbalances Contraindications: Hypersensitivity to mycophenolate mofetil and mycophenolic acid, pregnancy Interactions: Antacids, cholestyramine, decreased mycophenolate mofetil efficacy. Iron decreased mycophenolate mofetil efficacy. Azathioprine, drugs which interfere with enterohepatic recirculation, acyclovir, ganciclovir -------------------------------------------------------------------------------------------------------------------------------------- 253 14. HAEMATOLOGY / ONCOLOGY Cytotoxic drugs Sex hormones and hormone antagonists in malignant disease Bleeding disorder Miscellaneous Haematology / Oncology 254 Actinomycin D (Dactinomycin) 500 mcg/ml Injection A Trade Name : Cosmegen Indication : i) For solid tumours ii) Gestational trophoblastic disease Dosage : ADULT: 500 mcg IV daily for max of 5 days. CHILD: 1.5 mg/m2 once every 3 weeks (if weight less than 10 kg, 50 mcg/kg) ii) 500 mcg IV on Days 2, 4, 6, 8, 10, repeat every 7 - 10 days or 500 mcg IV bolus on Days 1 and 2, repeat every 15 days Precautions: Avoid extravasation, severe soft tissue damage. Concomitant radiation therapy may exaggerate dactinomycin toxicity Adverse Reaction: Myelosuppression, nausea, vomiting, mucositis, alopecia, rash, radiation recall reactions, hepatitis. Malaise, fatigue, fever, myalgia, gastrointestinal, haematologic and dermatologic effects Contraindications: Pregnancy, lactation, chickenpox or herpes zoster infection Interactions: Live vaccines may result in an increase risk of infection, radiation therapy, possibly reduced absorption of phenytoin -------------------------------------------------------------------------------------------------------------------------------------All-Trans Retinoic Acid 10 mg Capsule A* Trade Name : Vesanoid Indication : Acute promyelocytic leukaemia Dosage : Induction: 45 mg/m2 daily for 30 - 90 days. Maintenance: 45 mg/m2 daily for 2 weeks every 3 months. Refer to protocols Precautions: Avoid pregnancy during and for at least 1 month after stopping treatment. Monitor haematological, coagulation profile, liver function test, serum lipid levels. To be used with caution in pre-existing hypertriglyceridaemia, diabetes mellitus, obesity. Anticipate and treat retinoic acid syndrome Adverse Reaction: Headache, fever, weakness, fatigue, nausea, vomiting, dry skin, rash, peripheral oedema, mycosis, conjunctivitis, hypotension, hypertension, arrhythmias, heart failure, flushing, dizziness, anxiety, depression, paresthesias, confusion, pseudotumour cerebri, gastrointestinal bleeding, abdominal pain, diarrhoea, constipation, retinoic acid syndrome, bone pain, muscle pain, joint pain, increase in serum triglycerides and cholesterol Contraindications: Hypersensitivity to retinoids, pregnancy and lactation Interactions: Concurrent use with drugs which inhibit hepatic cytochrome P450 enzyme system, eg ketoconazole, cimetidine, ciclosporin, diltiazem, erythromycin, rifampicin, verapamil may increase risk of toxicity. Use together with vitamin A supplements may result in increase in toxicity. Avoid ethanol. Exposure to paclitaxel result in increased risk of paclitaxel toxicity. Tranexamic Acid may result in increased risk of thrombosis ------------------------------------------------------------------------------------------------------------------------------------ 255 Bleomycin HCl 15 mg Injection A Trade Name : Bleocin Indication : Squamous cell carcinoma, germ cell tumours, lymphomas. Routes: SC, IM, IV (either as bolus or as infusion over 24 hours), intra-arterial, intra-pleural Dosage : 15 - 60 mg weekly in divided doses or 10 - 20 mg/m2 once or twice weekly or 10 mg/m2 slow bolus in 15 minutes D1 and D15. Max: 400 mg. CHILD: 10 - 15 mg/m2 over 6 hours every 3 - 4 weeks Precautions: Beware of increased risk of pulmonary fibrosis in elderly patients (more than 70 years), if radiotherapy has been given to the chest, if cumulative lifetime doses of bleomycin are exceeded or if high concentrations of oxygen is given after bleomycin therapy. Monitor lung function. Risk of anaphylatic reaction is higher in patients with lymphoma receiving bleomycin. Reconstitute in 0.9% sodium chloride or sterile water. Should not reconstitute in dextrose-containing solutions Adverse Reaction: Erythema, hyperpigmentation of skin, nail changes, mucositis, chills, fever, pneumonitis, pulmonary fibrosis, Raynaud's phenomenon, hyperpyrexia, hyperkeratosis, striae, stomatitis Contraindications: Hypersensitivity to bleomycin, severe pulmonary disease, pregnancy, lactation Interactions: Phenothiazines, cisplatinum, radiotherapy, zidovudine -------------------------------------------------------------------------------------------------------------------------------------Capecitabine 500 mg Tablet A* Trade Name : Xeloda Indication : i)Metastatic breast cancer in elderly and poor performance status patients and refractory to taxanes ii) Metastatic colon cancer, first line in elderly and poor performance status patients iii) Colon cancer, adjuvant therapy for stage III (Duke's Stage C) following surgery Dosage : i) & ii) 1250 mg/m2 twice daily (morning and evening) for 2 weeks, every 21 days iii) Recommended for a total of 24 weeks (8 cycles of 2 weeks of drug administration and 1 week rest period Precautions: Patient with bone marrow suppression, poor nutritional status, elderly patients (more than 80 years), hepatic or renal dysfunction Adverse Reaction: Myelosuppression, oedema, fatigue, fever, abdominal pain, palmar-plantar erythrodysesthesia, dermatitis, nausea and vomiting, stomatitis, anorexia, diarrhoea, constipation, paraesthesia Contraindications: Hypersensitivity to capecitabine, fluorouracil or any component of formulation, severe renal impairment, pregnancy, lactation Interactions: Warfarin -------------------------------------------------------------------------------------------------------------------------------------Carboplatin 450 mg Injection Trade Name : Paraplatin Indication : Adult solid tumours, paediatric tumours. Salvage therapy for lymphoma 256 A* Dosage : 360 - 400 mg/m2 BSA, by IV infusion over 15 mins to 1 hour on Day 1 every 4 weeks. Alternatively, prescription may be based on Area Under Curve (AUC) calculations. CHILD: 500-600 mg/m2 over 1 hour once every 3 weeks. Salvage regimes in lymphomas - refer to specific protocols Precautions: Myelosuppression, renal impairment. Monitor blood counts and renal function. Do not use infusion sets or needles containing aluminium, avoid extravasation Adverse Reaction: Myelosuppression, alopecia, mucositis, electrolyte disturbances, nausea and vomiting, nephrotoxicity, ototoxicity, peripheral neuropathy Contraindications: Hypersensitivity to cisplatin/ platinum products or mannitol, pregnancy, lactation, severe myelosuppression Interactions: Nephrotoxic and ototoxic drugs, phenytoin. If platinum compound is used with taxane, to be given after taxane. Increased risk of infection by live vaccines, zidovudine -------------------------------------------------------------------------------------------------------------------------------------Chlorambucil 2 mg Tablet A Trade Name : Leukeran Indication : Low grade lymphoma, chronic lymphocytic leukaemia. Ovarian cancer Dosage : 200 mcg/kg body weight daily for 4 - 8 weeks Precautions: Myelosuppression. Monitor blood counts. History of seizures. If generalised skin rash develops during treatment, to stop therapy to avoid progressing to erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome Adverse Reaction: Myelosuppression, azoospermia/amenorrhoea, rash, allergic reactions, seizures, nausea and vomiting, diarrhoea, stomatitis, interstitial pneumonitis, pulmonary fibrosis, transient elevation of liver enzymes, secondary malignancies Contraindications: Hypersensitivity to chlorambucil, pregnancy Interactions: Ciclosporin, phenobarbital, phenytoin, allopurinol, live vaccines -------------------------------------------------------------------------------------------------------------------------------------Cisplatin (Cis-Platinum) 50 mg Injection A Trade Name : Platinul Indication : Germ cell tumours, ovarian tumours, adult solid tumours, lymphomas Dosage : Germ cell tumours: 20 mg/m2 daily for 5 days every 3 weeks for 3 - 4 courses. Ovarian tumours: 75 mg/m2 once every 3 weeks as part of combination therapy or 100 mg/m2 IV once every 3 weeks as a single agent. Baseline creatinine clearance, pretreatment hydration and forced diuresis are mandatory. CHILD: 100mg/m2 over 6 hours once every 3 weeks. Lymphomas: Refer to protocols Precautions: Monitor blood counts, renal and neurologic function. Protect from light. Materials used to prepare/administer cisplatin should not contain aluminium. Mandatory pre-hydration and posthydration with mannitol diuresis 257 Adverse Reaction: Acute renal failure, chronic renal insufficiency, myelosuppression, severe nausea and vomiting, ototoxicity, peripheral neuropathy, autonomic neuropathy, electrolyte disturbances (eg hypokalemia, hypomagnesemia), bone marrows and ears, seizures, loss of hearing, deafness or vestibular toxicity Contraindications: Hypersensitivity to cisplatin/platinum-containing products, pre-exisiting renal insufficiency, myelosuppression, hearing impairment. Pregnancy, lactation, peripheral neuropathy, severe bone marrow suppression Interactions: Sodium thiosulphate, bleomycin. If platinum compound is used with taxane, to be given after taxane, live vaccine, azidamfenicol, aminoglycosides -------------------------------------------------------------------------------------------------------------------------------------Cyclophosphamide 1 g Injection A Trade Name : Endoxan Indication : i) Solid tumours (adult and paediatric), leukaemia, non-Hodgkin's lymphoma, multiple myeloma ii) Severe lupus nephritis (Class III and IV) iii) Other systemic vasculitis iv) Systemic lupus erythematosus, rheumatoid arthritis, polyarteritis nodosa, wegener granulomatosis v) Pemphigus vulgaris Dosage : i) ADULT: 600 - 750 mg/m2 IV once every 3 weeks as part of combination regime. CHILD: Dose variable depending on disease and protocol. Range 600 mg/m2 to 2 g/m2 infusion over 1 hour to 6 hours (lower doses can be given as bolus). Care with pre and post-hydration. Mesna to be given with doses more than 1 g/m2. Higher doses are used in haematopoetic stem cell transplant-refer to specific protocols ii) 750 mg/m2 BSA monthly for 18 months iii) 750 mg/m2 BSA monthly for 6 months. Dose can be adjusted up to 1,000 mg/m2 BSA to achieve adequate leucocyte suppression iv) 500 - 1000 mg intravenously (Regime varies according to indication). Starting dose may be given fortnightly then at monthly intervals followed by 3 monthly intervals v) 500 mg infusion on the 2nd day of the dexamethasone-cyclophosphamide pulsed regime, the cycle is repeated every 4 weeks up to 6 cycles or till remission followed by oral cyclophosphamide Precautions: Myelosuppression, renal/hepatic impairment, elderly patients Adverse Reaction: Myelosuppression, syndrome of inappropriate ADH secretion, haemorrhagic cystitis, fibrosis of bladder, alopecia, nausea and vomiting, anorexia, diarrhoea, headache, rash, flushing of face. Adverse reactions with high doses of cyclophophamide include heart failure and interstitial pneumonitis Contraindications: Hypersensitivity to cyclophosphamide. Pregnancy, lactation Interactions: Doxorubicin, cimetidine, thiazide diuretics. Succinyl choline, halothane, nitrous oxide. Increased bone marrow depression with allopurinol, barbiturates, phenytoin, corticosteroids, chloramphenicol, interferon alfa. Radiotherapy, live vaccines -------------------------------------------------------------------------------------------------------------------------------------- 258 Cyclophosphamide 50 mg Tablet A Trade Name : Endoxan Indication : i) Solid tumours, leukaemia, lymphoma, autoimmune disorders, autoimmune bullous diseases, connective tissue disease, pyoderma gangrenosum ii) For severe lupus nephritis (Class III & IV), systemic vasculitis and steroid resistant/dependent nephrotic syndrome iii) Systemic lupus erythematosus (SLE), rheumatoid arthritis, polyarteritis nodosa, wegener granulomatosis Dosage : i) Solid tumours, leukaemia, lymphoma, autoimmune disorders, autoimmune bullous diseases, connective tissue disease, pyoderma gangrenosum ii) For severe lupus nephritis (Class III & IV), systemic vasculitis and steroid resistant/dependent nephrotic syndrome iii) Systemic lupus erythematosus (SLE), rheumatoid arthritis, polyarteritis nodosa, wegener granulomatosis Precautions: Myelosuppression, renal/hepatic impairment, elderly patients Adverse Reaction: Myelosuppression, syndrome of inappropriate ADH secretion, haemorrhagic cystitis, fibrosis of bladder, alopecia, nausea and vomiting, anorexia, diarrhoea, headache, rash, flushing of face Contraindications: Hypersensitivity to cyclophosphamide. Pregnancy, lactation Interactions: Doxorubicin, cimetidine, thiazide diuretics. Radiotherapy, live vaccines. Succinyl choline, halothane, nitrous oxide. Increased bone marrow depression with allopurinol, barbiturates, phenytoin, corticosteroids, chloramphenicol, interferon alfa -------------------------------------------------------------------------------------------------------------------------------------Cytarabine 100 mg Injection A Trade Name : Cytosar Indication : i) Central nervous system lymphoma ii) Meningeal leukemia iii) Non Hodgkin's Lymphoma iv) High dose cytarabine as conditioning to cytoreduce the disease before stem cell transplant for relapsed or refractory leukemia v) As salvage for acute lymphocytic leukemia vi) As salvage for acute myeloid leukemia vii) As palliative chemotherapy in elderly acute myeloid leukemia/ myelodysplastic syndrome Dosage : Standard doses 100 - 200 mg/m2 daily over 5 - 10 days. Higher doses for intensification/consolidation: 1000 - 3000 mg/m2 daily over 3 - 5 days depending on specific protocols. CHILD: Dose variable depending on disease and protocol. Range from 100 mg/m2 to 3 g/m2 twice daily. May be given as SC, IV bolus or infusion. Intrathecal dose: Less than 1 year: 15 mg, 1 - 2 years: 20 mg, 2 - 3 years: 25 mg, more than 3 years: 30 mg. (ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE) Precautions: Renal and hepatic impairment. Patients over 50 years old (for high dose therapy), pregnancy and lactation. Pre-existing drug-induced bone marrow suppression, leukocyte and platelet counts should be monitored daily, bone marrow examinations should be performed periodically, hepatic impairment, women of childbearing age, infants, severe gastrointestinal, central nervous system and pulmonary toxicity when using high dose schedules Adverse Reaction: Myelosuppression, alopecia, fever, mucositis, nausea and vomiting, rash, neurotoxicity, headache, dizziness, somnolence, photophobia, cerebellar toxicity, pneumonitis, pulmonary oedema, conjunctivitis, hepatic dysfunction 259 Contraindications: Hypersensitivity to cytarabine products. Pregnancy, lactation Interactions: Increased cytotoxicity when radiotherapy, alkylating agents, methotrexate and purine analogues are given together with cytarabine. Increased ototoxicity if used concurrently with cisplatin -------------------------------------------------------------------------------------------------------------------------------------Dacarbazine 100 mg Injection A* Indication : i) Malignant melanoma, sarcomas, neuroblastomas and other childhood solid tumours ii) Hodgkin's Disease Dosage : i) 250 mg/m2 for 5 days, may be repeated every 3 weeks ii) 375 mg/m2 IV every 2 weeks Precautions: Renal or hepatic impairment, bone marrow depression. Pregnancy. Avoid extravasation Adverse Reaction: Nausea, vomiting, myelosuppression, flu-like symptoms, alopecia, rash, photosensitivity, vesicant, paresthesias, ataxia, lethargy, headache, confusion, seizures, anaphylactic reactions, elevation of liver enzymes Contraindications: Hypersensitivity to dacarbazine products, pregnancy, lactation Interactions: Drugs that induce hepatic P450 enzymes (eg phenobarbital, phenytoin) may lead to decreased efficacy. Increased risk of infection by the live vaccine ------------------------------------------------------------------------------------------------------------------------------------Daunorubicin HCl 20 mg Injection A* Trade Name : Cerubidin Indication : i) Acute myeloblastic leukaemia (AML) ii) Acute lymphoblastic leukemia (ALL) Dosage : i) 45 - 60 mg/m2 IV daily for 3 - 5 days ii) 25 - 45 mg/m2 once a week for first 4 weeks during induction phase. Caution: Total cumulative dose of daunorubicin and doxorubicin must not exceed 500 mg/m2 due to risk of cardiotoxicity. CHILD: 30-45 mg/m2/dose infusion over 6 hours. Schedule depends on protocol. Need to check cardiac function closely by echocardiography every cumulative dose of 100mg/m2 to max. 360 mg/m2 Precautions: Hepatic impairment. Previous radiotherapy to chest. Avoid extravasation Adverse Reaction: Alopecia, radiation recall reactions. Hyperpigmentation of nails. Myelosuppression. Nausea, vomiting, mucositis, diarrhoea, hepatic/renal impairment, discolouration of urine. ECG abnormalities, congestive cardiac failure Contraindications: Hypersensitivity to daunorubicin. Pregnancy, lactation, pre-existing myelosupression, congestive cardiac failure, arrhythmias or previous treatment with high cumulative doses of anthracyclines Interactions: Increased risk of infection by live vaccines, azidamfenicol, chloramphenicol, ciclosporin ------------------------------------------------------------------------------------------------------------------------------------- 260 Docetaxel 20 mg/0.5 ml Injection A* Trade Name : Taxotere Indication : i)Adjuvant treatment of patients with high risk node-positive breast cancer in combination with doxorubicin and cyclophosphamide ii) Breast cancer, locally advanced or metastatic, not previously on cytotoxic therapy, in combination with doxorubicin iii) First line therapy in non small cell lung cancer in stage 3- 4 and performance status 0 ? 1, in combination with cisplatin iv) Inoperable locally advanced squamous cell carcinoma of head and neck, in combination with cisplatin and 5-FU for induction treatment v) Prostate cancer, in combination with prednisolone Dosage : i) 75 mg/m2 IV over 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles ii) 75 mg/m2 IV over 1 hour every 3 week in combination with doxorubicin 50 mg/m2 iii) Administer IV over 1 hour every 3 weeks. Chemotherapy-naive patients 75 mg/m2 immediately followed by 75 mg/m2 cisplatin over 30-60 mins or carboplatin (AUC 6 mg/mL/min) over 30-60 minutes. Monotherapy of non small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy 75 mg/m2 iv) 100 mg/m2 IV over 1 hour every 3 weeks v) 60-75 mg/m2 IV over 1 hour every 3 weeks, administer with oral prednisolone 5 mg twice daily given continuously Precautions: All patients should receive premedication with corticosteroids against hypersensitivity reactions. Monitor blood counts, liver function tests. Avoid extravasation Adverse Reaction: Fluid retention syndrome, hypersensitivity reactions. rash, alopecia, oedema, peripheral neuropathy, myelosuppression, elevation of liver enzymes, nausea, vomiting, stomatitis, diarrhoea, fatigue, weakness, paroxysmal atrial tachycardia, atrial flutter, dysrrhythmia, hypertension and heart failure Contraindications: Hypersensitivity to docetaxel or Polysorbate 80, neutrophil count less than 1500 cells/mm³. Severe liver impairment. Pregnancy and lactation Interactions: Increased risk of infection by the live vaccine. Drugs which affect liver cytochrome P450 enzyme system may affect the antitumour and toxic effects of docetaxel. Less toxicity if taxanes given before platinum compounds if combination of taxane and platinum is used -------------------------------------------------------------------------------------------------------------------------------------Doxorubicin HCl 50 mg Injection A Trade Name : Adriamycin Indication : i) Solid tumours, leukaemia, non-Hodgkin's lymphoma ii) Leukaemia (ALL induction) iii) Multiple myeloma Dosage : i) 30 - 75 mg/m2 IV as a single dose at 21 day intervals ii) 25 - 45 mg/m2 once a week for the first 4 weeks during induction or re-induction phase (refer to specific protocol. Caution: Total cumulative dose of doxorubicin must not exceed 550 mg/m2 due to risk of cardiotoxicity. CHILD: 30 mg/m2/dose over 6 - 24 hours for 1 - 2 days. Need to check cardiac function closely by echocardiography every cumulative dose of 100 mg/m2 to maximum 360 mg/m2 iii) 9 mg/m2 over 24 hours infusion for 4 days at monthly intervals Precautions: Cardiac failure, heart disease, hypertension. Previous radiotherapy to chest, elderly. Avoid in pregnancy and lactation. Avoid extravasation 261 Adverse Reaction: Alopecia, myelosuppression, mucositis, diarrhoea, hyperpigmentation of skin and nails, arrhythmias, congestive heart failure, nausea, vomiting, discolouration of urine, palmar-plantar erythrodysethesia, pericardial effusion, cardiomyopathy, radiation recall reactions, second malignancy Contraindications: Hypersensitivity to doxorubicin, marked myelosuppression induced by previous chemotherapy or radiotherapy. Previous treatment with tolerance doses of anthracyclines, significantly impaired cardiac function, angina pectoris, cardiac arrhythmias or recent myocardial infarction. Interactions: Live vaccines, phenytoin, radiation therapy, mitomycin C, 6-mercaptopurine, cyclophosphamide, 5fluorouracil, ciclosporin, digoxin, paclitaxel, phenobarbital, trastuzumab, stavudine, zidovudine -------------------------------------------------------------------------------------------------------------------------------------Epirubicin 50 mg Injection A* Trade Name : Adriamycin Indication : Breast cancer, Non-Hodgkin's lymphoma, Leukaemia (ALL induction), gastric cancer, ovarian cancer Dosage : 60 - 100 mg/m2 body area injected IV in 3 - 5 min, repeated at 21 day intervals. CHILD: 50 mg/m2 over 6 hours. Schedule depends on protocol Precautions: Pre-existing cardiac disease, renal or liver impairment, previous radiotherapy, elderly patients. Avoid extravasation. Avoid cumulative doses beyond 900 mg/m2 Adverse Reaction: Myelosuppression, leukopenia, thrombocytopenia, nausea, vomiting, cardiotoxicity (arrhythmias, conduction disturbances, myopericarditis syndrome, dilated cardiomyopathy, congestive cardiac failure), alopecia, mucositis, vesicant, rash, hyperpigmentation of skin and nails, radiation recall reaction, discolouration of urine Contraindications: Hypersensitivity to anthracyclines, severe cardiac impairment, recent myocardial infarct, severe liver dysfunction, pregnancy, lactation Interactions: Paclitaxel and other anthracyclines, Cimetidine, cyclophophamide, 5-fluorouracil, heparin, live vaccines, trastuzumab, zidovudine ------------------------------------------------------------------------------------------------------------------------------------Etoposide 100 mg/5 ml Injection A* Trade Name : Vepesid Indication : i) For treatment of children with solid tumours, juvenile myelomonocytic leukemia (JMML) and Langerhan cell histiocytosis ii) Leukaemia, lymphoma iii) Testicular cancer, lung cancer, gestational trophoblastic disease, gastric cancer, sarcoma Dosage : i) CHILD: 60-120 mg/m2/day by IV for 3 - 5 days every 3 - 6 weeks depending on protocols ii) Maintenance or palliative chemotherapy for elderly acute myeloid leukemia, consolidation therapy for acute lymphoblastic leukemia, stem cell mobilization (Refer to protocol) iii) 100 mg/m2 by IV every other day for 3 doses repeated every 3-4 weeks 262 Precautions: Use with caution in hepatic or renal impairment, myelosuppression. Administer intravenously over 30 to 60 minutes to reduce risk of hypotension. Anaphylaxis following IV administration to be anticipated and treated appropriately Adverse Reaction: Myelosuppression, nausea and vomiting, alopecia, hypersensitivity reaction, local inflammatory reaction at site of injection, radiation recall reaction, secondary malignancy Contraindications: Hypersensitivity to podophyllins, severe hepatic dysfunction, pregnancy, lactation Interactions: Ciclosporin, calcium antagonists, methotrexate, warfarin. Increased risk of infection by the live vaccine ----------------------------------------------------------------------------------------------------------------------------------Fluorouracil 250 mg/5 ml Injection A* Trade Name : 5-FU Indication : Cancers of gastro-intestinal tract, breast and pancreas, head and neck. Ophtalmological indication: trabeculectomy Dosage : 500 - 600 mg/m2 IV in combination with other cytotoxic agents, repeated every 3 weeks or 300 - 450 mg/m2 IV slow bolus daily for 5 days in combination with biological response modifiers, repeated every 4 weeks or 3000 - 3750 mg/m2 as a continuous infusion over 5 days in combination with a platinum compound every 3 to 4 weeks Precautions: Caution in ischaemic heart disease, renal or hepatic dysfunction, elderly. Previous pelvic irradiation, previous treatment with alkylating agents. Discontinue upon development of unexpected grade 3 or 4 stomatitis, oesophagopharyngitis, diarrhoea, myelosuppression or neurologic toxicities Adverse Reaction: Myelosuppression, mucositis, pigmentation of infused vein, somnolence, confusion, ataxia, fits, encephalopathy, changes in ECG, chest pain, nausea and vomiting, diarrhoea, photosensitivity, hand foot syndrome Contraindications: Hypersensitivity to fluorouracil, pregnancy, lactation Interactions: Leucovorin, warfarin, methotrexate, thymidine ----------------------------------------------------------------------------------------------------------------------------------Gemcitabine HCl 1 g Injection A* Trade Name : Gemzar Indication : i) Locally advanced or metastatic non-small cell lung cancer ii) Locally advanced or metastatic pancreatic cancer iii) In combination with carboplatin in the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed more than six months, following platinum-based therapy iv) In combination with paclitaxel for treatment of patients with metastatic breast cancer who have relapsed following adjuvant/ neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated Dosage : i) Alone or with cisplatin: 1000 mg/m2 day 1 & 8 every 3 weeks or 1000 mg/m2 day 1, day 8, day 15 every 4 weeks ii) Initially 1000 mg/m2 weekly for 7 weeks followed by 1 week rest. Subsequent cycles 1000 mg/ m2 weekly for 3 weeks followed by 1 week rest iii) Gemcitabine 1000 mg/m2 as 30 263 minutes IV infusion day 1 & 8 of each 21-day cycle followed by carboplatin on day 1 to attain a target AUC of 4 mg/ml/minute iv) 1250 mg/m2 on days 1 and 8 of each 21-day cycle with paclitaxel 175 mg/m2 given as a 3-hour infusion before gemcitabine on day 1 of each 21-day cycle Precautions: Caution in hepatic dysfunction, myelosuppression, renal impairment. Avoid prolonging infusion times more than 60 minutes Adverse Reaction: Flu-like symptoms, proteinuria, nausea, vomiting, myelosuppression, oral soreness, rash, pruritus, elevation of liver enzymes, haematuria, dyspnoea, allergic reactions, myalgia, alopecia, diarrhoea, haemolytic uraemic syndrome, adult respiratory distress syndrome Contraindications: Hypersensitivity to gemcitabine. Pregnancy, lactation Interactions: Increased risk of infection by live vaccines. Cisplatin, etoposide, radiotherapy --------------------------------------------------------------------------------------------------------------------------------Idarubicin 10 mg Injection A* Trade Name : Zavedos Indication : i) Acute promyelocytic leukaemia ii) Relapse Acute myeloid leukemia (with sibling match) iii) Acute myeloid leukemia, acute lymphoblastic leukemia (salvage therapy) Dosage : i) Induction phase: 12 mg/m2 IV slow bolus on Days 3, 5 and 7. Consolidation phase, month 1: 12 mg/m2 IV on Days 1 and 2. Repeat monthly for 3 courses ii) 12 mg/m2 D1-3 iii) 12 mg/m2 D1-3 as part of FLAG-IDA regimen Precautions: Risk for cardiotoxicity increased in elderly, hypertension, heart disease, previous treatment with anthracyclines, previous chest radiotherapy. Cumulative doses more than 150 mg/m2 are associated with decreased left ventricular ejection fraction. Monitor cardiac function. Caution against sun exposure. Avoid extravasation. Anticipate and prevent tumour lysis syndrome. Caution with abnormal liver function tests Adverse Reaction: Cardiotoxicity, myelosuppression, nausea, vomiting, diarrhoea, mucositis, alopecia, rash, photosensitivity, hyperpigmentation, vesicant, discolouration of urine, leukopenia, thrombocytopenia Contraindications: Hypersensitivity to idarubicin and other anthracyclines. Pregnancy, lactation, cardiac impairment, renal and hepatic impairment Interactions: Probenecid, sulfinpyrazone, heparin. Live vaccine, other myelosuppressants, azidamfenicol, chloramphenicol, ciclosporin, trastuzumab -------------------------------------------------------------------------------------------------------------------------------Ifosfamide 1 g Injection A* Trade Name : Holoxan Indication : i) Solid tumours ii) Leukaemia iii) Lymphoma Dosage : i) 1.2 - 2.4 g/m2/day for 3 - 7 days as a 30 - 120 minutes infusion. Alternatively, can also be given as a single high dose, eg. 5 g/m2 in a 24 hour infusion. Cycles may be repeated every 3 - 4 weeks ii) CHILD: 400 - 3000 mg/m2/day for 3 - 5 days according to protocol iii) Refer to protocols 264 Precautions: Brain metastases, electrolyte imbalance, hepatic and renal impairment. Hydration required. Renal function should be checked prior to administration. Co-administration with mesna, which is a urothelial protective agent is mandatory Adverse Reaction: Alopecia, myelosuppression, nausea and vomiting, diarrhoea, mucositis, transient abnormalities of liver enzymes, acute hepatocellular injury (not common at standard doses), erythematous rash, pruritis, pigmentary changes, photosensitivity, acute renal failure (high dose), headache, drowsiness, dizziness, encephalopathy/ acute confusion (high dose) Contraindications: Hypersensitivity to ifosfamide, pregnancy, lactation. Severe myelosupression Interactions: Phenobarbital, carbamazepine, phenytoin -------------------------------------------------------------------------------------------------------------------------------------Irinotecan HCl Trihydrate 100 mg/5ml Injection A* Trade Name : Campto Indication : Only for patients with colorectal cancer who: i) have relapsed within 6 months after the end of adjuvant chemotherapy with 5-fluorouracil-based regime ii) have progressive disease despite 5fluorouracil chemotherapy for advanced disease iii) good performance status (WHO of 2 or less) The treatment must be given in a tertiary oncology centre or have clearance in writing by an oncologist Dosage : In combination therapy (for previously untreated patients): 180 mg/m2 once every 2 weeks as an IV infusion over 90 mins followed by infusion with folinic acid and 5-fluorouracil. In monotherapy (for previously treated patients): 350 mg/m2 administered as an intravenous infusion over 90 minutes period once every 3 weeks Precautions: Diarrhoea (early or late) must be treated adequately with delay of subsequent cycle until recovery. Antiemetic premedication is recommended. Avoid extravasation. Caution with myelosuppression. Patients over 65 years old, patients who have previously received pelvic / abdominal radiation and with poor performance status have increased risk of bone marrow suppression and diarrhoea, neutopenia: may lead to sepsis and death Adverse Reaction: Myelosuppression, diarrhoea (early or late), nausea, vomiting, alopecia, dyspnoea, weakness, hypotension, acute renal failure, colitis Contraindications: Hypersensitivity to irinotecan, pregnancy and lactation, inflammatory bowel disease, bowel obstruction, plasma bilirubin concentration 1.5 times the upper limit of reference range Interactions: Increased risk of infection by the live vaccine, diuretics increase risks of dehydration secondary to vomiting/diarrhea, prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia, prochlorperazine may increase incidence of akathisia, antineoplastic agents (myelosuppression and diarrhoea) -------------------------------------------------------------------------------------------------------------------------------------L-Asparaginase 10,000 IU Injection Trade Name : Leunase Indication : i) Acute lymphoblastic leukemia ii) Non-hodgkin's lymphoma 265 A* Dosage : i) 5,000 iu/m2 for 10 days during induction, 10,000 iu/m2 also used with high dose methotrexate rescue in consolidation phase of acute lymphoblastic leukemia ii) CHILD: 5,000 - 25,000 iu/m2 per dose depending on protocol Precautions: Haematologic, renal and hepatic dysfunction, pregnancy. Monitor for severe allergic reactions, caution in underlying coagulopathy and lactation Adverse Reaction: Hypersensitivity reactions (urticaria, chills, fever, anaphylaxis), hyperglycaemia, lethargy, depression, confusion, coagulopathy, anorexia, mild nausea and vomiting, acute pancreatitis, coma, myelosuppression (usually mild), hepatic dysfunction, renal dysfunction, somnolence, hallucination, central nervous system disturbances including depression, coma, transient bone-marrow depression Contraindications: Hypersensitivity to L-Asparaginase, history of pancreatitis Interactions: Vincristine, cyclophosphamide, methotrexate, steroids, live vaccine -------------------------------------------------------------------------------------------------------------------------------------Melphalan 2 mg Tablet A Trade Name : Alkeran Indication : i) Multiple myeloma ii) Neuroblastoma, rhabdomyosarcoma iii) Recurrent neuroblastoma (palliative) Dosage : i) 8 - 10 mg/m2 for 4 days every 4 weeks ii) 10 - 35 mg/m2 once every month For dose regimes, refer to protocols Precautions: Use with caution in renal impairment and elderly. Dose adjustment with blood count. To be taken on empty stomach 1 hour before or 2 hours after meals Adverse Reaction: Bone marrow depression, mild gastrointestinal effects, diarrhoea, pulmonary fibrosis, interstitial pneumonitis, alopecia, syndrome of inappropriate ADH secretion, secondary malignancy Contraindications: Lactation, pregnancy, hypersensitivity to melphalan, severe myelosuppression Interactions: Ciclosporine, steroid, cimetidine -------------------------------------------------------------------------------------------------------------------------------------Mercaptopurine 50 mg Tablet A Trade Name : Puri-Nethol Indication : i) Langerhan's cell histocytosis ii) Acute lymphoblastic leukaemia iii) Acute promyelocytic leukaemia APML (maintenance) Dosage : ADULT: Maintenance therapy: 60 - 75 mg/m2 body surface area once daily. Adjust doses depending on peripheral blood counts. CHILD: 2.5 mg/kg body weight or 25 - 100 mg/m2 body surface area once daily according to protocol. Refer to protocols Precautions: Dose reduction with an abnormal liver or renal function. Myelosuppression (temporarily discontinue treatment with an abnormally large fall in any formed blood element), inherited deficiency of the enzyme thioguanine methyltransferase (TPMT), hepatotoxicity, reduce dosage when administered with allopurinol, pregnancy. Take on an empty stomach 266 Adverse Reaction: Bone marrow depression, nausea and vomiting, hepatotoxicity, rash, hyperpigmentation, hyperuricaemia Contraindications: Lactation, pregnancy, severe bone marrow suppression, severe liver disease, hypersensitivity to mercaptopurine Interactions: Allopurinol, methotrexate, warfarin, decreased anticoagulant effectiveness, sulfasalazine ----------------------------------------------------------------------------------------------------------------------------------Methotrexate 2.5 mg Tablet A Indication : i) Acute lymphoblastic leukaemia and acute promyelocytic leukemia (maintenance) ii) Extensive plaque psoriasis, erythrodermic psoriasis, pustular psoriasis, Reiter's syndrome, connective tissue disease Dosage : i) ADULT: 20 mg/m2 weekly. CHILD: 20 - 30 mg/m2 weekly according to protocol ii) Relapsed acute lymphoblastic leukaemia (ALL): 100 mg/m2/day for 5 days 6 weekly according to protocol iii) Dose used by dermatologist: 5 - 25 mg weekly. Liver biopsy after cumulative dose of 1.5 gram and repeat liver biopsy with additional gram received. Maximum cumulative dose is 4 gram. Monitor full blood count (FBC), renal and liver function iv) Rheumatoid arthritis, psoriatic arthropathy: dose used by rheumatologist: 2.5 mg/week orally starting dose, increasing to 7.5 - 20 mg/weekly Precautions: Impaired renal function, pleural effusion, ascitis, poor nutritional status, myelosuppression, acute or chronic hepatotoxicity (elevated transaminases, fibrosis, cirrhosis), pulmonary toxicity (dry cough, pneumonitis), nephrotoxicity with high-dose therapy, patients with a creatinine clearance of less than 60 ml/minute should not receive high-dose methotrexate, high-dose or intrathecal methotrexate therapy must not be formulated with diluents containing preservatives, women of child-bearing potential, gastrointestinal toxicity (vomiting, diarrhoea, stomatitis), tumour lysis syndrome in patients with rapidly growing tumors, severe and sometimes fatal skin reactions, potentially fatal infections (especially Pneumocystis carinii pneumonia), neurotoxicity (leukoencephalopathy, seizures), high-dose methotrexate therapy will generally require the use of leucovorin rescue, care should be taken in handling the body fluids of persons receiving antineoplastic agents Adverse Reaction: Myelosuppression, nausea, vomiting, diarrhoea, mucositis, transient abnormalities in serum levels of liver enzymes, acute hepatocellular injury (not common at standard dose), erythematous rash, pruritis, pigmentary changes, photosensitivity, acute renal failure (high dose), headache, drowsiness, dizziness, acute confusion (high dose), interstitial pneumonitis, myelosuppression, interstitial pneumonitis Contraindications: Pregnancy, lactation, severe myelosuppression, serious renal and liver impairment, increase risk of toxicity in the presence of third space fluid (pleural effusion, ascites) Interactions: Alcohol, aminophenazone, amiodarone, amitriptyline, antibiotics, cisplatinum, ciclosporin, cytosine arabinoside, diclofenac, etoposide, etretinate, 5-fluorouracil, NSAIDs, salicylates, nephrotoxic drugs, sulfonamides, tetracyclines, teniposide, warfarin, folic acid ----------------------------------------------------------------------------------------------------------------------------------- 267 Methotrexate 50 mg Injection A Indication : i) Solid tumours ii) Gestational trophoblastic disease iii) Acute leukaemia/lymphomas iv) Rheumatoid arthritis, psoriatic arthropathy, severe/erythrodermic psoriasis Dosage : i) 50 mg/m2 once every 2 - 3 weeks in combination with other drugs ii) 50 mg IV Day 1, 3, 5, 9 every 3 weeks. For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime iii) High dose regimes: 500 - 3000 mg/m2 per dose may be used, employing the 500 mg preparations. CHILD: Central nervous system prophylaxis for acute leukaemia 2 gm/m2 over 24 hours with folinic acid rescue, 3 doses for B-cell lineage. 4 doses for T-lineage all every 3 weeks. Relapse acute lymphoblastic leukaemia (ALL): 1 gm/m2 over 36 hours with folinic acid rescue every 3 weeks for 9 doses, maintenance: 50 mg/m2 every 2 weeks. B-cell lymphoma: 3 gm/m2 over 3 hours with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. The 500 mg strength is not for intrathecal (IT) use. Dosage for intrathecal treatment and prophylaxis in leukaemia: less than 1 year: 5 mg, 1 - 2 years: 7.5 mg, 2 - 3 years: 10 mg, more than 3 years: 12.5 mg. IT preparation must be clearly stated/verified. ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE iv) Dose used by rheumatologist: 10 - 15 mg IM injection or oral weekly. Dose used by dermatologist: 10 - 25 mg IM injection weekly Precautions: Patients with a creatinine clearance of less than 60 ml/minute, impaired renal function, pleural effusion, ascitis and poor nutritional status should not receive high-dose methotrexate. High-dose or intrathecal methotrexate therapy must NOT be formulated with diluents containing preservatives. High-dose methotrexate therapy requires the use of leucovorin rescue. Myelosuppression, acute or chronic hepatotoxicity (elevated transaminases, fibrosis, cirrhosis), pulmonary toxicity (dry cough, pneumonitis). Women of child-bearing potential, gastrointestinal toxicity (vomiting, diarrhoea, stomatitis), tumour lysis syndrome in patients with rapidly growing tumors, severe and sometimes fatal skin reactions, potentially fatal infections (especially pneumocystis carinii pneumonia), neurotoxicity (leukoencephalophathy, seizures), care should be taken in handling the body fluids of persons receiving antineoplastic agents Adverse Reaction: Myelosuppression, nausea, vomiting, diarrhoea, mucositis, transient abnormalities in serum levels of liver enzymes, acute hepatocellular injury (not common at standard dose), erythematous rash, pruritis, pigmentary changes, photosensitivity, acute renal failure (high dose), headache, drowsiness, dizziness, acute confusion (high dose), interstitial pneumonitis, myelosuppression, interstitial pneumonitis Contraindications: Pregnancy, lactation, severe myelosuppression, serious renal and liver impairment, increase risk of toxicity in the presence of third space fluid (pleural effusion, ascites) Interactions: Alcohol, aminophenazone, amiodarone, amitriptyline, antibiotics, cisplatinum, ciclosporin, cytosine arabinoside, diclofenac, etoposide, etretinate, 5-fluorouracil, NSAIDs, salicylates, nephrotoxic drugs, sulfonamides, tetracyclines, teniposide, warfarin, folic acid -------------------------------------------------------------------------------------------------------------------------------------Mitomycin-C 10 mg Injection A* Trade Name : Mitomycin-C Indication : i) Gastrointestinal, lung, breast, cervical cancers ii) Bladder tumours iii) Opthalmological conditions: conjunctival squamous neoplasia, squamous cell carcinoma of conjunctiva, trabeculectomy chronic lymphocytic leukaemia, chronic myelogenous leukaemia. Gastric, colorectal, lung cancer 268 Dosage : i) 10 - 20 mg/m2 body surface area (BSA) given as a single dose through a running IV infusion repeated every 6 - 8 weeks. The whole schedule may be repeated depending on the bone marrow ii) 10 - 40 mg daily or every other day (intravesical) iii) 0.4 mg topically as a single application for opthalmological conditions, duration: 1 to 3 minutes Precautions: Bleeding tendency, radiotherapy, extravasation, hepatic dysfunction, myelosuppression, renal impairment Adverse Reaction: Nephrotoxicity, delayed myelosuppression, nausea and vomiting, alopecia, congestive heart failure, fever, haemolytic uraemic syndrome-risk increase when cumulative dose more than 50 mg/m2, interstitial pneumonitis Contraindications: Thrombocytopenia, coagulation disorders, pregnancy, lactation, hypersensitivity to mitomycin, hepatotoxicty Interactions: Vinblastine, vince alkaloids may increase risk of cardiotoxicity when given together with mitomycin C ---------------------------------------------------------------------------------------------------------------------------------Mitoxantrone 20 mg/10ml Injection A* Trade Name : Novantrone Indication : Acute leukaemia, elderly patients with acute myeloid leukaemia (AML), relapsed/resistant acute leukaemia, non-Hodgkin's lymphoma (NHL) Dosage : 10 - 12 mg/m2 IV daily for 3 days, in combination with other cytotoxic agents. Refer to protocol. CHILD: 5 - 10 mg/m2 daily for 3 - 5 days according to protocol. Treatment of acute leukaemia, ADULT: 8 - 12 mg/m2/day once daily for 4 - 5 days. CHILD more than 2 years: same as adult dose. CHILD 2 years: 0.4 mg/kg/day once daily for 3 - 5 days Precautions: Myelosuppression or poor general condition in cases with functional cardiac changes including congestive heart failure and decrease in left ventricular ejection fraction, hepatic insufficiency, children, pregnancy, lactation Adverse Reaction: Myelosuppression, nausea, vomiting, stomatitis, alopecia, hepatotoxicity, congestive cardiac failure, constipation, diarrhoea, arrhythmias, discolouration of urine and other secretions, alopecia, secondary malignancy, fatigue, fever, headache, amenorrhoea, abdominal pain, acute myeloid leukaemia, myelodysplasia of the spinal cord Contraindications: Hypersensitivity to mitoxantrone products, pregnancy, lactation, severe myelosuppression, cardiac dysfunction Interactions: Increased risk of infection by the live vaccine, trastuzumab -------------------------------------------------------------------------------------------------------------------------------------Oxaliplatin 50 mg Injection A* Trade Name : Eloxatin Indication : Only for patients with colorectal cancer who: i) have relapsed within 6 months after the end of adjuvant chemotherapy with 5-fluorouracil-based regime ii) have progressive disease despite 5- 269 fluorouracil chemotherapy for advanced disease iii) good performance status (WHO of 2 or less). The treatment must be given in a tertiary oncology centre or have clearance in writing by an oncologist Dosage : 85 mg/m2 IV repeated every 2 weeks Precautions: Presence or history of peripheral neuropathy, pre-existing renal or hepatic impairment, significant bone marrow suppression may cause pulmonary fibrosis, avoid extravasation Adverse Reaction: Anaphylactic, anaemia, dyspnoea, febrile neutropenia, thrombocytopenia, fatigue, fever, nausea, diarrhoea, colitis, increased liver enzymes, dyspnoea Contraindications: Hypersensitivity to oxaliplatin, pregnancy, lactation, bone marrow suppression, hepatic impairment Interactions: Drugs with potential neurological toxicity, docetaxel, paclitaxel, aminoglycosides -----------------------------------------------------------------------------------------------------------------------------------Paclitaxel 30 mg/5 ml Injection A* Trade Name : Taxol / Anzatax Indication : i) Treatment of recurrent breast cancer, after failure of anthracycline-based chemotherapy ii) Primary adjuvant therapy in advanced ovarian cancer in combination with cisplatin iii) Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in chemonaive patients in combination with platinum compounds Dosage : i) 175 mg/m2 IV over 3 hours every 3 weeks ii) 175 mg/m2 IV over 3 hour followed by cisplatin 75 mg/m2 in every 3 weeks or 135 mg/m2 IV over 24 hours followed by cisplatin 75 mg/m2 every 3 weeks iii) 135 mg/m2 IV over 24 hours followed by cisplatin 75 mg/m2 every 3 weeks Precautions: Severe neutropenia, severe hepatic impairment. Caution in patients with ischaemic heart disease, myocardial infarction and conduction defects. Taxane to be given first when used in combination with platinum analogue to avoid myelosuppression. Increased risk of infection by live vaccines Adverse Reaction: Alopecia, myelosuppression, severe neutropenia, peripheral neuropathy, arrhythmias, hypotension, hypersensitivity reactions, arthralgia, myalgia Contraindications: History of hypersensitivity reaction to paclitaxel or polyoxyethylated castor oil (Cremophor EL) or any component of preparation. Pregnancy, lactation Interactions: Doxorubicin, live vaccines, phenytoin, ketoconazole, St John's Wort -------------------------------------------------------------------------------------------------------------------------------------Vinblastine Sulphate 10 mg Injection A Trade Name : Velbe Indication : Hodgkin's disease, choriocarcinoma resistant to other chemotherapeutic agents, non-small cell lung cancer, Langerhans cell histiocytosis Dosage : ADULT: Lung cancer - 6 mg/m2 (maximum 10 mg) on Day 1. Hodgkin's disease- refer to protocol. CHILD: Usual weekly dose: 6 mg/m2 weekly or 3 weekly depending on protocol 270 Precautions: Intrathecal administration can be fatal. Should not be injected into an extremity with impaired circulation. Patients carefully monitored for infection until white cell count has return to normal levels if leukopenia with less than 2000 white blood cells per mm3 occurs following dose Adverse Reaction: Myelosuppression, nausea, vomiting, anorexia, generalized fatigue, constipation, alopecia, dermatitis, vesicant, neurotoxicity, syndrome of inappropriate secretion of anti-diuretic hormone Contraindications: Hypersensitivity to vinblastine. Pregnancy, lactation. Leukopenia, presence of bacterial infection Interactions: Mitomycin C, phenytoin. Drugs which inhibit cytochrome P450 enzymes, voriconazole, itraconazole -------------------------------------------------------------------------------------------------------------------------------------Vincristine Sulphate 1 mg Injection A Trade Name : Oncovin Indication : i) Solid tumours ii) Gestational trophoblastic disease iii) Non-Hodgkin's lymphoma iv) Multiple myeloma v) Acute lymphoblastic leukemia Dosage : i) ADULT: 1.4 mg/m2 weekly (maximum 2 mg weekly) ii) Refer to protocol iii) 1.4 mg/m2 weekly (maximum 2 mg weekly) iv) 0.4 mg/m2 IV continuous infusion on days 1 - 4 v) Refer to protocol. CHILD: 1 mg/m2 to 2 mg/m2 weekly according to protocol (0.05 mg/kg for infants less than 10kg) Precautions: Pre-existing neuropathy or neuromuscular disease. Dose adjustment needed if impaired liver function, elderly patients. Avoid extravasation Adverse Reaction: Sensorimotor neuropathy, autonomic neuropathy (severe constipation, ileus, urinary retention and incontinence), cranial nerve dysfunction (hoarseness, diplopia, facial weakness), myelosuppression, alopecia. Vesicant, rash, abdominal pain, SIADH, hypersensitivity, pain in jaws, bone, limb or parotid gland, depression, confusion, nausea, vomiting, diarrhoea, myelosupression usually mild Contraindications: Hypersensitivity to vincristine. Pregnancy, lactation, Charcot-Marie-Tooth syndrome. Fatal if given intrathecally. NOT FOR INTRATHECAL USE Interactions: If used together with L-asparaginase, L-asparaginase should be given 12-24 hours after vincristine injection. Digoxin, paclitaxel, cisplatin, methotrexate, nifedipine, etoposide, isoniazid, melphalan, metronidazole, verapamil, phenytoin ------------------------------------------------------------------------------------------------------------------------------------Anastrozole 1 mg Tablet A* Trade Name : Arimidex Indication : Treatment of hormone responsive metastatic or locally advanced breast cancer after failure of tamoxifen Dosage : 1 mg daily Precautions: Hyperlipidemia, moderate to severe hepatic impairment, severe impairment of renal function (creatinine clearance less than 20 mL/min). Lowers circulating oestrogen levels which may cause a reduction in bone mineral density 271 Adverse Reaction: Hot flashes, asthenia, peripheral oedema, vaginal bleeding, deep vein thrombosis, arthralgia, backpain, cough, dypsnea, headache, nausea, rash, hypercholesterolaemia Contraindications: Hypersensitivity to anastrazole, pregnancy. Not indicated for premenopausal women Interactions: Oestrogens, tamoxifen ----------------------------------------------------------------------------------------------------------------------------------Letrozole 2.5 mg Tablet A* Trade Name : Femara Indication : i) Treatment of hormone responsive metastatic or locally advance breast cancer after failure of tamoxifen ii) Adjunct for node positive postmenopausal women with early breast cancer (positive or unknown oestrogen or positive progesterone receptor status / receptor status) who have received 5 years of adjuvant tamoxifen therapy Dosage : 2.5 mg once daily Precautions: Impaired liver function. Only to be used in postmenopausal women. Cirrhosis and severe hepatic dysfunction, risk of drug toxicity pregnancy, potential for maternal and fetal malformations Adverse Reaction: Headache, nausea, fatigue, arthralgia, musculoskeletal pain, hot flushes, facture of bone, heart failure, myocardial infarction Contraindications: Hypersensitivity to letrozole, pregnancy, lactation Interactions: Inhibitors of the cytochrome P450 enzymes, tamoxifen -------------------------------------------------------------------------------------------------------------------------------------Tamoxifen Citrate 20 mg Tablet A Trade Name : Nolvadex Indication : Breast cancer Dosage : 20-40 mg daily Precautions: Caution in patients with leukopenia, thrombocytopenia, retinopathy or with family/past history of hypercoagulable states or thromboembolic disease. Pelvic examination should be carried out for patients on long term use of tamoxifen Adverse Reaction: Menopausal symptoms, fluid retention, peripheral oedema, nausea, vomiting, myelosuppression, tumour flare, endometrial hyperplasia, polyps and small risk of endometrial cancer, visual disturbance including corneal changes, cataracts and retinopathy Contraindications: Hypersensitivity to Tamoxifen. Pregnancy and lactation, pulmonary embolus history, history of deep vein thrombosis 272 Interactions: Warfarin, allopurinol, ciclosporin, bromocriptine, rifampicin, clopidogrel, cyclophosphamide, fluorouracil, methotrexate, mitomycin, concurrent use with letrozole may result in reduced letrozole serum concentrations, aminoglutethimide may decrease tamoxifen plasma concentrations -------------------------------------------------------------------------------------------------------------------------------------Filgrastim (G-CSF) 30 MU/ml Injection A* Trade Name : Neupogen Indication : i) Reduction in the duration of neutropenia and incidence of febrile neutropenia in cytotoxic chemotherapy for malignancy except chronic myeloid leukemia and myelodysplastic syndrome ii) Haemopoeitic stem cell transplantation (HSCT)/stem cell harvesting Dosage : i) Adult: SC or IV 5 mcg/kg/day. Initiation: 24 - 72 hours after chemotherapy. Duration: Until a clinically adequate neutrophil recovery is achieved (absolute neutrophil count of at least 1 x 109/L on 2 consecutive days) ii) Refer to protocol Precautions: Secondary acute myeloid leukemia. Perform regular white blood cell, platelet and hematocrit count throughout therapy. Monitor ANC and spleen size. Bone marrow infiltrating infections or malignancy. Sickle cell disease. Pregnancy and lactation Adverse Reaction: Chest pain, fever, hypersensitivity reaction, alopecia. Bone pain, flu-like symptoms, nausea and vomiting, adult respiratory distress syndrome, sickle cell crisis, hepatomegaly, splenic enlargement, transient hypotension, epistaxis urinary abnormalities (dysuria, proteinuria, hematuria), exacerbation of rheumatoid arthritis, thrombocytopenia, anemia raised uric acid Contraindications: Hypersensitivity to filgrastim, severe congenital neutropenia (Kostmann's syndrome) with abnormal cytogenetics Interactions: Vincristine, topotecan, lithium -------------------------------------------------------------------------------------------------------------------------------------Imatinib Mesylate 100 mg Tablet A* Imatinib Mesylate 400 mg Tablet A* Trade Name : Glivec Indication : i) ADULT and CHILD: Philadelphia positive (Ph+) chronic myeloid leukaemia in chronic phase and in early acceleration after failure of interferon therapy ii) Treatment of patients with unresectable and or metastatic, malignant gastrointestinal stromal tumours (GIST) who are positive for CD117/c-kit Dosage : i) ADULT: Chronic phase chronic myeloid leukemia: 400 mg once daily. Accelerated phase or blast crisis chronic myeloid leukemia: 600 mg once daily. CHILD more than 2 years, chronic myeloid leukemia: 340 mg/m2 daily. Max: 60 mg/day ii) Unresectable and or metastatic, malignant gastrointestinal stromal tumours GIST: 400 mg/day Precautions: Hepatic or severe renal impairment. History of cardiac disease. Severe fluid retention may occur. It is recommended that patients be weighed regularly. Regular monitoring of complete blood counts and liver function tests. Children less than 3 year. Pregnancy, lactation (avoid) Adverse Reaction: Myelosuppression, gastrointestinal disturbances, eczema, rash, myalgia, arthralgia, fluid retention, pneumonia, cardiac failure and hepatic failure, gynaecomastia (due to reduced testosterone), vomiting, nausea 273 Contraindications: Hypersensitivity to imatinib or any component of the product. Avoid pregnancy and lactation Interactions: Alfuzosin, aprepitant, carbamazepine, dexamethasone, ketoconazole, levothyroxine, phenobarbital, phenytoin, rifampin, simvastatin, St John's Wort, warfarin, ciclosporin and paracetamol ----------------------------------------------------------------------------------------------------------------------------------Leucovorin Calcium (Calcium Folinate) 50 mg Injection A Trade Name : Leucovorin Calcium Indication : i) Biochemical modulator for 5-Fluorouracil in the treatment of colorectal cancer ii) As rescue for high dose methotrexate iii) Gestational trophoblastic disease Dosage : i) 20 mg/m2 daily for 5 days before 5-Fluorouracil or 200 mg/m2 IV infusion over 2 hours prior to 5Fluorouracil on Day 1 and Day 2 or 500 mg/m2 IV Day 1 weekly (refer to specific protocol) ii) Starting 24 - 42 hours of methotrexate administration, doses usually 15 - 30 mg/m2 every 6 hours for 8 to 12 doses depending on protocol and serum methotrexate levels iii) 6 - 12 mg exactly 30 hours after each dose of methotrexate. In EMA-CO regime for high risk gestational trophoblastic disease, use 30 mg IM Precautions: Pregnancy, lactation, seizure disorder Adverse Reaction: Anaphylatoid reactions, urticaria, nausea, vomiting Contraindications: Hypersensitivity to leucovorin, pernicious anaemia or megaloblastic anaemia where vitamin B12 is deficient Interactions: Phenobarbitone, phenytoin -------------------------------------------------------------------------------------------------------------------------------------Peginterferon Alpha-2a 180 mcg Prefilled Syringe A* Trade Name : Pegasys Indication : i) Chronic hepatitis C usually in combination with ribavirin (Important to establish hepatitis C virus (HCV) genotype and viral load where combination treatment is advocated) ii) For the treatment of both HbeAg-positive and HbeAg-negative chronic hepatitis B with compensated liver disease and evidence of viral replication who are not responding or tolerating oral antiviral therapy (Initiated by Hepatologist and Gasteroenterologist only) Dosage : i) 180 mcg weekly with ribavirin 800 mg daily for 24 weeks in patients in genotype 2 and 3 and 180 mcg weekly with ribavirin (1000 - 1200 mg) for 48 weeks for those with genotype 1 and 4. 135 mg dose may be used for patients who cannot tolerate the 180 mcg dose ii) 180 mcg subcutaneously once a week for 48 weeks Precautions: Chronic liver disease, cardiovascular disease, history of autoimmune disease, diabetes mellitus, hypothyroidism or hyperthyroidism, renal impairment, pregnancy, breast feeding, geriatric patient, monitor CBC regularly. Baseline neutrophil counts less than 1500 cells/mm3, baseline platelet counts less than 90,000 cells/mm3, baseline Hb less than 12 g/dL. Combination with myelosuppressive agents. Autoimmune disorders, psoriasis, hypoglycemia, hyperglycemia, history of depression, ophthalmic, cardiac or pulmonary disorders. Discontinue use in patients who develop evidence of 274 hepatic decompensation. Perform standard haematological and biochemical tests before and periodically during therapy. May impair ability to drive or operate machinery Adverse Reaction: Headache, alopecia, dermatitis, nausea, vomiting, abdominal pain, neutropenia, anaemia, dyspnoea, myalgia, fatigue, rigors, fever, depression, arthralgia, gastrointestinal disturbances, irritability, flulike symptoms, insomnia, asthenia, pharyngitis, weight loss, anorexia, dizziness, granulocytopenia, thrombocytopenia, injection site and acute hypersensitivity reactions Contraindications: Hypersensitivity, autoimmune hepatitis, decompensated cirrhosis, severe psychiatric disorder, pregnancy and lactation. Neonate and infant three years and below Interactions: ACEI, fluorouracil, melphalan, prednisolone, theophylline, warfarin, zidovudine, didanosine -----------------------------------------------------------------------------------------------------------------------------------Rituximab 500 mg/50 ml Injection A* Trade Name : Mabthera Indication : i) Treatment of patients with relapsed or chemo-resistant low grade or follicular B-cell NonHodgkin's lymphoma ii) Adjunctive therapy with combination chemoagents for aggressive NonHodgkin Lymphoma iii) Severe active rheumatoid arthritis with inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) including one or more tumour necrosis factor (TNF) inhibitor therapies Dosage : i) 375 mg/m2 body surface area administered as an IV infusion through a dedicated line once weekly for 4 weeks ii) Combination with CHOP as 375 mg/m2 BSA once every 3 to 4 weeks Precautions: Hypersensitivity reaction may be severe, caution in patient receiving cardiotoxic chemotherapy, history of cardiovascular disease and pregnancy. Monitor for tumour lysis syndrome. Use with caution in heart disease and monitor for infusion-related events. Medication for treatment of hypersensitivity must be available for immediate use during administration Adverse Reaction: Angina, cardiac arrythmias, lymphopenia, fever, chills, rigor, angioedema, nausea, rash, headache, dizziness, renal toxicity, hypotension, bronchospasm, mucocutaneous reactions, arrhythmias, chest pain, cough, rhinitis, dyspnoea Contraindications: Hypersensitivity or anaphylactic reactions to murine proteins or any component of the formulation, breast feeding Interactions: Cisplatin, live vaccines, rotavirus vaccines -------------------------------------------------------------------------------------------------------------------------------------- 275 16. NUTRITION AND BLOOD DISORDER Fluids and electrolytes Intravenous nutrition Minerals Vitamins Miscellaneous Nutrition and blood disorder 276 Continuous Ambulatory Peritoneal Dialysis Solution containing 1.5% Dextrose B Continuous Ambulatory Peritoneal Dialysis Solution containing 2.5% Dextrose B Continuous Ambulatory Peritoneal Dialysis Solution containing 4.25% Dextrose B Indication : For chronic renal diseases requiring dialysis and acute therapy-resistance renal failure eg. prior to transfer to a dialysis centre Dosage : Dose depending on clinical cases Precautions: Abdominal sepsis, previous abdominal surgery or severe inflammatory bowel disease. Dialysis solutions should be warmed to body temperature with dry heat because wet heat carries a risk of microbial contamination Adverse Reactions: Peritonitis, hernias, hyperglycaemia, protein malnutrition and catheter complications. Long-term peritoneal dialysis results in progressive structural changes to the peritoneal membrane ultimately resulting in dialysis failure Contraindications: Not known Interactions: Drug with low molecular weight, high water solubility, low volume of distribution, low protein binding and high renal clearance are most extensively removed by dialysis e.g. aminoglycosides. Dialysis-induced changes in fluids and electrolytes -------------------------------------------------------------------------------------------------------------------------------------Dextrose 50% Injection B Indication : For parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient Dosage : According to the needs of the patient Precautions: Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest or severe hypotension unless hypoglycaemia is suggested or until glucose is determined Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia, pulmonary embolism, right atrial thrombosis, extravasation Contraindications: Do not use concentrated solutions of dextrose in patients with anuria, diabetic coma, hyperglycaemia, intracranial or intraspinal haemorrhage, delirium tremens in dehydrated patients and glucose-galactose malabsorption syndrome. Do not administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------- 277 Human Albumin Injection B Indication : i) Acute hypovolemic shock ii) Hypoproteinaemia iii) Neonatal hyperbilirubinaemia Dosage : i) ADULT 25 g. CHILD 0.6 g/kg body weight ii) Maximum daily dose is 2g iii) 1 g/kg before exchange transfusion. Dose is given at rate of 1 ml of 25% solution per minute Precautions: Hepatic or renal failure due to protein load; rapid infusion of albumin solutions may cause vascular overload Adverse Reactions: CHF precipitation, oedema, hypertension, hypervolemia, hypotension, tachycardia,chills, fever, headache, pruritus, rash, urticaria, nausea, vomiting, bronchospasm, pulmonary oedema, anaphylaxis Contraindications: Hypersensitivity to albumin; patients at risk for acute circulatory overload (cardiac failure, pulmonary edema, severe anemia) Interactions: ACE inhibitors: May have increased risk of atypical reactions; withhold ACEIs for at least 24 hours prior to plasma exchanges using large volumes of albumin -------------------------------------------------------------------------------------------------------------------------------------Oral Rehydration Salt C Indication : Replacement of fluid and electrolytes loss in diarrhoea Dosage : ADULT: 200 - 400 ml ( 1 - 2 sachets ) for every loose motion. CHILD: 200 ml (1 sachet) for every loose motion. In severe dehydration 100 ml/kg for 3 - 4 hours. INFANT: 1 1.5 times their usual feed volume (50 ml per stool for small infant) Precautions: Cardiac failure, hypertension, impaired renal function, peripheral and pulmonary oedema, toxaemia in pregnancy Adverse Reactions: Hypernatremia, nausea and vomiting Contraindications: Patients with renal failure or hyperkalaemia Interactions: Potassium sparing diuretics -------------------------------------------------------------------------------------------------------------------------------------Potassium Chloride 1 g/10 ml Injection B Indication : For the correction of severe hypokalaemia and when sufficient potassium cannot be taken by mouth Dosage : By slow IV infusion depending on the deficit or the daily maintenance requirements. 1 g diluted in 500 ml normal saline or glucose and given slowly over 2 - 3 hours Precautions: Severe renal impairment, cardiac disease, hyperkalaemia. Initial potassium replacement therapy, should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration 278 Adverse Reactions: Nausea, vomiting, gastrointestinal ulceration, electrocardiogram changes Contraindications: Acute dehydration, heat cramps, hyperkalaemia, renal failure and in conditions in which potassium retention is present or where additives of potassium and chloride could be clinically detrimental Interactions: Potassium sparing diuretics, salt substitutes, ACE inhibitors, angiotensin-II receptor antagonists, methenamine, ciclosporin, tacrolimus -------------------------------------------------------------------------------------------------------------------------------------Potassium Chloride 1 g/15 ml Mixture C Indication : Potassium depletion Dosage : 1 g once or twice daily until serum potassium is restored Precautions: Severe renal impairment, cardiac disease, hyperkalaemia. Initial potassium replacement therapy, should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration Adverse Reactions: Nausea, vomiting, gastrointestinal ulceration, ECG changes Contraindications: Acute dehydration, heat cramps, hyperkalaemia, renal failure and in conditions in which potassium retention is present or where additives of potassium and chloride could be clinically detrimental Interactions: Potassium sparing diuretics, salt substitutes, ACE inhibitors, angiotensin-II receptor antagonists, methenamine, ciclosporin, tacrolimus -------------------------------------------------------------------------------------------------------------------------------------Potassium Chloride 600 mg SR Tablet B Trade Name : Slow-K Indication : For the treatment and specific prevention of hypokalaemia Dosage : ADULT: 2 - 3 tablets daily. Severe deficiency: 9 - 12 tablets daily or according to the needs of the patient Precautions: Severe renal impairment, cardiac disease, hyperkalaemia. Initial potassium replacement therapy, should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration Adverse Reactions: Nausea, vomiting, gastrointestinal ulceration, ECG changes Contraindications: Acute dehydration, heat cramps, hyperkalaemia, renal failure and in conditions in which potassium retention is present or where additives of potassium and chloride could be clinically detrimental Interactions: Potassium sparing diuretics, salt substitutes, ACE inhibitors, angiotensin-II receptor antagonists, methenamine, ciclosporin, tacrolimus -------------------------------------------------------------------------------------------------------------------------------------- 279 Ringer's Solution Injection B (contained sodium chloride, potassium chloride and calcium chloride) Indication : As a source of electrolytes and water for hydration/replenishing of chloride Dosage : According to the needs of the patient Precautions: Congestive heart failure, circulatory insufficiency, kidney dysfunction, hypoproteinaemia, cirrhotic disease, hypervolaemia, urinary tract obstruction and patients receiving drugs that cause sodium retention, eg corticosteroids or corticotropin Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, irritability, restlessness, weakness, headache, dizziness, obtundation, convulsions Contraindications: Hypernatraemia or fluid retention, hypersensitivity, sodium chloride solutions with preservatives in newborns for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Sodium Bicarbonate 8.4% (1 mmol/ml) Injection B Indication : For acceleration of excretion in drug intoxication (where excretion of the drug into the urine is accelerated by elevated urine pH) and for acidosis Dosage : According to the needs of the patient. In severe shock due to cardiac arrest: 50 ml by IV Precautions: Renal impairment, peptic ulcer, congestive heart failure, oedema, cirrhosis Adverse Reactions: Gastrointestinal cramps, flatulence, alkalosis Contraindications: Alkalosis, hypernatraemia, hypocalcaemia, hypochloraemia, severe pulmonary oedema, unknown abdominal pain Interactions: Amphetamine, aspirin, chlorpropamide, dextroamphetamine, ephedrine, itraconazole, ketoconazole, lithium, pseudoephedrine, flecainide -------------------------------------------------------------------------------------------------------------------------------------Sodium Chloride 0.18% with Dextrose 10% Injection Sodium Chloride 0.18% with Dextrose 4.23% Injection Sodium Chloride 0.45% with Dextrose 10% Injection Sodium Chloride 0.45% with Dextrose 5% Injection Sodium Chloride 0.9% with Dextrose 5% Injection Indication : For replenishing fluid and energy and for restoring or maintaining the concentration of sodium and chloride ions Dosage : According to the needs of the patient 280 B B B B C Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. Diabetes mellitus or carbohydrate intolerance and hyperglycaemia may accentuate neurologic damage for an ischaemic insult. Patients at risk for cerebral ischaemia, acute stroke, impending cardiac arrest or severe hypotension unless hypoglycaemia is suggested or until glucose is determined Adverse Reactions: Thrombophlebitis, rebound hypoglycaemia, hypokalaemia, sodium accumulation and oedema Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Sodium Chloride 0.45% Injection B Indication : For replenishing fluid and for restoring / maintaining the concentration of sodium and chloride ions Dosage : 100 - 1000 ml by IV or according to the needs of the patient Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, irritability, restlessness, weakness, headache, dizziness, obtundation and convulsions Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Sodium Chloride 20% Injection B Indication : Addition of sodium electrolyte in parenteral nutrition bags especially in paediatrics or neonates with restricted fluid allowance Dosage : According to the needs of the patient Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, irritability, restlessness, weakness, headache, dizziness, obtundation, convulsions 281 Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks Interactions: During therapy with corticosteroids or ACTH there may be an increased retention of sodium and chloride. Decreased levels of lithium -------------------------------------------------------------------------------------------------------------------------------------Sodium Chloride 3% Injection B Indication : Acute dilutional hyponatraemia Dosage : According to the needs of the patient Precautions: Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy Adverse Reactions: Nausea, vomiting, diarrhoea, abdominal cramps, congestive heart failure, hypertension, tachycardia, fluid accumulation, irritability, restlessness, weakness, headache, dizziness, obtundation, convulsion Contraindications: Hypernatraemia or fluid retention, hypersensitivity (ophthalmic products), sodium chloride solutions with preservatives in newborns, for injection or flushing of intravenous lines or mixing medications, hypertonic saline abortifacient in pregnancies less than 15 weeks Interactions: During therapy with corticosteroids or ACTH there may be an increased retention of sodium and chloride. Decreased levels of lithium -------------------------------------------------------------------------------------------------------------------------------------Sodium Lactate Compound (Hartmanns Solution/Ringer-lactate] C Indication : Replacement of extracellular losses of fluid and electrolytes, as an alkaliniser agent Dosage : 100-1000 ml by IV or according to the needs of the patient Precautions: Metabolic or respiratory alkalosis, congestive heart failure, other sodium-retaining conditions, concurrent corticosteroids, conditions impairing lactate utilisation (severe hepatic insufficiency, shock, beriberi, hypoxia) and during prolonged therapy Adverse Reactions: Anxiety, panic attacks, apprehension or fear, paraesthesias, tremors, dizziness, metabolic alkalosis, hypokalaemia Contraindications: Lactic acidosis, severe acidosis, hypernatraemia and conditions where sodium administration would be detrimental Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------- 282 Water for Injection C Indication : As a diluent and vehicle for the administration of medications Dosage : According to the needs of the patient Precautions: The stability of any medicament prepared should be checked Adverse Reactions: Not known Contraindications: Not known Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Amino Acids Injection A Trade Name : Vamin Indication : Source of amino acids in patients needing IV nutrition Dosage : Dose to be individualised. ADULT usually 500-2000 ml by IV. ADULT usual requirement for amino acid: 1-2 g/kg/day Precautions: Liver disease, renal impairment Adverse Reactions: Gastrointestinal upset, flushing, sweating, thrombophlebitis Contraindications: Patients with inborn errors of amino acid metabolism, irreversible liver damage, severe uraemia without dialysis Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Fat Emulsion 20% for IV Infusion A Trade Name : Intralipid Indication : Source of lipid in patients needing IV nutrition Dosage : Dose to be individualised. ADULT usual lipid requirement 2-3 g/kg/day. INFANT 0.5-1 g/kg/day Precautions: Renal insufficiency, uncompensated diabetes, certain forms of liver insufficiency (monitor liver function), metabolic disorders and sepsis Adverse Reactions: Fever, hypertriglyceridaemia, shivering, chills, nausea and vomiting Contraindications: Pathological hyperlipidaemia, severe liver damage and acute shock Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------- 283 Trace Elements and Electrolytes (Adult) Solution A* Trade Name : Addamel Solution Indication : Only to be used to cover daily loss of electrolyte and trace elements for patient on parenteral nutrition Dosage : 10 ml added to 500-1000 ml solution, given by IV infusion Precautions: Impaired biliary or renal function, liver dysfunction (especially cholestasis. Manganese blood levels and liver function should be monitored regularly (monthly). Should be stopped if manganese levels rise into the potentially toxic range Adverse Reactions: Not known Contraindications: Total biliary obstruction. Should not be given undiluted Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Calcium Carbonate 500 mg Tablet A/KK Indication : To be used only for elemental calcium supplementation and phosphate binding activity in patients with chronic renal failure Dosage : Initial 2.5 g daily and increased up to 17 g daily Precautions: Renal impairment, hypercalcaemia-associated disease eg, other malignancies, sarcoidosis, elderly Adverse Reactions: Gastrointestinal irritation, constipation, flatulence, gastric hypersecretion and acid rebound, hypercalcaemia, alkalosis and renal dysfunction Contraindications: Patients with calcium renal calculi or history of renal calculi, hypercalcaemia, hypophosphataemia Interactions: Co-administration with thiazide diuretics or vitamin D may lead to milk-alkali syndrome and hypercalcaemia. Decreased absorption with corticosteroids. Decreases absorption of tetracyclines, atenolol, iron, quinolones, alendronate, natrium fluoride, zinc and calcium-channel blockers. Enhances cardiac effects of digitalis glycosides and may precipitate digitalis intoxication -------------------------------------------------------------------------------------------------------------------------------------Calcium Gluconate 10% Injection B Indication : i) Acute hypocalcaemia ii) Hypocalcaemic tetany iii) Cardiac resuscitation Dosage : i) 1-2 g (2.25-4.5 mmol). CHILD 50 mg/kg ii) ADULT 1g (2.2 mmol) by slow IV injection followed by continuous infusion of 4 g (8.8 mmol) daily iii) IV or intracardiac injection, 10 ml Precautions: Extravasation during IV injection. Renal impairment, cardiac disease or sarcoidosis Adverse Reactions: Sloughing or necrosis of the skin, soft tissue calcification. Hypercalcaemia (excessive use) 284 Contraindications: Hypercalcaemia, hypercalciurea, severe renal failure, patients treated with digitalis Interactions: Increased inotropic and toxic effects when used with cardiac glycosides. Complex formation with tetracyclines -------------------------------------------------------------------------------------------------------------------------------------Calcium Lactate 300 mg Tablet C Indication : For prophylaxis of calcium deficiency and treatment of chronic hypocalcaemia Dosage : ADULT 1-5 g daily in divided doses Precautions: Calcium enhances the effect of cardiac glycosides on the heart and may precipitate arrhythmias. In large doses, monitor serum calcium concentration and kidney function weekly, renal impairment, history of renal stones Adverse Reactions: Mild gastrointestinal disturbances, bradycardia, arrhythmias Contraindications: Ventricular fibrillation during cardiac resuscitation, hypercalcaemia, hypercalciuria, severe renal failure Interactions: Allopurinol, aspirin, chlorothiazide, ciprofloxacin, digoxin, doxycycline, hydrochlorothiazide, itraconazole, ketoconazole, levothyroxine, metolazone, minocycline, norfloxacin, ofloxacin, oxytetracycline, pefloxacin, tetracycline, ticlopidine, verapamil, zalcitabine -------------------------------------------------------------------------------------------------------------------------------------Lanthanum Carbonate 1000mg Chewable Tablet A* Trade Name : Fosrenol Indication : Phosphate binding agent for the treatment of hyperphosphataemia in dialysis patients with sustained hypercalcaemia of more than three months and secondary hyperparathyroidism Dosage : Initial: 750 to 1500 mg/day in divided doses with meals, then titrate in increments of 750 mg/day at intervals of 2 to 3 weeks. Maintenance: 1500-3000 mg/day in divided doses. Max: 3750 g/day Precautions: Caution when used in patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction. Tablets should be thoroughly chewed before swallowing. Pregnancy and lactation Adverse Reactions: Gastrointestinal disturbances, including nausea, vomiting, constipation, diarrhoea, dyspepsia and abdominal pain Contraindications: Specific contraindications have not been determined Interactions: Possibly reduces absorption of ketoconazole, chloroquine, hydroxychloroquine or other compounds that are known to interact with antacids (give at least 2 hours apart) -------------------------------------------------------------------------------------------------------------------------------------- 285 Magnesium Sulphate 50% Injection C Indication : Treatment and prophylaxis of hypomagnesaemia. Prevention and treatment of life-threatening seizures in the treatment of toxemias of pregnancy (pre-eclampsia and eclampsia) Dosage : ADULT 5-10 ml by IM. CHILD 20-40 mg/kg body weight as a 20% solution by IM. Hypomagnesaemia: 0.5-1 mmol/kg body weight up to 160 mmol magnesium over to 5 days. Eclampsia: IV 4 g over up to 20 minutes followed by IV infusion at rate of 1 g every hour. Recurrent seizures may require an additional IV bolus of 2-4 g (4 g if body weight over 70 kg) Precautions: Impaired renal function and those receiving digitalis glycosides. Pregnancy and lactation. Product contains aluminum therefore increasing the risk of aluminum toxicity Adverse Reactions: Hypotension, flushing, sweating, depression of reflexes, flaccid paralysis, hypothermia, circulatory collapse, depression of cardiac function, central nervous system depression, abnormal ECG, heart block, hypotension, vasodilatation, blood coagulation disorder with prolonged bleeding time Contraindications: Heart block, myocardial damage Interactions: Additive central depressant effects with central nervous system depressants. Neuromuscular blocking agents, cardiac glycosides, nifedipine -------------------------------------------------------------------------------------------------------------------------------------Potassium Dihydrogen Phosphate Injection A Indication : For treatment of hypophosphataemia or phosphate replacement in parenteral nutrition Dosage : Parenteral nutrition: 10 - 20 mmoles of phosphate daily Precautions: Renal insufficiency, cardiac disease, metabolic alkalosis Adverse Reactions: Diarrhoea, nausea, stomach pain, flatulence, vomiting, bradycardia, hyperkalaemia, weakness, dyspnoea Contraindications: Renal insufficiency, renal failure, hyperphosphataemia, hypocalcaemia, hyperkalaemia, hypernatraemia, Addison's disease Interactions: Aluminium and magnesium-containing antacids, sucralfate, potassium-sparing diuretics, salt substitutes, ACE inhibitors, digitalis -------------------------------------------------------------------------------------------------------------------------------------Alfacalcidol 0.25 mcg Capsule A/KK Alfacalcidol 1 mcg Capsule A/KK Trade Name : One-alpha Indication : Treatment of: i) Renal osteodystrophy in patients on haemodialysis ii) Hypoparathyroidism and pseudohypoparathyroidism iii) Adjunct to the management of tertiary hyperparathyroidism iv) Rickets and osteomalacia v) Osteoporosis Dosage : Initial dose ADULT and CHILD above 20kg body weight : 1 mcg daily; CHILD under 20kg body weight : 0.05 mcg/kg/day. Maintenance dose : 0.25 mcg to 2 mcg daily 286 Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products Interactions: Antiepileptics, diuretics, barbiturates -------------------------------------------------------------------------------------------------------------------------------------Alfacalcidol 2 mcg/ml Drops A* Trade Name : One-Alpha Indication : Treatment of: i) Renal osteodystrophy in patients on haemodialysis ii) Hypoparathyroidism and pseudohypoparathyroidism iii) Adjunct to the management of tertiary hyperparathyroidism iv) Rickets and osteomalacia v) Osteoporosis Dosage : NEONATES : 0.1 mcg/kg/day Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products Interactions: Antiepileptics, diuretics, barbiturates -------------------------------------------------------------------------------------------------------------------------------------Alfacalcidol 2 mcg/ml Injection A* Trade Name : One-Alpha Indication : Treatment of: i) Renal osteodystrophy in patients on haemodialysis ii) Hypoparathyroidism and pseudohypoparathyroidism iii) Adjunct to the management of tertiary hyperparathyroidism iv) Rickets and osteomalacia v) Osteoporosis Dosage : Initial dose : 1 mcg per haemodialysis. Maximum dose 6 mcg per haemodialysis and not more than 12 mcg per week Precautions: Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products Interactions: Antiepileptics, diuretics, barbiturates -------------------------------------------------------------------------------------------------------------------------------------- 287 Ascorbic Acid 100 mg Tablet C Indication : Vitamin C deficiency Dosage : ADULT: 100-250 mg once or twice daily CHILD: 100 mg three times daily for one week followed by 100mg daily until symptoms abate. Precautions: Use cautiously in patients with preexisting kidney stone disease, erythrocyte G6PD deficiency, haemochromatosis, thalassaemia or sideroblastic anaemia and avoid rapid intravenous injections Adverse Reactions: In large doses, gastrointestinal disturbances, renal calcium oxalate calculi formation Contraindications: History of hyperoxaluria Interactions: Antacids, aspirin, contraceptives combination, cyanocobalamin, deferoxamine, gentamicin, haloperidol, iron, levodopa, methotrexate, warfarin -------------------------------------------------------------------------------------------------------------------------------------Calcitriol 0.25 mcg Capsule A/KK Trade Name : Rocaltrol Indication : Treatment of: i) Postmenopausal osteoporosis ii) Renal osteodystrophy in patients on haemodialysis iii) Hypoparathyroidism and rickets iv) Secondary hyperparathyroidism in renal failure Dosage : i) 0.25 mcg 2 times daily ii) Initial dose 0.25 mcg. In patients with normal or only slightly reduced serum calcium levels, doses of 0.25 mcg every other day is sufficient iii) 0.25 mcg/day given in the morning iv) ADULT and CHILD 3 years and older : Initially 0.25 mcg/ml. CHILD less than 3 years : 10 to 15 ng/kg/day Precautions: Monitor serum calcium, phosphorus, magnesium and alkaline phosphatase, urinary calcium and phosphorus. Patients on digitalis. Pregnancy and lactation. Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria, weakness, headache, somnolence, dry mouth, constipation, muscle pain, bone pain, metallic taste Contraindications: Hypercalcaemia, vitamin D toxicity, abnormal sensitivity to the effects of vitamin D, malabsorption syndrome Interactions: Cytochrome P450 effect. Cholestyramine, thiazides diuretics, corticosteroids, magnesium-containing antacids, digitalis -------------------------------------------------------------------------------------------------------------------------------------Calcitriol 1 mcg/ml Injection A* Trade Name : Calcijex Indication : Management of hypocalcaemia and/or secondary hyperparathyroidism in patients undergoing chronic renal dialysis Dosage : Initially dose, depending on severity, 1 mcg (0.02 mg/kg) to 2 mcg 3 times weekly, approximately every other day 288 Precautions: Monitor serum calcium, phosphorus, magnesium and alkaline phosphatase, urinary calcium and phosphorus. Patients on digitalis. Pregnancy and lactation.Take care to ensure correct dose to infants, monitor plasma calcium and creatinine during dosage titration Adverse Reactions: Hypercalcaemia, nausea, vomiting, polydipsia, polyuria, weakness, headache, somnolence, dry mouth, constipation, muscle pain, bone pain, metallic taste Contraindications: Hypercalcaemia, metastatic calcification, vitamin D toxicity and hypersensitivity to calcitriol products Interactions: Cytochrome P450 effect. Cholestyramine, thiazides diuretics, corticosteroids, magnesium-containing antacids, digitalis -------------------------------------------------------------------------------------------------------------------------------------Cyanocobalamin 1 mg Injection B Indication : i) Prophylaxis of anaemia associated with Vitamin B12 deficiency ii) Uncomplicated pernicious anaemia or Vitamin B12 malabsorption Dosage : i) Prophylaxis of anaemia: 250-1000 mcg IM every month ii) Uncomplicated pernicious anaemia or Vitamin B12 malabsorption: Initial 100 mcg daily for 5-10 days followed by 100-200 mcg monthly until complete remission is achieved. Maintenance: 100 mcg monthly. CHILD 30-50 mcg daily for 2 or more weeks (to a total dose of 1-5mg). Maintenance: 100 mcg monthly to sustain remission Precautions: Hereditary optic atrophy, vitamin B12 therapy can mask folic acid deficiency, hypokalaemia and risk of gastric cancer is higher in patients with pernicious anaemia Adverse Reactions: Diarrhoea, urticaria, pruritus, skin rash, hypokalaemia, polycythemia vera, volume overload Contraindications: Hypersensitivity to any component of cyanocobalamin or hydroxycobalamin formulations Interactions: Neomycin, aminosalicylic acid, histamine H2 receptor antagonists, colchicine, oral contraceptives, chloramphenicol -------------------------------------------------------------------------------------------------------------------------------------Multivitamin Injection B Trade Name : Parentrovite Indication : For prevention and treatment of vitamin deficiencies Dosage : Initially 2 - 4 pairs IV 4 - 8 hourly, reducing to 1 pair IV daily. For less serious cases, 1 pair IV 1 - 2 times daily or based on individual requirements Precautions: Severe renal or liver failure Adverse Reactions: Hypervitaminosis, high doses may induce paraesthesia and hypotension Contraindications: Hypersensitivity to product components 289 Interactions: Pyridoxine will antagonise the therapeutic effect of levodopa (should not be administered concurrently), vitamin B6 reduces the plasma levels of phenobarbitone and phenytoin, ascorbic acid increases plasma level of ethinyloestradiol -------------------------------------------------------------------------------------------------------------------------------------Multivitamin Syrup C Indication : For prevention and treatment of vitamin deficiencies Dosage : CHILD 5 ml daily or based on manufacturer Precautions: Severe renal or liver failure Adverse Reactions: Hypervitaminosis Contraindications: Hypersensitivity to product components Interactions: Pyridoxine will antagonise the therapeutic effect of levodopa (should not be administered concurrently), vitamin B6 reduces the plasma levels of phenobarbitone and phenytoin, ascorbic acid increases plasma level of ethinyloestradiol -------------------------------------------------------------------------------------------------------------------------------------Multivitamin Tablet B Indication : For prevention and treatment of vitamin deficiencies Dosage : 1 - 2 tablets daily or based on individual requirements Precautions: Severe renal or liver failure Adverse Reactions: Hypervitaminosis Contraindications: Hypersensitivity to product components Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Pyridoxine HCl 10 mg Tablet B Indication : i) Pyridoxine-dependent convulsions in infancy ii) Sideroblastic anaemia iii) B6-deficient anaemia in adult iv) Prophylaxis to peripheral neuritis in isoniazid therapy v) Nausea and vomiting of pregnancy and irradiation sickness Dosage : i) INFANT 4 mg/kg daily for short periods ii) 100 - 400 mg daily in divided doses iii) ADULT 20 - 50 mg up to 3 times daily iv) Prophylaxis 10 mg daily, therapeutic 50 mg 3 times daily v) 20 - 100 mg daily Precautions: Pregnancy, lactation, neonatal seizures, concurrent treatment with levodopa. Long term use in a dose of 200 mg or more daily has been associated with neuropathy 290 Adverse Reactions: Peripheral sensory neuropathy, hypotonia, respiratory difficulties, nausea and other gastrointestinal complaints, photosensitivity, vesicular lesions and bullous lesions Contraindications: Hypersensitivity to pyridoxine or any component of preparation Interactions: Levodopa, penicillamine, selegiline, phenytoin -------------------------------------------------------------------------------------------------------------------------------------Riboflavine 3 mg Tablet C Indication : For prevention and treatment of riboflavine deficiency Dosage : CHILD: 2.5-10 mg/day in divided doses. ADULT: 5-30 mg/day in divided doses Precautions: Riboflavin deficiency often occurs in the presence of other vitamin B deficiencies. High content of riboflavin and pyridoxine in some commercial infant formula Adverse Reactions: Urine discoloration Contraindications: Hypersensitivity to riboflavin products Interactions: Decreased absorption with probenecid -------------------------------------------------------------------------------------------------------------------------------------Thiamine Mononitrate 10 mg Tablet C Indication : i) For the prevention or treatment of Vitamin B1 deficiency syndromes including beri-beri and peripheral neuritis associated with pellagra ii) Wernicke-Korsakoff Syndrome Dosage : i) Mild to chronic deficiency: 10-25 mg daily. Severe deficiency: 200- 300 mg daily ii) 500 mg every 8 hours for 2 days, followed by 100 mg 2 times daily until patient can take oral dose Precautions: Not known Adverse Reactions: Contact dermatitis, chronic pigmented purpura, skin rash, itching Contraindications: Hypersensitivity to thiamine or any component Interactions: Alkaline solutions, bicarbonates, carbonates, citrates, erythromycin lactobionate, iron salts, methohexital, neutral solutions, alkaline barbiturate solutions (eg phenobarbital, thiopental) -------------------------------------------------------------------------------------------------------------------------------------Thiamine HCl 100 mg/ml Injection B Indication : i) For the prevention or treatment of Vitamin B1 deficiency syndromes including beri-beri and peripheral neuritis associated with pellagra ii) Wernicke-Korsakoff Syndrome Dosage : i) Mild to chronic deficiency: 10-25 mg daily. Severe deficiency: 200- 300 mg daily ii) 500 mg every 8 hours for 2 days, followed by 100 mg 2 times daily until patient can take oral dose 291 Precautions: Use with caution with parenteral route (especially IV) of administration Adverse Reactions: Pain on injection, contact dermatitis, chronic pigmented purpura Contraindications: Hypersensitivity to thiamine or any component Interactions: Alkaline solutions, bicarbonates, carbonates, citrates, erythromycin lactobionate, iron salts, methohexital, neutral solutions, alkaline barbiturate solutions (eg phenobarbital, thiopental) -------------------------------------------------------------------------------------------------------------------------------------Vitamin B Complex 10 ml Injection B Indication : Prophylaxis and treatment of vitamin B deficiency Dosage : 1-2 ml daily by IM Precautions: Not for treatment of pernicious anaemia or other megaloblastic anaemias where vitamin B12 is deficient Adverse Reactions: Risk of anaphylactic shock. Allergy to cobalamins, megaloblastic anaemia of pregnancy Contraindications: Allergy to cobalamins, megaloblastic anaemia of pregnancy Interactions: Pyridoxine reduces the effect of levodopa -------------------------------------------------------------------------------------------------------------------------------------Vitamin B Complex Tablet C Indication : Prophylaxis and treatment of vitamin B deficiency Dosage : 1-2 tablets daily Precautions: Not for treatment of pernicious anaemia or other megaloblastic anaemias where vitamin B12 is deficient Adverse Reactions: Peripheral neuropathies (long term administration of large doses of pyridoxine) Contraindications: Allergy to cobalamins, megaloblastic anaemia of pregnancy Interactions: Pyridoxine reduces the effect of levodopa -------------------------------------------------------------------------------------------------------------------------------------Vitamin B1, B6, B12 Injection Trade Name : Neurobion Indication : For deficiency or raised requirement of Vitamin B1, B6, B12 Dosage : Mild cases: 1 ampoule given by IM 2-3 times weekly. Severe cases: 1 ampoule daily 292 B Precautions: Photolysis. Repeated injection at the same site should be avoided. Care should be exercised when administering to neonates, premature infants, infants and children. The course of nerves should be avoided for the site of injection. If the patient complaints of pain or if blood reflux occurs when the needle is stuck, withdraw it immediately and try at a different site Adverse Reactions: Pain and induration at site of injection, headache, sweating or hot sensation Contraindications: Not known Interactions: High vitamin B6 dose decreases action of Levodopa -------------------------------------------------------------------------------------------------------------------------------------Vitamin B1, B6, B12 Tablet B Trade Name : Neurobion Indication : For deficiency or raised requirement of Vitamin B1, B6, B12 Dosage : 1 - 3 tablets 3 times daily swallowed unchewed Precautions: Discontinue medication if there is no response after taking orally for several months Adverse Reactions: Anorexia, nausea or diarrhoea, skin rash and hypersensitivity Contraindications: Patients treated with levodopa Interactions: High vitamin B6 dose decreases action of Levodopa -------------------------------------------------------------------------------------------------------------------------------------Vitamin K1 1 mg/ml Injection C Trade Name : Konakion Indication : Vitamin K deficiency in neonates Dosage : 1 mg given by IM or IV Precautions: IV or IM administration only when necessary (risk of anaphylaxis). Hypersensitivity reactions possible even at first administration. The anticoagulant action of heparin not counteracted by phytomenadione Vitamin K Adverse Reactions: Anaphylactic reactions during intravenous administration, dermatitis at injection site, haemolytic anaemia Contraindications: Hypersensitivity to Vitamin K, menadione (K3) administration in glucose-6-phosphate dehydrogenase deficiency Interactions: Decreases the effects of oral anticoagulants, fatty foods -------------------------------------------------------------------------------------------------------------------------------------- 293 Vitamin K1 10 mg/ml Injection B Trade Name : Konakion Indication : Haemorrhage associated with hypoprothrombinaemia caused by overdose of anticoagulants Dosage : 0.5 - 20 mg by very slow IV at a rate not exceeding 1 mg per minute Precautions: IV or IM administration only when necessary (risk of anaphylaxis). Hypersensitivity reactions possible even at first administration. The anticoagulant action of heparin not counteracted by phytomenadione Vitamin K. Reduce dose in elderly, liver impairment Adverse Reactions: Anaphylactic reactions during intravenous administration, dermatitis at injection site, haemolytic anaemia Contraindications: Hypersensitivity to Vitamin K, menadione (K3) administration in glucose-6-phosphate dehydrogenase deficiency Interactions: Decreases the effects of oral anticoagulants, fatty foods -------------------------------------------------------------------------------------------------------------------------------------Deferasirox 125 mg Dispersible Tablet A* Deferasirox 500 mg Dispersible Tablet A* Trade Name : Exjade Indication : Treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and pediatric patients aged 2 years and above Dosage : Initial 20 mg/kg/day. Starting dose can also be based on transfusion rate and existing iron burden. Max is 30 mg/kg/day Precautions: Increased risk of potentially fatal acute renal failure, concomitant use of medicines that depress renal function, elderly, haematologic disorders (including neutropenia, thrombocytopenia and agranulocytosis), acute renal failure with advanced-stage disorders renal conditions Adverse Reactions: Rash, urticaria, abdominal pain, diarrhoea, nausea, vomiting, backache, headache, cough, bronchitis, fever, influenza, cytopenia, drug-induced hepatitis, increased liver enzyme, anaphylaxis, hypersensitivity disorder, arthralgia, cataract, retinal disorder, raised intraocular pressure, hearing loss, infection of ear, fatigue, acute renal failure Contraindications: Hypersensitivity to deferasirox or to any component of the product Interactions: Aluminium containing antacids -------------------------------------------------------------------------------------------------------------------------------------Deferiprone 500 mg Tablet A* Trade Name : Ferriprox Indication : Treatment of iron overload in patients with thalassemia major for whom desferrioxamine therapy is contraindicated or inadequate. Add on therapy to desferrioxamine for thalassemia patients with cardiac complication 294 Dosage : 25 mg/kg 3 times a day for total daily dose of 75 mg/kg. Doses greater 100 mg/kg are not recommended Precautions: In case of persistent arthropathy, deferiprone therapy should be discontinued. Monitor neutrophil counts weekly. Interrupt therapy if patient develops an infection Adverse Reactions: Genotoxicity, neutropenia, agranulocytosis, tachycardia, vasculitis, weight gain, zinc deficiency, abdominal pain, urine discoloration, hepatotoxicity, visual impairment, joint problems, ototoxicity and skin rash Contraindications: Severe liver dysfunction, existing neutropenia, agranulocytosis, pregnancy and lactation Interactions: Aluminium containing antacids. Due to the risk of additive toxicity, use with drugs that may cause neutropenia or agranulocytosis is not recommended -------------------------------------------------------------------------------------------------------------------------------------Desferrioxamine B Methanesulphonate 0.5 g Injection A Trade Name : Desferal Indication : i) Acute iron poisoning in children ii) Investigation and treatment of haemochromatosis iii) Diagnosis and treatment of aluminium toxicity in patients with renal failure and dialysis iv) Chronic iron toxicity or overload Dosage : i) 2 g by IM immediately and 5 g by mouth after gastric lavage ii) 0.5 - 1.5 g by IM injection daily iii) Diagnosis: 5 mg per kg by slow intravenous infusion during the last hour of haemodialysis. Treatment: 5 mg per kg once a week by slow intravenous infusion during the last hour of dialysis iv) 30 - 50 mg/kg Precautions: Safety and effectiveness have not been established in children under the age of 3 years, vision or auditory problem. Concomitant vitamin C with desferrioxamine in patients with severe chronic iron overload or cardiac failure, high doses and concomitant low ferritin levels have been associated with growth retardation, increased susceptibility to Yersinia enterocolitica, Yersinia pseudotuberculosis, mucormycosis, patients with aluminum overload or aluminum-related encephalopathy Adverse Reactions: Thrombocytopenia, hypotension, tachycardia, flushing, rash, anaphylactic reaction, disturbance of vision and hearing, vomiting, diarrhoea, shock, tachyarrhythmia, ototoxicity (frequent), mycosis (rare) Contraindications: Anuria or severe renal disease Interactions: Ascorbic acid, phenothiazines -------------------------------------------------------------------------------------------------------------------------------------Erythropoietin Human Recombinant 2000 IU/0.5ml Injection A Trade Name : Eprex Indication : i) Treatment of anaemia associated with chronic renal failure. Dialysis patients who are haemoglobin less than 8 g or exhibiting symptoms of anaemia although haemoglobin more than 8 g and pretransplant cases ii) Anaemia in cancer (non-myeloid malignancies) with concomitant chemotherapy 295 Dosage : i) ADULT by IV injection over 1-5 minutes, initially 50 units/kg 3 times weekly adjusted according to response in step of 25 units/kg 3 times weekly at interval of at least 4 weeks. CHILD initially as for adult. Maintenance, bodyweight under 10 kg usually 75-150 units/kg 3 times weekly, bodyweight 10-30 kg usually 60-150 units/kg 3 times weekly, bodyweight over 30 kg usually 30-100 units/kg 3 times weekly ii) ADULT by SC injection (max. 1 ml per injection site), initially 150 units/kg 3 times weekly, increased if appropriate rise in haemoglobin not achieved after 4 weeks to 300 units/kg 3 times weekly. Discontinue if inadequate response after 4 weeks at higher dose Precautions: To minimize the risk of hypertension, the rate of increase in haemoglobin should not exceed 2 g/dL/month. Measure haemoglobin levels once weekly until levels stabilise and periodically thereafter, more frequent monitoring should be done in patients with a baseline haemoglobin of more than 14 g/dL. History of seizures, gout, porphyria. Conditions associated with thrombotic or vascular events, hepatic dysfunction. Monitor platelet count during first 8 week of therapy. Evaluate ferrous stores during therapy. Ferrous substitution is recommended for patients whose serum ferritin levels are 15 g/dL. Ischaemic heart disease, chronic heart failure. Pregnancy and lactation Adverse Reactions: Dizziness, drowsiness, headache, arthralgia, myalgia, increased blood pressure, hypertensive crisis, thrombocytosis, skin reactions at injection site (SC). Hyperkalaemia, hyperphosphataemia, increased BUN and uric acid, increased creatinine (especially in chronic renal failure patients) Contraindications: Uncontrolled hypertension. In elective surgery patients not participating in an autologous blood predonation programme who have severe coronary, peripheral, arterial, carotid or cerebrovascular diseases including patients with recent myocardial infarction or cerebrovascular accident Interactions: Potentiated by hematinic agents. Dose adjustment required if given together with ciclosporin -------------------------------------------------------------------------------------------------------------------------------------Ferric Ammonium Citrate 800 mg/10 ml Paediatric Mixture C Indication : Prevention and treatment of iron-deficiency anaemias Dosage : CHILD up to 1 year 5 ml, 1 - 5 years 10 ml, taken well diluted with water Precautions: Haemochromatosis, haemoglobinopthies, existing gastrointestinal diseases. Should be well diluted with water and drink through a straw to prevent teeth discoloration Adverse Reactions: Abdominal cramps, nausea, vomiting, diarrhoea or constipation, dark stools, heartburn, temporary teeth staining and discolouration of urine Contraindications: Not to be given in patient receiving repeated blood transfusion. Haemochromatosis, haemolytic anaemia, known hypersensitivity to iron salts Interactions: Concurrent administration with Vitamin C increases absorption of oral iron. Given with tetracycline, decreased tetracycline and iron effectiveness. Fluoroquinolones, levodopa, methyldopa, penicillamine, antacids, H2 blockers, proton pump inhibitors, chloramphenicol. Dairy foods, decreased iron bioavailability. Aluminium, calcium or magnesium containing products, decreased iron effectiveness -------------------------------------------------------------------------------------------------------------------------------------- 296 Ferrous Fumarate 200 mg Tablet C Indication : Prevention and treatment of iron-deficiency anaemias Dosage : Prophylactic 200 mg daily. Therapeutic 200 mg 2 times daily. CHILD up to 6 years 80-140 mg 2 times daily Precautions: Avoid in patients with peptic ulcer, enteritis, receiving frequent blood transfusions or ulcerative colitis. Administration of iron for more than 6 months should be avoided except in patients with continuous bleeding or menorrhagia Adverse Reactions: Abdominal cramps, nausea, vomiting, diarrhoea or constipation, dark stools, heartburn, temporary teeth staining and discolouration of urine Contraindications: Haemochromatosis, haemolytic anaemia, known hypersensitivity to iron salts Interactions: Concurrent administration with Vitamin C increases absorption of oral iron. Given with tetracycline, decreased tetracycline and iron effectiveness. Fluoroquinolones, levodopa, methyldopa, penicillamine, antacids, H2 blockers, proton pump inhibitors, chloramphenicol. Dairy foods, decreased iron bioavailability. Aluminium, calcium or magnesium containing products, decreased iron effectiveness -------------------------------------------------------------------------------------------------------------------------------------Folic Acid 5 mg Tablet C Indication : i) For the prevention and treatment of folate deficiency states ii) For the prevention of neural tube defect in the foetus Dosage : i) ADULT initially 5 mg daily for 4 months or until haematopoietic response obtained. Maintenance: 5 mg every 1 - 7 days depending on underlying disease CHILD up to 1 year, 500 mcg/kg daily; over 1 year, as adult dose ii) 5 mg daily starting before pregnancy and continued through the first trimester Precautions: Folic acid should never be given alone or in conjunction with inadequate amounts of vitamin B 12 for the treatment of undiagnosed megaloblastic anaemia (masking of true deficiency state) Adverse Reactions: Gastrointestinal disturbances, urticaria, pruritus Contraindications: Pernicious, aplastic or normocytic anaemias Interactions: Antiepileptics, oral contraceptives, aminosalicylates, barbiturates, antituberculous drugs, alcohol and folic acid antagonists such as aminopterin, methotrexate, trimethoprim and sulphonamides -------------------------------------------------------------------------------------------------------------------------------------Iron Dextran 50 mg Fe/ml Injection B Indication : Severe iron deficiency anaemia Dosage : An initial test dose of 0.5 ml should be given over the desired route. For severe iron deficiency anaemia, 1-2 ml daily given by deep IM. Dosage is individualized according to total iron deficit 297 Precautions: Anaphylaxis has occurred with parenteral iron dextran. Patients with history of allergic disorders, asthma, rheumatoid arthritis, inflammatory disorders such as lupus erythematosus Adverse Reactions: Anaphylactic reactions, chest pain, hypertension, urticaria, pruritus, rash, abdominal pain, nausea, vomiting, diarrhoea, leucocytosis, arthralgias, arthritis, convulsions, seizures, headache, respiratory arrest, dyspnoea, haematuria Contraindications: Haemachromatosis, haemosiderosis, haemolytic anaemia and all anaemias other than iron deficiency anaemia, hypersensitivity to product or any of its components and parenteral preparation is not for subcutaneous administration Interactions: Mycophenolate mofetil, decreased mycophenolate mofetil efficacy. Chloramphenicol, decreased iron effectiveness -------------------------------------------------------------------------------------------------------------------------------------Iron Sucrose 100 mg/5 ml Injection A* Trade Name : Venofer Indication : Dialysis patients on erythropoietin therapy, second and third trimester pregnancy and post partum anaemia patients with iron deficiency: i) who are not responsive to oral iron therapy ii) who may be at risk of allergic reactions to iron dextran injection Dosage : Individualised dosage. ADULT and ELDERLY: Cumulative dose is to be administered in single doses of 100 - 200 mg of iron 2 - 3 times weekly depending on Hb level. By IV drip infusion, slow IV injection or directly into the venous limb of the dialyser Precautions: Avoid fast infusion as can cause hypotension, cardiovascular collapse. Do not administer concomitant with oral iron preparations Adverse Reactions: Anaphylactoid reactions, metallic taste, headache, nausea, vomiting, hypotension, diarrhoea, leg cramp, loss of consciousness, seizure, dyspnoea Contraindications: Anaemia not due to iron deficiency, iron overload or disturbances in utilisation of iron, history of asthma, eczema or atopy, history of cirrhosis or hepatitis, serum transaminases 3 times the upper limit, acute or chronic infection, chronic alcoholism Interactions: Doxycycline, levodopa, methyldopa, mycophenolate mofetil, ofloxacin, omeprazole, penicillamine, tetracycline, zinc ----------------------------------------------------------------------------------------------------------------------------------- 298 17. RHEUMATOLOGY Antirheumatic Gout Drugs used in neuromuscular disorders Drugs for the relief of soft-tissue inflammation Miscellaneous rheumatology 299 Celecoxib 200 mg Capsule A* Trade Name : Celebrex Indication : i) Osteoarthritis ii) Rheumatoid Arthritis iii) Acute pain iv) Ankylosing Spondylitis Dosage : i) ADULTS: 200 mg once daily. CHILD not recommended ii) 100mg twice daily, increased if necessary to 200 mg 2 times daily; CHILD not recommended iii) 400mg as a single dose on first day followed by 200mg once daily on subsequent days iv) Initial, 200 mg once daily or 100 mg twice daily; if no effect after 6 weeks, may increase to max. 400 mg daily in 1-2 divided doses. If no response following 2 weeks of treatment with 400 mg/day, consider discontinuation and alternative treatment. Precautions: Hypertension, cardiac conditions, liver/renal dysfunction, elderly, fluid retention, children, asthmatic, coagulation defects, pregnancy (third trimester). Adverse Effects: GI disorders, flatulence, insomnia, pharyngitis, sinusitis, dizziness, vertigo, hearing disturbance, photosensitivity, blood disorder, fluid retention, renal failure, hepatic impairment, Steven-Johnson syndrome, allergic reactions, chest pain, oedema, hot flushes, flu-like symptoms. Gastric side effects are lesser with this drug as compared to other NSAIDs. Contraindications: Hypersensitivity to celecoxib, allergic-type reaction to sulphonamides, aspirin or other nonsteroidal anti-inflammatory agents, ischaemic heart disease and stroke patient. Interactions: Diuretics, anti-coagulants, sulphonylureas, captopril, phenytoin, digoxin, fluconazole, lithium, antacids, aspirin, glucocorticoids, warfarin. --------------------------------------------------------------------------------------------------------------------------------Etoricoxib 60 mg Tablet A* Etoricoxib 90 mg Tablet A* Etoricoxib 120 mg Tablet A* Trade Name : Arcoxia Indication : i)Acute and chronic treatment of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute gouty arthritis iii)Acute pain Dosage : i) OA: 60 mg once daily. RA: 90 mg once daily ii & iii) Acute gouty arthritis and acute pain: 120 mg once daily (Given the exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment) Precautions: Bleeding disorders, liver disease, renal impairment , hypertension, recent myocardial infarct, cardiovascular disease, hyperlipidaemia, diabetes, smoking, peripheral arterial disease. Adverse Effects: Small increase in blood pressure, increased risk of thrombotic complication, headache, dizziness, fatigue, insomnia, nausea, vomiting, diarrhoea, heartburn, taste disturbance, decreased appetite and flatulence. Contraindications: Patients who experienced asthma, urticaria or allergic type of reaction after taking aspirin or NSAIDs, acute peptic ulcer, severe renal or hepatic disease,ischaemic heart disease and stroke, hypertensive patient whose blood pressure is not under control. Interactions: Warfarin, ACEIs, lithium, methotrexate, oral contraceptives, rifampicin, aspirin, SSRIs. ------------------------------------------------------------------------------------------------------------------------------- 300 Hydroxychloroquine Sulphate 200 mg Tablet A Trade Name : Plaquenil Indication : i) SLE and mixed connective tissue disease for skin, joint and serosa ii) Second line therapy for acute rheumatoid arthritis Dosage : i) Initially 400 mg daily in divided dose. Maintenance : 200 - 400 mg daily ii) ADULT : 400 - 600 mg daily. Maintenance: 200 - 400 mg daily. CHILD : up to 6.5 mg/kg daily (maximum 400mg daily) Precautions: Liver disease, alcoholism or concurrent administration with known hepatotoxic drugs. G6PD deficiency, renal impairment or metabolic acidosis, patients with psoriasis or porphyria, haematologic disorders. If patient develops pigmentary abnormality or visual field defect, discontinue drug. Adverse Effects: Gastrointestinal disturbances, nausea, vomiting and diarrhea, headache, skin reactions, bleaching of hair, alopecia, blurred vision, difficulty in focusing, blood dyscrasias, drug-induced myopathy, disorder of cornea, cardiovascular: Torsades de pointes, agranulocytosis, retinopathy, ototoxicity (rare). Contraindications: Pre-existing maculopathy, pregnancy, hypersensitivity to 4-aminoquinoline compound, long-term use in children, retinal or visual field changes from prior 4-aminoquinoline compound. Interactions: Digoxin - increase level, metoprolol. -------------------------------------------------------------------------------------------------------------------------------------Leflunomide 10 mg Tablet A* Trade Name : Arava Indication : i) Persistent active rheumatoid arthritis ii) Active psoriatic arthritis Dosage : Loading dose: 100 mg once daily for 3 days. Maintenance: 10-20 mg once daily Precautions: Patients who are taking other drugs that can cause liver injury. Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter. If the alanine aminotransferase (ALT) rises to greater than two times the upper limit of normal while the patient is on leflunomide, leflunomide should be stopped, cholestyramine washout begun to speed the removal of leflunomide from the body and follow-up liver function tests conducted at least weekly until the ALT value is within normal range. Renal impairment, anaemia, leucopenia, thrombocytopenia, history of tuberculosis. Adverse Effects: Gastrointestinal disturbances, anorexia, oral mucosa ulceration, elevation of liver parameters, headache, dizziness, paraesthesias, increase blood pressure, weight loss, increase hair loss, eczema, dry skin, mild allergic reactions, leucopenia, mild hyperlipidaemia. Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. Contraindications: Patients with pre-existing liver disease. Patients with elevated liver enzymes (alanine aminotransferase greater than two times the upper limit of normal). Severe immunodeficiency state, serious infection, severe hypoproteinaemia, pregnant women or women of childbearing potential who are not using reliable contraception, lactation, significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia. 301 Interactions: Other antirheumatic or immuno-suppressive agents, alcohol, phenytoin, warfarin, tolbutamide. -------------------------------------------------------------------------------------------------------------------------------------Meloxicam 7.5 mg Tablet A/KK Trade Name : Mobic Indication : Only for patients not responding to other NSAIDs in the treatment of i) painful osteoarthritis ii) rheumatoid arthritis Dosage : i) initially 7.5 mg daily. May be increased to 15 mg daily ii) initially 15 mg daily. May be reduced to 7.5 mg daily. Maximum 15 mg daily. Child under 12 years not recommended Precautions: History of gastrointestinal disease, liver cirrhosis, dehydration. Chronic heart failure, nephrotic syndrome, overt renal disease, recent major surgical procedures. Withdraw if peptic ulceration or gastrointestinal bleeding occurs. Concomitant anticoagulant or diuretic treatment. Elderly. Adverse Effects: Dyspepsia, nausea, abdominal pain, pruritis, skin rash, constipation. Vomiting, flatulence, diarrhoea, anaemia, pruritus, lightheadedness, headache, oedema. Contraindications: Active peptic ulceration, pregnancy, lactation, hypersensitivity to NSAIDs or aspirin, severe hepatic insufficiency, non-dialysed severe renal insufficiency. Children less than 15 year. Interactions: NSAIDs, salicylates, oral anticoagulants, ticlopidine, heparin, thrombolytics, lithium, methotrexate, IUD, diuretics, antihypertensives, cholestyramine, ciclosporin. -------------------------------------------------------------------------------------------------------------------------------Naproxen Sodium 275 mg Tablet A Trade Name : Symflex Indication : i) Rheumatic arthritis, osteoarthritis and alkylosing spondylitis ii) Acute gout iii) Muscular skeletal disorder and dysmenorrhoea Dosage : i) 0.5 - 1 g daily in 2 divided doses ii) 750 mg initially then 250 mg 8 hourly iii) 500 mg initially then 250 mg every 6 - 8 hours as required Precautions: Active or previous history of gastrointestinal ulceration, bleeding or perforation. History of renal or liver dysfunction or coagulation defects. Hypertension or cardiac conditions aggravated by fluid retention and oedema, dehydration, diuretics, pregnancy and lactation. Adverse Effects: Abdominal discomfort, epigastric distress, gastrointestinal reactions, peptic ulceration, skin rash, pruritus, insomnia, visual disturbance, headache, nausea, peripheral oedema, tinnitus, vertigo. Prolongs bleeding time. Contraindications: Hypersensitivity, active or history of peptic ulceration. Patients whom aspirin & other NSAIDs induced symptoms of asthma, rhinitis, urticaria or other allergic reactions. Interactions: Probenecid, oral anticoagulants, thiazide diuretics, ACEIs, beta-blockers, methotrexate, lithium, aspirin, other NSAIDs. -------------------------------------------------------------------------------------------------------------------------------- 302 Allopurinol 300 mg Tablet B Trade Name : Zyloric Indication : Gout or uric acid and calcium oxalate renal stones Dosage : Initial dose : 100-300 mg daily. Maintenance : 300-600 mg daily. Maximum: 900 mg daily Precautions: Renal/hepatic dysfunction, asymptomatic hyperuricaemia, Hypersensitivity and pregnancy. Adverse Effects: Skin rash, maculopapular, pruritic, Stevens-Johnson Syndrome, peripheral neuritis, alopecia, GI upset, toxic epidermal necrolysis. Acute attack of gouty arthritis in early stages of therapy. Skin reactions (discontinue immediately at first sign of rash). Very rarely, granulomatous hepatitis. Occasionally; thrombocytopenia, agranulocytosis, & aplastic anaemia in patients with impaired renal function. Contraindications: Hypersensitivity to allopurinol, pregnancy, lactation, acute gout, asymptomatic hyperuricaemia. Interactions: Oral anticoagulants, azathioprine, antidiabetics, mercaptopurine.Use only quarter of the usual dose of 6-mercaptopurine or azathioprine when given concurrently. Increases plasma half-life of adenine arabinoside. Effects decreased by uricosurics & large doses of salicylates. -------------------------------------------------------------------------------------------------------------------------------------Eperisone HCl 50 mg Tablet A Trade Name : Myonal Indication : Myotonic symptoms associated with cervical syndrome, periarthritis of shoulder and lumbago spastic paralysis Dosage : 50 mg 3 times daily Precautions: Hepatic disorders, drug hypersensitivity. Adverse Effects: Weakness, dizziness, insomnia, drowsiness, numbness or trembling in the extremities, hepatic and renal dysfunction/ haematological changes, rashes, GI disturbances, urinary disorders. Contraindications: Not known. Interactions: Methocarbamol, tolperisone HCl. -------------------------------------------------------------------------------------------------------------------------------------Prolase Tablet Trade Name : Papase Indication : Oedema and inflammation in conjunction with other physical or chemotherapeutic measures Dosage : 2 tablet 4 times daily Precautions: Renal or hepatic dysfunction and pregnancy. Adverse Effects: Skin rash, vertigo and gastrointesinal upsets. Contraindications: 303 B Blood clotting disease. Interactions: No known. -------------------------------------------------------------------------------------------------------------------------------------- 304 18. OPHTHALMOLOGY Anti-infective eye preparations Anti-infective with steroids Corticosteroids Corticosteroids and other anti-inflammatory preparations Antiviral Mydristics and cycloplegics Treatment of glaucoma Local anaesthetics Miscellaneous ophthalmology 305 Amphotericin B 0.15% Eye Drops Indication : Fungal infection of the cornea Dosage : 1 drop hourly or 2 hourly Precautions : Renal impairment. Adverse Effects : Nausea and vomiting, anaemia, thrombocytopenia. Contraindications : Hypersensitivity to Amphotericin B. Interactions : Cyclosporin, digitalis glycosides, non-depolarizing neuromuscular blockers. -------------------------------------------------------------------------------------------------------------------------------Chloramphenicol 0.5% Eye Drops C Trade Name : CMC Indication : Broad spectrum antibiotic in superficial eye infections Dosage : 1 - 2 drops every 3 - 4 hours Precautions : Overgrowth of non-susceptible organisms in prolonged use. Adverse Effects : Allergic reactions, superinfection, bone marrow hypoplasia including aplastic anaemia. Contraindications : Hypersensitivity to chloramphenicol products. Interactions : Not known. --------------------------------------------------------------------------------------------------------------------------------Chloramphenicol 1% Eye Ointment C Trade Name : CMC Indication : Conjunctivitis and other superficial eye infection Dosage : Apply 1/2 inch of ointment every 3 - 4 times into the conjunctival sac Precautions : Overgrowth of non-susceptible organisms in prolonged use. Adverse Effects : Allergic reactions, superinfection, bone marrow hypoplasia including aplastic anaemia. Contraindications : Hypersensitivity to chloramphenicol products. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------- 306 A Ciprofloxacin HCl 0.3% Ophthalmic Solution A* Trade Name : Ciloxan Indication : i)For corneal ulcer ii) For bacterial conjunctivitis Dosage : i) 2 drops every 15 minutes for first 6 hours, then 2 drops every 30 minutes for the rest of the day. Second day : 2 drops every hour. Subsequent days (3rd - 14th day) : 2 drops every 4 hours. ii) 1 - 2 drops 2 hourly into the conjunctival sac while awake for 2 days and 1-2 drops 4 hourly while awake for the next 5 days Precautions : Prolonged use may result in overgrowth of nonsusceptible organisms. Discontinue use at first appearance of skin rash or other sign of hypersensitivity reactions. Children less than 1 year Adverse Reactions : Local burning or discomfort, itching, lid oedema, tearing, white crystalline precipitates which resolve Contraindications : History of hypersensitivity to ciprofloxacin or other quinolones Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Fusidic Acid 1% Eye Drops A Trade Name : Fucithalmic Indication : For staphylococcal infections Dosage : 1 drop in conjunctival sac 12 hourly. To be continued for 2 days after the eye appears normal. On the first day of treatment, may be applied more frequently : 1 drop 4 hourly. Surgical prophylaxis : 1 drop every 12 hours, 24 - 48 hours before operation Precautions : Do not apply to eyes with contact lenses. Adverse Effects : Transient stinging. Contraindications : Allergy to any of the constituents. Interactions : Cross allergy between fusidic acid and other antibiotics has not been reported. -------------------------------------------------------------------------------------------------------------------------------------Gentamicin 0.3% Eye Drops A/KK Trade Name : Garamycin Indication : Broad spectrum antibiotic in superficial eye infections and also for Pseudomonas aeruginosa Dosage : 1 - 2 drops every 4 hours, in severe infection dosage may be increased up to 2 drops every hour Precautions : Contact lens users, overgrowth of non-susceptible organisms on prolonged use, discontinue if irritation or sensitization occurs, pre-existing renal, vestibular, or auditory impairment, concomitant anesthesia, risk for neuromuscular blockade, respiratory paralysis, concomitant neurotoxic, ototoxic, nephrotoxic drugs. 307 Adverse Effects : Non-specific conjunctivitis, conjunctival epithelial defect and hyperemia, temporary burning sensation (rare), irritation, stinging, itching and dermatitis,hypokalemia, hypomagnesemia, hypocalcemia. Contraindications : Hypersensitivity to Gentamicin or aminoglycosides products. Interactions : Not known. --------------------------------------------------------------------------------------------------------------------------------Gentamicin 0.3% Eye Ointment A/KK Trade Name : Garamycin Indication : Conjunctivitis, blepharitis, blepharo-conjunctivitis, keratitis, keratoconjunctivitis, episcleritis, dacrocystitis, corneal ulcers, styes and infected eye socket Dosage : Apply into the conjunctival sac 3 - 4 times daily Precautions : Contact lens users, overgrowth of non-susceptible organisms on prolonged use, discontinue if irritation or sensitization occurs, pre-existing renal, vestibular, or auditory impairment, concomitant anesthesia, risk for neuromuscular blockade, respiratory paralysis, concomitant neurotoxic, ototoxic, nephrotoxic drugs. Adverse Effects : Non-specific conjunctivitis, conjunctival epithelial defect and hyperemia, temporary burning sensation (rare), irritation, stinging, itching and dermatitis,hypokalemia, hypomagnesemia, hypocalcemia. Contraindications : Hypersensitivity to Gentamicin or aminoglycosides products. Interactions : Not known. ----------------------------------------------------------------------------------------------------------------------------------Gentamicin 3% Fortified Eye Drops A Indication : Broad spectrum antibiotic in superficial eye infections and also for Pseudomonas aeruginosa Dosage : Dose according to the needs of the patient Precautions : Contact lens users, overgrowth of non-susceptible organisms on prolonged use, discontinue if irritation or sensitization occurs, pre-existing renal, vestibular, or auditory impairment, concomitant anesthesia, risk for neuromuscular blockade, respiratory paralysis, concomitant neurotoxic, ototoxic, nephrotoxic drugs Adverse Reactions : Non-specific conjunctivitis, conjunctival epithelial defect and hyperemia, temporary burning sensation (rare), irritation, stinging, itching and dermatitis,hypokalemia, hypomagnesemia, hypocalcemia Contraindications : Hypersensitivity to Gentamicin or aminoglycosides products Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------- 308 Moxifloxacin 0.5% Ophthalmic Solution A* Trade Name : Vigamox Indication : Treatment of conjunctivitis caused by susceptible organism Dosage : CHILD more than 1 year and ADULT: 1 drop to affected eye(s) 3 times daily for 7 days Precautions : Not to be injected subconjuctivally or introduced directly to the anterior chamber of the eye, prolong use, pregnancy and lactation. Adverse Effects : Conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, hyperemia, pain and pruritus, subconjunctival hemorrhage, tearing. Contraindications : Hypersensitivity to moxifloxacin and quinolone. Interactions : Warfarin, concomitant use with QT prolonging agents (eg. Class 1a and class III antiarrythmic, erythromycin, cisapride, antipsychotic, cyclic antidepressant), antacid, sucralfate. -------------------------------------------------------------------------------------------------------------------------------Betamethasone Disodium Phosphate 0.1% Eye/Ear Drops A Trade Name : Betnesol Indication : Non-infected inflammatory conditions of the eyes/ears Dosage : 1 - 2 drops every 1 - 2 hours until controlled then reduce frequency Precautions : Prolonged use in infants. May impair ability to drive or operate machinery. Pregnancy. Withdrawal if there is spread of infection. Adverse Effects : Rise in intraocular pressure, corneal ulcers. Rarely, acute sensitization to neomycin, optic nerve damage, visual acuity and field defects. Contraindications : Bacterial, fungal, viral, tuberculous or purulent conditions of the eye. Glaucoma, herpetic keratitis (e.g. dendritic ulcer). Hypersensitivity to any component of the preparation. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Dexamethasone and Neomycin Sulphate and Polymyxin B Sulphate Ophthalmic Suspension A Trade Name : Maxitrol Indication : Treatment of ocular inflammation when concurrent use of an antimicrobial is judged necessary Dosage : 1 - 2 drops hourly for severe cases and 4 - 6 hourly for mild infection Precautions : Glaucoma, corneal or scleral thinning, history of HSV infection. Adverse Effects : Burning and stinging or local irritation may occur. Hypersensitivity (due to neomycin content). Ocular itching, reddening, conjunctival oedema, rash or persistent irritation, periorbital oedema. 309 Contraindications : Hypersensitivity to its component, viral, fungal, tuberculosis and other infections of the eye. Interactions : Not known. ------------------------------------------------------------------------------------------------------------------------------------Dexamethasone and Neomycin Sulphate and Polymyxin B Eye Ointment A Trade Name : Maxitrol Indication : Treatment of ocular inflammation when concurrent use of an antimicrobial is judged necessary Dosage : Apply 1 - 1.5 cm 3 - 4 times daily, may be used adjunctively with drops at bedtime Precautions : Glaucoma, corneal or scleral thinning, history of HSV infection. Adverse Effects : Burning and stinging or local irritation may occur. Hypersensitivity (due to neomycin content). Ocular itching, reddening, conjunctival oedema, rash or persistent irritation, periorbital oedema. Contraindications : Hypersensitivity to its component, viral, fungal, tuberculosis and other infections of the eye. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Antazoline HCl, Tetrahydrozoline HCl and Benzalkonium Cloride Eye Drops A/KK Trade Name : Spersallerg Indication : Hay fever, conjunctivitis, allergic conjunctivitis, vernal keratoconjunctivitis and eczematosa Dosage : ADULT : Instill 1 drop, 3 - 4 times daily, into the lower eyelid. CHILD 2 - 12 years : Instill 1 drop daily or twice daily Precautions : Transient irritation may occur immediately after instillation. Adverse Effects : Mild burning sensation, headache, and sleepiness, tachycardia, blurred vision. Contraindications : Hypersensitivity to any of the components of product, dry eyes; especially keratoconjunctivitis sicca, risk of narrow angle glaucoma, receiving monoamine oxidase inhibitors or within 14 days of its treatment, children under two years of age; due to the greater incidence of systemic absorption and effects. Interactions : Not known. ------------------------------------------------------------------------------------------------------------------------------Fluorometholone 0.1% Ophthalmic Suspension Trade Name : FML liquifilm, Flarex ophth Susp Indication : Treatment of steroid responsive ocular inflammation Dosage : 1-2 drops 2 - 4 times dailyy Precautions : Glaucoma, corneal or scleral thinning. 310 A* Adverse Effects : Burning or stinging, ocular irritation, unpleasant taste, blurred vision, increased intra-ocular pressure, glaucoma, cataract, corneal thinning. Contraindications : Hypersensitivity to its component, ocular viral or fungal or tuberculosis infection, contact lense use. Interactions : Not known. ----------------------------------------------------------------------------------------------------------------------------------Acyclovir 3% Eye Ointment A* Trade Name : Zovirax Indication : Only for the treatment of herpes simplex keratitis Dosage : Apply 1 cm 5 times daily. Continue for at least 3 days after healing Precautions : Not known. Adverse Effects : Local irritation and inflammation reported , vision abnormalities. Contraindications : Hypersensitivity to acyclovir. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Atropine Sulphate 1% Eye Drops B Indication : Determination of refraction, strabismus, iritis and iridocyclitis, after extra or intracapsular extraction of lens Dosage : PREOPERATIVE MYDRIASIS : one drop of a 1% solution supplemented with one drop of 2.5 or 10% phenylephrine prior to surgery. ANTERIOR UVEITIS or POSTOPERATIVE MYDRIASIS : one drop of a 1% or 2% solution up to 3 times a day Precautions : Risk of systemic effects with the eye drops in infants under 3 months-eye ointment preferred Adverse Effects : Transient stinging and raised intra-ocular pressure, local irritation, hyperaemia, oedema and conjunctivitis Contraindications : Glaucoma or suspected glaucoma. Hypersensitivity Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Cyclopentolate 1% Eye Drops A Trade Name : Cyclogyl Indication : Mydriasis and cycloplegia Dosage : 1 - 2 drops several times a day. Refractory procedures, ADULT : 1 drop of 0.5% solution. CHILD 6 - 12 years : 1 drop of 1% solution. CHILD less than 6 years : 1 - 2 drops of 1% solution 311 Precautions : May impair ability to drive or operate machinery Adverse Effects : Mild tachycardia, secretion decrease and action on the CNS, blurred vision, increased intraocular pressure, allergic reactions Contraindications : Narrow-angle glaucoma Interactions : Cyclopentolate may interfere with antiglaucoma action of carbachol or pilocarpine -------------------------------------------------------------------------------------------------------------------------------------Homatropine 2% Eye Drops B Indication : Treatment of anterior segment inflammation. Producing cycloplegia and mydriasis for refraction Dosage : 1 drop 1 - 4 times daily Precautions : Systemic toxicity especially in infants and small children.Children with brain damage, Down's syndrome. Elderly, keratoconus, avoid bright light, driving, or hazardous activity while pupils are dilated,avoid contact with oral mucosa; wash hands thoroughly after use. Adverse Effects : Transient stinging, local irritation, keratitis, pain in eye, raised intraocular pressure. Contraindications : Hypersensitivity to homatropine products, primary glaucoma or tendency toward glaucoma (e.g. narrow anterior chamber). Interactions : Cisapride, procainamide. --------------------------------------------------------------------------------------------------------------------------------Phenylephrine HCI 2.5% Eye Drops B Trade Name : Mydfrin Indication : For pupillary dilation in uveitis, for refraction without cyclopegic. For fundoscopy and other diagnostic procedures Dosage : Mydriasis and vasoconstriction: 1 drop of 2.5% or 10% solution, repeated in one hour if necessary. Chronic mydriasis: 1 drop of a 2.5% or 10% solution 2 - 3 times a day. Uveitis with posterior synechiae (treatment) or synechiae, posterior (prophylaxis): 1 drop of a 2.5% or 10% solution, repeated in one hour if necessary, not to exceed three times a day. Treatment may be continued the following day, if necessary Precautions : Caution if administered with or up to 3 weeks after MAOI therapy. Infant with cardiac anomalies. To prevent pain and subsequent lacrimation on administration, a suitable topical anesthetic may be applied a few minutes before use of phenylephrine solution. Repeated use of phenylephrine, especially in older patients, may result in rebound miosis and a reduced mydriatic effect. Medication may cause increased sensitivity of eyes to light. Adverse Effects : Marked increase in blood pressure in low-weight neonates, infant and adult with idiopathic hypotension. Cardiovascular reactions in the elderly. 312 Contraindications : Narrow-angle glaucoma, infant, elderly with severe arteriosclerotic, cardiovascular or cerebrovascular disease. During intraocular operative procedures when corneal epithelial barrier is disturbed. Not recommended for use in low birth weight infants. Interactions : Tricyclic antidepressants, propranolol. ------------------------------------------------------------------------------------------------------------------------------Tropicamide 1% Eye Drops A/KK Trade Name : Mydriacyl Indication : Topical use to produce cycloplegic refraction for diagnostic purposes Dosage : 1 - 2 drops several times a day Precautions : Individuals susceptible to belladona alkaloids, inflammed eyes, pregnancy, children, elderly. Infants and children, may cause central nervous system disturbances. Adverse Effects : Increased intraocular pressure, dryness of mouth, transient stinging, allergic reactions, tachycardia, headache, parasympathetics stimulation, blurred vision, photosensitivity. Contraindications : Primary glaucoma or a tendency toward glaucoma. Sensitivity to tropicamide. Interactions : Antimuscarinic effects potentiated by concomitant use of amantadine, tricyclic antidepressants, phenothiazine and butyrophenones and antihistamines. -------------------------------------------------------------------------------------------------------------------------------Acetazolamide 250 mg Tablet B Trade Name : Diamox Indication : Reduction of intraocular pressure in open-angle glaucoma, secondary glaucoma and peri-operatively in angle-closure glaucoma Dosage : 250 - 500 mg daily Precautions : Not generally recommended for prolonged use but if given monitor blood count and plasma electrolyte concentration, pulmonary obstruction (risk of acidosis), elderly, pregnancy and lactation, Stevens-Johnson syndrome, toxic epidermal necrosis, high-dose aspirin, high dose may decrease diuresis and may increase drowsiness, pulmonary obstruction or emphysema. Adverse Effects : Nausea, vomiting, diarrhoea, taste disturbances, loss of appetite, paraesthesia, flushing, headache, dizziness, fatigue, irritability, depression, thirst, polyuria, reduced libido, metabolic acidosis and electrolyte disturbances on long-term therapy. Contraindications : Hypokalaemia, hyponatraemia, hyperchloraemic acidosis, severe hepatic impairment, renal impairment, sulphonamide hypersensitivity. Interactions : Aspirin, cyclosporin, digitalis , digoxin, lithium, phenytoin, quinidine, topiramate. --------------------------------------------------------------------------------------------------------------------------------- 313 Acetazolamide 500 mg Injection B Trade Name : Diamox Indication : Reduction of intra-ocular pressure in open-angle glaucoma, secondary glaucoma and perioperatively in angle-closure glaucoma Dosage : 250 - 500 mg given by IM or IV Precautions : Not generally recommended for prolonged use but if given monitor blood count and plasma electrolyte concentration, pulmonary obstruction (risk of acidosis), elderly, pregnancy and lactation, Stevens-Johnson syndrome, toxic epidermal necrosis, high-dose aspirin, high dose may decrease diuresis and may increase drowsiness, pulmonary obstruction or emphysema. Adverse Effects : Nausea, vomiting, diarrhoea, taste disturbances, loss of appetite, paraesthesia, flushing, headache, dizziness, fatigue, irritability, depression, thirst, polyuria, reduced libido, metabolic acidosis and electrolyte disturbances on long-term therapy. Contraindications : Hypokalaemia, hyponatraemia, hyperchloraemic acidosis, severe hepatic impairment, renal impairment, sulphonamide hypersensitivity. Interactions : Aspirin, cyclosporin, digitalis , digoxin, lithium, phenytoin, quinidine, topiramate. -------------------------------------------------------------------------------------------------------------------------------Bimatoprost 0.03% Ophthalmic Solution A* Trade Name : Lumigan Indication : Lowering of intraocular pressure in patients with open-angle glaucoma and ocular hyperten Dosage : 1 drop in affected eye(s) once daily at evening Precautions : Aphakia, pseudoaphakia, active intraocular inflammation, macular oedema, renal impairment, liver impairment, pregnancy, lactation. Adverse Effects : Eyelash formation, conjunctival hyperemia, iris pigmentation, ocular pruritus, conjunctival oedema, headache, hypertension, common cold, acute upper respiratory infection, superficial punctuate keratitis. Contraindications : Hypersensitivity to bimatoprost or any component of the product. Interactions : Latanoprost. -------------------------------------------------------------------------------------------------------------------------------Brimonidine Tartrate 0.15% Ophthalmic Trade Name : Alphagan P Indication : Lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension Dosage : 1 drop in the affected eye(s) 3 times daily Precautions : Severe cardiovascular disease, liver impairment, renal impairment, depression, Raynauld?s phenomenon, orthostatic hypotension, thromboangiitis obliterans, pregnancy, lactation. 314 A* Adverse Effects : Oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue, drowsiness, conjunctival follicles, ocular pruritus. Contraindications : Hypersensitivity to brimonidine, concomitant MAOI therapy. Interactions : Alcohol, sedative, barbiturates, opiates, anaesthesia, tricyclic antidepressant, beta blocker, antihypertensive. -------------------------------------------------------------------------------------------------------------------------------Dorzolamide HCl 2% Ophthalmic Solution A* Trade Name : Trusopt Indication : All glaucoma patients where beta-blockers are contraindicated and when intraocular pressure is not well controlled by other drugs Dosage : Monotherapy : 1 drop 3 times daily. Adjunctive therapy with an ophthalmic beta-blocker : 1 drop 2 times daily. When substituting for another ophthalmic antiglaucoma agent with this product, discontinue the other agent after proper dosing on one day and start Trusopt on the next day. If more than 1 topical ophthalmic drug is used, the drugs should be administered at least 10 mins apart Precautions : Patients with severe renal or hepatic impairment. Pregnancy and lactation. Children. Remove contact lens prior to administration and do not reinsert 15 minutes after use. Acute angle glaucoma, sensitivity to sulfonamide, concomitant use of oral carbonic-anhydrase inhibitors, conjunctivitis and lid reactions reported with chronic administration, ocular infection or inflammation, recent ocular surgery, reports of bacterial keratitis associated with the use of multiple dose containers of ophthalmic products Adverse Reactions : Burning, stinging, conjunctivitis, eyelid inflammation, eye itching, eyelid irritations, headache, bitter taste, nausea, itching, fatigue/asthenia, blurred vision, tearing. Rarely, iridocyclitis and rash. Angioedema, bronchospasm, urticaria, pruritis, dizziness, paraesthesia, transient myopia (resolve upon discontinuation) and superficial punctate keratitis Contraindications : Patients who are hypersensitive to any component of this product Interactions : High dose of salicylate therapy. Potential additive effect with oral carbonic anhydrase inhibitors -------------------------------------------------------------------------------------------------------------------------------------Latanoprost 0.005% Eye Drops A* Trade Name : Xalatan Indication : Reduction of elevated intraocular pressure in patients with open-angle glaucoma Dosage : The recommended dosage is one drop (1.5 µg) in the affected eye(s) once daily in the evening. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart Precautions : Inflammatory, neovascular, angle closure or congenital glaucoma, open angle glaucoma of pseudophakic patients, pigmentary glaucoma, acute attacks of closed angle glaucoma, pregnancy and lactation. Contact lens users. 315 Adverse Effects : Slight discomfort, mild to moderate conjunctival hyperaemia, transient punctate ephitelial erosions, increased pigmentation of iris, rash. Contraindications : Known hypersensitivity to any component of the products. Interactions : Effects additive to beta-adrenergic antagonist, adrenergic agonists, carbonic anhydrase inhibitors and cholinergic agonists. Other eye preparation containing thiomersal. --------------------------------------------------------------------------------------------------------------------------------Pilocarpine 2% Eye Drops B Indication : Miotics in chronic open-angle glaucoma Dosage : 1 drop 1 - 4 times a day Precautions : Retinal disease; conjunctival or corneal damage. Intraocular pressure and visual fields should be monitored in those with simple chronic glaucoma and those receiving long-term treatment with a miotic. Caution in cardiac disease, hypertension, asthma, peptic ulceration, urinary-tract obstruction and parkinson's disease. Adverse Effects : Ciliary spasm leads to headache and browache which may be more severe in the initial 2 - 4 weeks of treatment. Ocular side effects include burning, itching, smarting, blurred vision, conjunctival vascular congestion, myopia, lens changes with chronic use, vitreous haemorrhage and pupillary block. Contraindications : Contraindicated in conditions where pupillary constriction is undesirable such as acute iritis, anterior uveitis and some forms of secondary glaucoma. Acute inflammatory disease of the anterior segment. Interactions : Not known. ------------------------------------------------------------------------------------------------------------------------------Timolol Maleate 0.5% Eye Drops A Trade Name : Timoptol,timoptol-XE,Timo-comod Indication : Elevated intraocular pressure, chronic open angle galucoma Dosage : Initially, 1 drop of 0.25% 2 times daily, if clinical response is not adequate, 1 drop of 0.5% 2 times daily Precautions : History of atopy or a history of severe anaphylactic reaction to a variety of allergens, pregnancy and lactation. May impair ability to drive or operate machinery. Adverse Effects : Bradycardia, hypotension, confusion, depression, dizziness, fatigue, abdominal pain, diarrhoea, nausea, vomiting, dyspepsia, dry eye, ocular burning, corneal anaesthesia. Contraindications : Bronchial asthma or a history of bronchial asthma, severe COPD, sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure and cardiogenic shock. 316 Interactions : Cathecolamine-depleting drugs. Concurrent administration of oral or systemic beta-adrenergic blockers. Concurrent use of beta-blockers and digitalis with diltiazem or verapamil may have additive effects in prolonging atrioventricular conduction time. Quinidine. -------------------------------------------------------------------------------------------------------------------------------Proparacaine HCI 0.5% Ophthalmic Drops B Trade Name : Alcaine Indication : Topical anaesthesia in ophthalmic procedures Dosage : Deep anaesthesia, 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses. Superficial anaesthesia, 1 to 2 drops in each eye before surgery or diagnostic procedure. Tonometry and/or tonography procedure, 1 to 2 drops in each eye before procedure Precautions : Use cautiously in patients with cardiac disease and hyperthyroidism, prolonged use not recommended. Protect the eye from irritants, rubbing and foreign bodies during period of anaesthesia Adverse Effects : Transient stinging and burning, conjunctival redness, keratitis, systemic toxicity. Long term use may result in corneal damage, loss of vision and retard healing Contraindications : Hypersensitivity Interactions : Hyaluronidase, St John's wort, increase effects of phenylephedrine, tropicamide -------------------------------------------------------------------------------------------------------------------------------Balanced Salt Solution Trade Name : BSS Indication : For irrigation during ocular surgery Dosage : Irrigate as directed Precautions : For local use only. The use of additives with this solution may cause corneal decompensation Adverse Effects: Ocular irritation Contraindications : Hypersensitivity to any of the components of product Interactions : Not known A -------------------------------------------------------------------------------------------------------- Hypromellose 0.3% Eye Drops Trade Name : Dacrolux Indication : Tear deficiency, ophthalmic lubricant; for relief of dry eyes and eye irritation Dosage : 1 - 2 drops several times a day 317 B Precautions : Self-prescribed use as an ocular lubricant should not exceed 3 days, avoid contamination of the applicator tip through contact, remove viscoelastic solutions form the anterior chamber at the end of the surgical procedure, treat emergent elevations of intraocular pressure Adverse Effects : Increases in intraocular pressure, blurred vision Contraindications : Hypersensitivity to hydroxypropyl methylcellulose Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Hypromellose 0.3%, Carbomer 980 Ophthalmic Gel B Trade Name : Genteal Gel Indication : Symptomatic relief of severe dry eye conditions and as lens lubricant during ophthalmic diagnostic procedures Dosage : Instill 1-2 drops in affected eye(s) as needed Precautions : Avoid contamination of the applicator tip through contact, self-prescribed use as an ocular lubricant should not exceed 3 days ,treat emergent elevations of intraocular pressure. Adverse Effects : Blurred vision, raised intraocular pressure, transient, postoperatively, Sticking of eyelids (discharge). Contraindications : Hypersensitivity to hypromellose. Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------Ketorolac Tromethamine 0.5% Eye drops A Trade Name : Acular Indication : i) Ocular itching due to allergic conjunctivitis ii) Prophylaxis and reduction of inflammation and associated symptoms following ocular surgery Dosage : i) 1 drop 4 times daily ii) 1 drop 4 times daily starting 24 hours post-operation, continue for 2 weeks Precautions : Bleeding tendencies, ocular surgery, dry eye syndrome, diabetes mellitus, rheumatoid arthritis. Avoid contact lens use. Adverse Effects : Transient burning sensation in the eye, corneal edema, eye irritation. Contraindications : Hpersensitivity to its component, aspirin, NSAIDs or phenylacetic acid derivatives. Pregnancy third trimester. Interactions : Antiplatelet, anticoagulant, aspirin, NSAIDs : may increase ocular bleeding risk post-operation. Intraocular cholinergic agent : may decrease cholinergic agent efficacy. -------------------------------------------------------------------------------------------------------------------------------- 318 Sodium Chloride 0.9% Eye Drops C Indication : Irrigation of conjunctival sac Dosage : 1 - 2 drops every 3 - 4 hours Precautions : Not known Adverse Effects : Can cause temporary burning and irritation Contraindications : Hypersensitivity Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Sodium Cromoglycate 2% Eye Drops A/KK Trade Name : Opticrom Indication : Prevention and treatment of allergic conjunctivitis including seasonal and perennial allergic conjunctivitis and vernal keratoconjunctivitis Dosage : 1 or 2 drops 4 times daily Precautions : Pregnancy, lactation, children up to 4 years of age, elderly. Adverse Effects : Transient stinging and burning may occur after instillation and other symptoms of local irritation, itching, redness and severe swelling of the eyes. Contraindications : Patients with known hypersensitivity to sodium cromoglycate or any other ingredient of the products. Interactions : Not known. ----------------------------------------------------------------------------------------------------------------------------------- 319 19. EAR, NOSE AND OROPHARYNX Ear preparations Nose preparations Oropharynx preparations Antihistamies, hyposensitisation and allergic emergencies Mucolytics Aromatic inhalations Cough preparations Systemic nasal decongestants Miscellaneous ear, nose and oropharynx 320 Betamethasone Disodium Phoshate 0.1% Ear Drops B Betamethasone Disodium Phoshate 0.5% Ear Drops B Trade Name : Betnesol Indication : Non-infected inflammatory conditions Dosage : Apply 2 - 3 drops every 2 - 3 hours, reduce frequency when relief obtained Precautions : Prolonged use in infants, pregnancy, may result in secondary fungal infections. Adverse Reactions : Local sensitivity reactions. Contraindications : Viral, fungal, tuberculosis, purulent eye infection, glaucoma, herpetic keratitis, otitis media, history of perforation of the ear drum. Interactions : As general with other corticosteroids. -------------------------------------------------------------------------------------------------------------------------------------Chloramphenicol 5% w/v Ear Drops C Trade Name : Chloromycetin Indication : Acute otitis media, otitis externa with perforation Dosage : Apply 2 - 3 drops into the ear 2 - 3 times daily. Not to be used for long term Precautions : Use with caution in the presence of perforated tymphanic membrane. Overgrowth of nonsusceptible infection over prolonged use. Adverse Reactions : Sensitivity to the vehicle propylene glycol, local irritation with symptoms of burning, itching, urticaria, transient stinging. Contraindications : Hypersensitivity to chloramphenicol products, perforated tympanic membrane, chronic otitis media with perforation. Interactions : With other antibacterials, antiepileptics, anticoagulants, cyclosporine. -------------------------------------------------------------------------------------------------------------------------------------Framycetin Sulphate 0.5%, Dexamethasone 0.05% and Gramicidin 0.005% Ear Drops A/KK Trade Name : Sofradex Indication : Otitis externa Dosage : Apply 2 - 3 drops 3 to 4 times daily Precautions : Glaucoma, pregnancy, prolonged use in infants. Adverse Reactions : Sensitivity reactions. Contraindications : Herpes simplex infection, viral diseases of cornea and conjuctiva, tuberculosis and fungal diseases of eyes, herpetic keratitis. 321 Interactions : Can increase nephrotocixity with amphotericin, cyclosporine. -------------------------------------------------------------------------------------------------------------------------------------Ofloxacin 0.3% Otic Solution A Trade Name : Tarivid Indication : Acute otitis media with tympanostomy tubes, chronic suppurative otitis media with perforated tympanic membranes and otitis externa Dosage : CHILD: 1 - 12 years: 5 drops twice daily for 10 days. ADULT and CHILD over 12 years: 6 - 10 drops twice daily and remain in the ear about 10 minutes Precautions : If otic therapy does not resolve otorrhea after a full course of therapy, further evaluation is suggested for other underlying causes. Prolonged use may result in overgrowth of fungal. Adverse Reactions : Ear ache, secondary fungal infection, otalgia, hearing reduction. Contraindications : Hypersensitiviti to ofloxacin, pregnancy, lactation. Interactions : Antacids, sucralfate, oral antidiabetics, warfarin, theophylline, probenecid, aminoglycosides, betalactam antibiotics. ----------------------------------------------------------------------------------------------------------------------------------Sodium Bicarbonate 5% w/v Ear Drops C Indication : To soften the impacted ear wax Dosage : 2-3 drops 3-4 times daily Precautions : Not known. Adverse Reactions : Contact dermatitis to sodium bicarbonate. Contraindications : Not known Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Alkaline Nasal Douche Indication : To remove nasal plug due to radiation Dosage : To be diluted with an equal volume of warm water before use Precautions : Epistaxis, not to be used in cranial surgery or trans nasal neuro surgical procedure. Adverse Reactions : Excessive use can be toxic due to its absorption. Contraindications : Not known. 322 B Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Bismuth Subnitrate, Iodoform and Liquid Paraffin Paste B Trade Name : BIPP Indication : As a mild antiseptic for wounds and abscesses. Sterile gauze impregnated with paste for packing cavities after otorhinological surgery Dosage : As directed for local application Precautions : Hyperthyroidism, nasal packing use not more than 3 days. Ear packing use not more than 2 weeks. Adverse Reactions : Erythematous rash, encephalopathy reported only with large packs or when placed directly on neural tissue, nasal mucosal fibrosis. Contraindications : Allergy to iodine or other components in the preparations. Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Fusafungine 1% Nasal Spray A Trade Name : Locabiotal Indication : Local antibiotic, anti-inflammatory treatment of infectious and inflammatory syndromes of the respiratory mucosa Dosage : ADULT : 1 oral or 1 nasal inhalation 4 hourly, withdraw if no improvement after 7 days. CHILD : 1 oral or 1 nasal inhalation 6 hourly, withdraw if no improvement after 7 days Precautions : Treatment should be less than 10 days, reevaluate after this. Adverse Reactions : Rare cases of buccopharyngeal irritation and sneezing. Contraindications : Hypersensitivity to fusafungine. Children less than 30 months of age (risk of laryngospasm). Interactions : Systematically report any other ongoing treatment to the doctor or pharmacist so as to avoid any interaction between several drugs. -------------------------------------------------------------------------------------------------------------------------------------Mometasone Furoate 50 mcg Aqueous Nasal Spray A* Trade Name : Nasonex Indication : Allergic rhinitis Dosage : ADULT and CHILD over 12 years: 100 mcg/day (2 sprays) to each nostril once daily. Maximum 200 mcg (4 sprays) once daily. Reduce to 50 mcg (1 spray) once daily when control achieved. CHILD 6 - 12 years old: 50 mcg (1 spray) to each nostril once daily 323 Precautions : Presence of untreated localized infection involving the nasal mucosa, recent nasal surgery or trauma, pregnancy, infection e.g. tuberculosis, infection of the respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections or ocular herpes simplex, systemic effects e.g. hypercorticism, reduced bone mineral density and adrenal suppression, untreated systemic infections. Adverse Reactions : Headache, pharyngitis, cough epistaxis, viral infection, chest pain, dysmenorrhoea, vomiting, nausea, diarrhoea, dyspepsia. Contraindications : Severe nasal infections especially candidiasis, patients with haemorrhagic diathesis or a history of recurrent nasal bleeding, fungal, viral or tubercular skin lesions, herpes simplex or zoster, hypersensitivity to mometasone or other corticosteroids, status asthmaticus or other acute episodes of asthma (oral inhalation). Interactions : CYP3A4, amphotericin, antidiabetic agents, antifungal agents (imidazole), diuretics, potassiumwasting (loop or thiazide), fluoroquinolones. -------------------------------------------------------------------------------------------------------------------------------------Oxymetazoline HCl 0.025% (Paediatric) Nasal Spray A Trade Name : Afrin, Iliadin Indication : Acute colds, paranasal sinusitis and otitis media Dosage : 2 - 3 sprays into each nostril twice daily for child more than 1 year Precautions : Cardiovascular disease, diabetes mellitus, hypertension, prostatic enlargement, prolonged use over 3 to 5 days, thyroid disease. Adverse Reactions : After local use of oxymetazoline transient irritation may occur. Rebound congestion may occur after frequent or prolonged nasal use. Systemic effects have occurred after local administration, burning, sneezing, nasal dryness, hypertension. Contraindications : Skin and mucosal inflammation of the nasal vestibules with incrustation, narrow angle glaucoma, hypersensitivity to oxymetazoline or other adrenergic agents. Interactions : Anticholinergic, beta blockers, linezolid, methylphenidate, tricyclic antidepressants, hypertensive crisis if used during treatment with MAOI. -------------------------------------------------------------------------------------------------------------------------------------Oxymetazoline HCl 0.05% (Adult) Nasal Spray A Trade Name : Afrin, Iliadin Indication : Acute colds, paranasal sinusitis and otitis media Dosage : 2 - 3 sprays into each nostril twice daily, maximum 6 sprays per nostril/day Precautions : Cardiovascular disease, diabetes mellitus, hypertension, prostatic enlargement, prolonged use over 3 to 5 days, thyroid disease. Adverse Reactions : 324 After local use of oxymetazoline transient irritation may occur. Rebound congestion may occur after frequent or prolonged nasal use. Systemic effects have occurred after local administration, burning, sneezing, nasal dryness, hypertension. Contraindications : Skin and mucosal inflammation of the nasal vestibules with incrustation, narrow angle glaucoma, hypersensitivity to oxymetazoline or other adrenergic agents. Interactions : Anticholinergic, beta blockers, linezolid, methylphenidate, tricyclic antidepressants, hypertensive crisis if used during treatment with MAOI. -------------------------------------------------------------------------------------------------------------------------------------Benzydamine HCl 0.15% Solution B Trade Name : Difflam Indication : For relief of painful condition of the oral cavity Dosage : Used as a 30 seconds gargle or rinse, undiluted. ADULT 15 ml. CHILD less 12 years 5-15 ml. Uninterrupted treatment should not be more than 7 days Precautions : Hepatic or renal impairment, pregnancy, children less than 6 years, in bacterial infection, appropriate antibacterial therapy should be used in addition to product. Adverse Reactions : Oral numbness, dryness or thirst, tingling, warm feeling in mouth, altered sense of taste. Contraindications : Known hypersensitivity to the drug or to any of the components of the vehicle. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Chlorhexidine Gluconate 0.2 % Mouthwash C Trade Name : Hibitane Indication : As a gargle Dosage : Rinse mouth with 10 ml for about 1 minute twice daily Precautions : Avoid prolonged skin contact with alcoholic solution. Avoid contact with eyes, brain, meninges, middle ear and body cavities. For external use only. Adverse Reactions : Occasionally, irritative skin reactions, extremely rare, generalised allergic reactions. Contraindications : Patients who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reaction are extremely rare. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Choline Salicylate 8.7%, Cetylkonium Chloride 0.01% Dental Gel B Trade Name : Bonjela Indication : For relief of the pain and discomfort in mouth ulcers and sores, infant teething and denture irritation 325 Dosage : Apply to area 4 times daily Precautions : Excessive use can lead to salicylate poisoning. During therapy, do not give aspirin to children 16 year. Co-administration with drugs for blood clots and gout. Stomach ulcer. Pregnancy. Adverse Reactions : Not known. Contraindications : Infants less than 4 months or in patients with a history of salicylate sensitivity. Preparations containing aspirin should not be given to young children during treatment to avoid any risk of excessive salicylate levels. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Glycerin B Indication : As a lubricant and osmotic dehydrating agent Dosage : Apply to area when required Precautions : Cause irritation when given locally, local anesthetic may be used before application Adverse Reactions : Mainly due to dehydration action, irritation Contraindications : Not known Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Thymol Compound Gargle C Indication : For sore throat and minor mouth inflammation Dosage : To be gargled 3-4 times daily Precautions : Not to be swallowed. Adverse Reactions : Irritant to the gastric mucosa. Contraindications : Not known. Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------Triamcinolone Acetonide 0.1% Oral Paste Trade Name : Kenalog in Orabase Indication : Oral and perioral lesions Dosage : Apply a thin layer to affected area 2-4 times daily 326 B Precautions : Tuberculosis, peptic ulcer, diabetes mellitus, pregnancy. Adverse Reactions : Prolonged use may lead to possible absorption. Contraindications : Hypersensitivity to any of its components, fungal or bacterial infections of the mouth or throat, herpetic lesions of known viral origin or intraoral lesions. Interactions : Minor interaction with hypoglycaemic agents. -------------------------------------------------------------------------------------------------------------------------------------Cetirizine HCl 10 mg Tablet A/KK Trade Name : Zyrtec Indication : Urticaria, allergic dermatoses (insect bites, atopic eczema), perennial rhinitis, allergic rhinitis Dosage : ADULT and CHILD over 6 years:10 mg daily or 5 mg twice daily. Child 2-6 years: 5 mg once daily or 2.5 mg twice daily Precautions : Activities requiring mental alertness. Concurrent use of central nervous system depressants. Renal insufficiency or hepatic dysfunction, elderly. Patient less than 2 years. Adverse Reactions : Somnolence, fatigue, headache and dry mouth. Contraindications : Hypersensitivity to cetirizine or hydroxyzine. Interactions : Decreased cetirizine clearance resulting in elevated cetirizine serum concentrations and possibly cetirizine toxicity with theophylline. -------------------------------------------------------------------------------------------------------------------------------------Chlorpheniramine Maleate 10 mg/ml Injection B Trade Name : Piriton Indication : Allergic conditions Dosage : 10 - 20 mg IM or SC, repeated if required. Not to exceed 40 mg in 24 hours. 10 - 20 mg over 1 minute by slow IV Precautions : Porphyria, pregnancy, asthma, glaucoma, avoid operating vehicles or machinery. Parenteral injection have to be protected from light to prevent discolouration. Adverse Reactions : Drowsiness, dizziness, stinging or burning sensation at injection site, hypotension, CNS stimulation, tinnitus, blurred vision, irritability, lassitude. Contraindications : Hypersensitivity to chlorpheniramine. Interactions : Alcohol pontentiate CNS depressants, actions prolonged by MOAIs, anticholigernic drugs. -------------------------------------------------------------------------------------------------------------------------------------- 327 Chlorpheniramine Maleate 2 mg/5 ml Syrup C Trade Name : Piriton Indication : Symptomatic treatment of allergic conditions responsive to antihistamine Dosage : CHILD 1 - 2 years : 1 mg twice daily, 2 - 5 years : 1 mg every 4 - 6 hours (maximum 6 mg daily), 6 - 12 years : 2 mg every 4 - 6 hours (maximum 12 mg daily) Precautions : Porphyria, pregnancy, asthma, glaucoma, avoid operating vehicles or machinery. Adverse Reactions : Drowiness, dizziness, hypotension, CNS stimulation, tinnitus, blurred vision, irritability, lassitude. Contraindications : Hypersensitivity to chlorpheniramine. Interactions : Alcohol pontentiate CNS depressants, actions prolonged by MAOIs, anticholigernic drugs. -------------------------------------------------------------------------------------------------------------------------------------Chlorpheniramine Maleate 4 mg Tablet C Trade Name : Piriton Indication : Symptomatic treatment of allergic conditions responsive to antihistamines Dosage : ADULT : 4 mg every 4 - 6 hours. Maximum 24 mg daily. CHILD 1 - 2 years : 1 mg twice daily, 2 - 5 years : 1 mg every 4 - 6 hours (maximum 6 mg daily), 6 - 12 years : 2 mg every 4 - 6 hours (maximum 12 mg daily) Precautions : Prophyria, pregnancy, asthma, glaucoma avoid operating vehicles or machinery. Adverse Reactions : Drowsiness, dizziness, hypotension, CNS stimulation, tinnitus, blurred vision, irritability, lassitude. Contraindications : Hypersensitivity to chlorpheniramine. Interactions : Alcohol, CNS depressants, MAOIs, anticholinergics drugs. -------------------------------------------------------------------------------------------------------------------------------Desloratadine 5 mg Tablet A* Trade Name : Aerius Indication : Allergic rhinitis and chronic idiopathic urticaria Dosage : ADULT & CHILD more than 12 years : 5 mg once daily. CHILD: 6-11 yr: 2.5 mg; 1-5 yr: 1.25 mg; 6-11 mth: 1 mg. Doses to be taken once daily Precautions : Phenylketonuric patient, severe renal or hepatic failure; children less than 6 month, elderly, epilepsy, preg-nancy and lactation. Adverse Reactions : Fatigue, headache and dry mouth. Contraindications : Hypersensitivity to desloratadine or loratadine. 328 Interactions : Amphetamines, alcohol, betahistine, CNS depressants, acetylcholinesterase Inhibitors. -------------------------------------------------------------------------------------------------------------------------------------Hydroxyzine HCl 25 mg Tablet A Trade Name : Atarax Indication : Allergic pruritus Dosage : Initially 25 mg at night, increased if necessary up to 25 mg 3-4 times daily. ADULT and CHILD more than 10 years : 50 - 75 mg; 6 - 10 years: 25 - 50 mg; 1 - 5 years: 12.5 - 25 mg; to be taken daily in divided doses Precautions : Concomitant administration with central nervous system depressants, asthma, dose adjustment in liver disease. Avoid driving and operating machinery. Lactation, ECG abnormalities, porphyria. Adverse Reactions : Sleepiness, drowsiness, headache, dizziness, weakness, depression and irritability, dry mouth, chest tightness, tremor, convulsions, hypersensitivity reactions (wheezing, shortness of breath). Contraindications : Pregnancy, breastfeeding and hypersensitivity reaction. Interactions : Sedating antihistamines may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics. Have an additive antimuscarinic action with other antimuscarinic drugs. -------------------------------------------------------------------------------------------------------------------------------------Levocetirizine Dihydrochloride 5 mg Tablet A* Trade Name : Xyzal Indication : Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idopathic urticaria Dosage : Children above 6 years and adults: 5 mg orally once daily (Swallow whole, do not chew/crush). Precautions : Concurrent alcohol use; should be avoided due to potential increase in CNS depression and sedation, concurrent use of other central nervous system depressants; should be avoided due to potential increase in CNS depression and sedation, renal function, impaired; increased risk of adverse reactions, dosage adjustment required Adverse Reactions : Asthenia, somnolence, nasopharyngitis, pharyngitis, xerostomia, fatigue, fever Contraindications : Hemodialysis patients, hypersensitivity to levocetirizine, cetirizine, or any component of the product, end-stage renal disease, (CrCl less than 10 mL/min), renally impaired pediatric patients between 6 months and 11 years old Interactions : Concurrent alcohol use; should be avoided due to potential increase in CNS depression and sedation, concurrent use of other central nervous system depressants; should be avoided due to potential increase in CNS depression and sedation, renal function, impaired; increased risk of adverse reactions, dosage adjustment required -------------------------------------------------------------------------------------------------------- 329 Loratadine 1 mg/ml Syrup A Trade Name : Clarityne Indication : Allergic rhinitis, chronic urticaria and other allergic dermatological disorders Dosage : ADULT and CHILD over 6 years : 10 mg once daily. CHILD 2 - 6 years: 5 mg once daily Precautions : Impaired liver and renal function (use lower dose). Should not take with alcohol and avoid operating vehicle and machinery. Adverse Reactions : Headache, nervousness, sedation. Contraindications : Hypersensitivity to loratadine. Interactions : Cimetidine, erythromycin, ketoconazole and other hepatic enzyme inhibitors. -------------------------------------------------------------------------------------------------------------------------------------Loratadine 10 mg Tablet B Trade Name : Clarityne Indication : Allergic rhinitis and allergic dermatoses Dosage : ADULT and CHILD over 6 years 10 mg once daily. CHILD 2 - 6 years: 5 mg once daily Precautions : Impaired liver and renal function (use lower dose). Should not take with alcohol and avoid operating vehicle and machinery. Adverse Reactions : Headache, sedation, nervousness. Contraindications : Hypersensitivity to loratadine. Interactions : Cimetidine, erythromycin, ketoconazole and other hepatic enzyme inhibitors. -------------------------------------------------------------------------------------------------------------------------------------Loratadine 5 mg and Pseudoephedrine Sulphate 120 mg Tablet A/KK Trade Name : Clarinase Indication : For treatment of allergic rhinitis and allergic dermatoses Dosage : ADULT and CHILD over 12 years 1 tablet twice daily Precautions : Avoid in hepatic insufficiency, renal insufficiency (use lower initial dose), pregnancy, hypertension, diabetes mellitus, ischaemic heart disease, increased intraocular pressure, hyperthyroidism, prostatic hypertrophy, stenosing peptic ulcer, elderly, lactating, prostatic hypertrophy. Adverse Reactions : Headache, nervousness, dizziness, tachycardia, rhinitis, pruritis, acne, insomnia, fatigue, pharyngitis, somnolence, nausea, palpitations, tachycardia. Contraindications : Narrow-angle glaucoma, urinary retention, severe coronary artery disease, severe hypertension, concomitant therapy with MAOIs or within 10 days of continuing such treatment, hyperthyroidism, hepatic and renal impairment, hypersensitivity to loratadine or pseudoephedrine. 330 Interactions : Loratadine is metabolised by cytochrome P450 isoenzymes CYP3A4 and CYP2D6. Therefore concomitant administration of other drugs that inhibit or are metabolised by these hepatic enzymes may result in changes in plasma concentrations of either drug, bromocriptine, hydrocodone, selegiline. -----------------------------------------------------------------------------------------------------------------------------------Promethazine HCl 25 mg/ml Injection B Trade Name : Phenergan Indication : Allergic conditions Dosage : By deep IM: ADULT: 25 - 50 mg, maximum 100 mg. CHILD: 5 - 10 years : 6.25 - 12.5 mg. By slow IV: 25 - 50 mg in a solution of 2.5 mg/ml in water for injection. Maximum 100 mg Precautions : Pregnancy, lactation, cardiovascular or hepatic diseases, narrow angle glaucoma, asthma, COPD, pediatric patient, peptic ulcer, pyloduodenal obstruction, prostatic hypertrophy. Adverse Reactions : Sedation, gastrointestinal disturbances, antimuscarinic effects, muscular weakness, tinnitus, allergic reactions, blood disorders, respiratory depression. Contraindications : Hypersensitivity to promethazine. Comatose patients, acute attack of asthma, children under 2 years, SC and intra- or peri-arterial injection. Interactions : Antihypertensives, phenothiazines, alcohol, anticholinergics, tricyclic antidepressants, MAOIs, evening primrose oil. -------------------------------------------------------------------------------------------------------------------------------------Promethazine HCl 5 mg/5 ml Syrup B Trade Name : Phenergan Indication : Allergic conditions Dosage : CHILD 2 - 5 years: 5 - 15 mg daily, 5 - 10 years : 10 - 25 mg daily Precautions : Pregnancy, lactation, cardiovascular or hepatic diseases, narrow angle glaucoma, asthma, COPD, paediatric patient, peptic ulcer, pyloduodenal obstruction, prostatic hypertrophy. Adverse Reactions : Sedation, gastrointestinal disturbances, antimuscarinic effects, muscular weakness, tinnitus, allergic reactions, blood disorders, respiratory depression. Contraindications : Hypersensitivity to promethazine. Comatose patients, acute attack of asthma, children under 2 years. Interactions : Antihypertensives, phenothiazines, alcohol, anticholinergics, tricyclic antidepressants, MAOIs, evening primrose oil. -------------------------------------------------------------------------------------------------------------------------------------- 331 Bromhexine HCl 4 mg/2 ml Injection A Trade Name : Bisolvon Indication : Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucous secretion and impaired mucous transport Dosage : 4 mg SC, IM or IV 2 - 3 times daily Precautions : Gastrointestinal ulceration, pregnancy and lactation. Adverse Reactions : Occasionally gastrointestinal effects, skin rashes very rarely. Gastrointestinal disturbances, headache, dizziness, sweating, skin rash, transient rise in serum transaminase. Contraindications : Hypersensitivity to bromhexine. Interactions : May lead to higher antibiotic concentration in lung tissue. Oral anticoagulants. -------------------------------------------------------------------------------------------------------------------------------------Bromhexine HCl 8 mg Tablet B Trade Name : Bisolvon Indication : Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucous secretion and impaired mucous transport Dosage : ADULT and CHILD more than 12 years : 8 mg 3 times daily, 6 - 12 years : 4 mg 3 times daily, 2 - 6 years : 4 mg 2 times daily Precautions : Gastrointestinal ulceration, pregnancy and lactation. Adverse Reactions : Occasionally gastrointestinal effects, skin rashes very rarely. Gastrointestinal disturbances, headache, dizziness, sweating, skin rash, transient rise in serum transaminase. Contraindications : Hypersensitivity to bromhexine. Interactions : May lead to higher antibiotic concentration in lung tissue. Oral anticoagulants. -------------------------------------------------------------------------------------------------------------------------------------Menthol 1.6% in Industrial Methylated Spirit Inhalation C Indication : Decongestion of the upper respiratory tract Dosage : As directed for local use Precautions : Not known. Adverse Reactions : Hypersentivity reactions including contact dermatitis. Contraindications : Not known. Interactions : Not known -------------------------------------------------------------------------------------------------------------------------------------- 332 Ammonium Bicarbonate, Tincture Ipecac, etc Mixture C Trade Name : Expect Stimulant Indication : Cough Dosage : 10 - 20 ml 3 times daily Precautions : Can be irritant to mucous membrane. Adverse Reactions : If consumed in very large dose can cause nausea and vomiting. Contraindications : Hepatic or renal impairment. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Diphenhydramine HCl 10 mg/5 ml Elixir C Trade Name : Benadryl Indication : Cough and allergic rhinitis Dosage : CHILD 2 - 6 years : 6.25 mg 3 - 4 times daily, 6- 12 years : 12.5 - 25 mg 3 - 4 times daily Precautions : Renal or hepatic disease, glaucoma or in patients on MAOIs. May cause drowsiness, may impair ability to drive and operate machine. Adverse Reactions : Sedation, dizziness, coordination problems, dry mucous membranes, blurred vision, paradoxical CNS stimulation, nasal stuffiness, palpitation, epigastric discomfort. Contraindications : Hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure, in breastfeeding, newborns or infants. Interactions : Additive effects if use with hypnotics, sedatives, tranquilizers. Actions prolonged by MAOIs. -------------------------------------------------------------------------------------------------------------------------------------Diphenhydramine HCl 14 mg/5 ml and Ammonium Chloride 135 mg/5 ml Expectorant C Trade Name : Benadryl Indication : Cough Dosage : ADULT : 5 - 10 ml 2 - 3 times daily. CHILD : 2.5 - 5 ml 2 - 3 times daily Precautions : Renal or hepatic disease, glaucoma or in patients on MAOIs. May cause drowsiness, may impair ability to drive and operate machine. Adverse Reactions : Sedation, dizziness, coordination problems, dry mucous membranes, blurred vision, paradoxical CNS stimulation, nasal stuffiness, palpitation, epigastric discomfort. Contraindications : Hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure, lactation, newborns or infants. 333 Interactions : Additive effects if use with hypnotics, sedatives, tranquilizers. Actions prolonged by MAOIs. -------------------------------------------------------------------------------------------------------------------------------------Triprolidine HCl 2.5 mg and Pseudoephedrine HCl 60 mg Tablet B Trade Name : Actifed Indication : Decongestion of the upper respiratory tract in common cold, hay fever, allergic and vasomotor rhinitis and aerotitis Dosage : ADULT 2.5 mg every 4 - 6 hours; maximum dose 10 mg/day. CHILD 6 - 12 years : 1.25 mg every 4 - 6 hours; maximum dose 5 mg/day, 2 - 4 years : 0.625 mg every 4 - 6 hours; maximum dose 2.5 mg/day, 4 - 6 years : 0.938 mg every 4 - 6 hours; maximum dose 3.744 mg/day, 4 months - 2 years : 0.313 mg every 4-6 hours; maximum dose 1.25 mg/day. Not FDA approved in children less than 6 years old Precautions : Diabetes, hypertension, heart disease, hyperthyroidism, elevated intraocular pressure, prostatic enlargement, asthma, chronic obstructive pulmonary disease, prostatic hypertrophy, pyloric obstruction, stenosing peptic ulcer and avoid operating vehicles and machinery. Adverse Reactions : Drowsiness, sleep disturbances, skin rashes, dryness of nose, mouth and throat, hypotension or hypertension, tachycardia, anorexia, nausea, vomiting, constipation, diarrhea, abdominal pain, wheezing, tightness of chest, impotence, blurred vision, urinary retention. Contraindications : Angle-closure glaucoma, hypersensitivity to triprolidine products, neonates. Interactions : Antihypertensives, tricyclic antidepressants, decongestants, appetite suppressants, amphetaminelike psychostimulant, other sympathomimetics. -------------------------------------------------------------------------------------------------------------------------------------Betahistine Dihydrochloride 24 mg Tablet A* Trade Name : Betaserc® Indication : Vertigo, tinnitus and hearing loss associated with Meniere's disease Dosage : 24 mg twice daily Precautions : Betahistine should not be given to patients with phaeochromocytoma. It should be given with care to patients with asthma, peptic ulcer disease or a history of peptic ulcer disease. Antihistamines may block some or all of intended effects of betahistine. Liver disease, pregnancy, lactation. Adverse Reactions : Nausea, vomiting, skin rash, pruritus. Contraindications : Hypersensitivity, phaeochromocytoma. Interactions : Selegiline. -------------------------------------------------------------------------------------------------------------------------------------- 334 Cinnarizine 25 mg Tablet B Trade Name : Stugeron Indication : Vestibular disorders Dosage : One tablet 3 times daily Precautions : Pregnancy, Parkinson's disease. May affect ability to drive or operate machinery. Adverse Reactions : Gastrointestinal disturbances, epigastric pain, nausea and vomiting, tinnitus, lupus erythematosus. Contraindications : Avoid in porphyria. Interactions : Alcohol, CNS depressants. -------------------------------------------------------------------------------------------------------------------------------------Cocaine 10% Solution B Indication : To produce local anaesthesia or vasoconstriction during endoscopic nasal surgery, turbinectomy septoplasty, polypectomy etc Dosage : Maximum total dose recommended for application to the nasal mucosa in healthy adult is 1.5 to 2 mg/kg of a 10% cocaine solution Precautions : Avoid in porphyria and direct sunlight. Adverse Reactions : Can cause addiction, arrythmia, palpitation, central nervous system stimulation, syncope, seizure, coronary arteriosclerosis. Contraindications : Never given by injection due to its marked sympathomimetic effects. Interactions : Interacts with some drugs and can cause arrhythmia. -------------------------------------------------------------------------------------------------------------------------------------- 335 21. DERMATOLOGY Emollient and barrier preparation Topical local anaesthetics and antipruritics Topical corticosteroids Preparations for eczema and psoriasis Acne and rosacea Preparations for warts and calluses Shampoos and other preparations for scalp conditions Anti-infective skin preparations Disinfectants, skin cleaners & antiseptics Miscellaneous dermatology 336 Aqueous Cream C Indication : Dry skin Dosage : As a soap or apply to the skin as an emollient cream Precautions: It should not be used before phototherapy or in phototesting procedures Adverse Reaction: Not known Contraindications: Not known Interactions: Not known -----------------------------------------------------------------------------------------------------------------------------------Calamine Cream C Indication : Prickly heat or insect bites Dosage : Apply to the affected area as required Precautions: Avoid contact with eyes and other mucous membranes Adverse Reaction: Rash or irritation Contraindications: Not known Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Calamine Lotion C Indication : Prickly heat or insect bites Dosage : Apply to the skin as required and allow to dry, 1-3 times daily Precautions: Avoid contact with eyes and other mucous membranes Adverse Reaction: Rash or irritation Contraindications: Not known. Interactions: Not known. -------------------------------------------------------------------------------------------------------------------------------------Calamine with 2 - 6% Precipitated Sulphur Lotion Indication : Acne vulgaris Dosage : Apply to the skin as required and allow to dry, 1 - 3 times daily 337 C Precautions: Avoid contact with eyes and other mucous membranes. Do not use on children under 2 years without consulting a physician Adverse Reaction: Rash or irritation Contraindications: Not known Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Emulsificants Ointment C Indication : Xerosis and ichthyosis Dosage : Use as a soap and emollient Precautions: Should not be used before phototherapy or in phototesting procedures Adverse Reaction: Not known Contraindications: Hypersensitivity to any component Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Paraffin, White Soft C Paraffin, Yellow Soft C Trade Name : Vaseline Indication : Xerosis and ichthyosis Dosage : Apply to the affected area Precautions: Avoid exposure to fire Adverse Reaction: Hypersensitivity to any component Contraindications: Hypersensitivity to any component Interactions: Not known ----------------------------------------------------------------------------------------------------------------------------------Crotamiton 10 % Cream A/KK Trade Name : Eurax Indication : i) Pruritus ii) Scabies iii) Insect bite reactions Dosage : i) and iii) Massage into affected area until the medication is completely absorbed. Repeat as needed. Apply 2 or 3 times daily ii) Apply topically (do not rinse off), apply a second time and leave on skin for 338 24 - 48 hours. For resistant scabies, treatment (2 applications at 24 hour interval) may be repeated after 1 week Precautions: Avoid contact with eyes, face, mouth and mucous membranes. Pregnancy. Avoid applying to inflamed skin or raw, oozing skin surfaces. Discontinue use of crotamiton if severe skin irritation develops Adverse Reaction: Local skin irritation or contact allergy Contraindications: Do not apply on nipples when breastfeeding, hypersensitivity to crotamiton Interactions: Not known --------------------------------------------------------------------------------------------------------------------------------Miconazole 2% Cream B Trade Name : Daktarin Indication : i) Fungal infections: Tinea pedis, Tinea corporis, Tinea capitis and other dermatophyte infections caused by Trichophyton and Epidermophyton species ii) Antifungal agent that has been in various candida infections including vaginal candidiasis Dosage : i) Skin Infection: Apply sparingly and rub gently onto affected area 1-2 times daily continuing for 10 days after lesions have healed ii) Apply twice daily continuing for 10 days after lesions have healed Precautions: First trimester of pregnancy, lactation. Local sensitization or irritation, to discontinue use Adverse Reaction: Ocassional skin irritation or sensitivity, contact dermatitis, vaginal burning due to cream base Contraindications: Children less than 2 year. Hypersensitivity to manizole products Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Clobetasol Propionate 0.05% Cream A Trade Name : Dermovate Indication : Short term treatment only of more resistant dermatoses eg. psoriasis, recalcitrant eczemas, lichen planus, discoid lupus erythematosus and other conditions which do not respond satisfactorily to less potent steroids Dosage : Apply sparingly once or twice daily, changing to lower potency therapy as soon as condition is controlled. For mild to moderate use maximum for 2 weeks. For moderate to severe maximum duration 4 consecutive weeks. Max: 50 g/week Precautions: INFANTS and CHILD: prolonged and continuous use, pregnancy, avoid contact with eyes. Do not use for greater than 2 consecutive weeks or with occlusive dressing Adverse Reaction: Local atrophic skin changes, hypercorticism, burning, stinging, irritation and adrenal suppression Contraindications: Rosacea, acne vulgaris, skin lesions caused by viral, fungal and bacterial infections. Hypersensitivity to clobetasol or other corticosteroid 339 Interactions: Not known ------------------------------------------------------------------------------------------------------------------------------------Clobetasol Propionate 0.05% Ointment A Trade Name : Dermovate Indication : Short term treatment only of more resistant dermatoses eg. psoriasis, recalcitrant eczemas, lichen planus, discoid lupus erythematosus and other conditions which do not respond satisfactorily to less potent steroids Dosage : Apply sparingly once or twice daily, changing to lower potency therapy as soon as condition is controlled. For mild to moderate use maximum for 2 weeks. For moderate to severe maximum duration 4 consecutive weeks. Max:50 g/week Precautions: INFANT and CHILD: prolonged and continuous use, pregnancy, avoid contact with eyes. Do not use for greater than 2 consecutive weeks or with occlusive dressing Adverse Reaction: Local atrophic skin changes, hypercorticism, burning, stinging, irritation and adrenal suppression Contraindications: Rosacea, acne vulgaris, skin lesions caused by viral, fungal and bacterial infections. Hypersensitivity to clobetasol or other corticosteroid Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Clobetasone Butyrate 0.05% Cream A/KK Trade Name : Eumovate Indication : Eczema and dermatitis of all types Dosage : Apply up to four times daily until condition improves, then reduce frequency Precautions: Infants and children, prolonged and continuous use, pregnancy. Discontinue if secondary infection develops, avoid prolonged application to face Adverse Reaction: Hypersensitivity to clobetasone or other corticosteriods. Transient adrenal suppression. Pigmentation changes and hypertrichosis Contraindications: Skin lesions caused by viral, fungal and bacterial infections. Hypersensitivity to clobetasone or other corticosteroids Interactions: Not known ------------------------------------------------------------------------------------------------------------------------------------Clobetasone Butyrate 0.05% Ointment Trade Name : Eumovate Indication : Eczema and dermatitis of all types Dosage : Apply up to four times daily until condition improves, then reduce frequency 340 A Precautions: Infants and children, prolonged and continuous use, pregnancy. Discontinue if secondary infection develops, avoid prolonged application to face Adverse Reaction: Hypersensitivity to clobetasone or other corticosteriods. Transient adrenal suppression. Pigmentary changes and hypertrichosis Contraindications: Skin lesions caused by viral, fungal and bacterial infections. Hypersensitivity to clobetasone or other corticosteroids Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Hydrocortisone 1% Cream B Indication : Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses Dosage : Apply sparingly to affected area 2 - 3 times daily until condition improve, then reduce frequency Precautions: Prolonged use in infants and children, ulceration at infection site, diabetes mellitus Adverse Reaction: Local atrophic skin changes, impaired skin healing Contraindications: Fungal and bacterial infections, tuberculosis of the skin, viral disease of the skin, acne vulgaris, rosacea, perioral dermatitis. Hypersensitivity to hydrocortisone Interactions: Not known ----------------------------------------------------------------------------------------------------------------------------------Mometasone Furoate 0.1% Cream A* Trade Name : Elomet Indication : Steroid responsive dermatosis and vitiligo. Used where a potent steroid is required for short duration not more than 6 weeks Dosage : Apply once daily to affected areas. Do not use in paediatric patients for longer than 3 weeks Precautions: Systemic absorption may be increased if extensive body surface are treated. Do not use occlusive dressing. Long term use in infant and children. Avoid contact with eyes, pregnancy, lactation Adverse Reaction: Burning, pruritus, skin atrophy, paraesthesia, tingling or stinging Contraindications: Hypersensitivity to mometasone or any component of the formulation Interactions: CYP3A4 -------------------------------------------------------------------------------------------------------------------------------------- 341 Acitretin 25 mg Capsule A* Trade Name : Neotigason Indication : Generalised pustular and or erythrodermic psoriasis, pityriasis rubra pilaris, Darier's Disease, Icthyosiform Erythrodermas - Bullous and non-bullous forms, extensive naevus verrucosus, extensive psoriasis Dosage : ADULT: initially 25-30 mg daily for 2-4 weeks, then adjusted according to response, usually within range 25-50 mg daily for further 6-8 weeks (max: 75 mg daily). CHILD: 500 mcg/kg daily occasionally up to 1 mg/kg daily to a max. 35 mg daily for limited periods Precautions: Long-term treatment, diabetes, obesity, alcoholism, disturbances of lipid metabolism Adverse Reaction: Symptoms of hypervitaminosis A, localized but reversible hair loss, thinning and scaling of the skin, paronychia, muscle and joint pain Contraindications: Pregnancy and lactation, liver and kidney insufficiency, hypervitaminosis A, excessively elevated blood lipid values Interactions: Oral contraceptives, progestogen may result in loss of contraceptive effectiveness. Ethanol may result in a prolonged risk of teratogenicity. Possible hypervitaminosis with vitamin A. Reduces protein binding of Phenytoin -------------------------------------------------------------------------------------------------------------------------------------Calcipotriol 50 mcg/g Cream A* Trade Name : Daivonex Indication : Only for the treatment of Psoriasis Vulgaris Dosage : Apply to the affected skin lesions twice daily. Maintenance therapy may be achieved with less frequent application. The weekly dose should not exceed 100 g. Precautions: Should not be used on the face since the formulation may give rise to irritation of the facial skin. Careful handwashing after use is recommended Adverse Reaction: Transient local irritation and very rarely, facial dermatitis may occur, hypercalcaemia Contraindications: Hypersensitivity to any constituents of the calcipotriol. Disorders of calcium metabolism Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Calcipotriol 50 mcg/g Ointment A* Trade Name : Daivonex Indication : Only for the treatment of Psoriasis Vulgaris Dosage : Apply to the affected skin lesions twice daily. Maintenance therapy may be achieved with less frequent application. The weekly dose should not exceed 100 g 342 Precautions: Should not be used on the face since the ointment formulation may give rise to irritation of the facial skin. Careful handwashing after use is recommended Adverse Reaction: Transient local irritation and very rarely, facial dermatitis may occur, hypercalcaemia Contraindications: Hypersensitivity to any constituents of the calcipotriol. Disorders of calcium metabolism Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Calcipotriol 50 mcg/ml Scalp Solution A* Trade Name : Diavonex Indication : Only for the treatment of Psoriasis Vulgaris Dosage : Apply to the affected skin lesions twice daily. Weekly maintenance therapy may be achieved with less frequent application. The weekly dose should not exceed 100 g Precautions: Should not be used on the face since the formulation may give rise to irritation of the facial skin. Careful handwashing after use is recommended Adverse Reaction: Transient local irritation and very rarely, facial dermatitis may occur and hypercalcaemia Contraindications: Hypersensitivity to any constituents of the calcipotriol. Disorders of calcium metabolism Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Calcipotriol Hydrate 50 mcg/g & Betamethasone Dipropionate 0.5 mg/g Ointment A* Trade Name : Daivobet Indication : Resistant plaque psoriasis Dosage : Apply once daily up to 4 weeks with maximum weekly dose of 100g and maximum treatment area 30% of body surface Precautions: Avoid contact with face and eyes. Avoid application on large areas of damaged skin, under occlusive dressings or in skin folds. Pregnancy and lactation Adverse Reaction: Pruritus, rash, local transient irritation, dermatitis, erythema, aggravation of psoriasis, photosensitivity and hypersensitivity reactions Contraindications: Disorders of calcium metabolism, viral, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, rosacea, acne rosacea, perioral dermatitis, acne vulgaris, skin atrophy, striae atrophicae, fragility of skin Interactions: Alatrofloxacin, alcuronium, Amphotericin B Liposome, Anthrax Vaccine Adsorbed, Anthrax Vaccine Adsorbed, Bacillus of Calmette and Guerin Vaccine Live, Carbamazepine, Ciprofloxacin, Diphtheria Toxoid, Adsorbed, Ethinyl Estradiol, Etonogestrel ---------------------------------------------------------------------------------------------------------------------------------- 343 Carbamide (Urea) 10 % Cream B Trade Name : Calmurid Indication : Contact irritant dermatitis, infantile eczemas, acute and chronic allergic eczemas, icthyosis, hyperkeratotic Dosage : Apply sparingly and rub into affected area 2 - 3 times daily and when required after cleansing skin Precautions: Avoid contact with eyes, discontinue use if oral inflammation persists or worsens. Use with caution on inflammed skin or exudative lesions: irritation may results Adverse Reaction: Skin irritation, rash and ischaemic skin necrosis Contraindications: Hypersensitivity to urea or any component Interactions: Not known ----------------------------------------------------------------------------------------------------------------------------------Coal Tar 20% Solution B Indication : Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema and psoriasis Dosage : Use 100 ml in a bath Precautions: Do not apply to acutely inflammed skin. Avoid contact with eyes and do not apply coal tar preparations (other than bath emulsions) to genital or rectal areas Adverse Reaction: Skin ulcerations, hypersensitivity reactions including allergic contact dermatitis, aggravations of status varicosus. The use of ultraviolet light and coal tar may produce or aggravate herpes lesions keratocystomatosis, folliculitis, erythema and a smarting Contraindications: Presence of folliculitis and acne vulgaris. Active or inflammed psoriasis, weeping eczema, erythrodermic and generalized pustular psoriasis, photosensitivity Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Cocois Co. Ointment Indication : Scalp psoriasis and severe seborrhoeic dermatitis Dosage : Rub a small amount into the scalp gently Precautions: Avoid eyes, mucosa, genital, rectal areas, broken or inflammed skin Adverse Reaction: Dermatitis, folliculitis Contraindications: Hypersensitivity to any of its ingredients 344 B Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Hydroxyurea 500 mg Capsule A Trade Name : Hydrea Indication : i)Solid tumours ii) Chronic myelocytic leukaemia and myeloproliferative disease iii)Severe psoriasis eg. Extensive plaque psoriasis, erythrodermic psoriasis, pustular psoriasis -as third line therapy. Dosage : i)Intermittent therapy : 80 mg/kg orally as a single dose every 3rd day. Continuous therapy : 20 - 30 mg/kg orally as a single dose dly. Concomitant therapy with irradiation : 80 mg/kg orally as a single dose every 3rd day.(administration of hydroxyurea should be started at least 7 days before initiation of irradiation and continued during radiotherapy as well). ii)Continuous therapy (20 - 30 mg/kg orally as a single dose daily, therapy should be interrupted if the white blood cell count drops below 2500/mm3, or the platelet count below 100,000/mm3. iii) 500 mg tds. Precautions: Hydroxyurea is mutagenic and clastogenic. Correct anaemia prior to initiating hydroxyurea therapy. Exacerbation of postirradiation erythema. Elderly patients, marked renal dysfunction, impairment of fertility. Adverse Reaction: Myelosupression, GI disturbances, Hyperpigmentation, facial erythema, diffuse maculopapular rash, headache, drowsiness, confusion ,transient renal function abnormalities. Contraindications: Severe bone marrow depression , pregnancy, lactation, hypersensitivity to hydroxyurea products. Interactions: Didanosine, stavudine and zidovidine (in HIV-infected patients), fatal and non fatal pancreatitis, hepatotoxicity, and peripheral neuropathy. Live vaccines, fluorouracil, methotrexate, cytarabine -------------------------------------------------------------------------------------------------------------------------------------Salicylic Acid 2 - 10% Ointment C Indication : Seborrhoeic dermatitis, scalp, psoriasis and hyperkeratotic skin disorders Dosage : Apply sparingly to the affected area 2-3 times daily Precautions: Avoid contact with eyes and mucous membranes Adverse Reaction: Local irritation Contraindications: Hypersensitivity to salicylic acid. Age less than 2 years, diabetes with impaired circulation Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Tar, Coal Tar and Oleyl Alcohol Liquid Trade Name : Polytar Indication : Dandruff, seborrhoeic dermatitis and atopic dermatitis Dosage : Massage into wet hair, rinse and repeat. Use once or twice weekly 345 A/KK Precautions: Do not apply to acutely inflammed skin. Avoid contact with eyes, do not apply coal tar preparations (other than bath emulsions) to genital or rectal areas Adverse Reaction: Skin ulcerations and hypersensitivity reactions including allergic contact dermatitis, the use of ultraviolet light and coal tar may produce or aggravate folliculitis erythema and a smarting reaction Contraindications: Folliculitis and acne vulgaris, weeping eczema, erythrodermic, generalized pustular psoriasis and photosensitivity Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Zinc Oxide Cream C Indication : Skin protective in various skin conditions such as nappy rash, eczema and problem skin Dosage : Apply 3 times daily or as required Precautions: Hypersensitivity to any component. Avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations Adverse Reaction: Hypersensitivity to any component Contraindications: Weeping dermatoses Interactions: Not known -----------------------------------------------------------------------------------------------------------------------------Adapalene 0.1% Gel A* Trade Name : Differin Indication : Acne vulgaris where comedones, papules and pustules predominate in those sensitive to benzoyl peroxide or topical tretinoin [third line treatment] Dosage : Apply once daily to the affected areas after washing at bedtime Precautions: Avoid contact with eyes, lips angles of the nose and mucosa membranes. Do not apply to cuts, abrasion, eczematous skin or sunburned skin. Minimize exposure to slight including sunlamps Adverse Reaction: Erythema, scaling, dryness, pruritus, burning sensation Contraindications: Hypersensitivity to adapalene or any of its components Interactions: Methotrexate -------------------------------------------------------------------------------------------------------------------------------------Azelaic Acid 20% Cream Trade Name : Skinoren Indication : Acne vulgaris A* 346 Dosage : Apply twice daily. Treatment should not exceed 6 months Precautions: Avoid contact with eyes. May cause hypopigmentation. Should not use with occlusive dressings or wrappings Adverse Reaction: Occasionally, local skin irritation, pruritus, tingling feeling, burning or stinging Contraindications: Hypersensitivity to propylene glycol and azelaic acid products Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Benzoyl Peroxide 5% Gel B Trade Name : Panoxyl Indication : Mild to moderate acne vulgaris Dosage : Apply sparingly once or twice daily Precautions: Avoid contact with eyes, mouth and other mucous membranes. May bleach dyed clothing and fabrics. Avoid unnecessary sun exposure Adverse Reaction: Burning or stinging contact dermatitis, redness Contraindications: Hypersensitivity to benzoyl peroxide products Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Isotretinoin 10 mg Capsule A* Isotretinoin 20 mg Capsule A* Trade Name : Roaccutane Indication : Only for treatment of i) Severe nodulo-cystic acne ii) Acne conglobata iii) Acne fulminans iv) Severe acne vulgaris failing conventional treatment WARNING: THIS DRUG IS TERATOGENIC Dosage : Initially: 0.5 mg/kg body weight daily (in one to or two divided doses) with food once. Maintenance: 0.1 - 1 mg/kg daily body weight Precautions: Diabetes, obesity, alcoholism, disturbances of lipid metabolism and childbearing potential, hepatotoxicity, inflammatory bowel disease, nursing mothers, visual problems, corneal opacities Adverse Reaction: Dry mucosa, dermatitis facialis, pruritus, sweating. Occasionally, reversible alopecia, muscle and joint pain. Rarely, inflammatory bowel disease, hyperuricaemia, benign intracranial hypertension, visual disturbances and photosensitivity reactions. Haematuria or proteinuria, hirsutism, pancreatitis, lymphadenopathy Contraindications: Pregnancy and lactation. Hepatic or renal insufficiency. Hypervitaminosis A. Patients with excessively elevated blood lipid values. Concomitant tetramycin therapy. Hypersensitivity to isotretinoin products or paraben 347 Interactions: Concurrent use with vitamin A intensifies symptoms of hypervitaminosis A. Doxycycline, minocycline, tetracycline may result in pseudotumour cerebri. Ethanol - a disulfiram-like reaction. Food - Increases its bioavailability ----------------------------------------------------------------------------------------------------------------------------------Tretinoin 0.05% Cream A Trade Name : Retin-A Indication : Acne vulgaris and recalcitrant cases of acne (comedonal type) Dosage : Apply thinly to the affected area once daily or twice daily. Avoid exposure to sunlight. Duration of treatment: 8 - 12 weeks is required before any noticeable response Precautions: Exposure to sunlight including sunlamp should be minimized. Avoid contact with eyes, mouth, angle of the nose and mucous membrane. Eczema, sunburn, pregnancy and lactation. Special caution is indicated in cases of simultaneous treatment with other preparations Adverse Reaction: Erythema, oedema, blistering, hypopigmentation or hyperpigmentation, sensitivity to sunlight Contraindications: Acute dermatitis, rosacea. Hypersensitivity to tretinoin or parabens Interactions: Betamethasone, betamethasone dipropionate, clotrimazole, dexamethasone, fluconazole, hydrocortisone, ketoconazole, methotrexate, methylprednisolone, paclitaxel, prednisolone, tetracycline, tranexamic acid, triamcinolone -------------------------------------------------------------------------------------------------------------------------------------Podophyllum 10 - 20% Paint B Indication : External anogenital warts Dosage : Apply 2 - 3 drops carefully to lesion after protecting surrounding area with vaseline. Wash off after 6 hours or if feel burning sensation and repeat 2 - 3 times weekly or once weekly Precautions: Sensitive parts of the body. Caustic to healthy skin. Keep away from eyes Adverse Reaction: Inflammation of the surrounding skin may occur, in which case treatment should be suspended Contraindications: Pregnancy, use on bleeding warts, moles, birthmarks and concomitant steroid therapy Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Ketoconazole 2% Shampoo Trade Name : Nizoral Indication : Resistant dandruff only Dosage : Apply twice weekly for 2 - 4 weeks. Prophylaxis: Once every 1 - 2 weeks Precautions: After prolonged treatment with topical corticosteroids 348 A Adverse Reaction: Local irritation, pruritus, alopecia and photosensitivity Contraindications: Known hypersensitivity to ketoconazole products Interactions: Concurrent use with ethanol may result in a disulfiram-like reaction (flushing, vomiting, increased respiratory rate, tachycardia) -------------------------------------------------------------------------------------------------------------------------------------Acyclovir 5% Cream A* Trade Name : Zovirax Indication : Herpes simplex infections of the skin, including initial and recurrent labial and genital herpes simplex infections Dosage : Apply every 4 hours for 5 - 10 days Precautions: Application to mucous membranes, pregnancy, lactation. Should not be used in the eyes Adverse Reaction: Transient burning or stinging or erythema, mild drying or flaking of the skin Contraindications: Hypersensitivity to acyclovir or valacyclovir Interactions: Not known ------------------------------------------------------------------------------------------------------------------------------------Selenium Sulphide 2.5% Shampoo A/KK Trade Name : Selsun Indication : Dandruff, seborrheic dermatitis of scalp Dosage : Dandruff: apply 5-10 mL topically twice weekly for 2 weeks, then 1-4 times per month, as needed, leave on for 2-3 min, then rinse thoroughly. Seborrheic dermatitis of scalp: apply 5-10 mL topically twice weekly for 2 weeks, then 1-4 times per month, as needed, leave on for 2-3 min, then rinse thoroughly Precautions: Avoid contact with eyes, mucous membranes, inflamed or broken skin or to extensive areas of the skin Adverse Reaction: Oiliness or dryness of hair and scalp, hair discoloration, cutaneous sensitization and alopecia Contraindications: Acute inflammation or exudation, broken skin, hypersensitivity to drug Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Amorolfine 5 % Nail Lacquer Trade Name : Loceryl Indication : Fungal nail infections A* 349 Dosage : Apply to affected nail once or sometimes twice a week after filling and cleansing, allow to dry, treat finger nail for 6 months, toe nail for 9 - 12 months (review at intervals of 3 months) Precautions: Avoid contact with eyes, previous hypersensitivity or intolerance to other topical antifungal agents Adverse Reaction: Slight transient burning sensation Contraindications: Hypersensitivity to amorolfine Interactions: Not known ----------------------------------------------------------------------------------------------------------------------------------Benzoic Acid Compound Ointment C Trade Name : Whitfields Indication : Tinea infections of thickened skin of palms and soles Dosage : Apply sparingly to affected area once or twice daily Precautions: Contact with the eyes, mouth and other mucous membranes should be avoided Adverse Reaction: Local irritation Contraindications: Hypersensitivity, use in children less than 2 years, diabetes impaired circulation Interactions: Not known -----------------------------------------------------------------------------------------------------------------------------------Benzyl Benzoate 25 % Emulsion (Adult) C Indication : Scabies and pediculosis Dosage : After bath, apply over the whole body, neck down and leave on for 24 hours then wash off. Reapply for another 24 hours, the first repeat application should be within 5 days of the initial application, a third application may be required in some cases Precautions: Contact with mucous membranes, head, face, broken or inflammed skin, avoid contact with eyes. Not recommended for children, lactation (withhold during treatment) Adverse Reaction: May be irritant to the skin of some patients, burning sensation especially on genitalia and excoriations occasionally rashes, stinging and contact dermatitis, local irritation, particularly in children, splash contact with benzyl benzoate may produce irritation to the eyes and mucous membranes Contraindications: Hypersensitivity to benzyl benzoate Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------- 350 Clotrimazole 1% Cream B Trade Name : Canesten Indication : Cutaneous candidiasis, Tinea corporis, Tinea cruris, Tinea pedis and Tinea versicolor Dosage : Rub in gently onto affected and surrounding skin 2 or 3 times daily continuing for about 2 weeks beyond the dissapearance of all symptoms Precautions: Contact with eyes and mucous menbranes should be avoided Adverse Reaction: Skin reactions, contact dermatitis, pruritis Contraindications: Hypersensitivity to clotrimazole Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Fusidic Acid 2% Cream A Trade Name : Fucidin Indication : Skin infections caused by staphylococci, streptococci, corynebacterium minutissumun and other sodium fusidate-sensitive organisms Dosage : Apply to affected area 2 - 3 times daily Precautions: Avoid contact with eyes and other mucous membranes Adverse Reaction: Rashes, irritation, pruritus and contact dermatitis Contraindications: Infections caused by non-susceptible organisms in particular Pseudomonas aeruginosa Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Fusidic Acid 2% in Betamethasone Valerate 0.1% Cream A/KK Trade Name : Fucicort Indication : Inflammatory dermatosis where bacterial infection is likely to occur eg atopic eczema, discoid eczema, stasis eczema, seborrhoic dermatitis, contact dermatitis, lichen simplex chronicus, psoriasis, discoid lupus erythematosus Dosage : Uncovered lesion- Apply 2 to 3 times daily. Covered lesions- Less frequent applications may be adequate Precautions: Avoid prolong use on flexures and intertriginous areas should be avoided Adverse Reaction: Mild stinging, irritation, rash Contraindications: Viral disease of skin, perioral dermatitis, acne rosacea and ulcerative condition 351 Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Gamma Benzene Hexachloride 0.1 % Lotion C Trade Name : Lindane Indication : Scabies Dosage : Apply lotion to entire body from neck down for 8 to 12 hours, then rinse Precautions: Seizures, dermatitis, dizziness, eczema, papular lesions, itching, Henoch- Schonlein purpura, percutaneous absorption, atypical leukaemia, aplastic anemia and abnormal vision on the use of lindane cream Adverse Reaction: Seizures, dermatitis, dizziness, eczema, papular lesions, itching, Henoch- Schonlein purpura, percutaneous absorption, atypical leukaemia, aplastic anemia and abnormal vision on the use of lindane cream Contraindications: Pregnancy and premature babies, lactation. Avoid in patients with a history of epilepsy (e.g. HIV, history of head trauma or prior seizure, CNS tumor, excessive alcohol consumption) or who have a low body-weight, hypersensitivity to lindane products, Norwegian (crusted) scabies ,other skin conditions (e.g. atopic dermatitis, psoriasis) that may increase systemic absorption Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Gentamicin 0.1% Cream A* Trade Name : Garamycin Indication : For localised infections Dosage : Apply 2 - 3 times daily Precautions: Discontinue if irritation or sensitization occurs Adverse Reaction: Avoid prolonged use Contraindications: Hypersensitivity to gentamicin or other aminoglycosides Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Mupirocin 2% Ointment Trade Name : Bactroban Indication : For MRSA infections only Dosage : ADULT and CHILD: Apply up to three times daily for 3 - 5 days 352 A Precautions: Not for ophthalmic or intranasal use. Use with caution if there is evidence of moderate or severe renal impairment Adverse Reaction: Stinging or burning, pruritus Contraindications: Hypersensitivity to mupirocin products Interactions: Avoid products with polyethylene glycol --------------------------------------------------------------------------------------------------------------------------------Neomycin 0.5% Cream B Indication : Infections of the skin due to susceptible organisms Dosage : Apply sparingly to affected area up to 3 times daily (For short term use, 1 - 2 weeks) Precautions: Superinfection may occur on prolonged use. Renal impairment Adverse Reaction: Skin sensitization or contact dermatitis. The sensitivity disappears when treatment is discontinued Contraindications: Hypersensitivity to neomycin or other aminoglycosides Interactions: Not known --------------------------------------------------------------------------------------------------------------------------------Nystatin 100,000 units/g Cream C Trade Name : Mycostatin Indication : Prevention and treatment of cutaneous infections caused by Candida albicans Dosage : Apply liberally to affected area twice daily or as required. After lesion has disappeared continue treatment for 10 days to prevent relapses. Nail infection: Cut nails as short as possible. Apply cream once daily until growth of new nail has set in Precautions: Pregnancy Adverse Reaction: Skin irritation Contraindications: Hypersensitivity to nystatin Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Permethrin 5% w/v Lotion A* Trade Name : A-Scabs Indication : Treatment of scabies Dosage : Apply thoroughly to all body parts. Leave on for 8 - 14 hours. Not recommended for children less than 2 years old 353 Precautions: May exacerbate pruritus, oedema and erythema Adverse Reaction: Swelling, erythema, pruritus, rash, stinging of skin, burning sensation Contraindications: Hypersensitivity to permethrin and other synthetic pyrethrin Interactions: Not known --------------------------------------------------------------------------------------------------------------------------------Silver Sulfadiazine 1% Cream B Trade Name : Flamazine Indication : Prevention and treatment of infections in severe burns, leg ulcers where infections may prevent healing and for the prophylaxis of infections in skin grafting Dosage : Burns: Apply 3 mm thick layer twice daily with sterile applicator. Leg ulcer: apply at least 3 times a week Precautions: Those allergic to sulfonamides may show cross-sensitivity to silver sulfadiazine. Haemolysis may occur with glucose-6-phosphate deficiency. Accumulation may occur in renal or hepatic insufficiency Adverse Reaction: Transient leucopenia has occurred with topical silver, haemolytic anaemia, probable febrile reaction, irritation, itching and burning at the application site, argyria, hyperpigmentation Contraindications: Hypersensitivity to silver or to silver sulphadiazine. Pregnant women at or near term (increased kernicterus). Preterm infants or newborns during first two months Interactions: Concomitant cimetidine therapy may increase the likelihood of causing leucopenia in silver sulfadiazine-treated burn patients ------------------------------------------------------------------------------------------------------------------------------------Sodium Fusidate 2% Ointment A Trade Name : Fucidin Indication : Skin infections caused by staphylococci, streptococci, corynebacterium minutissumun and other sodium fusidate-sensitive organisms Dosage : Apply to affected area 2 - 3 times daily Precautions: Avoid contact with eyes and other mucous membranes Adverse Reaction: Rash, irritation, pruritus, contact dermatitis Contraindications: Infection caused by non-susceptable organism in particular pseudomonas aeruginosa Interactions: Not known ----------------------------------------------------------------------------------------------------------------------------------- 354 Sodium Thiosulphate 10-20% Solution C Indication : Fungicides. For the treatment of pityriasis versicolor Dosage : Apply to all affected parts of the body and face with a brush after a bath once daily or twice daily or 3 times daily Precautions: Discontinue topical use if irritation or sensitivity occurs, rapid IV infusion has caused transient hypotension Adverse Reaction: Hypotension, coma, psychosis, confusion, contact dermatitis, local irritation, neuromuscular and skeletal weakness, tinnitus, diarrhoea (following large accidental ingestion) Contraindications: Hypersensitivity to sodium thiosulphate or any component of the formulation Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Acriflavine 0.1% Lotion C Indication : Infected skin, lesions, cuts, abrasions, wounds and burns Dosage : Apply undiluted three times daily to the affected part Precautions: Prolonged application, may stain skin, hair & fabric. Adverse Reaction: Hypersensitivity to acriflavine compound Contraindications: Hypersensitivity to acriflavine compound. Interactions: Not known ------------------------------------------------------------------------------------------------------------------------------------Alcohol 70% Solution C Indication : Use as antiseptic and disinfectant Dosage : Apply to the skin undiluted or when needed Precautions: Pregnancy, nursing mothers, elderly Adverse Reaction: Mental impairment, gastrointestinal disturbances, severe effects include respiratory depression, coma and death Contraindications: Not known Interactions: Chlorpropamide, metronidazole, cefoperazone, cefoperazone/sulbactam and cefotaxime -------------------------------------------------------------------------------------------------------------------------------------- 355 Cetrimide 1-2% Lotion. C Trade Name : Cetavlon Indication : As shampoo and cleansing agent Dosage : Apply to affected area Precautions: Contact with the eyes, brain, meninges, and middle ear should be avoided. Cetrimide should not be used in body cavities or as an enema Adverse Reaction: Cutaneous irritation and local effects Contraindications: Hypersensitivity to cetrimide Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Chlorhexidine Gluconate 4% Scrub C Trade Name : Hibiscrub Indication : Surgical hand scrub/disinfection, pre-op skin preparation Dosage : Surgical hand disinfection: Apply 5ml to clean hands and forearms for 1 min. Rinse and repeat with another 5ml for a further 2 mins and then rinse and dry. General skin disinfection: Apply appropriate quantity to wet area and scrub for 1 min. Rinse thoroughly & dry Precautions: For external use only. Avoid contact with eyes and middle ear Adverse Reaction: Occasionally irritative skin reactions, generalised allergic reactions, may cause gastrointestinal disturbances. Inhalation of solvent vapours may give rise to nausea, headaches and dizziness Contraindications: Hypersensitivity to chlorhexidine gluconate or any component of the formulation Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Chlorhexidine Gluconate 5% Solution C Trade Name : Hibitane Indication : i) Preoperative skin disinfection ii) Wounds or burns iii) Emergency disinfection of instruments Dosage : i) & iii) 1 : 10 in 70 % Alcohol ii) 1 : 100 Precautions: Avoid contact with meninges, application into hairy areas and not use as a preoperative skin preparation for the face or head. Keep disinfectant solution out of the eyes, ears and mouth Adverse Reaction: Mucosal irritation (discontinue if desquamation), parotid gland swelling, irritation and gastrointestinal disturbances. Inhalation of solvent vapours may give rise to nausea, headaches and dizziness Contraindications: Hypersensitivity to any of its components 356 Interactions: Avoid cemented glass components -------------------------------------------------------------------------------------------------------------------------------------Chlorinated Lime Solution & Buffered Acetate Solution C Trade Name : Eusol-T Indication : Wound or ulcer Dosage : Apply to affected areas undiluted as a cleansing agent Precautions: Topically applied hypochlorites may dissolve blood clots and cause bleeding Adverse Reaction: Skin irritation Contraindications: Patients who have previously shown a hypersensitivity reaction Interactions: Not known ---------------------------------------------------------------------------------------------------------------------------------Hydrogen Peroxide 20 volume Solution C Indication : Skin disinfection, particularly cleansing and deodorising wounds and ulcers Dosage : Hydrogen Peroxide 6% (=approx. 20 vol) shall be dispensed. For cleansing wounds: 1.5% to 6% solution apply 2-3 times daily or when nescessary. As a mouthwash: rinse the mouth for 2-3 minutes with 15ml of hydrogen peroxide 6% diluted in half a tumblerful of warm water 2-3 times daily. Disinfecting cleaned equipment: immersion for 30 minutes in 6% solution. As ear drop for removal of wax: hydrogen peroxide 6% diluted with 3 parts of water preferably just before use Precautions: Large or deep wound, avoid normal skin, bleaches fabric. Strong solution which contain 27% and 30% (100 vol) are only for the preparation of weaker solution and should not be applied to tissue undiluted Adverse Reaction: Bleaching effect on hair, irritating burn on the skin, mucous membrane and eye. Continued use as a mouthwash may cause reversible hypertrophy of the papillae of the tongue Contraindications: Should not be used in abscesses Interactions: Incompatible with reducing agents, including organic matter and oxidisable substances, some metals, metallic salts, iodides and permanganates ------------------------------------------------------------------------------------------------------------------------------------Potassium Permanganate 1:10,000 Solution Indication : Cleansing and deodorising suppurative eczematous reactions and wounds Dosage : As soaks or wet dressing 1 - 3 times daily or as required Precautions: Avoid contact with eyes and other mucous membranes 357 C Adverse Reaction: Irritant to tissues and stain skin brown Contraindications: Hypersensitivity to any component Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------Povidone Iodine 10% (equivalent to 1% iodine) Solution B Indication : Skin operation prior to surgery, in cleansing open wounds, as an antiseptic for operative wounds infections Dosage : Paint the area once or twice daily and allow to dry Precautions: Highly toxic if ingested, sodium thiosulfate is the most effective chemical antidote, avoid contact with eyes, use with caution in infants and nursing women Adverse Reaction: Rash, pruritus, local oedema Contraindications: Hypersensitivity to iodine or any component of the formulation Interactions: Not known -----------------------------------------------------------------------------------------------------------------------------------Colchicine 0.5 mg Tablet B Indication : i) Acute gout and prophylaxis of recurrent gout. ii) Leucocytoclastic Vasculitis either cutaneous or systemic involvement, Behcet's syndrome, Urticarial vasculitis, Systemic sclerosis, Sweet's syndrome and severe recalcitrant aphthous stomatitis Dosage : i) Initial dose, 0.5-1.2 mg, then 0.5-0.6 mg every hour until relief of pain is obtained or vomiting or diarrhoea occurs (Maximum : 8 mg). The course should not be repeated within 3 days. Prevention of attacks during initial treatment with allopurinol or uricosuric drugs: 0.5 mg 1-3 times daily. ii) 0.5 mg 1-3 times daily depends on disease and severity, up to a maximum of 3 mg/day Precautions: Pregnancy, lactation, children and elderly, GI disease, cardiac, renal and hepatic impairment. Prolonged therapy not recommended Adverse Reaction: Bone marrow depression with aplastic anaemia, peripheral neuritis, myopathy, hair loss, gastrointestinal disturbances, epigastric pain, diarrhoea, nausea, vomiting, myelosuppression, abdominal pain, diarrhoea, gastrointestinal haemorrhage, rashes, renal and hepatic damage in excessive doses. Rarely peripheral neuritis, myopathy, alopecia and with chronic therapy blood disorders like agranulocytosis, aplastic anaemia Contraindications: Serious GI, renal, hepatic & cardiac disorders and those with blood dyscrasias, hypersensitivity to colchicine, children under 2 years old, pregnancy, debilitated patients, SC/IM administration Interactions: Reversible malabsorption of Vit B12, action inhibited by acidifying agents & enhanced by alkalinizing agents, cyclosporin, erythromycin. Response to CNS depressants and sympathomimetics may increase when used concurrently with colchicine. Increased risk of myopathy when used 358 concurrently with simvastatin. Potential risk of severe drug interactions, including death in certain patients treated with colchicine and concomitant P-glycoprotein or strong CYP3A4 inhibitors such as clarithromycin, ciclosporin, erythromycin, calcium channel antagonists (verapamil, diltiazem), telithromycin, ketoconazole, itraconazole, HIV protease inhibitors and nefazodone. P-glycoprotein or strong CYP3A4 inhibitors are not to be used in patients with renal or hepatic impairment who are taking cochicine. A dose reduction or interruption of colchicine treatment should be considered in patients with normal renal and hepatic function if treatment with a P-glycoprotein or a strong CYP3A4 inhibitors required. Avoid consuming grapefruit and grapefruit juice while using colchicines -------------------------------------------------------------------------------------------------------------------------------------Magnesium Sulphate 45% Paste C Indication : Inflammatory skin conditions such as boils and carbuncles Dosage : Apply under dressing Precautions: Avoid contact with eyes and other mucous membranes Adverse Reaction: Prolonged or repeated use may damage the surrounding skin Contraindications: Hypersensitivity to magnesium sulfate Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Protein Free Haemodialysate 10% Jelly A Trade name: Soloseryl Indication : Trophic lesions in patients with arterial occlusive disease and with chronic venous insufficiency, burn injuries, impaired wound healing, decubitus ulcers and skin ulcer caused by irradiation Dosage : Apply 3 - 5 times daily Precautions: Burning sensation after application Adverse Reaction: Allergic skin reactions Contraindications: Hypersensitivity to any component Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Protein Free Haemodialysate 5% Ointment A Trade name: Soloseryl Indication : Trophic lesions in patients with arterial occlusive disease and with chronic venous insufficiency, burn injuries, impaired wound healing, decubitus ulcers and skin ulcer caused by irradiation Dosage : Apply 3 - 5 times daily Precautions: Burning sensation after application 359 Adverse Reaction: Allergic skin reactions Contraindications: Hypersensitivity to any component Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------- 360 22. IMMUNOLOGICAL PRODUCTS AND VACCINES Vaccines and antisera Immunoglobulins 361 BCG Vaccine Freeze-Dried Injection C Indication : For the prevention of tuberculosis Dosage : 0.1 ml by intradermal injection. INFANT under 12 months: 0.05 ml Precautions : Children born to HIV positive mothers, pregnancy. Adverse Effects : Superficial, self healing ulceration, injection site reaction, lymphadenopathy. Contraindications : Congenital or acquired cell-mediated immune deficiencies (including HIV), patients with systemic corticosteroid/ immunosuppressive treatment, malignant condition, pyrexia, generalised infected dermatoses, organ abnormalities. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Haemophilus Influenzae Type B Conjugate 10 mcg Vaccine C Trade Name : Act-Hib Indication : Immunisation of infants against Haemophilus Influenzae Type B Dosage : 0.5 ml IM Precautions : Presence of fever or acute infection. Adverse Effects : Injection site reaction, fever. Contraindications : Hypersensitivity to any components of the vaccine. Interactions : Not known. -----------------------------------------------------------------------------------------------------------------------------------Hepatitis B Vaccine Injection C Trade Name : B-Hepavac Indication : Immunisation against infections caused by Hepatitis B virus Dosage : ADULTS over 20 years: 10 mcg/dose. ADOLESCENT 11 - 19 years: 5 mcg/dose. NEWBORN and CHILD up to 10 years: 2.5 mcg/dose. INFANTS born to HBsAg positive mothers: 3 doses of 0.5 ml each. Second dose to be given after 1 month and booster dose after 6 months Precautions : Pregnancy, immunodeficiency and or receiving immunosuppresant therapy, severely compromised cardiopulmonary status. Adverse Effects : Fatigue, malaise, nausea, diarrhoea, reactions at injection site. Contraindications : Hypersensitivity to any of the components. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------- 362 Meningococcal A, C, Y, W 135 Vaccine Injection B Indication : Immunisation against meningococcal diseases caused by Neisseria meningitis Group A, Group C, Group Y or Group W-135 Dosage : Prophylaxis: 0.5 ml subcutaneously Precautions : Infants less than 18 months have a lower rate of seroconversion to C, Y and W135. Adverse Effects : Temporary hyperthermia and mild erythema at injection site. Contraindications : Hypersensitivity to thiomersal or any component of the form. Interactions : Decreased effect with administration of immunoglobulin within 1 month. --------------------------------------------------------------------------------------------------------------------------------Pneumococcal Vaccine (Polyvalent) A Trade Name : Pneumo 23 Indication : Prevention of pneumococcal infections in high risk subjects from the age of 2 years including patient with a history of splenectomy or scheduled splenectomy Dosage : Primary injection: 1 single injection (0.5 ml) only. Booster: Must not be given within 5 years except in very high risk patient who received the vaccine while under immunosuppressive treatment Precautions : Pregnancy. Adverse Effects : Injection site reaction, fever, haemolytic anaemia, thrombocytopenia, anaphylactoid reaction. Contraindications : Hypersensitivity to pneumococcal vaccine components. Interactions : Not known. -------------------------------------------------------------------------------------------------------------------------------------Rabies Human Diploid Cell Vaccine (Lyophilised) Injection B Trade Name : Imorab Indication : Pre-exposure and post-exposure vaccination against rabies Dosage : Prophylaxis: 3 dose (1 ml each) schedule on days 0, 7 and 28. Booster dose after every 2 - 3 years. Post exposure prophylaxis: use after attack of a potential rabid animal: 1 dose on days 0, 3, 7, 14 and 30. In previously vaccinated individuals 2 doses on day 0 and 3 Precautions : Allergy to neomycin. Adverse Effects : Erythema of injection site, fever with mild asthenia. Contraindications : Pregnancy, acute febrile illness. Interactions : Corticosteroids, immunosuppressives. ---------------------------------------------------------------------------------------------- 363 Tetanus Toxoid Injection C Trade Name : ATT Indication : Immunization against tetanus infection Dosage : 0.5 ml at 2 months followed by second dose after 4 weeks and third dose after another 4 weeks. Booster every 10 years Precautions : Not recommended for children less than 7 years. Adverse Effects : Local reaction, fever, headache and malaise, brachial (cervical) neuritis, Guillain-Barre syndrome, nausea, arthralgia, anaphylaxis, Arthus type urticaria. Contraindications : Hypersensitivity to any component of the vaccine, febrile illness or acute infection. Interactions : Chloramphenicol. -------------------------------------------------------------------------------------------------------------------------------------Tuberculine PPD Injection B Trade Name : Tuberculine Indication : For routine Mantoux (tuberculin sensitivity) test Dosage : 10 units is injected intradermally Precautions : Sensitivity to tuberculin may be diminished in the following conditions: viral or severe bacterial infection including HIV infection and severe tuberculosis, neoplastic disease particularly lymphoma, sarcoidosis, corticosteroid or immunosuppressive therapy, recent administration of live virus vaccines, ultraviolet light treatment, chronic renal failure and malnutrition. Tuberculins may be adsorbed onto the surface of syringes and should therefore be administered immediately. Tuberculin skin tests should not generally be administered to known tuberculin reactors because of the risk of a severe reaction at the test site. Adverse Effects : Pain and pruritus may occur at the injection site, occasionally with vesiculation, ulceration or necrosis in highly sensitive persons. If given to patients with tuberculosis a severe reaction may occur. Granuloma has been reported. Hypersensitivity reactions, including anaphylaxis, to tuberculins have been reported rarely. Contraindications : Subcutaneous injection, hypersensitivity to tuberculin purified protein derivative, previous severe reaction (e.g. Vesiculation, ulceration, necrosis). Interactions : Corticosteroid, immunosuppressive therapy, live virus vaccines. -------------------------------------------------------------------------------------------------------------------------------------Varicella Virus Vaccine Live Attenuated Injection A* Trade Name : Okavax, varivax, varilrix Indication : Dosage : ADULT and CHILD 13 years or more: 2 doses of 0.5 ml SC injection separated by 4 - 8 weeks apart. CHILD 12 months - 12 years: 0.5ml SC as a single dose 364 Precautions : Discontinue maintenance chemotherapy equal or less than 1 week prior to injection and recommence therapy after equal or more than 1 week after injection. Malignant solid tumours, women of child-bearing potential should practise adequate contraceptive measures 1 month prior to vaccination and 2 month after vaccination. Cardiovascular, kidney, liver, haematological or developmental abnormalities. History of seizures, diagnosed immunodeficiency states, abnormal immune system function. Concomitant immunosupressive therapy. Vaccine may not effective in patients receiving blood or gamma-globulin preparation within 3 month prior to vaccination. Other live viral vaccines should only be given equal or more than 4 weeks after Okavax. Adverse Effects : Fever, rash, urticaria, erythema, pruritus. Rarely, local reaction, anaphylactoid symptoms. Contraindications : Reinforcement therapy for leukaemia or extensive therapy using strong immunosuppressives. Acute myelogenous leukaemia or malignant lymphoma. Interactions : Transfusion and administration of gamma-globulin preparations: The vaccine may not be effective in those receiving blood or gamma-globulin preparation within 3 month before vaccination. Vaccination of such individuals should be delayed until equal or more than 3 months has elapsed. For those receiving high dose gamma-globulin therapy, ie equal or more than 200 mg/kg, eg patients with Kawasaki disease or acute immune thrombocytopenic purpura (ITP), vaccination should be delayed until equal or more than 6 months has elapsed. If gamma-globulin is administered within 14 days after administration of the vaccine, the vaccine may not be effective. Such individuals should be re-vaccinated equal or more than 3 months after the initial vaccination. Other live vaccine preparations: Those receiving other live vaccines, eg oral polio, measles, mumps, rubella, BCG or yellow fever vaccine, are advised to wait until equal or more than 4 weeks has elapsed before being vaccinated. Incompatibilities: The vaccine should not be mixed with other vaccines or medications in the same syringe. -------------------------------------------------------------------------------------------------------------------------------Anti RhD Gamma Globulin 250 mcg/2 ml Injection (500 units=100 mcg) B Trade Name : Rhogam Indication : Prevention of Rh(D) sensitisation by IM injection to rhesus-negative woman after delivery of rhesuspositive infant Dosage : 50 - 100 mcg within 72 hours after incompatible blood transfusion: 25 mcg (125 units) per ml transfused blood, up to 1000 mcg Precautions : Never administer by IV or to infant. IgA deficiency. Hypersensitivity to thiomersal or human Ig. Adverse Effects : Pain at injection site. Slight temperature elevation. Contraindications : RhD positive mother. Interactions : Live virus vaccines. ----------------------------------------------------------------------------------------------------------------------------------- 365 Hepatitis B Immunoglobulin (Human) Injection A Trade Name : Hyperhep/Hepabig Indication : i) For post-exposure prophylaxis of hepatitis B ii) Prophylaxis against recurrence of hepatitis B infection in chronic hepatitis B post liver transplantation Dosage : i) Recommended dose in ADULT and CHILD more than 10 years: A single dose of 500 units IM within 48 hours and not more than 1 week after exposure ii) Different regimens depending on hepatitis B virus (HBV) DNA positivity Precautions : Extreme hypogammaglobulinaemia, severe thrombocytopenia, bleeding disorders. Adverse Effects : Local reaction at injection site, headache, malaise, fever, nephrotic syndrome. Contraindications : Selective IgA deficiencies. Interactions : Live vaccines. -------------------------------------------------------------------------------------------------------------------------------------Tetanus Immunoglobulin Human 250 Units/Vial Injection B Trade Name : Hyper-Tet Indication : Passive immunization against tetanus Dosage : Prophylaxis of tetanus: IM 250 units. Treatment of tetanus: IM 30 - 300 units/kg Precautions : Known intolerence to blood or blood derivatives. Adverse Effects : Pain, tenderness, erythema at injection site, fever (mild), urticaria, angioedema, muscle stiffness, anaphylaxis reaction, sensitization to repeated injections. Contraindications : HIV patients. Interactions : Never administer tetanus toxoid and tetanus immunoglobulin (TIG) in same syringe (toxoid will be neutralized), toxoid may be given at a separate site, concomitant administration with T-dependant antigen (Td) may decrease its immune response, especially in individuals with low prevaccination antibody titers. ------------------------------------------------------------------------------------------------------------------------------------ 366 20. ANAESTHESIA Induction / Maintenance Neuromuscular blocker Topical anaesthesia Local anaesthesia Miscellaneous anaesthesia 367 Dexmedetomidine HCl 100 mcg/ml Injection A* Trade Name : Precedex Indication : Sedation of intubated and mechanically ventilated ICU patients. For use only by specialist anaesthetist Dosage : Not to be infused for more than 24 hours, 1 mcg/kg over 10 minutes as loading dose. Maintenance dose: 0.2 - 0.7 mcg/kg/hr Precautions : Significant cardiovascular dysfunction, advanced heart block, renal and hepatic impairment, elderly more than 65 years, pregnancy, lactation, diabetes mellitus, chronic hypertension. Adverse Reactions: Hypotension (more frequent), hypertension, cardiovascular disease, nausea, dry mouth, hypoxia, somnolence. Contraindications: Hypersensitivity to dexmedetomidine. Interactions: Enhances effects of anaesthesia, sedative, hypnotics and other CNS depressants, opiods. -----------------------------------------------------------------------------------------------------------------------------------Etomidate 20 mg/10 mg Injection A* Trade Name : Etomidate Lipuro Indication : Induction of general anaesthesia for haemodynamically unstable patients Dosage : CHILD greater 10 years and ADULT: 0.15 - 0.3 mg/kg ELDERLY: 0.15 mg/kg - 0.2 mg/kg Precautions : Not for administration by prolonged infusion due to hazarads of prolonged suppression of endogenous cortisol and aldosterone production, severe asthma, severe cardiovascular disease. Not to use for maintenance of anaesthesia. Opioid analgesics or benzodiazepines may be given as premedications to reduce risk of convulsions. Pre-existing epilepsy. Elderly and child less than 10 years. Pregnancy and lactation. Adverse Reactions: Hypotension, adrenal suppression, myoclonus, transient skeletal movements, uncontrolled eye movements, hiccups. Excitatory phenomena eg, involuntary myoclonic muscle movements, convulsions; hypersensitivity reactions, pain on injection; postoperative nausea and vomiting. Contraindications: Hypersensitivity to etomidate. Reduced or at risk of reduced adrenocortical function. Porphyria. Interactions: Fentanyl, verapamil, St. John'swort. Antipsychotics, sedatives or opioids; calcium-channel blockers. ---------------------------------------------------------------------------------------------------------------------------------Isoflurane Liquid B Trade Name : Forane Indication : i) Induction and ii) Maintenance of anaesthesia Dosage : i) Induction- Initiate at a concentration of 0.5 % ii) Maintenance- 1 - 2.5 % in oxygen or nitrous oxide mixture. 0.5 - 0.75 % with oxygen and nitrous oxide for Caesarian section 368 Precautions : Uterine curettage, raised intracranial pressure, cardiac, respiratory, renal or hepatic impairment. Elderly or obese patients. May impair ability to drive or operate machinery. Avoid alcohol. Concomitant use with adrenaline or other sympathomimetics. Pregnancy and lactation. Adverse Reactions: Cardio-respiratory depression, hepatic injury, hepatotoxicity, jaundice, malignant hyperthermia, gastrointestinal upset, ileus, post-operation shivering. Hypotension, arrhythmias, transient rise in cerebrospinal fluid pressure. Contraindications: Hypersensitivity to isoflurane, halogenated agents. Genetic susceptibility to malignant hyperthermia. Porphyria. Interactions: Potentiates action of nondepolarising muscle relaxants. Enhance effects of neuromuscular blockers, central nervous system depressants. Enhanced hypotensive effects of ACE inhibitors, tricyclic antidepressants (TCAs), MAOIs, antihypertensives, antipsychotics, beta-blockers -----------------------------------------------------------------------------------------------------------------------------------Ketamine 10 mg/ml Injection B Trade Name : Ketalar Indication : Sole anaesthetic for short procedures or induction of anaesthesia in certain types of patients (e.g in shock states) Dosage : IV - onset 30 sec : 2 mg/kg body weight or IM - onset 3 - 4 min : 10 mg/kg body weight Precautions : Those prone to hallucinations, severe coronary heart disease, eclampsia/pre-eclampsia, history of convulsive or psychiatric disorders, raised intracranial or intraocular pressure. Glaucoma, elderly, alcoholics, epilepsy. Adverse Reactions: Cardiovascular stimulation, increased arterial pressure, tachycardia, emergence phenomena (hallucination and other transient psychotic squelae, vivid dreams), muscle hyperactivity. Irrational behaviour. Increased muscle tone sometimes resembling seizures. Temporary hypertension, hypotension, bradycardia, arrhythmias. respiratory depression, apnoea, laryngospasm, diplopia, nystagmus; nausea, vomiting, lachrymation; hypersalivation; raised intraocular and cerebrospinal fluid pressure; skin irritation and pain at injection site. Contraindications: Hypersensitivity to ketamine products, conditions where hypertension is hazardous. History of cardiovascular accident; severe angina, myocardial infarction, raised ocular and intracranial pressure, psychiatric disorders. Interactions: Atracurium, metrizamide, theophylline, tramadol, tubocurarine, barbiturates, opioid. Inhalational anaesthetics and cerebral depressants may prolong effect of ketamine and delay recovery. Prolonged recovery with concomitant use of barbiturates and/or opioids. Sustained hypertension with thyroid hormones. ----------------------------------------------------------------------------------------------------------------------------------Midazolam 5 mg/ml Injection Midazolam 15mg/3ml Injection Trade Name : Dormicum Indication : A A 369 Pre-operative sedation, induction of general anaesthesia, premedication and sedation in ICU and sedation for minor procedures Dosage : Usual sedative range 2.5 - 7.5 mg (about 70 mcg/kg by IV injection over 30 seconds). Premedication by IM injection 70 - 100 mcg/kg 30 -60 minutes before surgery; ELDERLY: 1 - 1.5 mg/kg. Induction: Induction by slow IV infusion 200 - 300 mcg/kg (ELDERLY 100 - 200 mcg/kg. CHILD over 7 years 150 200 mcg/kg); Maximum: 0.35mg/kg. Sedation in ICU 0.03 - 0.2 mg/kg/hour Precautions : Elderly, COPD, congestive heart failure, respiratory failure, severe electrolyte and fluid disturbances, pregnancy and lactation, hepatic and renal impairment, labor and delivery, prolonged use and abrupt withdrawal, moderate lowering of intraocular pressure in ophthalmic. Children under 15 kg not to exceed 1 mg/ml. Adverse Reactions: Muscle stiffness, induration of veins, pain, redness, headache, apnoea, nausea, coughing, vomitting, drowsiness, respiratory depression, phlebitis, gastrointestinal disturbances, increased appetite, jaundice, hypotension, bronchospasm, pain at the site of injection. Contraindications: Acute narrow angle glaucoma, hypersensitivity to midazolam products, acute alcohol intoxication, shock, lactation. Interactions: Neuroleptics, tranquilizer, antidepressant, hypnotics, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepiletics, antihistamines, erythromycin, clarithromycin, cimetidine, omeprazole, diltiazem, efavirenz, indinavir, nelfinavir, ritonavir, saquinavir, fluvoxamine, halothane, sevoflurane, thiopental, itraconazole, theophylline, atorvastatin. ---------------------------------------------------------------------------------------------------------------------------------Midazolam 7.5 mg Tablet A/KK Trade Name : Dormicum Indication : Pre and post-operative sedation Dosage : ADULT: Usually 7.5 - 15 mg at bedtime; or for premedication, 30 - 60 minutes before the procedure. For ELDERLY, debilitated or impaired liver/kidney function: 7.5 mg Precautions : Elderly, COPD, congestive heart failure, respiratory failure, severe electrolyte and fluid disturbances, pregnancy and lactation, hepatic and renal impairment, labor and delivery, prolonged use and abrupt withdrawal, moderate lowering of intraocular pressure in ophthalmic. Children under 15 kg not to exceed 1 mg/ml. Adverse Reactions: Muscle stiffness, induration of veins, pain, redness, headache, apnoea, nausea, coughing, vomitting, drowsiness, respiratory depression, phlebitis, gastrointestinal disturbances, increased appetite, jaundice, hypotension, bronchospasm, pain at the site of injection. Contraindications: Acute narrow angle glaucoma, hypersensitivity to midazolam products, acute alcohol intoxication, shock, lactation. Interactions: Neuroleptics, tranquilizer, antidepressant, hypnotics, analgesics, anaesthetics, antipsychotics, anxiolytics, antiepiletics, antihistamines, erythromycin, clarithromycin, cimetidine, omeprazole, diltiazem, efavirenz, indinavir, nelfinavir, ritonavir, saquinavir, fluvoxamine, halothane, sevoflurane, thiopental, itraconazole, theophylline, atorvastatin. ---------------------------------------------------------------------------------------------------------------------------------- 370 Propofol 1 % Injection A* Trade Name : Diprivan Indication : Induction & maintenance of general anaesthesia. Sedation of ventilated ICU patients Dosage : Induction: 1.5-2.5mg/ kg at the rate of 20-40 mg every 10 seconds. CHILD more than 8 years: usually 2.5mg/ kg. Maintenance: IV 25-50 mg repeated according response. IV infusion: 4-12mg/kg/hour; CHILD more than 3 years: 9-15 mg/kg/ hour. Sedation: 0.3 - 4 mg/kg/hour up to 3 days Precautions : Monitor blood lipid concentration in patients at risk for fat overload, risk of convulsion in epileptic patients, monitor signs of hypotension, airway obstruction and oxygen desaturation. Cardiac, respiratory, renal or hepatic impairment; hypovolaemic or debilitated patients; disorders of fat metabolism or conditions where lipid emulsions should be used cautiously. Do not use in pregnancy, do not use for obstetric anaesthesia. Avoid in lactation, has been used for termination in 1 st trimester. Ability to drive or operate machinery may be affected. Bradycardia. Contains EDTA which chelates metal ions, including zinc. Hence, consider need for supplemental zinc during prolonged administration especially in patients predisposed to zinc deficiency eg. patients with burns, diarrhoea, major sepsis. Contains no antimicrobial preservatives. When aspirated, must be drawn aseptically into sterile syringe or giving set immediately after opening ampoule or breaking vial seal. Administration must commence with or without delay. Asepsis must be maintained for Diprivan & infusion instrument throughout infusion period. Any fluids added to Diprivan line must be administered close to cannula site. Diprivan must not be administered via microbiological filter. Single infusion must not exceed 12 hour. At the end of the procedure or at 12 hours, whichever is sooner, both reservoir & infusion line must be discarded & replaced as appropriate. Adverse Reactions: Very common: Local pain on induction. Common: Hypotension, bradycardia, transient apnoea during induction, nausea & vomiting & headache during recovery phase, withdrawal symptoms in children, flushing in children. Uncommon: Thrombosis & phlebitis. Rare: Epileptiform movements, including convulsions & opisthotonus during induction, maintenance & recovery. Very rare: Rhabdomyolysis, pancreatitis, post-operative fever, discoloration of urine following prolonged administration, anaphylaxis - may include angioedema, bronchospasm, erythema & hypotension - sexual disinhibition, pulmonary oedema, post-operative unconsciousness. Contraindications: Children less than 3 years and obstetric anaesthesia. Interactions: Bupivacaine, lidocaine, succinylcholine. Diprivan has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular-blocking drugs, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered. Lower doses of Diprivan may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques. Incompatibilities: Diprivan should not be mixed prior to administration with injections or infusion fluids other than with 5% Dextrose in PVC bags or glass infusion bottles or lignocaine injection or alfentanil injection in plastic syringes. The neuromuscularblocking agents, atracurium and mivacurium should not be given the same IV line as Diprivan without prior flushing. --------------------------------------------------------------------------------------------------------------------------------Sevoflurane Liquid Trade Name : Sevorane Indication : To be used only for i) induction and ii) maintenance of anaesthesia 371 A* Dosage : i) Up to 8% in oxygen or nitrous oxide-oxygen mixture ii) maintenance: 1 - 3% Precautions : Avoid the use of flow rates of less than 2 litres/minute with soda lime in patients with renal disease. Raised intracranial pressure, cardiac, respiratory, renal or hepatic impairment, elderly or obese patients. Maintenance of haemodynamic stability is important in patients with coronary artery disease. Concomitant use with adrenaline or other sympathomimetics. Pregnancy and lactation. Adverse Reactions: Cardiorespiratory depression, hypotension, malignant hyperthermia, agitation, laryngospasm, increased cough, salivation, acute renal failure, shivering, nausea, vomiting, rarely dystonic movements in children, postoperative hepatitis and seizure-like activity. Contraindications: Hypersensitivity to sevoflurane/halogenated anaesthetics, malignant hyperthermia. Interactions: Isoniazid, nitrous oxide, thiopental, midazolam, phenobarbital, primidone, rocuronium, vecuronium, atracurium, succinylcholine, tubocurarine, verapamil. Potentiates action of non-depolarising muscle relaxants. -------------------------------------------------------------------------------------------------------------------------------------Thiopental Sodium 500 mg Injection B Trade Name : Pentothal Indication : i) General anaesthesia, induction ii) Anticonvulsant for cases resistant to conventional anticonvulsants in the ICU Dosage : i) ADULT : For induction 200 - 400 mg. For repeat injection 3 - 5 mg/kg over 10 - 15 seconds until desired depth of anaesthesia is obtained. Not FDA approved for use in pediatric patients ii) 75 - 125 mg IV single dose; for local-anaesthetic induced convulsion: 125 - 250 mg IV over 10 minutes Precautions : Reduce dose in severe liver disease, cardiovascular disease, elderly, bronchiol asthma, adrenocorticol insufficiency, lactation, renal function impairment, hypotension or shock, neoplastic lesion of lower bowel. Adverse Reactions: Cardio-respiratory depression, arrhythmias, coughing, laryngospasm, bronchoconstriction, haemolytic anaemia with renal failure, vasodilation, intracranial pressure changes, hepatotoxicity and erythema, delirium, headache, amnesia, seizures, rash, abdominal pain, rectal bleeding, thrombophlebitis, pain at injection site, salivation, shivering. Contraindications: Porphyria, status asthmaticus, respiratory failure, shock and fixed cardiac output states, hypersensitivity to barbiturates, undergoing rectal surgery. Interactions: Alfentanil, hydromorphone, metoclopramide, midazolam, sevoflurane, nalbuphine, pentazocine, propoxyphene, alcohol, succinylcholine, probenecid. ------------------------------------------------------------------------------------------------------------------------------------Atracurium Besylate 25 mg/2.5 ml Injection Trade Name : Tracrium Indication : Muscle relaxation Dosage : A* 372 ADULT and CHILD more than 1 month: Initially 300 - 600 mcg/kg IV injection. Subsequent doses of 80 - 200 mcg/kg may be given as necessary. IV infusion: 5 - 10 mcg/kg/minute (300 - 600 mcg/kg/hour) Precautions : Other neuromuscular disease, severe cardiovascular disease, myasthenia gravis & severe electrolyte disorders. Adverse Reactions: Tachycardia, flushing, skin and allergic reactions.Transient hypotension attributed to histamine release. Rarely, bronchospasm, anaphylactoid reactions. Contraindications: Not known. Interactions : Effect enhanced by inhalation anaesthesia, aminoglycoside, polymyxins, lithium, magnesium salts, procainamide and quinidine. ------------------------------------------------------------------------------------------------------------------------------------Pancuronium Bromide 4 mg/2 ml lnj B Trade Name : Pavulon Indication : Muscle relaxant as an adjunct to general anaesthesia Dosage : ADULT: Initially 50 - 100 mcg/kg IV, then 10 - 20 mcg/kg as required. CHILD: Initially 60 - 100 mcg/kg then 10 - 20 mcg/kg. NEONATE: 30 - 40 mcg/kg then 10 - 20 mcg/kg. Intensive care, by IV, 60 mcg/kg every 60 - 90 minutes Precautions : Pre-existing pulmonary and renal disease, pregnancy and neonate acidosis, severe electrolyte disturbances. Adverse Reactions: Local reaction at injection site. Contraindications: Myasthenia gravis or myasthenic syndrome. Interactions: Increased activity with ether, halothane, isoflurane and cyclopropane. -------------------------------------------------------------------------------------------------------------------------------------Rocuronium Bromide 10 mg/ml Injection A* Trade Name : Esmeron Indication : As an adjunct to general anaesthesia to facilitate endotracheal intubation, to provide skeletal muscle relaxation during surgery and to facilitate mechanical ventilation in adults, children and infants from 3 months of age Dosage : ADULT (usual) : Intubation: (rapid sequence intubation) initial, 0.6-1.2 mg/kg IV Intubation: (tracheal intubation) initial, 0.6 mg/kg IV Intubation: maintenance, 0.1-0.2 mg/kg IV repeated as needed. Intubation: maintenance, 0.01-0.012 mg/kg/minute continuous IV infusion. Skeletal muscle relaxation: initial, 0.6 mg/kg IV, maintenance, 0.1-0.2 mg/kg IV repeated as needed or 0.01-0.012 mg/kg/minute continuous IV infusion. CHILD: (usual) Intubation: (age 3 months-12 yr) initial, 0.6 mg/kg/dose IV, maintenance, 0.075-0.125 mg/kg IV as needed or 0.012 mg/kg/min continuous IV infusion. Skeletal muscle relaxation: (age 3 months-12 yr) initial, 0.6 mg/kg/dose IV, maintenance, 0.075-0.125 mg/kg IV as needed or 0.012 mg/kg/min continuous IV infusion Precautions : Hepatic, biliary tract and renal diseases, condition associated with prolonged circulation time, neuromuscular disease, hypothermic condition, obesity, hypokalaemia, hypermagnesaemia, 373 hypocalcaemia, hypoproteinaemia, dehydration, acidosis, hypercapnia, cachexia increases effects. Not recommended to drive or operate machinery within 24 hour after full recovery. Adverse Reactions: Minimal histamine-releasing and cardiovascular effects, high doses produce mild vagolytic activity. Rare anaphylactic reactions. Itching and erythematous reactions at the site of injection and or generalized histaminoid reactions example bronchospasm and cardiovascular changes. Contraindications: Hypersensitivity to rocuronium products. Interactions: Anaesthetics, other non-depolarising neuromuscular blocking agents, neostigmine, edrophonium, pyridostigmine, aminopyridine derivatives, phenytoin or carbamazepine, noradrenaline, azathioprine, theophylline and calcium chloride. ----------------------------------------------------------------------------------------------------------------------------------Suxamethonium Chloride 50 mg/ml lnj B Trade Name : Scoline Indication : Muscle relaxant as an adjunct to anaesthesia Dosage : Initial test dose 5 - 10 mg may be given. Usual single dose 0.3 - 1.1 mg/kg IV. Maximum 100 mg according to the depth and duration of relaxation required. 2.5 - 4 mg/kg IM, maximum 150 mg Precautions : Cardiac disease, severe trauma or electrolyte imbalance, pre-existing hyperkalaemia. Ocular surgery, glaucoma. Elderly. Adverse Reactions : Transient muscle fasciculation before relaxation, increased intraocular and intragastric pressure, post-operative pain, bradycardia, tachycardia, hypertension, hypotension, muscarinic effects. Contraindications : Patients who are burnt, severely hyperkalaemic with penetrating eye wounds, malignant hyperpyrexia, massively traumatised patients or those with extensive muscle degeneration eg. recent paraplegia. Interactions : Enhanced effect by aminoglycoside, clindamycin, cyclophosphamide, neostigmine, pyridostigmine, rivastigmine and possibly donepezil. Arrhythmias if given with digoxin. -------------------------------------------------------------------------------------------------------------------------------------Ethyl Chloride Spray C Indication : For minor surgical procedures including lancing boils, incision and drainage of small abscesses, pain due to athletic injuries and pain due to injection administration Dosage : Spray to affected area at a distance of about 30cm until a fine white film is produced Precautions : Ethyl chloride is highly flammable and mixtures of the gas with 5% to 15% of air are explosive; never use it in the presence of an open flame or near electric cautery equipment. Caution should be taken to avoid frostbite; when used for cryotherapy, protect adjacent skin with petrolatum. Inhalation of ETHYL CHLORIDE can produce narcosis or even fatal coma with respiratory or cardiac arrest. Cover eyes, nose and mouth if spraying near the face.To protect against tissue sloughing, cover the skin adjacent to the area being treated with petrolatum. Avoid spilling the liqd on the skin. Freezing may also distort the histological structure of biopsy specimens. Highly flammable. Avoid inhalation when used as local anaesthesia 374 Adverse Reactions : Transient hypertension, narcosis, vomiting and coma. Thawing of frozen tissue after surgery may be painful. Chemical frostbite may occur following prolonged spraying onto the skin. Nephrotoxicity or hepatotoxicity (long-term exposure) Contraindications: Hypersensitivity to ethyl chloride products and vascular impairment of the extremities. Porphyria. Application on broken skin or mucous membranes Interactions : Cisatracurium, St John's Wort -------------------------------------------------------------------------------------------------------------------------------------Lidocaine 25mg and Prilocaine 25mg Cream A Trade Name : Emla Indication : Used for painless venepunctures, radial artery cannulations before extradural/spinal and other regional blocks in children above 1 year old and adults. Also used in chronic renal failure patients for insertion of A-V fistulas and shunts for haemodialysis. Dosage : Apply a thick layer under occlusive dressing at least 1 hour before the procedure Precautions : Not for use on wounds or mucous membrane, atopic dermatitis. Application in vicinity of the eyes Adverse Reactions : Oedema, itching and exanthema allergic reactions, increase methaemoglobin level. Paleness, erythema (redness). Mild burning sensation, itch or warmth in leg ulcer Contraindications : Congenital or idiopathic methaemoglobinaemia, avoid in infant less than 6 months old. Open wounds other than leg ulcers. Genital mucosa of children. Impaired tympanic membrane. Prior to intracutaneous injection of a live vaccine eg BCG, infants less or 12 month, preterm infants with gestational age less than 37 week Interactions : Potentiation of cardiac effects, antiarrhythmias; other local anaesthetics. Increased risk of systemic toxicity in patients receiving other local anaesth. Sulfonamides -------------------------------------------------------------------------------------------------------------------------------------Lignocaine 10 % w/w Spray B Indication : For surface anaesthesia in dental practice, in otorhinolaryngology and paracentesis Dosage : Spray to affected part Precautions : Cardiovascular disease, wounds or traumatised mucosa in the application region. Partial or complete heart block, elderly and patients in poor general health. Advanced liver disease or severe renal dysfunction. Avoid contact with eyes, wound or traumatised mucosa Adverse Reactions : Circumoral paraesthesia, numbness of the tongue, light headedness, tinnitus, severe hypotension, bradycardia, arrhythmia, cardiovascular collapse. Sore throat, hoarseness, loss of voice, allergic reactions (rare) Contraindications : Hypersensitivity to lidocaine or amide type of local anaesthetics 375 Interactions : Potentiation of cardiac effects antiarrhythmias. Lidocaine should be used with caution with dental injection anaesthesia, other local anaesthetics or class intrabursal (IB) antiarrhythmic drugs, as the toxic effects are additive. Tocainide and drugs that reduce the clearance of lidocaine (eg, cimetidine or β-blockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period -------------------------------------------------------------------------------------------------------------------------------------Lignocaine 2% Jelly B Trade Name : Xylocaine Indication : Use for endotracheal tubes and instruments, painful procedures in the ear, nose and throat, burns, wounds, abrasions, lacerations; catheterisation of the male and female urethra and for symptomatic treatment of cystitis and urethritis Dosage : Apply to affected area 10 mins before catheterization, etc Precautions : Traumatised mucosa and sepsis in the region of application, chronic heart failure, bradycardia or respiratory depression, hepatic insufficiency. Should not be used as ophthalmic drug. Presence of sepsis or severely traumatized mucosa in area of application. When used for endotracheal tube lubrication, avoid introducing into the lumen of the tube. Closely supervise patients being treated with class III antiarrhythmic drugs eg amiodarone and monitor ECG due to the additive effects. Adverse Reactions: Allergic reactions. Intoxication, cutaneous and hypersensitivity symptoms. Sore throat. Central nervous system excitation followed by depression with drowsiness, respiratory failure and coma, numbness of tongue and perioral region, myocardial depression, peripheral vasodilation, hypotension, bradycardia, arrhythmia, cardiac arrest. Prolonged use in the eye may lead to severe contact keratitis and corneal damage. Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Hypovolaemia, heart block or other conduction disturbances. Interactions: Potentiation of cardiac effects antiarrhythmias. Drugs structurally related to local anaesthesia. -------------------------------------------------------------------------------------------------------------------------------Bupivacaine 0.5 % Heavy Injection A Trade Name : Marcaine Spinal Heavy Indication : Used for spinal anaesthesia Dosage : ADULT: 2 - 4 ml. Not to exceed 2 mg/kg in a single dose Precautions : Neurological disorder, severe bradycardia, cardiac conduction abnormalities, hypoxaemia, acidosis, hyperkalaemia, predisposition to malignant hypothermia, pregnancy. Resuscitative equipment & drugs should be immediately available. Hypovolaemia due to haemorrhage or dehydration, aortocaval occlusion, coronary or cerebrovascular disease. Chronic neurological disorders. May impair ability to drive or operate machinery. Adverse Reactions: Confusion, nervousness, dizziness, tinnitus, respiratory depression and convulsion, hypotension and bradycardia, hypersensitivity. 376 Contraindications: Hypovolaemia, complete heart block, intravenous regional anaesthesia (Bier's block). Acute active disease of the CNS eg meningitis, tumours, poliomyelitis & cranial haemorrhage, active TB or metastatic lesions in the vertebral column. Septicaemia. Pernicious anaemia with subacute combined degeneration of the spinal cord. Pyrogenic infection of the skin at or adjacent to the site of puncture. Cardiogenic or hypovolaemic shock. Coagulation disorders or ongoing anticoagulant treatment. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias. -------------------------------------------------------------------------------------------------------------------------------------Bupivacaine 0.5 % Injection B Trade Name : Marcaine Indication : For peripheral sympathetic nerve and epidural (excluding caudal) anaesthesia and obstetrics anaesthesia Dosage : Regional nerve block or epidural block: 15 - 30 ml. Nerve block of finger or toe: 2 - 6 ml. Maximum: 2 mg/kg body weight in any 4 hours period, equivalent to 25 - 30 ml in adults of average weight Precautions : Neurological disorder, severe bradycardia, cardiac conduction abnormalities, hypoxaemia, acidosis, hyperkalaemia, predisposition to malignant hypothermia, pregnancy Adverse Reactions: Confusion, nervousness, dizziness, tinnitus, respiratory depression and convulsion, hypotension and bradycardia, hypersensitivity, arrhythmias and cardiac arrest; methemoglobinaemia; seizures, restlessness. Prolonged block. Contraindications: Hypovolaemia, complete heart block, intravenous regional anaesthesia (Bier's block). Acute active disease of the CNS eg meningitis, tumours, poliomyelitis & cranial haemorrhage, active TB or metastatic lesions in the vertebral column. Septicaemia. Pernicious anaemia with subacute combined degeneration of the spinal cord. Pyrogenic infection of the skin at or adjacent to the site of puncture. Cardiogenic or hypovolaemic shock. Coagulation disorders or ongoing anticoagulant treatment. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias. --------------------------------------------------------------------------------------------------------------------------------Bupivacaine 0.5 % with Adrenaline 1:200,000 Injection B Trade Name : Marcaine-Adrenaline Indication : Regional nerve block or epidural block. Dosage : 10 - 40 ml (0.25 %) or maximum : 2 mg/kg body weight in any 4 hours period, equivalent to 25 - 30 ml of 0.5% solution Precautions : Preexisting neurological or neuromuscular disease eg myasthenia gravis; CNS or spinal cord disease eg meningitis, spinal fluid block, cranial or spinal haemorrhage, tumours, poliomyelitis, syphilis, TB or metastatic lesions of the spinal cord, severe hepatic disease, severe renal dysfunction, hyperthyroidism, epilepsy, severe bradycardia, severe cardiac conduction abnormalities, severe shock or digitalis intoxication, Stokes-Adams or Wolff-Parkinson-White syndrome, hypoxaemia, acidosis, hyperkalaemia, predisposition to malignant hypothermia, fetal bradycardia/tachycardia 377 frequently follows paracervical block with some amide type local anesth & may be associated with fetal acidosis & hypoxia. Added risk in prematurity, toxaemia of pregnancy & fetal distress. Monitor fetal heart rate. Pregnancy. Allergic type reactions including anaphylactic type symptoms & lifethreatening or less severe asthmatic episodes in certain susceptible people. Extreme caution in patients with severe or untreated hypertension, poorly controlled thyrotoxicosis, ischaemic heart disease, heart block, cerebrovascular insufficiency, advanced diabetes & any other pathological condition that might be aggravated by effects of adrenaline. Adrenaline may induce anginal pain in patients suffering from ischaemic heart disease. Ventricular fibrillation, prefibrillatory rhythm, tachycardia, myocardial infarction, phenothiazine-induced circulatory collapse & prostatic hypertrophy. Adverse Reactions: Light headedness, nervousness, apprehension, euphoria, confusion, drowsiness, tinnitus, blurred vision, diplopia, nausea, vomiting, sensations of heat, cold or numbness, urinary retention, paraesthesia circumoral, hyperacusis, twitching, tremors, convulsions, unconsciousness, resp depression &/or arrest, agitation, numbness of the tongue, difficulty in swallowing & slurred speech. CV: bradycardia, hypotension: Haemodynamic: maternal hypotension. Neurologic: spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal motor, sensory &/or autonomic (sphincter control) deficit of some lower spinal segment w/ slow recovery (several mth) or incomplete recovery in rare instances when caudal or lumbar epidural block has been attempted. Backache & headache. Neuropathy, peripheral nerve injury & arachnoiditis. Inadvertent subarachnoid inj may lead to CNS depression, resp arrest & CV collapse. Allergic: cutaneous lesions, urticaria, oedema or anaphylactoid reactions. Contraindications: Allergy or hypersensitivity to amide type local anesth. Epidural or spinal anesth in patients with uncorrected hypotension. Infection and/or septicaemia. Obstetric paracervical block, IV regional anesth (Bier's block). Thyrotoxicosis; regions with compromised blood supply, extremities. severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output (spinal anesthesia). Interactions: May potentiate the cardiac effects of antiarrhythmics (eg mexiletine & lignocaine). CNS acting drugs: tricyclic antidepressants or MAOIs, phenothiazines & butyrophenones. Oxytocic drugs of the ergot type. Adrenergic neuron blocking agents eg guanethidine, debrisoquine, bethanidine. β-blocker eg propranolol. Inhalation anesth eg chloroform, halothane, cyclopropane, trichloroethylene or other halogenated cmpds. Cardiac glycosides, quinidine, hypoglycaemics. ----------------------------------------------------------------------------------------------------------------------------------Levobupivacaine 5mg/ml Injection A Trade Name : Chirocaine Indication : Production of local or regional anesthesia for surgery and obstetrics, and for postoperative pain management Dosage : Surgical anesthesia : Lumber epidural : 10 - 20 ml (50 - 150 mg) , caesarean section : 15 - 30 ml (75 150 mg), intrathecal: 3 ml (15 mg), peripheral nerve block : 1 - 40 ml, ilioinguinal/iliohypogastric block. CHILD : 0.25 - 0.5 ml/kg (1.25-2.5 mg/kg) Precautions : Use with caution in patients with hypotension, hypovolemia, heart block, hepatic or cardiac impairment. Adverse Reactions: Hypotension, anemia, nausea, vomiting, fever, pruritus, cardiac arrest, cardiac dysrhythmia, apnea. Contraindications: Hypotension, anemia, nausea, vomiting, fever, pruritus, cardiac arrest, cardiac dysrhythmia, apnea. 378 Interactions: St John's Wort. -------------------------------------------------------------------------------------------------------------------------------------Lignocaine HCl (Lidocaine) 2% Injection B Trade Name : Xylocaine Indication : Local anesth by infiltration IV regional anesthesia and nerve block. Emergency management of ventricular arrhythmias particularly after myocardial infarction and cardiac surgery Dosage : Local anesthesia : ADULT Maximum: 200 mg; CHILD Maximum: 30 mg/kg Cardiac arrhythmias : ADULT 50-100 mg IV. Maximum: 200-300 mg/hour; CHILD Loading dose: 0.8-1 mg/kg IV repeated if necessary up to 3-5 mg/kg followed by a continuous infusion of 10-50 mcg/kg/min Precautions : Neurological disorder, severe bradycardia, cardiac conduction abnormalities, pregnancy, congestive heart failure, respiratory depression, hepatic or renal insufficiency, epilepsy, shock, myasthenia gravis. Elderly. Pregnancy and lactation. Adverse Reactions: Nervousness, dizziness, sedation, blurred vision, tinnitus, gastrointestinal effects, dose-related methaemoglobinaemia and cyanosis. Restlessness, excitement, nervousness, paraesthesia, vomiting, muscle twitching and tremors, convulsions. Numbness of tongue and perioral region, light headedness, sedation, CNS depression, respiratory failure and coma. Arrhythmias, bradycardia, cardiac arrest, anaphylaxis. Lassitude, amnesia, foetal intoxication. Contraindications: Local inflammation and/or sepsis, septicaemia. Hypovolaemia, heart block and other conduction disturbances, bradycardia, cardiac decompensation or hypotension. Interactions: Potentiation of cardiac effects antiarrhythmias, phenytoin, beta-blockers, cimetidine. -------------------------------------------------------------------------------------------------------------------------------------Lignocaine 2% Viscous Solution A Trade Name : Xylocaine Indication : For post-tonsilectomy, sore throat, dumping syndrome, hiccough, reflux vomiting, painful lesions of the mouth, cardiospasm, instrumentation of the respiratory and digestive tract Dosage : To be taken orally as directed Precautions : Traumatised mucosa and sepsis, minimum interval between doses: 3 hours. Monitoring should be considered with amiodarone. Partial or complete heart block, elderly and patients in poor general health. Advanced liver disease or severe renal dysfunction. Adverse Reactions: Intoxication, hypersensitivity, drowsiness, excitement, dizziness, nausea, vomiting, blurred vision. Allergic reactions (rare). Contraindications: Hypersensitivity to lidocaine or amide type of local anaesthetics. Interactions: Potentiation of cardiac effects, antiarrhythmias. Dental injection anaesthesia, other local anaesthesia or class intrabursal (IB) antiarrhythmic drugs. -------------------------------------------------------------------------------------------------------------------------------------- 379 Ropivacaine HCl 2 mg/ml Injection A* Ropivacaine HCl 7.5 mg/ml Injection A* Trade Name : Naropin Indication : i) Surgical anaesthaesia including obstetrics ii) Acute pain management Dosage : Dose adjusted according to patient physical status and nature of procedure. i) Lumbar epidural: 1525 ml of 7.5 mg/ml solution; Caesarean section, 15-20 ml of 7.5 mg/ml solution in incremental doses ( max . total dose 150 mg). ii) lumbar epidural: 10-20 ml of 2mg/ml solution followed by 10-15 ml of 2 mg/ml solution at interval at of least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution Precautions : Severe liver disease, acidosis, chronic renal disease. Resuscitative equipment and drugs for treating toxic reactions should be immediately available. Adverse Reactions: Confusion, respiratory depression and convulsion, hypersensitivity, tachycardia, nausea, backache, Horner's syndrome. Bradycardia, vomiting, paraesthesia, temperature elevation, headache, urinary retention, dizziness, hypertension, hypotension, rigors, tachycardia, anxiety, hypoesthesia. Contraindications: Hypovolaemia, hypersensitivity to ropivacaine/amide-type anaesthetics, severe hypotension, complete heart block. General contraindications related to epidural anaesthesia, regardless of the local anaesthetic used, should be taken into account. Interactions: Hyaluronidase, propofol, rapacuronium, verapamil, antiarrhythmias, fluvoxamine, imipramine, theophylline and enoxacin. Concomitant use with other related amide-type local anaesthetic. -------------------------------------------------------------------------------------------------------------------------------------Atropine Sulphate 1mg/ml Injection B Indication : i) Reduce vagal inhibition,salivary and bronchiol secretion in anaesthesia ii) Reversal of excessive bradycardia iii) Reversal of effect of competitive muscle relaxants iv) Overdosage with other compounds having muscarinic action v) Organophosphate poisoning Dosage : i) ADULT 300-600 mcg IM/SC 30-60 minutes before anaesthesia or 300-600 mcg IV immediately before induction of anaesthesia ii) ADULT 0.5-1 mg repeated, every 3-5 minutes. Max Dosage: 0.04 mg/kg body weight iii) ADULT 0.6-1.2 mg before or with anticholinesterase iv) ADULT 0.5-1 mg IV/SC, repeated every 2 hour v) ADULT 2 mg IV/IM, every 30 minutes according to clinical response. Cholinesterase reactivator should be given at the earliest possible time Precautions : paediatric and geriatric patients, debilitated patients with lung disease, autonomic neuropathy, hepatic or renal disease, may cause heat prostration, patients with ileostomy or colostomy, diarrhoea may indicate incomplete intestinal obstruction, avoid driving or hazardous activities, may cause neuromuscular blockade resulting in weakness or paralysis, hyperthyroidism, coronary heart disease, acute myocardial ischemia, CHF, tachyarrhythmia, tachycardia, HTN, or prostatic hypertrophy, pregnancy, neonates. Adverse Reactions: Constipation, transient bradycardia (followed by tachycardia, palpitations & arrhythmias), reduced bronchial secretions, urinary urgency & retention, dilatation of the pupils with loss of accommodation, photophobia, dry mouth, flushing & dryness of the skin. 380 Contraindications: Hypersensitivity to atropine or anticholinergics, narrow-angle glaucoma, reflux oesophagitis, obstructive gastrointestinal disease/uropathy, ulcerative colitis or toxic megacolon, unstable cardiovascular status in acute haemorrhage or thyrotoxicosis. Interactions: Loss of cisapride efficacy, procainamide coadministered with atropine may result in additive antivagal effects on atrioventricular nodal conduction Major interaction with potassium, topiramate, effect of atropine and other antimuscuranic may be enahnced by concomitant administration of drug with antimuscuranic properties. MAOIs may enhance atropine effect. Reduce GIT motality may affect other oral drug absorption. ----------------------------------------------------------------------------------------------------------------------------------Glycopyrrolate 200 mcg/ml Injection A* Indication : i) To reduce secretions (respiratory tract) for certain types of surgery ii) Reversal of neuromuscular block in patients where atropine is contraindicated Dosage : i) ADULT: 0.2 - 0.4 mg by IV before anaesthesic induction or intraoperatively. CHILD: 4-8 mcg/kg up to a max of 200 mcg (0.2 mg) by IV ii) 0.2 mg by IV for each 1 mg of neostigmine or 5 mg pyridostigmine Precautions : Autonomic neuropathy, children and elderly patients, congestive heart failure, coronary heart disease, hypertension, hyperthyroidism, ileostomy or colostomy, mild hepatic or renal disease, prostatic hypertrophy, tachyarrythmia, tachycardia. May cause heat prostration, neuromuscular blockade. Adverse Reactions : Dry mouth, blurred vision, tachycardia, urinary retention, constipation, severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly. Contraindications : Glaucoma, obstructive uropathy, GI obstruction, myasthenia gravis, hypersensitivity to glycopyrrolates newborns less than 1 month of age. Interactions : Cisapride, with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects.Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. -------------------------------------------------------------------------------------------------------------------------------------- 381 22. DIAGNOSTIC Radiocontrast media Diagnostic aids and test preparation 382 Barium Sulphate Suspension B Trade Name : Baritop, Barytgen Indication : For x-ray examination of the alimentary tract: i) Oesophagus ii) Stomach and duodenum iii) Colon Dosage : i) Up to 150 ml of a 50% - 200% suspension orally ii) Up to 300 ml of a 30% - 200% suspension orally iii) Up to 2 litre of a 30% - 200% suspension orally Precautions : Intestinal obstruction, pyloric stenosis or lesions which may predispose to obstruction, conditions which may predispose to perforation such as acute ulcerative colitis and acute diverticulitis. Adequate hydration should be ensured after the procedure to prevent severe constipation, history of bronchial asthma or allergy, previous reaction to a contrast agent, hypertension, advanced cardiac disease, intussusception with symptoms of more than 24 hours duration, tracheoesophageal fistula Adverse Reactions : Hypersensitivity reactions, constipation, aspiration pneumonia if aspirated, ventricular fibrillation, bradycardia, asystole, electrocardiographic changes, and hypotension, urticaria, pruritus, erythema and generalized rashes, dysphagia, constipation, diarrhea, acute pritonitis, anaphylactic reactions, headache, dyspnea Contraindications : Gastrointestinal perforation, acute bleeding from gastrointestinal tract, peritonitis, pneumatosis intestinalis, gross intestinal obstruction, known or suspected perforation, hypersensitivity to anything in the barium sulfate suspension Interactions : Not known -------------------------------------------------------------------------------------------------------- Fluorescein 1 mg Ophthalmic Strip B Trade Name : Fluorets Indication : Diagnostic fluorescein angiography or angioscopy of the fundus and of the iris vasculature Dosage : Moisten tip with tear fluid from lower fornix, sterile water or ophthalmic solution and gently stroke across the conjunctiva Precautions : History of allergy or bronchial asthma. Pregnancy especially in the first trimester, lactation Adverse Effects : Nausea and headache, other symptoms and signs of hypersensitivity, allergic conjunctivitis, periorbital oedema, anaphylactic reaction, urticaria, rash Contraindications : Hypersensitivity to any of the components of product. Not to be used with soft contact lenses Interactions : Not known -------------------------------------------------------------------------------------------------------- 383 Hydroxyethyl Cellulose Jelly B Trade Name : KY Jelly Indication : For lubricating purpose Dosage : Apply sufficiently for lubricating purpose Precautions: Not known Adverse effects: Not known Contraindications: Not known Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------- 384 23. MISCELLANEOUS General disinfectant Other disinfectant Diagnostic radiopharmaceuticals Therapeutic radiopharmaceutials 385 Ether Solvent C Indication : To remove adhesive plaster from the skin Dosage : Dose depending on the route and procedure Precautions: Not known Adverse Reactions: Not known Contraindications: Hypersensitivity to iohexol/iopromide products, intrathecal corticosteroids, immediate repeat myelography, local or systemic infection Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------Chlorinated Lime Powder C Indication : Antiseptic and disinfectants Dosage : Not applicable Precautions: Bleaches fabric, irritant, do not use on open wounds Adverse Reactions: Irritating to skin, dissolves blood clots, delay clotting Contraindications: Not known Interactions: No interaction found -------------------------------------------------------------------------------------------------------------------------------------Sodium Hypochlorite Solution C Trade Name : Milton, Clorox Indication : Low-level disinfectant and antiseptic Dosage : Antiseptic: less than 0.5%. Disinfectant: 5% Precautions: For external use only, avoid eye or mucous membrane contact, do not use on open wounds Adverse Reactions: Dissolves blood clots, delays clotting. Higher concentration-corrosive to the eye, the skin and respiratory tract Contraindications: Hypersensitivity to any component of the formulation Interactions: Not known -------------------------------------------------------------------------------------------------------------------------------------- 386 INDEX 387 3TC, 193 5-FU, 263 Abilify, 113 Acarbose 50 mg Tablet, 205 Acetazolamide 250 mg Tablet, 313 Acetazolamide 500 mg Injection, 314 Acetylcysteine 200mg/ml, 9 Acetylsalicylic Acid 100 mg, Glycine 45 mg Tablet, 71 Acetylsalicylic Acid 300 mg Soluble Tablet, 96 Acitretin 25 mg Capsule, 342 Acriflavine 0.1% Lotion, 355 Act-Hib, 362 Actifed, 334 Actinomycin D (Dactinomycin) 500 mcg/ml Injection, 255 Actrapid, 208, 209 Acular, 318 Acyclovir 200 mg Tablet, 190 Acyclovir 250 mg Injection, 191 Acyclovir 3% Eye Ointment, 311 Acyclovir 5% Cream, 349 Acyclovir 800 mg Tablet, 190 Adalat, 63 Adapalene 0.1% Gel, 346 Addamel Solution, 284 Adenocor, 45 Adenosine 3 mg/ml Injection, 45 Adrenaline Acid (Epinephrine) Tartrate 1 mg/ml Injection, 66 Adriamycin, 261, 262 Aerius, 328 Afrin, 324 Albendazole 200 mg Tablet, 202 Albendazole 200 mg/5 ml Suspension, 202 Alcaine, 317 Alcohol 70% Solution, 355 Aldactone, 45 Aldomet, 54 Alendronate Sodium 70mg and Cholecalciferol 2800 IU Tablet, 222 Alfacalcidol 0.25 mcg Capsule, 286 Alfacalcidol 1 mcg Capsule, 286 Alfacalcidol 2 mcg/ml Drops, 287 Alfacalcidol 2 mcg/ml Injection, 287 Alkaline Nasal Douche, 322 Alkeran, 266 Allopurinol 300 mg Tablet, 303 All-Trans Retinoic Acid 10 mg Capsule, 255 Alphagan P, 314 Alphanate, 76 Alphanine, 75 Alprazolam 0.25 mg Tablet, 112 Alprim, 184 Alprostadil 500 mcg/ml Injection, 81 Amantadine HCl 100 mg Capsule, 144 Amikacin 250 mg/2 ml Injection, 158 Amikacin 500 mg/2 ml Injection, 158 Amikin, 158 Amiloride HCl 5 mg & Hydrochlorothiazide 50 mg Tablet, 42 Amino Acids Injection, 283 Aminophylline 25 mg/ml Injection, 83 Amiodarone 150mg/3 ml Injection, 46 Amiodarone 200 mg Tablet, 46 Amitriptyline HCl 25 mg Tablet, 124 Amlodipine 10 mg Tablet, 60 Amlodipine 5 mg and Valsartan 160 mg Tablet, 60 Amlodipine 5 mg Tablet, 60 Ammonium Bicarbonate, Tincture Ipecac, etc Mixture, 333 Amorolfine 5 % Nail Lacquer, 349 Amoxicillin & Clavulanate 228 mg/5 ml Syrup, 158 Amoxicillin 1 g & Clavulanate 200 mg Injection, 158 Amoxicillin 250 mg Capsule, 159 Amoxicillin 500 mg & Clavulanate 125 mg Tablet, 159 Amoxicillin Trihydrate 125 mg/5 ml Syrup, 160 Amphotericin B 0.15% Eye Drops, 306 Amphotericin B 50 mg Injection, 185 Ampicillin Sodium 1g & Sulbactam Sodium 500mg Injection, 160 Ampicillin Sodium 500 mg Injection, 160 Ampicillin Trihydrate 125 mg/5 ml Suspension, 161 Anastrozole 1 mg Tablet, 271 Anexate, 13 Angised, 62 Antazoline HCl, Tetrahydrozoline HCl and Benzalkonium Cloride Eye Drops, 310 Anti RhD Gamma Globulin 250 mcg/2 ml Injection (500 units=100 mcg), 365 Antilymphocyte/Antithymocyte Immunoglobulin (from Horse) Injection, 249 Antivenene Malaysian Pit Viper Injection, 9 Antivenene Serum (Cobra) Injection, 9 Antivenene Serum (Sea snake) 1000 units/26.3 ml Injection, 10 388 Antivenene Serum Snake polyvalent Injection, 10 Anusol, 29 Anzatax, 270 Aprepitant 125 mg Capsule, 33 Aprovel, 52 Aqueous Cream, 337 Arava, 301 Aredia, 224 Aricept, 151 Arimidex, 271 Aripiprazole 10mg Tablet, 113 Aripiprazole 15mg Tablet, 113 AripMT, 113 Arixtra, 68 Artane, 144 A-Scabs, 353 Ascorbic Acid 100 mg Tablet, 288 Aspirin Soluble, 96 Atarax, 329 Atenolol 100 mg Tablet, 47 Atgam, 249 Ativan, 113 Atomoxetine HCl 10 mg Capsule, 152 Atomoxetine HCl 18 mg Capsule, 152 Atorvastatin 20 mg Tablet, 77 Atracurium Besylate 25 mg/2.5 ml Injection, 372 Atropine Sulphate 1% Eye Drops, 311 Atropine Sulphate 1mg/ml Injection, 380 Atrovent, 83, 85 ATT, 364 Augmentin, 158 Aurorix, 128 Avandia, 211 Avodart, 244 Azathioprine 50 mg Tablet, 249 Azelaic Acid 20% Cream, 346 Azithromycin 250 mg Tablet, 161 Azithromycin 500 mg Injection, 161 Bacampicillin 400 mg Tablet, 162 Baclofen 10 mg Tablet, 153 Bactrim, 183, 184 Bactroban, 352 Balanced Salt Solution, 317 Baraclude, 193 Baritop, 383 Barium Sulphate Suspension, 383 Barytgen, 383 BCG Vaccine Freeze-Dried Injection, 362 Beclomethasone Dipropionate 100 mcg/dose Inhalation, 90 Becotide, 90 Benadryl, 333 Benzathine Penicillin 2.4 mega units Injection (1.8 g), 162 Benzhexol 2 mg Tablet, 144 Benzoic Acid Compound Ointment, 350 Benzoyl Peroxide 5% Gel, 347 Benzydamine HCl 0.15% Solution, 325 Benzyl Benzoate 25 % Emulsion (Adult), 350 Benzylpenicillin 1 mega unit (600 mg) Injection, 163 Benzylpenicillin 5 mega units (3 g) Injection, 163 Beractant Intratracheal Suspension (200 mg phospholipids in 8 ml vial), 93 Betahistine Dihydrochloride 24 mg Tablet, 153, 334 Betaloc, 49 Betamethasone Disodium Phoshate 0.1% Ear Drops, 321 Betamethasone Disodium Phoshate 0.5% Ear Drops, 321 Betamethasone Disodium Phosphate 0.1% Eye/Ear Drops, 309 Betaserc, 153, 334 Betnesol, 309, 321 B-Hepa, 362 Bimatoprost 0.03% Ophthalmic Solution, 314 BIPP, 323 Bisacodyl 10 mg Suppository, 27 Bisacodyl 5 mg Tablet, 28 Bismuth Subgallate and Benzyl Benzoate Suppository, 29 Bismuth Subnitrate, Iodoform and Liquid Paraffin Paste, 323 Bisolvon, 332 Bisoprolol Fumarate 2.5 mg Tablet, 47 Bisoprolol Fumarate 5 mg Tablet, 47 Bleocin, 256 Bleomycin HCl 15 mg Injection, 256 Bonjela, 325 Bonviva, 223 Botox, 154 Bricanyl, 87, 88, 89 Brimonidine Tartrate 0.15% Ophthalmic, 314 Bromhexine HCl 4 mg/2 ml Injection, 332 Bromhexine HCl 8 mg Tablet, 332 Bromocriptine Mesilate 2.5 mg Tablet, 225 Brufen, 108 BSS, 317 Budesonide 1 mg/2 ml Nebulising Solution, 91 389 Budesonide 160 mcg and Formoterol 4.5 mcg Inhalation, 94 Budesonide 200 mcg/dose Inhalation, 91 Budesonide 500 mcg/2 ml Nebulising Solution, 91 Bumetanide 0.5 mg/ml Injection, 43 Bupivacaine 0.5 % Heavy Injection, 376 Bupivacaine 0.5 % Injection, 377 Bupivacaine 0.5 % with Adrenaline 1:200,000 Injection, 377 Burinex, 43 Buscopan, 20 Ca Disod. Versenate, 11 Cabergoline 0.5 mg Tablet, 226 Calamine Cream, 337 Calamine Lotion, 337 Calamine with 2 - 6% Precipitated Sulphur Lotion, 337 Calcijex, 288 Calcipotriol 50 mcg/g Cream, 342 Calcipotriol 50 mcg/g Ointment, 342 Calcipotriol 50 mcg/ml Scalp Solution, 343 Calcipotriol Hydrate 50 mcg/g & Betamethasone Dipropionate, 343 Calcitonin (synthetic Salmon) 100 IU Injection, 223 Calcitonin (Synthetic Salmon) 200 IU Nasal Spray, 223 Calcitriol 0.25 mcg Capsule, 288 Calcitriol 1 mcg/ml Injection, 288 Calcium Carbonate 500 mg Tablet, 284 Calcium Disodium Edetate 200 mg Injection, 11 Calcium Gluconate 10% Injection, 284 Calcium Polystyrene Sulphonate Powder, 11 Calmurid, 344 Campto, 265 Cancidas, 186 Candid Ear Drops, 186 Canesten, 351 Capecitabine 500 mg Tablet, 256 Capoten, 50 Captopril 25 mg Tablet, 50 Carbamazepine 100 mg/5 ml (2% w/v) Syrup, 133 Carbamazepine 200 mg CR Tablet, 133 Carbamazepine 200 mg Tablet, 134 Carbamide (Urea) 10 % Cream, 344 Carbimazole 5 mg Tablet, 212 Carboplatin 450 mg Injection, 256 Carboprost Tromethamine 250 mcg Injection, 235 Cardura XL, 244 Carminative, 19 Carvedilol 25 mg Tablet, 48 Carvedilol 6.25 mg Tablet, 48 Caspofungin Acetate 50 mg Injection, 186 Caspofungin Acetate 70 mg Injection, 186 Cefazolin Sandoz, 163 Cefazolin Sodium 1 g Injection, 163 Cefepime 1 g Injection, 163 Cefobid, 164 Cefoperazone Sodium 1 g Injection, 164 Cefoperazone Sodium 500 mg & Sulbactam Sodium 500 mg Injection, 164 Cefotaxime 1 g Injection, 165 Ceftazidime 1 g Injection, 165 Ceftazidime 2 g Injection, 165 Ceftriaxone 0.25mg Injection, 165 Ceftriaxone 1g Injection, 166 Cefuroxime Axetil 125 mg Tablet, 167 Cefuroxime Axetil 125 mg/5 ml Suspension, 167 Cefuroxime Sodium 1.5 g Injection, 167 Cefuroxime Sodium 750 mg Injection, 167 Celebrex, 106, 300 Celecoxib 200 mg Capsule, 106, 300 Cellcept, 253 Cephalexin Monohydrate 125 mg/5 ml Syrup, 168 Cephalexin Monohydrate 250 mg Capsule, 168 Ceporex, 168 Cerubidin, 260 Cervagem, 236 Cetirizine HCl 10 mg Tablet, 327 Cetrimide 1-2% Lotion., 356 Charcoal, Activated 250 mg Tablet, 12 Chirocaine, 378 Chloral Hydrate 200 mg/5 ml Mixture, 112 Chlorambucil 2 mg Tablet, 257 Chloramphenicol 0.5% Eye Drops, 306 Chloramphenicol 1% Eye Ointment, 306 Chloramphenicol 5% w/v Ear Drops, 321 Chloramphenicol Sodium Succinate 1 g Injection, 169 Chlorhexidine Gluconate 0.2 % Mouthwash, 325 Chlorhexidine Gluconate 4% Scrub, 356 Chlorhexidine Gluconate 5% Solution, 356 Chlorinated Lime Powder, 386 Chlorinated Lime Solution & Buffered Acetate Solution, 357 Chloromycetin, 169, 306, 321 390 Chloroquine Phosphate 250 mg Tablet (150 mg Chloroquine base), 200 Chlorpheniramine Maleate 10 mg/ml Injection, 327 Chlorpheniramine Maleate 2 mg/5 ml Syrup, 328 Chlorpheniramine Maleate 4 mg Tablet, 328 Chlorpromazine HCl 100 mg Tablet, 114 Chlorpromazine HCl 25 mg Tablet, 114 Choline Salicylate 8.7%, Cetylkonium Chloride 0.01% Dental Gel, 325 Chorionic Gonadotrophin Human (HCG) 5000 IU Injection, 233 Ciclosporin 100 mg/ml Drink Solution, 252 Ciclosporin 25 mg Capsule Microemulsion, 251 Cinnarizine 25 mg Tablet, 335 Ciprobay, 169 Ciprofloxacin 100 mg/50 ml Injection, 169 Ciprofloxacin 250 mg Tablet, 169 Cisplatin (Cis-Platinum) 50 mg Injection, 257 Claforan, 165 Clarinase, 330 Clarithromycin 250 mg Tablet, 170 Clarityne, 330 Clexane, 67 Clindamycin HCl 300 mg Capsule, 170 Clobetasol Propionate 0.05% Cream, 339 Clobetasol Propionate 0.05% Ointment, 340 Clobetasone Butyrate 0.05% Cream, 340 Clobetasone Butyrate 0.05% Ointment, 340 Clomid, 234 Clomifene Citrate 50 mg Tablet, 234 Clonazepam 2 mg Tablet, 135 Clopidogrel 75 mg Tablet, 71 Clopixol - Acuphase, 122 Clopixol Depot, 122 Clorox, 386 Clostridium Botulinum Toxin Type A 100 units, 154 Clostridium Botulinum Toxin Type A 500 units, 154 Clotrimazole 1% Cream, 351 Clotrimazole 1% Ear Drop, 186 Clotrimazole 500 mg Vaginal Tablet, 237 Cloxacillin Sodium 125 mg/5 ml Suspension, 171 Cloxacillin Sodium 250 mg Capsule, 171 Cloxacillin Sodium 250 mg Injection, 172 Cloxacillin Sodium 500 mg Injection, 172 Clozapine 100 mg Tablet, 114 Clozaril, 114 Coal Tar 20% Solution, 344 CoAprovel, 52 Cocaine 10% Solution, 335 Cocois Co. Ointment, 344 Co-Diovan, 59 Colchicine 0.5 mg Tablet, 358 Combivent, 84 Combivir, 199 Comtan, 145 Concor, 47 Conjugated Oestrogens 0.625 mg & Medroxyprogesterone Acetate 2.5 mg, 229 Conjugated Oestrogens 0.625 mg Tablet, 229 Conjugated Oestrogens 0.625 mg/g Cream, 238 Continuous Ambulatory Peritoneal Dialysis Solution containing 1.5% Dextrose, 277 Continuous Ambulatory Peritoneal Dialysis Solution containing 2.5% Dextrose, 277 Continuous Ambulatory Peritoneal Dialysis Solution containing 4.25% Dextrose, 277 Controloc, 23, 24 Cordarone, 46 Cosmegen, 255 Coumadin, 70 Coversyl, 56 Coversyl Plus, 55 Cozaar, 52 Cravit, 177 Crestor, 80 Crinone, 218 Crixivan, 193 Crotamiton 10 % Cream, 338 Cuprimine, 12 Cyanocobalamin 1 mg Injection, 289 Cyclogyl, 311 Cyclopentolate 1% Eye Drops, 311 Cyclophosphamide 1 g Injection, 258 Cyclophosphamide 50 mg Tablet, 259 Cyklokapron, 76 Cymbalta, 125 Cyproterone Acetate 2 mg & Ethinyloestradiol 0.035 mg Tablet, 238 Cytarabine 100 mg Injection, 259 Cytosar, 259 Dabigatran Etexilate 110 mg Capsule, 70 Dacarbazine 100 mg Injection, 260 Dacrolux, 317 Daflon, 31 Daivobet, 343 Daivonex, 342 Daktarin, 339 391 Danazol 200 mg Capsule, 226 Daonil, 205 Dapsone 100 mg Tablet, 172 Daunorubicin HCl 20 mg Injection, 260 Decadron, 215 Deferasirox 125 mg Dispersible Tablet, 294 Deferasirox 500 mg Dispersible Tablet, 294 Deferiprone 500 mg Tablet, 294 Dermovate, 339, 340 Desferal, 295 Desferrioxamine B Methanesulphonate 0.5 g Injection, 295 Desloratadine 5 mg Tablet, 328 Desmopressin 0.1 mg Tablet, 219 Desmopressin 0.2 mg Tablet, 219 Desmopressin 100 mcg/ml Nasal Spray, 219 Desmopressin Acetate 4 mcg/ml Injection, 220 Desogestrol 150 mcg & Ethinyloestradiol 30 mcg Tablet, 239 Detrusitol SR, 246 Dexamethasone 0.5 mg Tablet, 215 Dexamethasone and Neomycin Sulphate and Polymyxin B Eye Ointment, 310 Dexamethasone and Neomycin Sulphate and Polymyxin B Sulphate, 309 Dexamethasone Sodium Phosphate 8 mg/2 ml Injection, 215 Dexmedetomidine HCl 100 mcg/ml Injection, 368 Dextrose 50% Injection, 277 Dextrose Powder, 205 DF 118, 98 Diamicron, 206 Diamicron MR, 206 Diamox, 313, 314 Diane 35, 238 Diavonex, 343 Diazepam 10 mg/2 ml Injection, 135 Diazepam 5 mg Rectal Solution, 136 Diazepam 5 mg Tablet, 154 Diclofenac 1% Emulgel, 106 Diclofenac Sodium 12.5 mg Suppository, 107 Diclofenac Sodium 25 mg Suppository, 107 Diclofenac Sodium 50 mg Suppository, 107 Diclofenac Sodium 50 mg Tablet, 107 Diclofenac Sodium 75 mg/3 ml Injection, 108 Didanosine 2 g Oral Solution (ddI), 192 Differin, 346 Difflam, 325 Diflucan, 186, 187 Digoxin 0.25 mg Tablet, 40 Digoxin 50 mcg/ml Elixir, 40 Digoxin 500 mcg/2 ml Injection, 41 Dihydrocodeine Tartrate 30 mg Tablet, 98 Dilantin, 139, 140 Dilatrend, 48 Diltiazem HCl 30 mg Tablet, 61 Dinoprostone (Prostagladine E2) 3 mg Vaginal Tablet, 235 Diosmin 450 mg and Hesperidin 50 mg Tablet, 31 Diovan, 59 Diphenhydramine HCl 10 mg/5 ml Elixir, 333 Diphenhydramine HCl 14 mg/5 ml and Ammonium Chloride 135 mg/5 ml Expectorant, 333 Diphenoxylate with Atropine Sulphate Tablet, 27 Diprivan, 371 Dipyridamole 75 mg Tablet, 72 Dobutamine HCl 250 mg/20 ml Injection A, 41 Dobutrex, 41 Docetaxel 20 mg/0.5 ml Injection, 261 Dogmatil, 120 Domperidone 1 mg/ml Suspension, 19 Domperidone 10 mg Tablet, 19 Donepezil HCl 5 mg Tablet, 151 Dopamine HCl 40 mg/ml Injection, 42 Dormicum, 369, 370 Dorzolamide HCl 2% Ophthalmic Solution, 315 Dostinex, 226 Dothiepin HCl 75 mg Tablet, 124 Doxazosin Mesilate 4 mg CR Tablet, 244 Doxorubicin HCl 50 mg Injection, 261 Doxycycline 100 mg Capsule, 172 D-Penicillamine 0.25 g Capsule, 12 Dulcolax, 27, 28 Duloxetine 30 mg Capsule, 125 Duloxetine 60 mg Capsule, 125 Duphalac, 28 Duphaston, 230 Durogesic, 99 Duspatalin, 21 Dutasteride 0.5 mg Capsule, 244 Dydrogesterone 10 mg Tablet, 230 Dynastat, 98 EES, 173 Efavirenz 600 mg Tablet, 192 Efexor XR, 129 Elomet, 341 Eloxatin, 269 Emend, 33 392 Emla, 375 Emulsificants Ointment, 338 Enalapril 10 mg Tablet, 51 Enalapril 20 mg Tablet, 51 Enalapril 5 mg Tablet, 51 Endoxan, 258, 259 Enoxaparin Sodium 40 mg Injection, 67 Enoxaparin Sodium 60 mg Injection, 67 Entacapone 200 mg Tablet, 145 Entecavir 0.5 mg Tablet, 193 Eperisone HCl 50 mg Tablet, 303 Ephedrine HCl 30 mg/ml Injection, 66 Epilim, 141, 142 Epirubicin 50 mg Injection, 262 Eprex, 295 Ergometrine Maleate 0.5 mg/ml Injection, 236 Erythrocin, 173, 174 Erythromycin Ethylsuccinate 200 mg/5 ml Suspension, 173 Erythromycin Ethylsuccinate 400 mg Tablet, 173 Erythromycin Lactobionate 500 mg Injection, 174 Erythropoietin Human Recombinant 2000 IU/0.5ml Injection, 295 Escapelle, 239 Escitalopram 10 mg Tablet, 125 Esmeron, 373 Esomeprazole 20 mg Tablet, 21 Esomeprazole 40 mg Injection, 22 Esomeprazole 40 mg Tablet, 21 Essential Phospholipids Capsule, 31 Essentiale, 31 Estradiol 1 mg (14 tablet) & Estradiol 1 mg with Dydrogesterone 10 mg, 230 Estradiol 1 mg with Dydrogesterone 5 mg Tablet, 231 Estradiol Valerate 1 mg Tablet, 231 Estradiol Valerate 2 mg and Norgestrel 500 mcg with Estradiol Valerate, 231 Ethambutol HCl 400 mg Tablet, 174 Ether Solvent, 386 Ethyl Chloride Spray, 374 Etomidate 20 mg/10 mg Injection, 368 Etomidate Lipuro, 368 Etoposide 100 mg/5 ml Injection, 262 Etoricoxib 120 mg Tablet, 300 Etoricoxib 60 mg Tablet, 300 Etoricoxib 90 mg Tablet, 300 Eumovate, 340 Eurax, 338 Eusol-T, 357 Evista, 242 Exelon, 151 Exelon® patch 5, 152 Exelon®patch 10, 152 Exforge, 60 Exjade, 294 Expect Stimulant, 333 Ezetimibe 10 mg & Simvastatin 20 mg Tablet, 77 Ezetimibe 10 mg Tablet, 78 Ezetrol, 78 Factor IX Injection, 75 Factor VIIa (Recombinant) eptacog alfa (activated) 60 KIU (1.2 mg) Injection, 75 Factor VIII Inhibitor Bypassing Activity Injection, 74 Factor VIII Injection, 76 Fansidar, 202 Farlutal, 232, 240 Fat Emulsion 20% for IV Infusion, 283 Feiba, 74 Felodipine 10 mg Tablet, 61 Felodipine 5 mg Tablet, 61 Femara, 272 Femoston 1/10, 230 Femoston Conti, 231 Fentanyl 25 mcg/h Transdermal Patch, 99 Fentanyl 50 mcg/h Transdermal Patch, 99 Fentanyl Citrate 50 mcg/ml Injection, 99 Ferric Ammonium Citrate 800 mg/10 ml Paediatric Mixture, 296 Ferriprox, 294 Ferrous Fumarate 200 mg Tablet, 297 Filgrastim (G-CSF) 30 MU/ml Injection, 273 Finasteride 5 mg Tablet, 244 Flagyl, 178 Flamazine, 354 Flarex ophth Susp, 310 Flavoxate HCl 100 mg Tablet, 246 Fleet solution, 33 Fluanxol, 115 Fluconazole 100 mg Capsule, 186 Fluconazole 2 mg/ml Injection, 187 Flumazenil 0.5 mg/5 ml Injection, 13 Flunarizine HCl 5 mg Capsule, 132 Fluorescein 1 mg Ophthalmic Strip, 383 Fluorets, 383 Fluorometholone 0.1% Ophthalmic Suspension, 310 Fluorouracil 250 mg/5 ml Injection, 263 Fluoxetine HCl 20 mg Capsule, 126 393 Flupenthixol Decanoate Depot 20 mg/ml lnjection, 115 Fluvoxamine 100 mg Tablet, 126 Fluvoxamine 50 mg Tablet, 126 FML liquifilm, 310 Folic Acid 5 mg Tablet, 297 Follitropin Alpha (Recombinant Human FSH) 75 IU Injection, 234 Fondaparinux Sodium 2.5 mg/0.5 ml Injection, 68 Forane, 368 Fortum, 165 Fosamax Plus, 222 Fosrenol, 285 Framycetin Sulphate 0.5%, Dexamethasone 0.05% and Gramicidin 0.005% Ear Drops, 321 Fucicort, 351 Fucidin, 175, 351, 354 Fucithalmic, 307 Fulcin, 188 Fuller's Earth, 13 Fuller's Earth 30% Suspension, 13 Fungizone, 185 Furadantin, 179 Furosemide 20 mg/2 ml Injection, 43 Furosemide 40 mg Tablet, 43 Fusafungine 1% Nasal Spray, 323 Fusidic Acid 1% Eye Drops, 307 Fusidic Acid 2% Cream, 351 Fusidic Acid 2% in Betamethasone Valerate 0.1% Cream, 351 Fusidic Acid 500 mg Injection, 175 Gabapentin 300 mg Capsule, 136 Gabapentin 600 mg Tablet, 136 Gamma Benzene Hexachloride 0.1 % Lotion, 352 Garamycin, 175, 307, 308, 352 Gardenal, 138 Gemcitabine HCl 1 g Injection, 263 Gemeprost (Prostagladin E1 Synthetic Analogue) 1 mg Pessary, 236 Gemfibrozil 300 mg Capsule, 78 Gemzar, 263 Gentamicin 0.1% Cream, 352 Gentamicin 0.3% Eye Drops, 307 Gentamicin 0.3% Eye Ointment, 308 Gentamicin 3% Fortified Eye Drops, 308 Gentamicin Sulphate 80 mg/2 ml Injection, 175 Genteal Gel, 318 Glibenclamide 5 mg Tablet, 205 Gliclazide 30 mg Modified Release Tablet, 206 Gliclazide 80 mg Tablet, 206 Glivec, 273 Glucagen, 207 Glucagon (Lyophilised) 1 mg/ml Injection, 207 Glucobay, 205 Glucophage, 211 Glucophage XR, 210 Glucovance, 210 Glycerin, 326 Glycerin 25% and Sodium Chloride 15% Enema, 28 Glyceryl Trinitrate 0.5 mg Tablet, 62 Glyceryl Trinitrate 25 mg/5 ml Injection, 62 Glycopyrrolate 200 mcg/ml Injection, 381 Glypressin, 221 Gonal F, 234 Goserelin 3.6 mg Depot Injection, 227 Granisetron HCl 1 mg Tablet, 34 Granisetron HCl 3 mg/3 ml Injection, 34 Griseofulvin (Ultramicrosize 125 mg = 250 mg Microsize) Tablet, 188 Haemophilus Influenzae Type B Conjugate 10 mcg Vaccine, 362 Haloperidol 1.5 mg Tablet, 116 Haloperidol 5 mg Tablet, 116 Haloperidol 5 mg/ml Injection, 116 Harnal® OCAS, 245 Hemabate, 235 Hemofil M, 76 Hepabig, 366 Heparin 1000 units/ml Injection, 69 Heparin 5000 units/ml Injection, 69 Heparin Sodium 50 units in Sodium Chloride Injection, 69 Hepatitis B Immunoglobulin (Human) Injection, 366 Hepatitis B Vaccine Injection, 362 Hepsal, 69 Herbesser, 61 Hibiscrub, 356 Hibitane, 325, 356 Holoxan, 264 Homatropine 2% Eye Drops, 312 Human Albumin Injection, 278 Humulin, 208 Hydralazine HCl 20 mg Injection, 51 Hydrea, 345 Hydrochlorothiazide 50 mg Tablet, 44 Hydrocortisone 1% Cream, 341 Hydrocortisone 10 mg Tablet, 216 Hydrocortisone Enema 0.1%, 29 394 Hydrocortisone Sodium Succinate 100 mg Injection, 216 Hydrogen Peroxide 20 volume Solution, 357 Hydroxychloroquine Sulphate 200 mg Tablet, 301 Hydroxyethyl Cellulose Jelly, 384 Hydroxyurea 500 mg Capsule, 345 Hydroxyzine HCl 25 mg Tablet, 329 Hyoscine N-Butylbromide 10 mg Tablet, 20 Hyoscine N-Butylbromide 20 mg/ml Injection, 20 Hyperhep, 366 Hyper-Tet, 366 Hypromellose 0.3% Eye Drops, 317 Hypromellose 0.3%, Carbomer 980 Ophthalmic Gel, 318 Hytrin, 245 Hyzaar, 53, 54 Ibandronic Acid 150 mg Tablet, 223 Ibuprofen 200 mg Tablet, 108 Idarubicin 10 mg Injection, 264 Ifosfamide 1 g Injection, 264 Iliadin, 324 Imatinib Mesylate 100 mg Tablet, 273 Imatinib Mesylate 400 mg Tablet, 273 Imdur, 63 Imipenem 500 mg and Cilastatin 500 mg Injection, 176 Imorab, 363 Imuran, 249 Inderal, 49 Indinavir Sulfate 400 mg Capsule, 193 Indocid, 109 Indomethacin 25 mg Capsule, 109 Insulatard, 208 Insulin Aspart 100 IU/ml Injection, 207 Insulin Glargine 300 IU/3ml Injection, 208 Insulin Recombinant Neutral Human shortacting 100 IU/ml Injection in 10ml vial, 208 Insulin Recombinant Synthetic Human, intermediate-acting 100 IU/ml Penfill and Refill, 208 Insulin Recombinant Synthetic Human, premixed 100 IU/ml Penfill and Refill, 209 Insulin Recombinant Synthetic Human, shortacting 100 IU/ml Penfill and Refill, 209 Intralipid, 283 Intropin, 42 Invega, 123 Iodine and Potassium Iodide Solution, 213 Ipratropium Bromide 0.0125% Inhalation Solution (125 mcg/ml), 83 Ipratropium Bromide 0.025% Inhalation Solution (250 mcg/ml), 83 Ipratropium Bromide 0.5 mg and Salbutamol 2.5 mg per UDV, 84 Ipratropium Bromide 20 mcg and Salbutamol base 100 mcg/dose Inhalation, 84 Ipratropium Bromide 20 mcg/dose Inhalation, 85 Irbesartan 150 mg Tablet, 52 Irbesartan 300 mg & Hydrochlorothiazide 12.5 mg Tablet, 52 Irbesartan 300 mg Tablet, 52 Irinotecan HCl Trihydrate 100 mg/5ml Injection, 265 Iron Dextran 50 mg Fe/ml Injection, 297 Iron Sucrose 100 mg/5 ml Injection, 298 Isoflurane Liquid, 368 Isoniazid 100 mg Tablet, 176 Isoniazid 400 mg Tablet, 176 Isoptin, 65 Isordil, 63 Isosorbide Dinitrate 10 mg Tablet, 63 Isosorbide-5-Mononitrate 30 mg SR Tablet, 63 Isotretinoin 10 mg Capsule, 347 Isotretinoin 20 mg Capsule, 347 Itraconazole 10 mg/ml Oral Solution, 188 Itraconazole 100 mg Capsule, 189 Januvia, 212 Jumex, 150 Kaletra, 194, 195 Kalimate, 11 Kemadrin, 149 Kenacort-A, 218 Kenalog in Orabase, 326 Keppra, 137 Ketalar, 369 Ketamine 10 mg/ml Injection, 369 Ketoconazole 2% Shampoo, 348 Ketoconazole 200 mg Tablet, 189 Ketoprofen 2.5% Gel, 109 Ketoprofen 30 mg Transdermal Plaster, 109 Ketorolac Tromethamine 0.5% Eye drops, 318 Ketorolac Tromethamine 30 mg/ml Injection, 96 Ketotop, 109 Klacid, 170 Konakion, 293, 294 KY Jelly, 384 Kytril, 34 Labetalol HCl 100 mg Tablet, 48 Labetalol HCl 100 mg/20 ml Injection, 49 Lactulose 3.35 g/5 ml Liquid, 28 395 Ladogal, 226 Lamictal, 137 Lamisil, 190 Lamivudine 10 mg/ml Oral Solution, 193 Lamivudine 100 mg Tablet, 194 Lamivudine 150 mg Tablet, 194 Lamotrigine 100 mg Tablet, 137 Lamotrigine 50 mg Tablet, 137 Lanoxin, 40, 41 Lansoprazole 30 mg Tablet, 22 Lanthanum Carbonate 1000mg Chewable Tablet, 285 Lantus, 208 Largactil, 114 Laroxyl, 124 Lasix, 43 L-Asparaginase 10,000 IU Injection, 265 Latanoprost 0.005% Eye Drops, 315 Leflunomide 10 mg Tablet, 301 Letrozole 2.5 mg Tablet, 272 Leucovorin Calcium, 274 Leucovorin Calcium (Calcium Folinate) 50 mg Injection, 274 Leukeran, 257 Leunase, 265 Levetiracetam 500 mg Tablet, 137 Levobupivacaine 5mg/ml Injection, 378 Levocetirizine Dihydrochloride 5 mg Tablet, 329 Levodopa 100 mg and Carbidopa 25 mg Tablet, 147 Levodopa 100 mg, Benserazide 25 mg HBS capsule, 145 Levodopa 200 mg, Benserazide 50 mg Tablet, 146 Levodopa 250 mg and Carbidopa 25 mg Tablet, 147 Levofloxacin 500 mg Tablet, 177 Levonorgestrel 1.5mg Tablet, 239 Levonorgestrel Releasing Intrauterine System, 240 Levophed, 67 Levothyroxine Sodium 100 mcg Tablet, 213 Levothyroxine Sodium 25 mcg Tablet, 214 Lexapro, 125 Lidocaine 25mg and Prilocaine 25mg Cream, 375 Lignocaine 10 % w/w Spray, 375 Lignocaine 2% Jelly, 376 Lignocaine 2% Viscous Solution, 379 Lignocaine HCl (Lidocaine) 2% Injection, 379 Lignocaine, Aluminium Acetate, Zinc Oxide and Hydrocortisone Ointment, 30 Lignocaine, Aluminium Acetate, Zinc Oxide and Hydrocortisone Suppository, 30 Lincocin, 170 Lindane, 352 Linezolid 2 mg/ml Injection, 177 Lioresal, 153 Lipitor, 77 Liquid Paraffin, 29 Lithium Carbonate 300 mg Tablet, 117 Livial, 233 Locabiotal, 323 Loceryl, 349 Lomotil, 27 Loniten, 55 Lopid, 78 Lopinavir 200 mg and Ritonavir 50 mg Tablet, 194 Lopinavir/Ritonavir Oral Solution, 195 Loratadine 1 mg/ml Syrup, 330 Loratadine 10 mg Tablet, 330 Loratadine 5 mg and Pseudoephedrine Sulphate 120 mg Tablet, 330 Lorazepam 1 mg Tablet, 113 Losartan 50 mg Tablet, 52 Losartan Potassium 100 mg and Hydrochlorothiazide 12.5 mg Tablet, 53 Losartan Potassium 50 mg and Hydrochlorothiazide 12.5 mg Tablet, 54 Losec, 23 Lovastatin 20 mg Tablet, 79 Loxof, 177 Lugol's Solution, 213 Lumigan, 314 Luminal, 138 Luvox, 126 Maalox Plus, 31 Mabthera, 275 Madopar, 145, 146 Magnesium Sulphate 45% Paste, 359 Magnesium Sulphate 50% Injection, 286 Magnesium Trisilicate Mixture, 18 Magnesium Trisilicate Tablet, 18 Magnesium, Aluminium Hydroxide and Simethicone Suspension, 31 Mannitol 10% Injection (10 g/100 ml), 44 Mannitol 20% Injection (20 g/100 ml), 44 Marcaine, 377 Marcaine Spinal Heavy, 376 Marcaine-Adrenaline, 377 Marvelon, 239 396 Maxipime, 163 Maxitrol, 309, 310 Maxolon, 35, 36 Mebeverine HCl 135 mg Tablet, 21 Meclozine HCl 25 mg and Pyridoxine 50 mg Tablet, 35 Mecobalamin 500 mcg Tablet, 155 Medroxyprogesterone Acetate 150 mg/3 ml Injection, 240 Medroxyprogesterone Acetate 5 mg Tablet, 232 Mefenamic Acid 250 mg Tablet, 110 Meloxicam 7.5 mg Tablet, 302 Melphalan 2 mg Tablet, 266 Meningococcal A, C, Y, W 135 Vaccine Injection, 363 Menthol 1.6% in Industrial Methylated Spirit Inhalation, 332 Mercaptopurine 50 mg Tablet, 266 Meronem, 178 Meropenem 1 g Injection, 178 Meropenem 500 mg Injection, 178 Mesalazine 500 mg Tablet, 32 Mesna 400 mg/4 ml Injection, 14 Mestinon, 156 Metalyse, 73 Metformin 500 mg and Glibenclamide 2.5 mg Tablet, 210 Metformin 500 mg and Glibenclamide 5 mg Tablet, 210 Metformin HCl 500 mg Extended Release Tablet, 210 Metformin HCl 500 mg Tablet, 211 Methadone 5mg/ml Syrup, 150 Methotrexate 2.5 mg Tablet, 267 Methotrexate 50 mg Injection, 268 Methyl Salicylate 25% Ointment, 110 Methylcobal, 155 Methyldopa 250 mg Tablet, 54 Methylene Blue 1% Injection, 14 Methylphenidate HCl 10 mg Tablet, 129 Methylprednisolone Sodium Succinate 0.5 g Injection, 216 Metoclopramide HCl 10 mg Tablet, 35 Metoclopramide HCl 10 mg/2 ml Injection, 36 Metoclopramide HCl 5 mg/5 ml Syrup, 36 Metoprolol Tartrate 100 mg Tablet, 49 Metrogyl, 178 Metronidazole 200 mg Tablet, 178 Metronidazole 500 mg/100 ml Injection, 178 Mevacor, 79 Miacalcic, 223 Micardis, 58 Micardis Plus. See Miconazole 2% Cream, 339 Midazolam 5 mg/ml Injection, 369 Midazolam 7.5 mg Tablet, 370 Milton, 386 Minipress, 57 Minirin, 219, 220 Minoxidil 5 mg Tablet, 55 Mirena, 240 Mirtazapine 15 mg Orodispersible Tablet, 127 Mirtazapine 30 mg Orodispersible Tablet, 127 Mist Carminative Paed, 18 Mitomycin-C, 268 Mitomycin-C 10 mg Injection, 268 Mitoxantrone 20 mg/10ml Injection, 269 Mixtard, 209 Mobic, 302 Moclobemide 150 mg Tablet, 128 Moduretic, 42 Mometasone Furoate 0.1% Cream, 341 Mometasone Furoate 50 mcg Aqueous Nasal Spray, 323 Montelukast Sodium 10 mg Tablet, 92 Montelukast Sodium 4 mg Oral Granules, 92 Montelukast Sodium 5 mg Chewable Tablet, 93 Morphine HCl 10 mg/5 ml Solution, 100 Morphine Sulphate 10 mg Controlled Release Tablet, 100 Morphine Sulphate 10 mg/ml Injection, 101 Morphine Sulphate 30 mg Controlled Release Tablet, 100 Motilium, 19 Moxifloxacin 0.5% Ophthalmic Solution, 309 MST Continus, 100 Multivitamin Injection, 289 Multivitamin Syrup, 290 Multivitamin Tablet, 290 Mupirocin 2% Ointment, 352 Myambutol, 174 Mycophenolate Mofetil 250 mg tablet, 253 Mycophenolate Mofetil 500 mg tablet, 253 Mycophenolate Sodium 360mg Tablet, 250 Mycostatin, 189, 353 Mydfrin, 312 Mydriacyl, 313 Myfortic, 250 Myonal, 303 Nalbuphine HCl 10 mg/ml Injection, 102 Naloxone HCl 0.4 mg/ml Injection, 14 Naproxen Sodium 275 mg Tablet, 302 397 Narcan, 14 Naropin, 380 Nasonex, 323 Navidoxine, 35 Neo-mercazole, 212 Neomycin 0.5% Cream, 353 Neostigmine Methylsulphate 2.5 mg/ml Injection, 155 Neotigason, 342 Netilmicin Sulphate 150mg/2ml Injection, 179 Netromycin, 179 Neupogen, 273 Neurobion, 292, 293 Neurontin, 136 Nevirapine 200 mg Tablet, 195 Nexium, 21, 22 Nifedipine 10 mg Tablet, 63 Nimodipine 10 mg/50 ml Infusion Solution, 64 Nimotop, 64 Nipride, 57 Nitro-bid, 62 Nitrofurantoin 100 mg Tab, 179 Nizoral, 189, 348 Nolvadex, 272 Nootropil, 147, 153 Noradrenaline Acid Tartrate (Norepinephrine Bitartrate) 4 mg/4 ml Injectio, 67 Norethisterone 0.35mg Tablet, 241 Norethisterone Enanthate 200 mg/ml Injection, 241 Noriday, 241 Noristerat, 241 Norvasc, 60 Norvir, 196 Novantrone, 269 Novonorm, 211 Novorapid, 207 Novoseven, 75 Nubain, 102 Nuelin, 89 Nuelin SR, 89 Nystatin 100,000 units/g Cream, 353 Nystatin 100,000 units/ml Suspension, 189 Octreotide 0.1 mg/ml Injection, 220 Ofloxacin 0.3% Otic Solution, 322 Ofloxacin 100 mg Tablet, 180 Okavax, 364 Olanzapine 10mg Disintegrating Tablet, 117 Olanzapine 5mg Disintegrating Tablet, 117 Omeprazole 20 mg Capsule, 23 Omeprazole 40 mg Injection, 23 Oncovin, 271 Ondansetron, 37 One-alpha, 286 One-Alpha, 287 Opticrom, 319 Oral Rehydration Salt, 278 Orbenin, 171, 172 Oroxine, 213 Orudis, 109 Oxaliplatin 50 mg Injection, 269 Oxycodone HCl 10 mg Immediate Release Capsules, 103 Oxycodone HCl 10 mg Prolonged Release Tablet, 102 Oxycodone HCl 20 mg Prolonged Release Tablet, 102 Oxycodone HCl 5 mg Immediate Release Capsules, 103 Oxycontin, 102 Oxymetazoline HCl 0.025% (Paediatric) Nasal Spray, 324 Oxymetazoline HCl 0.05% (Adult) Nasal Spray, 324 Oxynorm, 103 Oxytocin 10 units/ml Injection, 236 Oxytocin 5 units & Ergometrine Maleate 0.5 mg/ml Injection, 237 Paclitaxel 30 mg/5 ml Injection, 270 Paliperidone 3mg Extended Release Tablet, 123 Paliperidone 6mg Extended Release Tablet, 123 Palivizumab 100mg Injection, 196 Pamidronate Disodium 30 mg Injection, 224 Panadol, 97 Pancuronium Bromide 4 mg/2 ml lnj, 373 Panoxyl, 347 Pantoprazole 40 mg Injection, 23 Pantoprazole 40 mg Tablet, 24 Papase, 303 Paracetamol 120 mg/5 ml Syrup, 97 Paracetamol 125 mg Suppository, 97 Paracetamol 250 mg Suppository, 97 Paracetamol 500 mg Tablet, 97 Paraffin, White Soft, 338 Paraffin, Yellow Soft, 338 Paraplatin, 256 Parecoxib Sodium 40mg Injection, 98 Parentrovite, 289 Pariet, 24 Parlodel, 225 Parvolex, 9 Pavulon, 373 398 Pegasys, 274 Peginterferon Alpha-2a 180 mcg Prefilled Syringe, 274 Penadur L.A, 162 Penbritin, 160, 161 Penglobe, 162 Penicillin V, 180 Pentothal, 372 Pentoxifylline 400 mg Tablet, 64 Perindopril 4 mg and Indapamide 1.25 mg Tablet, 55 Perindopril 4 mg Tablet, 56 Perindopril 8 mg Tablet, 56 Permethrin 5% w/v Lotion, 353 Perphenazine 4 mg Tablet, 118 Persantin, 72 Pethidine HCl 100 mg/2 ml Injection, 104 Pethidine HCl 50 mg/ml Injection, 104 Phenergan, 331 Phenobarbitone 30 mg Tablet, 138 Phenobarbitone Sodium 200 mg/ml Injection, 138 Phenoxymethyl Penicillin 125 mg Tablet, 180 Phenylephrine HCI 2.5% Eye Drops, 312 Phenytoin Sodium 100 mg Capsule, 139 Phenytoin Sodium 125 mg/5ml Suspension, 139 Phenytoin Sodium 250 mg/5ml Injection, 140 Pilocarpine 2% Eye Drops, 316 Piperacillin 4 g & Tazobactam 500 mg Injectio, 181 Piracetam 1 g Injection, 153 Piracetam 1.2 g Tablet, 147 Piribedil 50 mg Tablet, 148 Piriton, 327, 328 Pitocin, 236 Pitressin, 222 Pizotifen 0.5 mg Tablet, 132 Plaquenil, 301 Platinul, 257 Plavix, 71 Plendil, 61 Pneumo 23, 363 Pneumococcal Vaccine (Polyvalent), 363 Podophyllum 10 - 20% Paint, 348 Polytar, 345 Ponstan, 110 Potassium Chloride 1 g/10 ml Injection, 278 Potassium Chloride 1 g/15 ml Mixture, 279 Potassium Chloride 600 mg SR Tablet, 279 Potassium Citrate 3 g/10 ml and Citric Acid Mixture, 246 Potassium Dihydrogen Phosphate Injection, 286 Potassium Permanganate 1:10,000 Solution, 357 Povidone Iodine 10% (equivalent to 1% iodine) Solution, 358 Pradaxa, 70 Pralidoxime 0.5 g/20 ml Injection, 15 Pramipexole Dihydrochloride 0.125 mg Tablet, 148 Pravachol, 79 Pravastatin Sodium 20 mg Tablet, 79 Prazosin HCl 1 mg Tablet, 57 Prazosin HCl 2 mg Tablet, 57 Precedex, 368 Prednisolone 3 mg/5 ml Syrup, 217 Prednisolone 5 mg Tablet, 217 Prednisone, 217 Pregnyl, 233 Premarin, 229, 231, 238 Premelle 2.5, 229 Prevacid, 22 Primaquine 7.5 mg base Tablet, 200 Procaine Benzylpenicillin Aqueous 4 mega units (4 g) Injection, 181 Prochlorperazine Maleate 5mg Tablet, 37 Prochlorperazine Mesylate 12.5 mg/ml Injection, 38 Procyclidine HCl 10 mg/2 ml Injection, 149 profilnine, 75 Progesterone 8% Vaginal Gel, 218 Prograf, 250 Progyluton, 231 Progynova, 231 Prolase Tablet, 303 Promethazine HCl 25 mg/ml Injection, 331 Promethazine HCl 5 mg/5 ml Syrup, 331 Proparacaine HCI 0.5% Ophthalmic Drops, 317 Propofol 1 % Injection, 371 Propranolol HCl 40 mg Tablet, 49 Propylthiouracil 50 mg Tablet, 214 Proscar, 244 Prostigmine, 155 Prostin E2, 235 Prostin VR, 81 Protamine Sulphate 50 mg/5 ml Injection, 15 Prothiaden, 124 Protopam, 15 Provera, 232, 240 Prozac, 126 Pulmicort, 91 Puri-Nethol, 266 399 Pyrazinamide 500 mg Tablet, 182 Pyridostigmine Bromide 60 mg Tablet, 156 Pyridoxine HCl 10 mg Tablet, 290 Quetiapine Fumarate 300 mg Extended Release Tablet, 119 Quetiapine Fumarate 400 mg Extended Release Tablet, 119 Quinine Dihydrochloride 600 mg/2 ml Injection, 201 Quinine Sulphate 300 mg Tablet, 201 Rabeprazole Sodium 20 mg Tablet, 24 Rabies Human Diploid Cell Vaccine (Lyophilised) Injection, 363 Raloxifene HCl 60 mg Tablet, 242 Ramipril 5 mg Tablet, 57 Ranitidine 150 mg Tablet, 25 Ranitidine 150 mg/10 ml Syrup, 25 Ranitidine 300 mg Table, 25 Ranitidine 50 mg/2 ml Injection, 26 Ravin, 28 Renitec, 51 Repaglinide 2 mg Tablet, 211 Requip, 149 Retin-A, 348 Retrovir, 198, 199 Rhogam, 365 Riboflavine 3 mg Tablet, 291 Rifadin, 182 Rifampicin 150 mg Capsule, 182 Rifampicin 300 mg Capsule, 182 Ringer's Solution Injection (contained sodium chloride, potassium chloride and calcium chloride), 280 Risperdal, 119 Risperidone 1 mg Tablet, 119 Risperidone 2 mg Tablet, 119 Ritalin, 129 Ritonavir 100 mg Capsule, 196 Rituximab 500 mg/50 ml Injection, 275 Rivastigmine 1.5 mg Capsule, 151 Rivastigmine 4.6mg/24hr Transdermal Patch, 152 Rivastigmine 9.5 mg/24hr Transdermal Patch, 152 Rivotril, 135 Roaccutane, 347 Rocaltrol, 288 Rocephin, 165, 166 Rocuronium Bromide 10 mg/ml Injection, 373 Ropinirole HCl 0.25 mg Tablet, 149 Ropivacaine HCl 2 mg/ml Injection, 380 Ropivacaine HCl 7.5 mg/ml Injection, 380 Rosiglitazone 8 mg Tablet, 211 Rosuvastatin 10 mg Tablet, 80 Rosuvastatin 20 mg Tablet, 80 Salazopyrin, 32 Salbutamol 0.5 % Inhalation Solution, 85 Salbutamol 0.5 mg/ml Injection, 85 Salbutamol 100 mcg/dose Inhalation, 86 Salbutamol 2 mg Tablet, 86 Salbutamol 200 mcg Inhalation Powder, 87 Salbutamol 5 mg/5 ml Injection, 242 Salicylazosulphapyridine (Sulfasalazine) 500 mg Tablet, 32 Salicylic Acid 2 - 10% Ointment, 345 Salmeterol 25 mcg and Fluticasone Propionate 125 mcg Inhalation, 94 Salmeterol 50 mcg and Fluticasone Propionate 250 mcg Inhalation, 94 Salofalk, 32 Sandimmum Neoral, 252 Sandimmun Neoral, 251 Sandomigran, 132 Sandostatin, 220 Scoline, 374 Sebivo, 197 Selegiline HCl 5 mg Tablet, 150 Selenium Sulphide 2.5% Shampoo, 349 Selsun, 349 Serenace, 116 Seretide, 94 Seroquel XR, 119 Sertraline HCI 50 mg Tablet, 128 Sevoflurane Liquid, 371 Sevorane, 371 Sibelium, 132 Sifrol, 148 Silver Sulfadiazine 1% Cream, 354 Simvastatin 20 mg Tablet, 80 Simvastatin 40 mg Tablet, 80 Didasine 100 mg Tablet (ddI), 191 Sinemet, 147 Singulair, 92, 93 Sitagliptin 100 mg Tablet, 212 Skinoren, 346 SLN 40, 197 Slow-K, 279 Sodium Bicarbonate 5% w/v Ear Drops, 322 Sodium Bicarbonate 8.4% (1 mmol/ml) Injection, 280 Sodium Bicarbonate Mixture (Paediatric), 18 Sodium Bicarbonate, Citric Acid, Sodium Citrate and Tartaric Acid - 4 g per sachet, 247 400 Sodium Bicarbonate, Magnesium Carbonate, Tincture Cardamom Compound Mixture, 19 Sodium Biphosphate 16%, Sodium Phosphate 6% Solution, 33 Sodium Chloride 0.18% with Dextrose 10% Injection, 280 Sodium Chloride 0.18% with Dextrose 4.23% Injection, 280 Sodium Chloride 0.45% Injection, 281 Sodium Chloride 0.45% with Dextrose 10% Injection, 280 Sodium Chloride 0.45% with Dextrose 5% Injection, 280 Sodium Chloride 0.9% Eye Drops, 319 Sodium Chloride 0.9% with Dextrose 5% Injection, 280 Sodium Chloride 20% Injection, 281 Sodium Chloride 3% Injection, 282 Sodium Cromoglycate 2% Eye Drops, 319 Sodium Fusidate 2% Ointment, 354 Sodium Hypochlorite Solution, 386 Sodium Lactate Compound (Hartmanns Solution/Ringer-lactate], 282 Sodium Nitroprusside 50 mg/5 ml Injection, 57 Sodium Thiosulphate 10-20% Solution, 355 Sodium Thiosulphate 500 mg/ml Injection, 16 Sodium Valproate 200 mg Tablet, 141 Sodium Valproate 200 mg/5 ml Syrup. See Sodium Valproate 400 mg Injection, 142 Sofradex, 321 Solu-Cortef, 216 Solu-Medrol, 216 Spersallerg, 310 Spiriva, 90 Spironolactone 25 mg Tablet, 45 Sporanox, 188, 189 Stavudine 30 mg Capsule, 196 Stavudine 40 mg, Lamivudine 150 mg & Nevirapine 200 mg Tablet, 197 Stelazine, 121 Stemetil, 37, 38 Stesolid, 136 Stocrin, 192 Strattera, 152 Streptase, 73 Streptokinase 1,500,000 IU Injection, 73 Streptomycin Sulphate 1 g Injection, 182 Stugeron, 335 Sucralfate 1 g Tablet, 26 Sulfadoxine 500 mg and Pyrimethamine 25 mg Table, 202 Sulperazon, 164 Sulphamethoxazole 200 mg & Trimethoprim 40 mg/5ml Suspension, 183 Sulphamethoxazole 400 mg & Trimethoprim 80 mg Injection, 183 Sulphamethoxazole 400 mg & Trimethoprim 80 mg Tablet, 184 Sulpiride 200 mg Tablet, 120 Survanta, 93 Suxamethonium Chloride 50 mg/ml lnj, 374 Symbicort, 94 Symmetrel, 144 Synacthen, 221 Synagis, 196 Synthetic ACTH (Tetracosactrin Acetate) 250 mcg/ml Injection, 221 Syntometrine, 237 Tacrolimus 0.5 mg Capsule, 250 Tacrolimus 1 mg Capsule, 250 Tamoxifen Citrate 20 mg Tablet, 272 Tamsulosin HCl 400 mcg Extended Release Tablet, 245 Tar, Coal Tar and Oleyl Alcohol Liquid, 345 Tarivid, 180, 322 Taxol, 270 Taxotere, 261 Tazocin 4.5g, 181 Tegretol, 133, 134 Tegretol CR, 133 Telbivudine 600 mg Tablet, 197 Telmisartan 40 mg Tablet, 58 Telmisartan 80 mg & Hydrochlorothiazide 12.5 mg Tablet, 58 Telmisartan 80 mg Tablet, 58 Tenecteplase 10,000 unit (50 mg) Injection, 73 Tenormin, 47 Terazosin HCl 1 mg Tablet, 245 Terazosin HCl 2 mg Tablet, 245 Terbinafine HCl 250 mg Tablet, 190 Terbutaline Sulphate 0.3 mg/ml Syru, 87 Terbutaline Sulphate 0.5 mg/ml Injection, 88 Terbutaline Sulphate 10 mg/ml Inhalation Solution, 88 Terbutaline Sulphate 2.5 mg Tablet, 89 Terlipressin 1 mg Injection, 221 Testosterone 250 mg/ml Injection, 218 Testoviron-Depot, 218 Tetanus Immunoglobulin Human 250 Units/Vial Injection, 366 Tetanus Toxoid Injection, 364 Theophylline 125 mg Tablet, 89 Theophylline 250 mg Long Acting Tablet, 89 401 Thiamine HCl 100 mg/ml Injection, 291 Thiamine Mononitrate 10 mg Tablet, 291 Thiopental Sodium 500 mg Injection, 372 Thymol Compound Gargle, 326 Tibolone 2.5 mg Tablet, 233 Ticlid, 72 Ticlopidine HCl 250 mg Tablet, 72 Tienam, 176 Timo-comod, 316 Timolol Maleate 0.5% Eye Drops, 316 Timoptol, 316 timoptol-XE, 316 Tiotropium Bromide Inhalation 18 mcg Capsules, 90 Tolterodine Tartrate ER 2 mg Capsule, 246 Topamax, 143 Topiramate 15 mg Capsule Sprinkle, 143 Topiramate 25 mg Tablet, 143 Topiramate 50 mg Tablet, 143 Toradol, 96 Trace Elements and Electrolytes (Adult) Solution, 284 Tracrium, 372 Tramadol HCl 50 mg Capsule, 104 Tramadol HCl 50 mg/ml Injection, 105 Tramal, 104, 105 Trandate, 48, 49 Tranexamic Acid 100 mg/ml Injection, 76 Tranexamic Acid 250 mg Capsule, 76 Transamin, 76 Trental, 64 Tretinoin 0.05% Cream, 348 Triamcinolone Acetonide 0.1% Oral Paste, 326 Triamcinolone Acetonide 40 mg/ml Injection, 218 Trifluoperazine HCI 5 mg Tablet, 121 Trimetazidine 20 mg Tablet, 81 Trimetazidine 35 mg MR Tablet, 81 Trimethoprim 300 mg Tablet, 184 Triprolidine HCl 2.5 mg and Pseudoephedrine HCl 60 mg Tablet, 334 Tritace, 57 Trivastal Retard, 148 Tropicamide 1% Eye Drops, 313 Trusopt, 315 Tuberculine, 364 Tuberculine PPD Injection, 364 Unasyn 1.5, 160 Ural, 247 Urispas, 246 Urokinase, 74 Urokinase 6000 IU Injection, 74 Uromitexan, 14 Ursodeoxycholic Acid 250 mg Capsule, 30 Ursofalk, 30 Valium, 135, 154 Valsartan 80 mg and Hydrochlorothiazide 12.5 mg Tablet, 59 Valsartan 80 mg Tablet, 59 Vancocin, 185 Vancomycin HCL 500mg Injection, 185 Varicella Virus Vaccine Live Attenuated Injection, 364 varilrix, 364 varivax, 364 Vaseline, 338 Vasopressin 20 units/ml Injection, 222 Vastarel, 81 Vastarel MR, 81 Velbe, 270 Venlafaxine HCl 75 mg Extended Release Capsule, 129 Venofer, 298 Ventolin, 85, 86, 242 Vepesid, 262 Verapamil HCl 40 mg Tablet, 65 Verapamil HCl 5 mg/2 ml Injection, 65 Vesanoid, 255 Vibramycin, 172 Videx, 191, 192 Vigamox, 309 Vinblastine Sulphate 10 mg Injection, 270 Vincristine Sulphate 1 mg Injection, 271 Vitamin B Complex 10 ml Injection, 292 Vitamin B Complex Tablet, 292 Vitamin B1, B6, B12 Injection, 292 Vitamin B1, B6, B12 Tablet, 293 Vitamin K1 1 mg/ml Injection, 293 Vitamin K1 10 mg/ml Injection, 294 Voltaren, 106, 107, 108 Vytorin, 77 Warfarin Sodium 1 mg Tablet, 70 Warfarin Sodium 2 mg Tablet, 70 Warfarin Sodium 3 mg Tablet, 70 Warfarin Sodium 5 mg Tablet, 70 Water for Injection, 283 Whitfields, 350 Xalatan, 315 Xanax, 112 Xeloda, 256 Xylocaine, 376, 379 Xyloproct, 30 Xyzal, 329 Zantac, 25, 26 402 Zavedos, 264 Zeffix, 194 Zeldox, 123 Zentel, 202 Zerit, 196 Zidovudine 1% Injection, 198 Zidovudine 10 mg/ml Syrup, 198 Zidovudine 100 mg Capsule, 199 Zidovudine 300 mg & Lamivudine 150 mg Tablet, 199 Zinacef, 167 Zinc Oxide Cream, 346 Zinnat, 167 Ziprasidone 20mg/ml Injection, 123 Zithromax, 161 Zocor, 80 Zofran, 37 Zoladex, 227 Zoledronic Acid 4 mg Injection, 225 Zoloft, 128 Zometa, 225 Zovirax, 190, 191, 311, 349 Zuclopenthixol Acetate 50 mg/ml Injection, 122 Zuclopenthixol Decanoate 200 mg/ml Injection, 122 Zydis, 117 Zyloric, 303 Zyprexa, 117 Zyrtec, 327 Zyvox, 177 403