Workbook – Standing orders for registered nurses in primary care

Transcription

|NHC 2013
|NHC 2013
|NHC 201
Sore Throat Clinics
Workbook
- Standing Orders for Registered Nurses in Primary Care
For the treatment of Group A Streptococcal sore throats in Primary Health Care
ISBN: 978-0-473-32154-3
1
Table of Contents
Introduction
2
Directions
2
Medico‐Legal/Professional Requirements
2
Pre‐requisites & Learning Resources
3 Associated Documents and References
3
WORKBOOK: Standing Orders for Registered Nurses
Questions Specific To Standing Orders for Registered Nurses
Throat Swabbing Procedure
Quick Reference Medication Table
Standing orders
4‐ 11 12‐15
16
17 18‐ 20
DATA SHEETS: NEW ZEALAND DATA SHEET: CILICAINE VK
21‐28
NEW ZEALAND DATA SHEET: OSPAMOX
29‐43
NEW ZEALAND DATA SHEET: E‐MYCIN
44‐53
NEW ZEALAND DATA SHEET: BICILLIN
54‐61 NEW ZEALAND DATA SHEET: LIDOCAINE CLARIS
62‐ 74
INTRAMUSCULAR INJECTION OF BICILLIN >30KG
75‐76
INTRAMUSCULAR INJECTION OF BICILLIN <30KG
77‐78
APPENDIX: 1. Counties Manukau Rheumatic Fever
79
2. What is Mana Kidz?
80 COMPULSORY READINGS: Rheumatic fever. The Neglected Disease (2010) Best Practice
Journal 32: 15–18. MoH Standing Order Guidelines 2012 New Zealand Guideline for Rheumatic Fever: Group A Streptococcal Sore Throat Management Guideline: 2014 Update. P. 23‐55. http://www.heartfoundation.org.nz/uploads/Sore%20Throat%20Algorithm%202014.pdf 2
Introduction
This workbook will meet the requirements for education and demonstration of competence required by the Ministry of Health. Learning Objectives Upon completion of this workbook nurses will be able to: 1.
2.
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Describe the antimicrobial actions of main classes of antibiotics. Explain the process of medication reconstitution. Demonstrate professional nursing responsibilities and accountabilities when working under Standing Orders within their organization. Locate and Implement the Medication Policies and Protocols relating to the use of Standing Orders. Demonstrate accurate clinical decision making skills in the assessment and treatment process. Apply the principles of documentation with all nursing interventions. Competently perform a throat swab. DIRECTIONS 
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Standing Orders cannot be utilized until the Standing Order Workbook and assessment have been successfully completed. It is a requirement that competency to work under Standing Orders is reassessed annually (MoH 2011) by appropriate person within the clinic. MEDICO‐LEGAL REQUIREMENTS/PROFESSIONAL REQUIREMENTS A standing order is a written instruction issued by a medical practitioner or dentist in accordance with specific regulations. A standing order permits a Registered Nurse to supply and/or administer medicines pursuant to a standing order while they are engaged in the delivery of a health service. It does not enable a Registered Nurse to prescribe (MoH, 2011). The standards by which Registered Nurses obtain approval and authority to work using a standing order for delegated medical authority are clearly outlined in theMinistry of Health 2012 Standing Order Guidelines (Appendix 4). Registered Nurses supplying or administering under a Standing Order must: 
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Fully comply with all Standing Order requirements Have completed competency requirements to work under Standing Orders Assess and monitor the patient. Any treatment of the patient (including any adverse reactions) are followed up as required Seek clarification of medication decisions on an individual case by case basis through consultation with the issuers of the Standing Order. Document all medication given under Standing Order including assessments, treatments, and patient’s response in the patient’s clinical record. Document on the patients medication chart, the date, time, drug, dose, frequency, ‘as per standing order’, sign, print name, designation. 3
PRE‐REQUISITES AND LEARNING RESOURCES 1. Meet all education requirements for standing orders:  Pre Workshop compulsory readings  Complete one hour e‐Learning module (Primary Prevention of Rheumatic Fever in Children within the Primary Health Care Setting) http://www.goodfellowclub.org/case/primary‐prevention‐rheumatic‐fever‐children‐
within‐primary‐health‐care‐setting  Attend 2 hour workshop: Sore Throat Clinics in Primary Care 2. Must work in the area the standing order was generated by i.e. Primary Care 3. Review: Ministry of Health Standing Orders Guideline, 2012 4. Review: Med Safe Data sheet for specific Standing Order drugs:  Amoxycillin  Erythromycin Ethyl Succinate  Penicillin V  Benzathine Penicillin G (BPG) ASSOCIATED DOCUMENTS & REFERENCES (as per individual organisation or appendixed)  NZ Guidelines for Rheumatic Fever: Group A Streptococcal Sore Throat Management Guideline: 2014 Update  Infection Control and Standing Orders policies  Medication Policies/Procedures  NZNO Guidelines on medication administration http://www.nzno.org.nz/resources/nzno_publications  Ministry of Health (2012). Guidelines for the Development and Operation of Standing Orders: New Zealand. References: Drug Monographs Information for Health Professionals. Medsafe.govt.nz. URL: http://www.medsafe.govt.nz/profs/datasheet/DSForm.asp Drug Monographs Mims Online © UBM Medica (NZ) Ltd 2007. URL: http://mimsonline.co.nz/SimpleSearch.aspx Health Practitioners Competence Assurance Act (2003). http://www.legislation.govt.nz/act/public/2003 /0048/latest/DLM203312.html?src=qs Lennon D., Farrell, E., Martin D., R. Stewart. (2008).Once‐daily amoxicillin versus twice‐daily penicillin V in group A ‐
haemolytic streptococcal pharyngitis. Archives of Disease in childhood 93:474–478. Medicines Act 1981 and Regulations 1984. http://www.legislation.govt.nz/regulation/public/1984/0143/latest/DLM95668.html Misuse of Drugs Act and Regulations 1987. http://www.legislation.govt.nz/act/public/1975/0116/latest/DLM436106.html Nursing Council of New Zealand, Code of Conduct for Nurses: http://nursingcouncil.org.nz/Media/Files/Code‐of‐
Conduct‐Booklet‐full2 4
Oral Amoxycillin:
Please complete the following table utilising the recommended drug reference guides Oral Amoxycillin: Key points Indications for use Charting and Administration Pharmokinetics Nursing monitoring required Drug interactions 5
Contraindications Adverse reactions Management of adverse reaction Patient Education Notes: 6
Erythromycin Ethyl Succinate (EES)
Please complete the following table utilising the recommended drug reference guides Erythromycin Ethyl Succinate (EES): Key points Indications for use Charting and Administration Pharmokinetics Nursing monitoring required Drug interactions 7
Oral Penicillin V
Please complete the following table utilising the recommended drug reference guides Oral Penicillin V Key points Indications for use Charting and Administration Pharmokinetics Nursing monitoring required Drug interactions 9
Benzathine Penicillin G (BPG)
Please complete the following table utilising the recommended drug reference guides Benzathine Penicillin G (BPG) Key points Indications for use Charting and Administration Pharmokinetics Nursing monitoring required Drug interactions 11
Test
Name: __________________________________ Practice: _________________________________ Instructions: Please complete all sections and return via email to: Liz Pillay, [email protected] Roles and Responsibilities: The following questions relate to your role and responsibilities as set out in Ministry of Health (2012). Guidelines for the Development and Operation of Standing Orders: New Zealand. Answer the following questions by circling either True (T) or false (F) 1.
RN can prescribe medication under standing orders? T / F (1) 2.
RN can supply medications under standing orders? T / F (1) 3.
RN can administer medications under standing orders? T / F (1) 4.
RN is answerable if they act beyond the scope of standing orders? T / F (1) Under Standing Orders RNs are: 5.
Required to supply medication? T / F (1) 6.
Empowered to supply medication? T / F (1) 7.
Permitted to supply medication? T / F (1) Complete the following multi‐choice questions by circling the most correct answer: 8. Who is accountable for accurate decision making and the application of the standing order? a) b) c) The RN acting under standing orders The Issuing Medical Practitioner Both of the above (1) 9. Who holds responsibility to undertake an assessment on allergy status and clearly and legibly document a patient’s allergy status or adverse drug reaction? a) The RN acting under standing orders b) The Issuing Medical Practitioner c) Both of the above (1) Documentation: 10. Information on all medications supplied under standing orders must be documented on: a) Medtech / My Practice b) The packet or bottle containing the medication c) Medication adherence charts (if used) d) All of the above (1) ( /10) 13
Allergies and adverse reactions: 11. What are the minimum steps the RN acting under standing orders must take to establish the presence or absence f a an allergy? a) b) c) d) Check previous notes Check with the patient Check with the caregiver All of the above (1) Answer the following sets of questions by circling either True (T) or false (F) 12. Which of the following statements increase a child’s/young person’s risk of an adverse event in relation to medications? a) b) c) d) Weight based dosing. T / F (1) Weight increases and weight decreases. T / F (1) Young children do not have the communication skills to warn about potential mistakes or adverse effects. T / F (1) Young children may try to get out of having further doses by crying and complaining. T / F (1) Complete the following multi‐choice questions by circling the correct answer Reconstitution 13.The amount of drug in a quantity of solution expressed as a ratio is called: a)
An emulsion c) A Suspension b)
The concentration d) A diluent (1) 14. The solution used to reconstitute powders and crystals from a dry form of medication to liquid form is called: a) An emulsion c) A suspension b) An elixir d) A diluent (1) 15.Solutions that deteriorate rapidly in liquid form are considered to have a short shelf life and are described as: a) Crystals c) Bacteriostatic b) Unstable d) Diluents (1) 16.The process of combining a liquid with a solid form of medication so that the medication can be used is called: a) Reconstitution c) Calibration b) Dilution d) Concentration (1) 17.Accurate measurement of liquid meds require which type of equipment: a) Household droppers and cups b) Metric equipment with calibrations 14
c) A syringe and needle d) Household teaspoons and tablespoon (1) (10) 18. Which of the following statements can lead to medication calculation errors? a) Suspensions must be combined with a precise amount of diluent and thoroughly mixed b) Elixers are solutions that contain alcohol c) Extracts are solutions that are concentrated d) It is acceptable to use household teaspoons and tablespoons to measure liquids (1) Medications Circle the correct answer: Beta‐Lactam Antibiotics work in the following ways: a) Combats infection by reducing the number of bacteria b) Interferes with synthesis of structural elements in bacterial cells c) Inhibits the process of DNA synthesis d) Slows down the assembly of peptidoglycan (1) Erythromycin Ethyl Succinate: a) Interferes with protein synthesis b) Combats infection by reducing the number of bacteria c) Interferes with the synthesis of structural elements in bacterial cells d) Interferes with ribosome structure of bacteria (1) Answer the following questions by circling either true (T) or False (F): 21. Antibiotics that act against Gram +ve and Gram –ve bacteria are termed ‘broad sprectrum’ antibiotics. They are very useful, however the more widely acting the antibiotic the more likely it will kill off normal bacterial flora. This may lead to super infections such as oral candidiasis. T/F (1) 22. A 9 year old girl has a sore throat. The swab culture is positive for group A streptococcus. Which of the following statements are true? a) All household members of the child should have their throats swabbed T/F (1) b) If the child is given a 10 day course of amoxicillin and then presents with another sore throat six weeks later they can be assumed to have a viral infection and do not need to be swabbed T/F (1) 23. When administering an oral medication to a child you should: a) Tell the child the medication tastes nice, regardless of its taste T/F (1) b) Restrain the child until you are sure the medication has been swallowed T/F (1) c) Add the medication to a drink if the child won’t take the medication by itself T/F (1) d) Give a developmentally appropriate explanation to the child T/F (1) ( /10) 24. Amoxycillan is contra‐indicated in: a) Children/youth who are allergic to penicillin T/F (1) b) Children/youth who have severe liver impairment T/F (1) 15
c) Children/youth who are currently taking ergotamine T/F (1) 25. Erythromycin Ethyl Succinate is contraindicated in: a) Children/youth who are allergic to penicillin T/F (1) b) Children/youth who have severe liver impairment T/F (1) c) Children/youth who are currently taking ergotamine T/F (1) 26. Which of the following antibiotics may interact with oral contraceptives? a) Erythromycin Ethyl Succinate T/F (1) b) Amoxycillan T/F (1) c) Penicillan T/F (1) 27. Which of the following antibiotics can cause nausea, diarrhoea or vomiting? a) Erythromycin Ethyl Succinate T/F (1) b) Amoxycillan T/F (1) c) Penicillan T/F (1) Briefly answer the following questions: 28. Should Group C and/G streptococcal sore throats be treated with antibiotics? (1) 29. List TWO measures that improve medication adherence : (1) a) b) 30. List TWO measures to reduce pain when administering bicillin injection: a) b) ( /15) Total ( /45) 16
Throat Swab Procedure RNs/ENs/ Community Health Workers must have had adequate training in taking throat swabs. This includes at minimum, reading the technique for taking a throat swab, as below, observing a throat swab being taken and being observed taking one by a colleague. Equipment 
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Culture tube and applicator (sterile) Tongue depressor Light source Gloves (optional) Mask (optional) Laboratory form Plastic ziplock specimen bag Technique 
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Explain what you are about to do to the child or young person and their parent / caregiver. Wash hands and dry thoroughly (put on gloves and mask if needed). Remove sterile applicator by rotating cap to break seal. Ask the patient to tilt head back and open the mouth widely and say a long “ah”. The tongue should be gently depressed with a tongue depressor and the throat adequately exposed and illuminated (see diagram below). Examine the pharynx and tonsillar area for redness, swelling or exudate The swab is then gently passed over (avoiding touching) the tongue and into the posterior pharynx. The mucosa behind the uvula and between the tonsils should then be gently swabbed with a back and forth motion: the swab should touch each tonsillar region and the posterior pharynx and any area exhibiting exudate. Avoid contaminating the swab by touching the tongue and lips. Label the specimen tube with name, date of birth, NHI, site of swab, date and time taken. Place the throat swab into plastic ziplock bag with laboratory form. Refrigeration is not required unless an excessive delay is anticipated. GAS results can be expected in 1‐3 days. Figure 1 Technique for taking a throat swab (based on the ARPHS throat swabbing technique and Wellington Regional Health School Sore Throats Protocol). 17
Quick Reference Medication Table:
Medication: Strep throats Dose Amoxycillin Children less than 30kg 750mg once daily for 10 days Either 3 x 250 mg tabs daily or 15 mls of 250mg/5mls oral suspension daily* Children 30kg and over 1000mg once daily for 10 days Either 2 x 500 mg tabs daily or 20 mls of 250mg/5mls oral suspension daily** Erythromycin for GAS and Children less than 20kg
penicillin allergy 20mg/kg twice a day for 10 days Use 200mg/5ml or 400mg/5ml oral suspension Children 20kg and over, and Adults
400mg twice a day for 10 days Use either 1 x 400mg tabs twice a day or 5 mls of 400mg/5ml oral suspension*** * Mix 2 bottles and discard 50mls from the 2nd (thus provide 150mls) ** Mix the 2 bottles (no need to discard as supplies 200mls) *** Mix 1 bottle (no need to discard as supplies 100mls) 18
Standing Order for Sore Throat Clinics for the treatment of Group A Streptococcal
throat infection in Primary Care Programme
Issued on: 20 August 2014 Review date: 20 August 2015 Medicine standing order : Administration of Medicines to treat likely Group A Streptococcal throat infection Rationale All likely Group A Streptococcus throat infections in high risk for rheumatic fever patients are treated Organisation /Clinic Primary Care Sore Throat Clinic –[Practice Name] Scope For the treatment of sore throats for: i. High risk 4 – 19 years olds (without positive culture results or while waiting for them) ii. All those with a culture positive for Group A beta‐haemolytic streptococcus. Medicines Oral Amoxicillin Oral Erythromycin if concern about IgE mediated or anaphylactic response to beta lactams Oral Penicillin V IM Benzathine penicillin G (BPG) with Lignocaine 2% Dosage instructions Oral amoxicillin Children under 30 kg: 750mg once daily for 10 days Use three 250mg capsules per dose if able to swallow capsules OR 15ml of 250mg/5ml oral suspension per dose if not able to swallow capsules Children 30 kg and over: 1000mg once daily for 10 days Use two 500mg capsules per dose, or 20ml of 250mg/5ml oral suspension per dose if not able to swallow capsules Oral Erythromycin ethyl succinate Children less than 20kg: 20mg/kg twice a day for 10 days Use 200mg/5ml or 400mg/5ml oral suspension Children 20kg and over and Adults: 400mg twice a day for 10 days Use either 1 x 400mg tabs twice a day or 5 mls of 400mg/5ml oral suspension Oral Penicillin V Children less than 20kg: 250mg two times daily for 10 days Use 250mg/5ml oral suspension, or 250mg caps if able to swallow capsules 19
Children 20kg and over and Adults: 500mg two times daily for 10 days Use 250mg/5ml oral suspension or 500mg caps if able to swallow capsules Benzathine Penicillin G (BPG) Administered IM into ventrogluteal muscle Children under 30 kg – 600,000 U single dose Adults and children over 30kg 1,200,000U single dose With: Lignocaine 2% Administered IM into ventrogluteal muscle All ages 0.25mls of 2% Lignocaine (to be added to IM Benzathine) Route of administration Oral – Amoxicillin Oral – Erythromycin ethyl succinate Oral – Penicillin V IM ‐ Benzathine penicillin G (BPG) IM – Lignocaine 2% Indication /circumstances Provide antibiotic treatment to eligible children and young people (i.e. aged 4‐19 years) for activating the identified as high risk on Heart Foundation Algorithm 4 Criteria standing order Or: Throat swab culture positive for Group A beta‐haemolytic streptococcus. Precautions and Amoxicillin: exclusions that apply to Interactions with oral contraceptives this standing order Interactions with anticoagulants Impaired liver or kidney function If infectious mononucleosis is suspected there is an increased risk of drug induced morbilliform rash Severe gastrointestinal disturbances with diarrhoea and vomiting (risk of reduced absorption) Phenylketonuria Lymphatic leukaemia (increased risk of skin rash) Allergic diathesis and asthma Erythromycin Ethyl Succinate: May interact with antiepileptics or warfarin Penicillin V: Hypersensitivity reactions Most common reactions are nausea, vomiting, epigastric distress, diarrhoea, pruritis ani, black hairy tongue, allergic skin reaction, urticaria and other serum sickness reactions Antibiotic associated pseudomembraneous colitis has been reported May reduce effectiveness of contraceptives Not recommended for chronic ,severe or deep seated infections Antacids may reduce absorption of this medication 20
Persons authorised to administer the standing order Competency /training requirements for the person(s) authorised to administer Countersigning of this order is to occur within Countersigning not required for this order an audit will be taken Decreased clearance of methotrexate toxicity monitor closely if on methotrexate Platelet dysfunction and haemorrhage Renal function impairment as penicillin is excreted through kidneys Benzathine Penicillin G (BPG): Serious and occasionally fatal hypersensitivity Use in caution in patients with a history of significant allergies and or asthma Injection near a nerve can result in permanent neurological damage select site with care
Antibiotic pseudomembraneous colitis has been reported as well as the following adverse events: Haemolytic anaemia, leucopenia thrombocytopenia Neuropathy,nephropathy Lignocaine 2% Known hypersensitivity to local anaesthetics of the amide type Complete heart block Hypovolaemia Dosage reduction may be required in patients presenting with impaired hepatic function. Registered nurses who have completed the 2 hours training package and competency assessment on standing orders and Group A Streptococcal sore throat management, or appropriate equivalent. Prior to administering oral Amoxicillin , Penicillin V, Erythromycin Ethyl Succinate, IM Benzathine penicillin G,or Lignocaine 2% under this standing order the registered nurse is required to undergo the 2 hours training session on the policy, procedure and documentation requirements for standing orders and sore throat clinics for management of Group A Streptococcal sore throats. A record of this training will be kept in the practice records. Issuer has the option of either countersigning every administration and/or supply of a medicine, or GP Name: If countersigning is not required, or required less frequently than once a month, the issuer must, at least once a month, audit a sample of the records of administration and/or supply under the standing order. Signature: Date: RN Name: Date: Signature: Notes: This standing order is not valid after the review date. The review date is one year after the date the order was signed by the issuer. The organisational standing order policy and procedure must be signed by management, the issuer, and every person operating under standing orders, and attached to the standing order. 21
New Zealand Data Sheets
|NHC 2013
New Zealand Data Sheet
CILICAINE VK
Phenoxymethyl penicillin capsules 250 mg & 500 mg
Presentation
CILICAINE VK 250mg capsules: Size 2 hard gelatine capsule shell, opaque
rusty red cap and body containing 250mg phenoxymethyl penicillin.
CILICAINE VK 500mg capsules: Size 0 hard gelatine capsule shell, opaque
rusty red cap and body containing 500mg phenoxymethyl penicillin.
Uses
Actions
Penicillin V exerts a bactericidal action against penicillin sensitive microorganisms during the stage of active multiplication. It is not active against the
penicillinase producing bacteria, which include many strains of staphylococci.
Sensitive organisms include the following:
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Gram-positive cocci, e.g. Streptococci (groups A,C,G,H,L and M), and
non-penicillinase producing Staphylococcus pyogenes.
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Gram-positive bacilli, e.g. Clostridium tetani, Cl. Perfrigens,
Corynebacterium diphtheriae and Bacillus anthracis.
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Gram-negative bacteria, both Neisseria meningitidis and N.
gonorrhoeae are sensitive to a degree but Haemophilus influenzae is
moderately resistant and other aerobic Gram-negative bacilli are highly
resistant.
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Treponema pallidum is sensitive, but treatment of syphilis with oral
penicillins is not recommended.
Phenoxymethylpenicillin produces a bacterial effect on penicillin sensitive
organisms during the stage of active multiplication through inhibition of
biosynthesis of cell wall mucopeptides. The antibacterial spectrum of
phenoxymethylpenicillin is similar to that of benzyl penicillin, however, it has
the advantage of being acid stable and hence better absorbed from the
gastrointestinal tract than benzyl penicillin. It is resistant to inactivation by
gastric acid. It may be given with meals; however, blood levels are slightly
higher when given on an empty stomach. Average blood levels are two to five
1
times higher than the levels following the same dose of oral penicillin G and
show much less individual variation.
Pharmacokinetics
Usually, up to 60% of the medicine is absorbed into the blood stream after
oral administration. Absorption is usually rapid and may produce peak serum
concentrations within 30 minutes and demonstrable levels are maintained for
4 hours.
Approximately 80% of phenoxymethylpenicillin is serum protein bound. About
56% of a 500mg oral dose of the medicine is metabolised into inactive
metabolite and about 23 to 36% of the medicine is rapidly excreted in the
unchanged form in the urine. Bile excretion depends on renal function, being
low in normal renal function and high in renal impairment. The oral plasma
half-life is about 30 minutes in healthy adults and about 1 to 3 hours in
neonates. The half life is greatly extended in patients with renal or hepatic
impairment.
The medicine is excreted as rapidly as it is absorbed in individuals with
normal kidney function; however, recovery of the medicine from the urine
indicates that only about 25% of the dose given is absorbed. In neonates,
young infants and individuals with impaired kidney function, excretion is
considerably delayed.
Tissue levels are highest in the kidneys with lesser amounts in the liver, skin
and intestines. Small amounts are found in all other body tissues and the
cerebrospinal fluid.
Indications
When oral therapy is required in the treatment of mild to moderately severe
infections due to penicillin sensitive organisms. Therapy should be guided by
bacteriological studies, including sensitivity tests, and by clinical response.
For prophylactic use in recurrent streptococcal infections including the
prevention of recurrence following rheumatic fever and/or Sydenham's chorea
and to prevent bacterial endocarditis in patients with rheumatic fever and/or
congenital heart disease who are about to undergo dental or upper respiratory
surgery or instrumentation.
Note: Oral penicillin should not be used as adjunctive prophylaxis for
genitourinary instrumentation or surgery, lower intestinal tract surgery,
sigmoidoscopy or complications of childbirth.
Dosage and Administration
Adults
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250mg to 500mg every four to six hours, preferably one hour before food. The
dosage should be determined according to sensitivity of the organisms and
severity of the infection.
Prevention of recurrence following rheumatic fever: 250mg twice a day
continuously.
Contraindications
Hypersensitivity to penicillins and/or cephalosporin.
Warnings and Precautions
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have
been reported in patients on penicillin therapy. Although anaphylaxis is more
frequent following parenteral therapy, it has occurred in patients on oral
penicillins. These reactions are more likely to occur in individuals with a
history of penicillin hypersensitivity and/or history of sensitivity to multiple
allergens. There have been reports of individuals with a history of penicillin
hypersensitivity who have experienced severe reactions when treated with
cephalosporins. Before initiating therapy with any penicillin, careful inquiry
should be made concerning previous hypersensitivity reactions to penicillins,
cephalosporins or other allergens. If an allergic reaction occurs, the medicine
should be discontinued and the appropriate therapy instituted. Serious
anaphylactoid reactions require immediate emergency treatment with
adrenaline. Oxygen, intravenous steroids, and airway management, including
intubation, should also be administered as indicated.
Antibiotic associated pseudomembranous colitis has been reported with many
antibiotics including phenoxymethylpenicillin. A toxin produced with
Clostridium difficile appears to be the primary cause. The severity of the colitis
may range from mild to life threatening. It is important to consider this
diagnosis in patients who develop diarrhoea of colitis in association with
antibiotic use (this may occur up to several weeks after cessation of antibiotic
therapy). Mild cases usually respond to medicine discontinuation alone.
However, in moderate to severe cases appropriate therapy with a suitable oral
antibacterial agent effective against Clostridium difficile should be considered.
Fluids, electrolytes and protein replacement should be provided when
indicated.
Agents which delay peristalsis, e.g. opiates and diphenoxylate with atropine
(Lomotil) may prolong and/or worsen the condition and should not be used.
Phenoxymethylpenicillin is not recommended for chronic, severe or deep
seated infections as therapeutic concentrations may not be achieved in the
relevant tissues.
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Oral administration should not be relied upon to achieve therapeutic levels in
some patients with severe illness or with nausea, vomiting, gastric dilation,
cardio-spasm or intestinal hypermotility. Occasionally patients will not absorb
therapeutic amounts of oral penicillin. Parenteral administration of suitable
antibiotics is recommended in these patients.
In a streptococcal infection, therapy should continue for a minimum of ten
days. Cultures should be taken following completion of treatment to determine
whether Streptococci have been eradicated.
Use of an alternative or additional method of contraception is strongly
recommended if an oestrogen containing contraceptive is taken concurrently
(see Interactions below).
History of Bleeding Disorders
Some penicillins may cause platelet dysfunction and haemorrhage.
Renal Function Impairment
Because most penicillins are excreted through the kidneys, a reduction in
dosage, or increase in dosing interval, is recommended in patients with renal
function impairment; and the potassium content of high doses of
phenoxymethylpenicillin potassium, should be considered in patients with
severe renal function impairment.
Prolong Use
Prolonged use of penicillins may lead to the development of oral candidiasis.
Carcinogenicity
Long term studies have not been performed in animals
Genotoxicity
The genotoxic potential of phenoxymethylpenicillin has not been examined.
Effect on Fertility
Reproductive studies performed in the mouse, rat and rabbit have revealed no
evidence of impaired fertility due to phenoxymethylpenicillin.
Use in Pregnancy and Lactation
Human experience with the penicillins during pregnancy has not shown any
positive evidence of adverse effects on the fetus. There are, however, no
adequate and well controlled studies in pregnant women showing conclusively
that harmful effects of these drugs on the fetus can be excluded. Because
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animal reproduction studies are not always predictive of human response,
penicillin should be used during pregnancy only if clearly needed.
The medicine is excreted in breast milk in concentrations lower than plasma
levels. As safety to newborn infants has not been established, it is not
recommended for breast-feeding mothers unless the benefits outweigh any
potential risk.
Use in Children
The half-life of Phenoxymethylpenicillin is prolonged in premature infants and
neonates up to 3 months of age. Consequently only three doses a day may
be adequate to maintain plasma levels in these infants.
Use in Elderly
There are no age specific problems documented with the use of
Phenoxymethylpenicillin, However, the elderly are more likely to have agerelated renal function impairment, which may require dosage adjustment
Renal or Hepatic Impairment
The half-life is greatly extended in these patients.
Adverse Effects
The most common reactions are nausea, vomiting, epigastric distress,
diarrhoea, pruritis ani, black hairy tongue, allergic skin reactions, urticaria and
other serum sickness reactions.
The hypersensitivity reactions reported are skin eruptions (macropapular to
exfoliative dermatitis), urticaria and other serum sickness-like reactions,
laryngeal oedema and anaphylaxis. Fever and eosinophilia may frequently be
the only reaction observed.
Haemolytic anaemia, leucopenia, thrombocytopenia, neuropathy and
nephropathy are uncommon reactions usually associated with high doses of
parenteral penicillin.
Anaphylaxis is a less common reaction.
Interactions
Bacteriostatic agents may antagonise the effect of penicillin.
Probenecid reduces the tubular excretion of penicillin, thereby increasing
concentrations in the blood stream of concomitantly administered penicillin.
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Food has a variable effect, generally delaying absorption.
Antacids may reduce absorption of the medicine.
When used concurrently with an oestrogen-containing oral contraceptive, the
effectiveness of the oral contraceptive may be decreased because of
stimulation of oestrogen metabolism or reduction of enterohepatic circulation
of oestrogens, resulting in menstrual irregularities, intermenstrual bleeding
and unplanned pregnancies. This interaction may be of greater clinical
significance with long-term use of this penicillin; patients should be advised to
use an alternative or additional method of contraception while taking this
penicillin.
Aminoglycosides: mixing penicillins with aminoglycosides in vitro has resulted
in substantial mutual inactivation.
Methotrexate: concurrent use with penicillins has resulted in decreased
clearance of methotrexate toxicity; probably due to competition for renal
tubular secretion; patients should be closely monitored.
Laboratory value alterations
With diagnostic test results:
Glucose, urine: High urinary concentrations of penicillin may produce false
positive or elevated test results with copper sulfate tests (Benedict’s, Clinitest
or Fehling’s).
Direct antiglobulin (Coombs’ ) tests: False positive results may occur during
therapy with any penicillin.
White blood cell count: leukopenia or neutropenia is associated with the use
of all penicillins; the effect is more likely to occur with prolonged therapy and
severe hepatic function impairment.
Overdosage
Phenoxymethylpenicillin has low toxicity. However, if there is gross renal
impairment, the medicine may accumulate in the blood, and the dose should
be reduced accordingly.
Treatment
Management of overdose should include monitoring of electrolyte balance,
cardiovascular status and renal function. Penicillins are generally not readily
removed by dialysis.
Pharmaceutical Precautions
6
Store below 25°C.
Shelf-life 36 months when stored below 25°C.
Medicine Classification
Prescription Medicine.
Package Quantities
CILICAINE VK capsules 250mg: packets containing 50 capsules in blisters.
CILICAINE VK capsules 500mg: packets containing 50 capsules in blisters.
Further Information
Other Excipients:
Cilicaine VK 250 mg capsules contain: Gelatin, Iron Oxide Red, Titanium
Dioxide and Magnesium Stearate.
Cilicaine VK 500 mg capsules contain: Gelatin, Iron Oxide Red, Titanium
Dioxide, and Magnesium Stearate.
Phenoxymethylpenicillin (or penicillin V) potassium is the potassium salt of the
phenoxymethyl analogue of penicillin G. It is soluble in water and polar
organic solvents but practically insoluble in vegetable oils and liquid paraffins.
Its chemical name is potassium (6R)-6-(2-phenoxyacetamido)penicillinate with
an empirical formula of C16H17KN2O5S and a molecular weight of 388.5.
Name and Address
Pharmacy Retailing (NZ) Limited
Trading as Healthcare Logistics
58 Richard Pearce Drive
Airport Oaks
Auckland
Ph (09) 918 5100
Fax (09) 901 5101
Date of Preparation
7
13 July 2010
8
NEW ZEALAND DATA SHEET
Ospamox
Amoxicillin Trihydrate Ph Eur, powder filled capsules 250 mg and 500 mg,
dried suspension 125 mg/5 ml, 250 mg/5 ml and 100 mg/ml (as amoxicillin)
Presentation
Ospamox capsules
250 mg
Capsule, powder filled, Size 2, yellow opaque cap and body, approximately 17.5 mm length and 6.3
mm diameter. Each capsule contains Amoxicillin Trihydrate Ph Eur equivalent to amoxicillin 250 mg.
500 mg
Capsule, powder filled, Size 0, yellow opaque cap and body, approximately 21.2 mm length and 7.6
mm diameter. Each capsule contains Amoxicillin Trihydrate Ph Eur equivalent to amoxicillin 500 mg.
Ospamox powder for oral suspension
125 mg/5 ml
Suspension, oral, powder for, white to yellowish colour. Reconstituted suspension contains in 5 ml,
Amoxicillin Trihydrate Ph Eur equivalent to amoxicillin 125 mg.
250 mg/5 ml
500 mg/5 ml
Ospamox Paediatric Drops 100 mg/ml
Suspension, oral, granules for, white to yellowish colour. Reconstituted suspension contains in 1 ml,
Uses
Actions
Amoxicillin is an aminobenzyl penicillin that has a bactericidal action due to its inhibition of the
synthesis of the bacterial cell wall. It exerts a bactericidal effect against many Gram-positive and
Gram-negative microorganisms. Amoxicillin is not effective against beta-lactamase producing
organisms.
Pharmacotherapeutic group
J01CA04 – Penicillins with extended spectrum, amoxicillin.
Mechanism of action
Beta-lactam antibiotic.
Pharmacodynamic effects
Inhibition of bacterial cell wall synthesis.
Antibiotic class
Amoxicillin is a semi-synthetic aminopenicillin of the beta-lactam group of antibiotics.
Antibiotic nature and mode of action
Amoxicillin has a broad spectrum of antibacterial activity against many Gram-positive and Gramnegative microorganisms, acting through the inhibition of biosynthesis of cell wall mucopeptide.
Amoxicillin is active in vitro against beta-lactamase negative strains of Proteus mirabilis, and
Haemophilus influenza. In vitro studies have also demonstrated activity against most strains of alphaand beta-haemolytic streptococci. Streptococcus pneumoniae, and beta-lactamase negative strains of
staphylococci, Neisseria gonorrhoeae, Neisseria meningitidis and Enterococcus faecalis. However,
some of the organisms are sensitive to amoxicillin only at concentrations achieved in the urine.
Strains of gonococci which are relatively resistant to benzyl penicillin may also be resistant to
amoxicillin.
Amoxicillin is susceptible to degradation by beta-lactamases and therefore it is ineffective against
bacteria which produce these enzymes particularly resistant staphylococci, which now have a high
prevalence. All strains of Pseudomonas, Klebsiella and Enterobacter, indole positive Proteus, Serratia
marcescens, Citrobacter, penicillinase producing N. gonorrhoeae and penicillinase producing H.
influenzae are also resistant. Escherichia coli isolates are becoming increasingly resistant to
amoxicillin in vitro due to the presence of penicillinase-producing strains.
Susceptibility
The prevalence of resistance may vary geographically and with time for selected species and local
information on resistance is desirable, particularly when treating severe infections. As necessary,
expert advice should be sought when the local prevalence of resistance is such that the utility of the
agent in at least some types of infections is questionable.
Breakpoints
The MIC breakpoints for susceptible organisms vary according to species. Enterobacteriaceae are
considered susceptible when inhibited at NMT 8 mcg/ml amoxicillin and resistant at NLT 32 mcg/ml.
From NCCLS recommendations and using NCCLS-specified methods, M. catarrhalis (beta-lactamase
negative) and H. influenzae (beta-lactamase negative) are considered susceptible at NMT 1 mcg/ml
and resistant at NLT 4 mcg/ml; Str. pneumoniae are considered susceptible to amoxicillin at MIC NMT
2 mcg/ml and resistant at NLT 8 mcg/ml.
Susceptibility data
Strains of the following named organisms are generally sensitive to the bactericidal action of
amoxicillin in vitro.
Susceptible Gram-positive aerobes include: Enterococcus faecalis (Note 2), Streptococcus
pneumoniae (Notes 1, 3), Streptococcus pyogenes (Notes 1, 3), Streptococcus viridans (Note 2),
Streptococcus agalactiae, Streptococcus bovis, Staphylococcus aureus (penicillin sensitive),
Corynebacterium species (Note 2), Bacillus anthracis, Listeria monocytogenes.
Susceptible Gram-negative aerobes include: Haemophilus influenzae (Note 3), Haemophilus
parainfluenzae (Note 3), Escherichia coli (Note 3), Proteus mirabilis, Salmonella species (Note 2),
Shigella species (Note 2), Bordetella pertussis, Brucella species (Note 1), Neisseria gonorrhoeae
(Note 2), Neisseria meningitidis (Note 1), Pasteurella septica, Helicobacter pylori, Leptospira spp,
Vibrio Cholerae
Susceptible anaerobes include: Bacteroides melaninogenicus (Note 2), Clostridium species,
Fusobacterium spp. (Note 2), Peptostreptococci
Other susceptible organisms include Borrelia burgdorferi.
Note 1: No beta-lactamase producers have as yet been reported for these bacterial species.
Note 2: Inconstantly susceptible; susceptibility is therefore unpredictable in the absence of
susceptibility testing.
Note 3: Clinical efficacy has been demonstrated for susceptible isolates in approved clinical
indications.
Resistance
Bacteria may be resistant to amoxicillin due to production of beta-lactamases which hydrolyse
aminopenicillins, due to alteration in penicillin-binding proteins, due to impermeability to the drug, or
due to drug efflux pumps. One or more of these mechanisms may co-exist in the same organism,
leading to a variable and unpredictable cross-resistance to other beta-lactams and to antibacterial
drugs of other classes.
Resistant Gram-positive aerobes include: Staphylococcus (beta-lactamase producing strains).
Resistant Gram-negative aerobes include: Acinetobacter spp., Citrobacter spp., Enterobacter spp.,
Klebsiella spp., Moraxella catarrhalis (non-susceptible isolates), Proteus spp. (indole positive),
Proteus vulgaris, Providencia spp., Pseudomonas spp., Serratia spp.
Resistant anaerobes include: Bacteroides fragilis.
Other resistant organisms include: Chlamydia, Mycoplasma, Rickettsia.
Pharmacokinetics
Absorption
Amoxicillin is stable in the presence of gastric acid and rapidly absorbed from the gut to an extent of
72 to 93%. Absorption is independent of food intake. Peak blood levels are achieved 1 to 2 hours
after administration. After 250 and 500 mg doses of amoxicillin, average peak serum concentrations
of 5.2 mcg/ml and 8.3 mcg/ml respectively have been reported.
Distribution
Amoxicillin is not highly protein bound. Approximately 18% of total plasma drug content is bound to
protein. Amoxicillin diffuses readily into most body tissues and fluids, including sputum and saliva but
not the brain and spinal fluid. Inflammation generally increases the permeability of the meninges to
penicillins and this may apply to amoxicillin. Amoxicillin diffuses across the placenta and a small
percentage is excreted into the breast milk.
Biotransformation
Amoxicillin is excreted mainly via the urine where it exists in a high concentration. Amoxicillin is also
partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to 10 to 25% of the
initial dose. Small amounts of the drug are also excreted in faeces and bile. Concentrations in the bile
may vary and are dependent upon normal biliary function.
Elimination
Approximately 60 to 70% of amoxicillin is excreted unchanged in urine during the first 6 hours after
administration of a standard dose. The elimination half life is approximately 1 hour. Concurrent
administration of probenecid delays amoxicillin excretion. In patients with end-stage renal failure, the
half-life ranges between 5 to 20 hours. The substance is haemodialysable.
Indications
Treatment of infection
Ospamox is indicated in the treatment of infections due to susceptible organisms.
Ospamox may be useful in instituting therapy prior to bacteriology; however bacteriological studies to
determine the causative organisms and their sensitivity to amoxicillin should be performed.
Prophylaxis for endocarditis
Ospamox may be used for the prevention of bacteraemia, associated with procedures such as dental
extraction, in patients at risk of developing bacterial endocarditis.
Dosage and administration
Upper respiratory tract infections, Genito-urinary tract infections, skin and soft
tissue infections
For upper respiratory tract infections due to streptococci, pneumococci, non-penicillinase-producing
staphylococci and H. influenzae) or Genito-Urinary Tract Infections (due to Escherichia coli, Proteus
mirabilis and Streptococcus faecalis or Skin and Soft Tissue Infections due to streptococci, sensitive
staphylococci and Escherichia coli:
Adults: 250 mg every 8 hours.
Children (under 20 kg): 25 mg/kg/day in equally divided doses every 8 hours.
In severe infections or those caused by less susceptible organisms, 500 mg every 8 hours for adults
and 50 mg/kg/day in equally divided doses every 8 hours for children may be needed.
Lower respiratory tract infections
For lower respiratory tract infections (due to streptococci, pneumococci, non-penicillinase producing
staphylococci and H. influenzae:
Adults: 500 mg every 8 hours.
Children (under 20 kg): 50 mg/kg/day in equally divided doses every 8 hours.
High dosage therapy
The maximum recommended oral dosage 6 g daily in divided doses. An adult dosage of 3 g twice
daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection
of the respiratory tract.
Prophylaxis of Endocarditis - Dental Procedures
Prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues who have
not received a penicillin in the previous month. Patients with prosthetic heart valves should be
referred to hospital (see below).
Patient not having a general anaesthetic
Adults – 3 g orally, 1 hour before procedure. A second dose may be given 6 hours later if considered
necessary. Children under 10 - half the adult dose. Children under 5 - quarter adult dose.
Patients having a general anaesthetic, oral antibiotics considered to be appropriate
Adults - initially 3 g orally 4 hours prior to anaesthesia followed by 3 g orally (or 1 g
amoxicillin/ampicillin IM if the dose is not tolerated) 6 hours after the initial dose.
Children under 10 - half adult dose.
Children under 5 - quarter adult dose.
Patient having general anaesthesia, oral antibiotics not appropriate
Adults – 1 g amoxicillin IM immediately before induction with 500 mg orally 6 hours later.
Children under 10 - half adult dose.
Note: If prophylaxis with amoxicillin is given twice within one month, emergence of resistant
streptococci is unlikely to be a problem. Alternatively, antibiotics are recommended if more frequent
prophylaxis is required, or the patient has received a course of treatment with a penicillin during the
previous month.
Patients for whom referral to hospital is recommended
- Patients to be given a general anaesthetic who have been given a penicillin in the previous month.
- Patients to be given a general anaesthetic who have a prosthetic heart valve.
- Patients who have had one or more attacks of endocarditis.
Adults - Initially 1 g amoxicillin/ampicillin with 120 mg gentamicin IM immediately prior to anaesthesia
(if given) or 15 minutes prior to dental procedure, followed by 500 mg Ospamox orally, 6 hours later.
Children under 10 - the dose of amoxicillin should be half the adult dose. The dose of gentamicin
should be 2 mg/kg.
Note: Amoxicillin and gentamicin should not be mixed in the same syringe. Please consult the
appropriate Data Sheet for parenteral amoxicillin and gentamicin.
Urethritis (due to Neisseria gonorrhoeae)
Adults: 3 g as single dose. Cases of gonorrhoea with a suspected lesion of syphilis should have dark
field examinations before receiving amoxicillin and monthly serological tests for a minimum of four
months.
Lower urinary tract infections
For acute, uncomplicated lower urinary tract infections (due to Escherichia coli, Proteus mirabilis,
Streptococcus faecalis, non-penicillinase producing staphylococci):
Adults: 3 g as a single dose.
NOTE: The children's dose is intended for individuals whose weight will not cause dosage to be
calculated greater than that recommended for adults. Children weighing more than 20 kg should be
dosed according to the adult recommendations.
It should be recognised that in the treatment of chronic urinary tract infections, frequent bacteriological
and clinical appraisals are necessary. Smaller doses than those recommended above should not be
used. In stubborn infections, therapy may be required for several weeks. It may be necessary to
continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Treatment duration
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient
becomes asymptomatic or evidence of bacterial eradication has been obtained.
It is recommended that there be at least 10 days treatment for any infection caused by haemolytic
streptococci to prevent the occurrence of rheumatic fever or glomerulonephritis.
Impaired renal function
In renal impairment the excretion of amoxicillin will be delayed. Depending on the degree of
impairment, it may be necessary to reduce the total daily dosage. No dosage adjustment is required
in patients with a creatinine clearance > 30 ml/min. The maximum recommended dose in patients with
creatinine clearance between 10 and 30 ml/min is 500 mg twice daily. The maximum recommended
dose in patients with a creatinine clearance < 10 ml/min is 500 mg/day.
In patients receiving peritoneal dialysis, the maximum recommended dose in 500 mg/day. Amoxicillin
may be removed from the circulation by haemodialysis.
Renal impairment in children under 40 kg
- Creatinine clearance >30 ml/min: No adjustment necessary
- Creatinine clearance 10 to 30 ml/min: 15 mg/kg give twice daily (maximum 500 mg/twice daily)
- Creatinine clearance <10 ml/min: 15 mg/kg given as a single daily dose (maximum 500 mg)
In the majority of cases, parenteral therapy will be preferred.
Contraindications
Amoxicillin is a penicillin and should not be given to patients with a history of hypersensitivity to betalactam antibiotics (e.g. penicillins, cephalosporins).
Warnings and precautions
Warnings
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients
receiving beta-lactam antibiotics. Before initiating therapy with amoxicillin, careful enquiry should be
made concerning previous hypersensitivity reactions to penicillins, cephalosporins. Cross-sensitivity
between penicillins and cephalosporins is well documented. Patients should be told about the
potential occurrence of allergic reactions and instructed to report them. If an allergic reaction occurs,
amoxicillin should be discontinued and appropriate alternative therapy instituted. Serious anaphylactic
reactions may require immediate emergency treatment with adrenaline or epinephrine. Oxygen,
intravenous steroids and airway management, including intubation, may also be required.
Amoxicillin should be given with caution to patients with lymphatic leukaemia as they are susceptible
to amoxicillin induced skin rashes.
Amoxycillin should not be used for the treatment of bacterial infections in patients with viral infections,
presenting with sore throat, pharyngitis or infectious mononucleosis, as a high incidence of amoxycillin
induced erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving
amoxicillin.
.
As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be
made during prolonged therapy. Prolonged use may occasionally result in overgrowth of nonsusceptible organisms. The possibility of superinfection with mycotic or bacterial pathogens should be
particularly considered. If superinfection occurs (usually involving Aerobacter, Pseudomonas or
Candida) discontinue amoxicillin and/or initiate appropriate therapy.
Pseudomembranous colitis should be borne in mind if severe persistent diarrhoea occurs (in most
cases caused by Clostridium difficile) In this case Amoxicillin should be discontinued and an adequate
therapy has to be started. The use of antiperistaltics is contraindicated..
Abnormal prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin
and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulation treatment
is prescribed concurrently and the dose of the anticoagulant adjusted as necessary.
At high doses, adequate fluid intake and urinary output must be maintained to minimise the possibility
of amoxicillin crystalluria.
Precaution should be taken in premature children and during neonatal period: renal, hepatic and
haematological functions should be monitored.
As with other beta-lactams, the blood formula should be checked regularly during high-dose therapy.
High dose therapy with beta-lactams for patients with renal insufficiency or seizures history, treated
epilepsy and meningeal affection, could exceptionally lead to seizures.
The occurrence of a generalized erythema with fever and pustules at the beginning of treatment
should make suspect a generalized acute exanthematic pustulosis; this necessitates the interruption
of therapy and contraindicated any further administration of amoxicillin.
Precautions
Dosage should be adjusted in patients with renal impairment (refer to Dosage and administration).
Following single dose therapy of acute lower urinary tract infections, the urine should be cultured. A
positive culture may be evidence of a complicated or upper urinary tract infection, and higher dose or
prolonged course of treatment may be appropriate.
Following administration of ampicillin to pregnant women a transient decrease in plasma
concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol has
been noted. This effect may also occur with amoxicillin.
In patients with reduced urine output crystalluria has been observed very rarely, predominantly with
parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain
adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria
(refer to Overdosage). The presence of high urinary concentrations of amoxicillin can cause
precipitation of the product in urinary catheters. Therefore, catheters should be visually inspected at
intervals.
Patients suffering from severe gastrointestinal disturbances with diarrhoea and vomiting should not be
treated with Ospamox, due to the risk of reduced absorption. In these cases a parenteral treatment
with amoxicillin is advisable.
Ospamox should be used with caution in patients with allergic diathesis and asthma.
Precautions should be taken for children, premature infants and during the neonatal period, renal,
hepatic and haematological functions should be monitored.
Ospamox Suspensions, which contain aspartame, should be used with caution in patients with
phenylketonuria.
Ospamox Paediatric Drops contain sucrose and saccharin sodium as sweeteners.
Ospamox Powder for Oral Suspension and Ospamox Paediatric Drops contain sodium benzoate.
Pregnancy and lactation
Use in pregnancy
Assigned Category A by the Australian Drug Evaluation Committee. This category includes medicines
which have been taken by a large number of pregnant women and women of childbearing age without
any proven increase in the frequency of malformations or other direct or indirect harmful effects on the
foetus having been observed. The safety of amoxicillin for use in human pregnancy has not been
established by well controlled studies in pregnant women. Reproduction studies have been performed
in mice and rats at doses up to ten times the human dose and these studies have revealed no
evidence of impaired fertility or harm to the foetus due to amoxicillin. Amoxicillin may be used in
pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Use in labour and delivery
Oral ampicillin class antibiotics are generally poorly absorbed during labour. Studies in guinea pigs
have shown that intravenous administration of ampicillin decreased the uterine tone, frequency and
duration of contractions. However, it is not known whether the use of amoxicillin in humans during
labour or delivery has immediate or delayed adverse effects on the foetus, prolongs the duration of
labour or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation
of the newborn will be necessary.
Use in lactation
Residual amoxicillin may be present in breast milk at levels corresponding to approximately 0.7% of
the maternal dose. Penicillins are considered to be compatible with breastfeeding although there are
theoretical risks of alterations to infant bowel flora and allergic sensitisation. So far no detrimental
effects for the breast-fed infant have been reported after taking amoxicillin. Amoxicillin can be used
during breast-feeding. However, breast-feeding must be stopped if gastrointestinal disorders
(diarrhoea, candidosis or skin rash) occur in the new born
Effects on ability to drive and use machines
This medicine is presumed to be safe or unlikely to produce an effect.
Adverse effects
Side-effects, as with other penicillins, are uncommon and mainly of a mild and transitory nature. The
majority of the side-effects listed below are not unique to amoxicillin and may occur when using other
penicillins.
Undesirable effects are classified systematically and by frequency according to the following
convention: very common (above 1 in 10); common (from 1 in 100 to 1 in 10); uncommon (from 1 in
1000 to 1 in 100; rare (from 1 in 10,000 to 1 in 1,000); very rare (below 1 in 10,000).
Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years
of post-marketing reports.
Haemic and the lymphatic system disorders
Very rare
Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia and
leucopenia (including severe neutropenia or agranulocytosis), have been reported during therapy with
other penicillins. All were reversible on discontinuation of therapy and are believed to be
hypersensitivity phenomena. Prolongation of bleeding time and prothrombin time have also been
reported rarely (refer to Warnings and precautions).
Immune system disorders
Very rare
As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (refer
to Warnings and precautions), serum sickness and allergic vasculitis. If a hypersensitivity reaction is
reported, the treatment must be discontinued. (see also Skin and subcutaneous tissue disorders).
Infections and infestations
Uncommon
Prolonged and repeated use of the preparation can result in superinfections and colonisation with
resistant organisms or yeasts such as oral and vaginal candidiasis.
Gastrointestinal disorders
Common
Gastric complaints, nausea, loss of appetite, flatulence, soft stools, diarrhoea, enanthemas
(particularly in the region of the mouth), dry mouth, taste disturbances. These effects on the
gastrointestinal system are mostly mild and frequently disappear either during the treatment or very
soon after completion of therapy. The occurrence of these side effects can generally be reduced by
taking amoxicillin during meals.
Uncommon
Vomiting.
Rare
Superficial discoloration of the teeth (especially with the suspension). Usually the discoloration can be
removed by teeth brushing.
Very rare
Mucocutaneous candidiasis. Antibiotic associated colitis including pseudomembranous colitis and
haemorrhagic colitis. If severe and persistent diarrhoea occurs, the very rare possibility of
pseudomembranous colitis should be considered. The administration of anti-peristaltic agents is
contraindicated.
Development of a black hairy tongue.
.
General disorders and administration site conditions
Rare
Drug fever
Hepatobiliary disorders
Rare
Hepatitis and cholestatic jaundice.
Uncommon
Moderate and transient increase of liver enzymes. The significance of a rise in liver enzymes is
unclear
Nervous system disorders
Rare
Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal
function, epilepsy meningitis, or in those receiving high doses.
Skin and subcutaneous tissue disorders
Common
Cutaneous reactions such as exanthema, pruritus, urticaria, erythematous maculopapular rash; the
typical morbilliform exanthema occurs 5 to 11 days after commencement of therapy. The immediate
appearance of urticaria indicates an allergic reaction to amoxicillin and therapy should therefore be
discontinued.
Rare
Skin reactions such as Angioneurotic oedema (Quincke's oedema , erythema multiforme exudativum,
exsudativum, acute generalized pustulosis, Lyell’s syndrome, Stevens-Johnson syndrome, toxic
epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous
pustulosis (see also Immune system disorders).
Renal and urinary tract disorders
Rare
Interstitial nephritis, crystalluria (refer to Overdosage)
The incidence of these adverse events was derived from clinical studies involving a total of
approximately 6,000 adult and paediatric patients taking amoxicillin.
Interactions
Medicines and other pharmacologically active substances
Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of
allergic skin reactions.
Concomitant administration of amoxicillin and anticoagulants, such as coumarin, may increase the
incidence of bleeding due to prolongation of prothrombin time. Appropriate monitoring should be
undertaken when anticoagulation treatment is prescribed concurrently and the dose of the
anticoagulant adjusted as necessary. A large number of cases showing an increase of oral
anticoagulant activity has been reported in patients receiving antibiotics. The infectious and
inflammatory context, age and the general status of the patient appear as risk factors. In these
circumstances, it is difficult to know the part of the responsibility between the infectious disease and
its treatment in the occurrence of INR disorders. However, some classes of antibiotics are more
involved, notably fluoroquinolones, macrolides, cyclines, cotrimoxazole and some cephalosporins
There is a possibility that the bactericidal action of amoxicillin could be antagonised on coadministration with bacteriostatic agents such as macrolides, tetracyclines, sulphonamides or
chloramphenicol.
An increase in the absorption of digoxin is possible on concurrent administration with amoxicillin. A
dose adjustment of digoxin may be necessary Interaction between amoxicillin and methotrexate
leading to methotrexate toxicity has been reported. Serum methotrexate levels should be closely
monitored in patients who receive amoxicillin and methotrexate simultaneously. Amoxicillin decreases
the renal clearance of methotrexate, probably by competition at the common tubular secretion
system.
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin may
result in increased and prolonged levels of amoxicillin in serum and bile.
Administration of amoxicillin can transiently decrease the plasma level of estrogens and
progesterone, and may reduce the efficacy of oral contraceptives. It is therefore recommended to take
supplemental non-hormonal contraceptive measures.
Forced diuresis leads to a reduction in blood concentrations by increased elimination of amoxicillin.
It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment,
enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of
amoxicillin, false positive readings are common with chemical methods
The occurrence of diarrhoea may impair the absorption of other medicines consequently limiting their
efficacy.
Amoxicillin may decrease the amount of urinary estriol in pregnant women.
At high concentrations, amoxicillin may diminish the results of serum glycemia levels
Amoxicillin may interfere with protein testing when colormetric methods are used
Abnormal laboratory test results
At high risk concentrations, amoxicillin may diminish the results of serum glycaemia levels. It is
recommended that when testing for the presence of glucose in urine during amoxicillin treatment,
enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of
amoxicillin, false positive readings are common with chemical methods.
Amoxicillin may interfere with protein testing when colorimetric methods are used
Overdosage
Signs and symptoms
Cases of overdosage with amoxicillin are usually asymptomatic. Gastrointestinal disturbances such
as nausea, vomiting and diarrhoea and symptoms of fluid-electrolyte imbalance may be evident. In
patients with severely impaired renal function, large overdoses can result in signs of renal toxicity and
crystalluria is possible. During the administration of high doses of amoxicillin, adequate fluid intake
and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria.
Management
There is no specific antidote for an overdose of amoxicillin. Treatment consists primarily of
administration of activated charcoal (a gastric lavage is usually not necessary), or symptomatic and
supportive measures. Particular attention should be directed to the water and electrolyte balance of
the patient. Amoxicillin can be removed from the circulation by haemodialysis.
Pharmaceutical precautions
Instructions for use/handling
Reconstitution instructions for Ospamox powder for oral suspension
125 mg/5 ml: Add 94 ml of water to make up 100 ml.
250 mg/5 ml: Add 92 ml of water to make up 100 ml.
Close and shake well at once. Shake well before use. Store the reconstituted suspension below 25°C
and use within 14 days of preparation.
Reconstitution instructions for Ospamox Paediatric Drops
100 mg/ml: Add 16 ml of water to make up 30 ml. Close and shake well at once. Shake well before
use. Store the reconstituted suspension below 25°C and use within 14 days of preparation.
Incompatibilities
None known.
Special precautions for storage
Ospamox capsules
Store at or below 25°C. Protect from moisture.
Store at or below 25°C. Protect from moisture.
Ospamox Paediatric Drops
Store at or below 25°C. Protect from light. Protect from moisture.
Medicine classification
Package quantities
Ospamox capsules
250 mg: bottles of 500 capsules.
500 mg: packs of 100 capsules in blister strips.
125 mg/5 ml: Bottle of 100 ml.
Ospamox Paediatric Drops 100 mg/ml
Bottle of 30 ml with graduated dosing syringe.
Not all pack sizes and/or strengths may be currently marketed.
Further information
List of excipients
Ospamox capsules
Gelatin, microcrystalline cellulose, magnesium stearate.
Guar gum, aspartame, citric acid anhydrous, sodium benzoate, talc, trisodium citrate anhydrous,
colloidal anhydrous silica, lemon flavour, orange flavour, peach-apricot flavour.
Ospamox Paediatric Drops
Sucrose, trisodium citrate anhydrous, sodium benzoate, simethicone, guar gum, saccharin sodium,
strawberry flavour, raspberry flavour, passion fruit flavour.
Name and address
Novartis New Zealand Limited
Private Bag 65904 Mairangi Bay
AUCKLAND 0754
Telephone: (09) 361 8100
Date of preparation
2nd February 2012
E-MYCIN
Erythromycin ethylsuccinate
Tablets, Film Coated 400 mg
Granules for Oral Suspension 200 mg per 5 mL and 400 mg per 5 mL
Presentation
E-MYCIN 200: Granules for oral suspension. Free flowing pink granules which when mixed with the stated
quantity of water provide a cherry flavoured suspension containing erythromycin ethylsuccinate 234 mg per 5
mL, equivalent to 200 mg per 5 mL of erythromycin.
E-MYCIN 400: Granules for oral suspension. Free flowing pink granules which when mixed with the stated
quantity of water provide a cherry flavoured suspension containing erythromycin ethylsuccinate 468 mg per 5
mL, equivalent to 400 mg per 5 mL of erythromycin.
E-MYCIN TABLET: oval, normal convex, flesh pink coated tablet debossed "E-N" on one side and "α" on the
other. Each tablet contains erythromycin ethylsuccinate 482 mg, equivalent to 400 mg of erythromycin.
Uses
Actions
Microbiology:
Erythromycin is a macrolide antibiotic that acts by inhibition of protein synthesis of the pathogen by binding
50S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism has
been demonstrated in vivo between erythromycin and clindamycin, lincomycin and chloramphenicol.
Many strains of Haemophilus influenzae are resistant to erythromycin alone but are susceptible to
erythromycin and sulphonamides together.
Staphylococci resistant to erythromycin may emerge during a course of therapy.
Erythromycin is usually active against most strains of the following organisms both in vitro and in clinical
infections.
Gram-Positive Organisms:
Corynebacterium diphtheriae, Corynebacterium minutissimum, Listeria monocytogenes, Staphylococcus
aureus (resistant organisms may emerge during treatment), Streptococcus pneumoniae, Streptococcus
pyogenes.
Gram-Negative Organisms:
Bordetella pertussis, Legionella pneumophilia, Neisseria gonorrhoeae.
Other Micro-Organisms:
Chlamydia trachomatis, Entamoeba histolytica, Mycoplasma pneumoniae, Ureaplasma urealyticum.
Erythromycin has been shown to be active in vitro against most strains of the following organisms; however,
the safety and efficacy of erythromycin in treating infections due to these organisms have not been
established in adequate and well-controlled trials:
Gram-Positive Organisms:
Alpha haemolytic streptococci (viridans group).
Page 1 of 9
Gram-Negative Organisms:
Morazella (Branhamella) catarrhalis.
Other Micro-Organisms:
Entamoeba histolytica, Treponema pallidum.
Not all strains of the organism listed above are sensitive and culture and susceptibility testing should be
done. Several strains of Haemophilus influenzae and Staphylococci have been found to be resistant to
erythromycin alone but are susceptible to erythromycin and sulphonamides together.
Susceptibility Testing
Dilution or diffusion techniques - either quantitative (MIC) or breakpoint, should be used following a regular
updated, recognized and standardised method (eg.CLSI).
Standardised susceptibility test procedures require the use of laboratory control microorganisms to control
the technical aspects of the laboratory procedures.
• A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial
compound in the blood reaches the concentrations usually achievable.
• A report of "Intermediate" indicates that the result should be considered equivocal, and if the
microorganism is not fully susceptible to alternative clinically feasible drugs, the test should be
repeated. This category implies possible clinical applicability in body sites where the drug is
physiologically concentrated or in situations where high dosage of drug can be used. This category
also provides a buffer zone, which prevents small-uncontrolled technical factors from causing major
discrepancies in interpretation.
• A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial
compound in the blood reaches the concentrations usually achievable: other therapy should be
selected.
Note 1: The prevalence of resistance may vary geographically for selected species and local information on
resistance is desirable, particularly when treating severe infections.
Note 2: Many strains of Haemophilus influenzae are resistant to erythromycin alone but are susceptible to
erythromycin and sulfonamides together. Staphylococci resistant to erythromycin may emerge during a
course of erythromycin therapy. Culture and susceptibility testing should be performed.
Pharmacokinetics
Orally administered erythromycin ethylsuccinate tablets and suspension are readily and reliably absorbed.
Comparable levels of erythromycin are achieved in the fasting and non-fasting states.
Erythromycin diffuses readily into most body fluids. Only low concentrations are normally achieved in the
spinal fluid, but passage of the medicine across the blood-brain barrier increases in meningitis. In the
presence of normal hepatic function erythromycin is concentrated in the liver and excreted in the bile. The
effect of hepatic dysfunction on excretion of erythromycin by the liver into the bile is not known. Less than 5
percent of the orally administered dose is excreted in active form in the urine.
Indications
Streptococcus pyogenes (Group A beta-haemolytic streptococcus):
Upper and lower respiratory tract, skin and soft tissue infections of mild to moderate severity.
When oral medication is preferred for treatment of streptococcal pharyngitis and in long term prophylaxis of
rheumatic fever, erythromycin is an alternate drug of choice.
When oral medication is given, the importance of strict adherence by the patient to the prescribed dosage
regimen must be stressed. A therapeutic dose should be administered for at least 10 days.
Prevention of Initial Attacks of Rheumatic Fever:
Penicillin is considered to be the drug of choice in the prevention of initial attacks of rheumatic fever
(treatment of Group A beta-haemolytic streptococcal infections of the upper respiratory tract e.g. tonsillitis or
Page 2 of 9
pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose
should be administered for 10 days.
Prevention of Recurrent Attacks of Rheumatic Fever:
Penicillin or sulphonamides are considered to be the drugs of choice in the prevention of recurrent attacks of
rheumatic fever. In patients who are allergic to penicillin and sulphonamides, oral erythromycin is
recommended in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent
attacks of rheumatic fever).
Prevention of Bacterial Endocarditis:
Although no controlled clinical efficacy trials have been conducted, oral erythromycin has been
recommended for prevention of bacterial endocarditis in penicillin-allergic patients with prosthetic cardiac
valves, most congenital cardiac malformations, surgically constructed systemic pulmonary shunts, rheumatic
or other acquired valvular dysfunction, idiopathic hypertrophic subaortic stenosis (IHSS), previous history of
bacterial endocarditis or mitral valve prolapse with insufficiency when they undergo dental procedures or
surgical procedures of the upper respiratory tract.
Alpha-haemolytic streptococci (viridans group):
Although no controlled clinical efficacy trials have been conducted, oral erythromycin has been suggested for
use in a regimen for prophylaxis against bacterial endocarditis in patients hypersensitive to penicillin who
have congenital heart disease, or rheumatic or other acquired valvular heart disease when they undergo
dental procedures or surgical procedures of the upper respiratory tract. Erythromycin is not suitable prior to
genitourinary or gastrointestinal tract surgery.
Staphylococcus aureus:
Acute infections of skin and soft tissue of mild to moderate severity. Resistant organisms may emerge
during treatment.
Streptococcus pneumoniae (Diplococcus pneumoniae):
Upper respiratory tract infections (e.g. otitis media, pharyngitis) and lower respiratory tract infections (e.g.
pneumonia) of mild to moderate degree.
Mycoplasma pneumoniae (Eaton agent, PPLO):
For respiratory infections due to this organism.
Haemophilus influenzae:
For upper respiratory tract infections of mild to moderate severity. Not all strains of this organism are
susceptible to erythromycin at concentrations achieved with usual therapeutic doses; resistant strains may
require concomitant therapy with sulphonamides.
Ureaplasma urealyticum:
For the treatment of urethritis caused by these organisms in adult males.
Neisseria gonorrhoeae:
ERA-IV (erythromycin lactobionate for injection) in conjunction with erythromycin orally, as an alternative
drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a
history of sensitivity to pencillin. Before treatment of gonorrhoea, patients who are suspected of also having
syphilis should have a microscopic examination for T. pallidum (by immunofluorescence or darkfield) before
receiving erythromycin, and monthly serologic tests for a minimum of 4 months thereafter.
Chlamydia trachomatis:
Erythromycin is indicated for treatment of the following infections caused by Chlamydia trachomatis;
conjunctivitis of the newborn, pneumonia of infancy and urogenital infections during pregnancy (see
Warnings and Precautions). When tetracyclines are contraindicated or not tolerated, erythromycin is
indicated for the treatment of uncomplicated urethral, endocervical or rectal infections in adults due to
Chlamydia trachomatis.
Treponema pallidum:
Page 3 of 9
Erythromycin is an alternate choice of treatment for primary syphilis in patients allergic to the penicillins. In
treatment of primary syphilis, spinal fluid examinations should be done before treatment and as part of
follow-up therapy. Erythromycin should not be used for the treatment of syphilis in pregnancy because it
cannot be relied upon to cure an infected foetus.
Corynebacterium diphtheriae:
As an adjunct to antitoxin, to prevent establishment of carriers, and to eradicate the organism in carriers.
Corynebacterium minutissimum:
For the treatment of erythrasma.
Entamoeba histolytica:
In treatment of intestinal amoebiasis only. Extra-enteric amoebiasis requires treatment with other agents.
Listeria monocytogenes:
Infections due to this organism.
Bordetella pertussis:
Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering
them non-infectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of
pertussis in exposed susceptible individuals.
Legionnaire’s Disease:
Clinical evidence suggests that erythromycin is the preferred antibiotic for treating Legionnaire’s Disease.
Dosage and Administration
E-Mycin suspensions and tablets may be administered without regard to meals.
Children:
Age, weight, and severity of the infection are important factors in determining the proper dosage. In mild to
moderate infections the usual dosage of erythromycin (as erythromycin ethylsuccinate) for children is 30 to
50 mg/kg/day in equally divided doses every six hours. For more severe infections this dosage may be
doubled.
If twice-a-day dosage is desired one-half of the total daily dose may be given every 12 hours. Doses may
also be given three times daily if desired by administering one-third of the total daily dose every 8 hours.
The following dosage schedule is suggested for mild to moderate infections
Body weight
<4.5kg
Total daily dose
(erythromycin base)
30-50 mg/kg/day
4.5 - 6.8kg
200 mg
6.8 - 11.3kg
400 mg
11.3 – 22.7kg
800 mg
22.7 - 45.4kg
1200 mg
Over 45.4kg
1600 mg
Adults:
400 mg erythromycin (as erythromycin ethylsuccinate) every 6 hours is the usual dose. Dosage may be
increased up to 4 g per day according to the severity of the infection. If twice-a-day dosage is desired, onehalf of the total daily dose may be given every 12 hours. Doses may also be given three times daily by
administering one-third of the total daily dose every 8 hours.
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In the treatment of streptococcal infections, a therapeutic dosage of erythromycin (as erythromycin
ethylsuccinate) should be administered for at least 10 days. In continuous prophylaxis against recurrences
of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg
twice a day.
For prophylaxis against bacterial endocarditis in patients with congenital heart disease, or rheumatic or
other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the
upper respiratory tract, give 1.6 g (20 mg/kg for children) orally 1.5 to 2 hours before the procedure, and then
800 mg (10 mg/kg for children) orally every 6 hours for 8 doses.
For treatment of urethritis due to C. trachomatis or U. urealyticum 800 mg every 6 to 8 hours for 7 days or
400 mg every 6 to 8 hours for 14 days.
For treatment of primary syphilis: Adults 48 to 64 g given in divided doses over a period of 10 to 15 days.
For intestinal amoebiasis: Adults 400 mg four times daily for 10 to 14 days. Children 30 to 50 mg/kg/day in
divided doses for 10 to 14 days.
For use in pertussis: Although optimal dosage and duration have not been established, doses of
erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14
days.
For treatment of Legionnaire’s Disease: Although optimal doses have not been established, doses utilized
in reported clinical data were 1.6 to 4 g daily in divided doses.
Contraindications
Erythromycin is contraindicated in patients with known hypersensitivity to erythromycin or any of the
excipients in the formulation, or to other antibiotics from the macrolide family.
Severely impaired hepatic function.
Erythromycin is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide, and
ergotamine or dihydroergotamine (see Interactions).
Warnings and Precautions
Hepatic dysfunction, including increased liver enzymes and hepatocellular and/or cholestatic hepatitis, with
or without jaundice, has been infrequently reported with erythromycin. As erythromycin is principally
excreted by the liver, caution should be exercised when administering erythromycin to patients with impaired
liver function.
There have been reports suggesting erythromycin does not reach the foetus in adequate concentrations to
prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early
syphilis should be treated with an appropriate penicillin regimen.
Pseudomembranous colitis has been reported with most antibacterial agents, including erythromycin.
Therefore, it is important to consider this diagnosis in patients who develop diarrhoea in association with
antibiotic use.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving
erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and
erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels.
There have been reports erythromycin may aggravate the weakness of patients with myasthenia gravis.
During prolonged or repeated therapy, there is a possibility of overgrowth of non-susceptible bacteria or
fungi. If such infections occur, the drug should be discontinued and appropriate therapy instituted.
When indicated, incision and drainage or other surgical procedures should be performed in conjunction with
antibiotic therapy.
Page 5 of 9
Effects on the neonate:
There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following
erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis
prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and
were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. Since erythromycin may
be used in the treatment of conditions in infants, which are associated with significant mortality or morbidity
(such as pertussis or chlamydia), the benefit of erythromycin therapy needs to be weighed against the
potential risk of developing IHPS. Patients should be informed to contact their physician if vomiting or
irritability with feeding occurs.
Carcinogenesis:
Long term (2 year) oral studies conducted in rats up to 400 mg/kg/day and in mice up to 500 mg/kg/day with
erythromycin stearate did not provide evidence of tumorigenicity.
Genotoxicity:
Erythromycin was not genotoxic in assays for bacterial and mammalian mutagenicity and for clastogenicity in
vitro. The clastogenic potential of erythromycin has not been investigated in vivo.
Impairment of Fertility:
There was no apparent effect on male or female fertility in rats treated with erythromycin base by oral
gavage at 700 mg/kg/day (approximately 9 times the maximum human dose).
Pregnancy:
No evidence of teratogenicity or embryotoxicity was observed when erythromycin base was given by oral
gavage to pregnant rats and mice at 700 mg/kg/day (approximately 9 times the maximum human dose), and
to pregnant rabbits at 125 mg/kg/day (approximately 1.5 times the maximum human dose).
A slight reduction in birth weights was noted when female rats were treated prior to mating, during mating,
gestation and lactation at an oral dosage of 700 mg/kg/day of erythromycin base; weights of the offspring
were comparable to those of the controls by weaning. No evidence of teratogenicity or effects on
reproduction were noted at this dosage. When administered during late gestation and lactation periods, this
dosage of 700 mg/kg/day (approximately 9 times the maximum human dose) did not result in any adverse
effects on birth weight, growth and survival of offspring.
There are no adequate and well controlled studies in pregnant women. However, observational studies in
humans have reported cardiovascular malformations after exposure to medicinal products containing
erythromycin during early pregnancy.
Erythromycin has been reported to cross the placental barrier in humans, but foetal plasma levels are
generally low.
Erythromycin should be used by women during pregnancy only if clearly needed.
Use in Lactation:
Erythromycin appears in breast milk. It is not known whether it can harm the nursing child. The expected
benefits and the potential hazards should be carefully assessed.
Laboratory Tests:
Erythromycin interferes with the fluorometric determination of urinary catecholamines.
Adverse Effects
The most frequent side effects of erythromycin preparations are gastrointestinal and are dose-related. They
include nausea, vomiting, abdominal pain, diarrhoea and anorexia.
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Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur (see
Warnings and Precautions).
Pseudomembranous colitis has been rarely reported in association with erythromycin therapy.
Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred. Skin
reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome and toxic
epidermal necrolysis have rarely been reported.
There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal
insufficiency and in patients receiving high doses of erythromycin.
As with other macrolides, QT prolongation, ventricular tachycardia and torsades de pointes have been rarely
reported with erythromycin.
There have been isolated reports of transient central nervous system side effects including seizures,
hallucinations, confusion, vertigo, and tinnitus; however a cause and effect relationship has not been
established.
There have been rare reports of pancreatitis and convulsions.
Infantile Hypertrophic Pyloric Stenosis (IHPS):
7 out of 157 [5%] newborns developed severe non-bilious vomiting or irritability with feeding and IHPS who
were given oral erythromycin for pertussis prophylaxis. The relative risk of IHPS was increased 6.8 fold (95%
CI=3-16) compared to a retrospective cohort of infants.
There have been reports of interstitial nephritis coincident with erythromycin use.
Interactions
Theophylline:
Erythromycin use in patients who are receiving high doses of theophylline may be associated with an
increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity
and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is
receiving concomitant erythromycin therapy.
There have been published reports suggesting when erythromycin is given concomitantly with theophylline
there is a significant decrease in erythromycin serum concentrations. This could result in subtherapeutic
concentrations of erythromycin.
Digoxin:
Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin
serum levels.
Anticoagulants:
There have been reports of increased anticoagulant effects when erythromycin and warfarin were used
concomitantly.
Triazolobenzodiazepines (such as triazolam and alprazolam) and related benzodiazepines:
Erythromycin has been reported to decrease the clearance of triazolam, and midazolam, and thus may
increase the pharmacologic effect of these benzodiazepines.
Drugs metabolised by the cytochrome P450:
The use of erythromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system
may be associated with elevations in serum levels of these drugs. There have been reports of interactions of
erythromycin with carbamazepine, cyclosporine, hexobarbital, phenytoin, alfentanil, disopyramide,
bromocriptine, valproate, tacrolimus, quinidine, methylprednisolone, cilostazol, vinblastine, sildenafil,
terfenadine, astemizole and rifabutin. Serum concentrations of drugs metabolised by the cytochrome P450
system should be monitored closely in patients concurrently receiving erythromycin.
Page 7 of 9
Terfenadine:
Erythromycin significantly alters the metabolism of terfenadine when taken concomitantly. Rare cases of
serious cardiovascular adverse events including death, cardiac arrest, torsades de pointes, and other
ventricular arrhythmias have been observed (see Contraindications and Adverse Effects).
Zopiclone:
Erythromycin has been reported to decrease the clearance of zopiclone and this may increase the
pharmacodynamic effects of this drug.
Astemizole:
Erythromycin significantly alters the metabolism of astemizole when taken concomitantly. Rare cases of
serious cardiovascular adverse events including cardiac arrest, torsade de pointes, and other ventricular
arrhythmias have been observed (see Contraindications and Adverse Effects).
Cisapride:
Elevated cisapride levels have been reported in patients receiving erythromycin and cisapride concomitantly.
This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular
fibrillation and torsade de pointes. Similar effects have been observed in patients taking pimozide and
clarithromycin, another macrolide antibiotic.
HMG-CoA Reductase Inhibitors:
Erythromycin has been reported to increase concentrations of HMG-CoA Reductase Inhibitors (e.g.
lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these
drugs concomitantly.
Colchicine:
There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin and
colchicine.
Ergotamine / dihydroergotamine:
Post-marketing reports indicate that co-administration of erythromycin with ergotamine or dihydroergotamine
has been associated with acute ergot toxicity characterised by vasospasm and ischemia of the extremities
and other tissues including the central nervous system (see Contraindications).
Overdosage
Reports indicate that the ingestion of large amounts of erythromycin can be expected to produce
gastrointestinal distress, hearing problems and other adverse effects (see Adverse Effects). In case of
overdosage, erythromycin should be discontinued. Overdosage should be treated by the prompt elimination
of unabsorbed drug and supportive measures. Erythromycin serum levels are not appreciably altered by
haemodialysis or peritoneal dialysis.
For advice on the management of overdose please contact the Poisons Information Centre on 0800 764
766.
Pharmaceutical Precautions
Store tablets below 30°C.
Store granules below 25°C.
Reconstitution of Granules
Add 77 mL of water in small volumes and shake vigorously until no lumps are visible.
Reconstituted suspension should be refrigerated at 2° - 8°C and used within 10 days; do not freeze. Discard
remaining portion thereafter. Shake well before use.
Page 8 of 9
Medicine Classification
Package Quantities
E-MYCIN 200: Granules for oral suspension 100 mL. Reconstituted suspension contains erythromycin
ethylsuccinate equivalent to 200 mg per 5 mL of erythromycin.
E-MYCIN 400: Granules for oral suspension 100 mL. Reconstituted suspension contains erythromycin
ethylsuccinate equivalent to 400 mg per 5 mL of erythromycin.
E-MYCIN TABLETS: 100 film coated tablets each containing erythromycin ethylsuccinate equivalent to 400
mg of erythromycin.
Further Information
List of Excipients
E-MYCIN tablets
E-Mycin tablets contain calcium hydrogen phosphate anhydrous, maize starch, sorbic acid, povidone,
purified talc, sodium starch glycollate and magnesium stearate. The film coating also contains polyvinyl
alcohol, titanium dioxide, lecithin, iron oxide red and xanthan gum.
E-Mycin tablets do not contain lactose or gluten.
E-MYCIN suspensions
E-Mycin granules contain sorbitol, sodium citrate dihydrate, aspartame, propylene glycol alginate, silicon
dioxide colloidal, sodium benzoate, erythrosine CI45430 and cherry flavour (contains preservative 320).
E-Mycin suspensions do not contain lactose or gluten.
Name and Address
Mylan New Zealand Limited
PO Box 11-183
Ellerslie
AUCKLAND 1542
Telephone 09-579-2792
Date of Preparation
9 October 2013
Page 9 of 9
DATA SHEET
BICILLIN L-A 2.3 mL
(Benzathine Benzylpenicillin Injection)
for deep IM injection only
NAME OF DRUG
BICILLIN L-A
Benzathine Benzylpenicillin 900 mg (1,200,000 Units)/2.3mL size Pre-filled syringe and Needle.
DESCRIPTION
BICILLIN L-A (sterile benzathine benzylpenicillin suspension) is chemically designated as
(2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2carboxylic acid compound with N,N’-dibenzylethylenediamine (2:1), tetrahydrate.
Its chemical structure is as follows:
H
COOH
O
CH3
CH3
N
CH2CONH
.4H2-0
S
H
H
2
CH2
CH2
HNCH 2CH2NH
BICILLIN L-A contains benzathine benzylpenicillin (the benzathine salt of benzylpenicillin) in
aqueous suspension with anhydrous sodium citrate buffer; and as w/v, approximately 0.5%
lecithin, 0.6% carmellose sodium, 0.6% povidone, 0.1% methyl hydroxybenzoate and 0.01%
propyl hydroxybenzoate.
BICILLIN L-A suspension in the disposable pre-filled syringe formulation is viscous and opaque.
PHARMACOLOGY
Microbiology
Benzylpenicillin exerts a bactericidal action against penicillin-sensitive micro-organisms during
the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall
peptidoglycan, rendering the cell wall osmotically unstable. It is not active against the
penicillinase-producing bacteria or against organisms resistant to beta-lactams because of
alterations in the penicillin-binding proteins.
The following in-vitro data are available but the clinical significance is unknown.
Benzylpenicillin exerts high in vitro activity against Staphylococci (except penicillinaseproducing strains), Streptococci (Groups A, C, G, H, L and M) and Pneumococci. Other
Version pfdbicii10612
Superseded: pfdbicii10112
Page: 1 of 8
organisms sensitive to benzylpenicillin are: Neisseria gonorrhoea, Corynebacterium diphtheria,
Bacillus anthracis, Clostridia spp, Actinomyces bovis, Streptobacillus moniliformis, Listeria
monocytogenes and Leptospira spp. Treponema pallidum is extremely sensitive to the bactericidal
action of benzylpenicillin.
General
Intramuscular benzathine benzylpenicillin is absorbed very slowly into the bloodstream from the
intramuscular site and converted by hydrolysis to benzylpenicillin. This combination of
hydrolysis and slow absorption results in blood serum levels much lower but much more
prolonged than other parenteral penicillins.
Intramuscular administration of 225 mg of benzathine benzylpenicillin in adults results in blood
levels of 22.5 to 37.5 nanogram per mL, which are maintained for 4 to 5 days. Similar blood
levels may persist for 10 days following administration of 450 mg and for 14 days following
administration of 900 mg. Blood concentrations of 2.25 nanogram per mL may still be detectable
4 weeks following administration of 900 mg.
Approximately 60% of benzylpenicillin is bound to serum protein. The drug is distributed
throughout the body tissues in widely varying amounts. Highest levels are found in the kidneys
with lesser amounts in the liver, skin and intestines. Benzylpenicillin penetrates into all other
tissues and the spinal fluid to a lesser degree.
With normal kidney function, the drug is excreted rapidly by tubular excretion. In neonates and
young infants and in individuals with impaired kidney function, excretion is considerably
delayed.
INDICATIONS
Intramuscular benzathine benzylpenicillin is indicated in the treatment of infections due to
penicillin-sensitive micro-organisms that are susceptible to the low and very prolonged serum
levels common to this particular dosage form. Therapy should be guided by bacteriological
studies (including sensitivity tests) and by clinical response.
The following infections will usually respond to adequate dosage of intramuscular benzathine
benzylpenicillin:
Streptococcal infections (Group A - without bacteraemia). Mild-to-moderate infections of the
upper respiratory tract (eg., pharyngitis).
Venereal infections - Syphilis, yaws, bejel and pinta.
Medical conditions in which benzathine benzylpenicillin therapy is indicated as prophylaxis:
Rheumatic fever and/or chorea - Prophylaxis with benzathine benzylpenicillin has proven
effective in preventing recurrence of these conditions. It has also been used as follow-up
prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.
Page: 2 of 8
CONTRAINDICATIONS
Previous hypersensitivity reaction to any of the penicillins.
PRECAUTIONS
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in
patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral
therapy, it has occurred in patients on oral penicillins. These reactions are more apt to occur in
individuals with a history of sensitivity to multiple allergens. There have been well-documented
reports of individuals with a history of penicillin hypersensitivity reactions who have experienced
severe hypersensitivity reactions when treated with a cephalosporin. Before therapy with a
penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to
penicillins, cephalosporins and other allergens. If an allergic reaction occurs, the drug should be
discontinued and the patient treated with the usual agents, e.g., pressor amines, antihistamines
and corticosteroids. Severe anaphylactoid reactions require emergency treatment with adrenaline.
Oxygen and intravenous corticosteroids and airway management, including intubation, should
also be administered as indicated.
Penicillin should be used with caution in individuals with histories of significant allergies and/or
asthma. Whenever allergic reactions occur, penicillin should be withdrawn unless, in the opinion
of the physician, the condition being treated is life-threatening and amenable only to penicillin
therapy.
Do not inject intravenously or admix with other intravenous solutions. There have been
reports of inadvertent intravenous administration of benzathine which has been associated with
cardiorespiratory arrest and death. (See DOSAGE AND ADMINISTRATION.)
Inadvertent intravascular administration, including inadvertent direct intra-arterial injection or
injection immediately adjacent to arteries, of BICILLIN L-A and other penicillin preparations has
resulted in severe neurovascular damage, including transverse myelitis with permanent paralysis,
gangrene requiring amputation of digits and more proximal portions of extremities, and necrosis
and sloughing at and surrounding the injection site. Such severe effects have been reported
following injections into the buttock, thigh and deltoid areas. Other serious complications of
suspected intravascular administration which have been reported include immediate pallor,
mottling or cyanosis of the extremity, both distal and proximal to the injection site, followed by
bleb formation; severe oedema requiring anterior and/or posterior compartment fasciotomy in the
lower extremity.
Severe effects and complications following accidental intravascular administration have most
often occurred in infants and small children. Prompt consultation with an appropriate specialist is
indicated if any evidence of compromise of the blood supply occurs at, proximal to, or distal to
the site of injection. (See CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION
sections).
Injection into or near a nerve may result in permanent neurological damage. Quadriceps femoris
fibrosis and atrophy have been reported following repeated intramuscular injections of penicillin
preparations into the anterolateral thigh.
Page: 3 of 8
Antibiotic-associated pseudomembranous colitis has been reported with many antibiotics
including penicillin. Treatment with antibacterial agents alters the normal flora of the colon
leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of Clostridium difficile
associated diarrhea (CDAD). Hypertoxin producing strains of C. difficile cause increased
morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may
require colectomy. CDAD must be considered in all patients who present with diarrhea following
antibacterial use. Careful medical history is necessary since CDAD has been reported to occur
over two months after the administration of antibacterial agents.
The severity of the colitis may range from mild to life-threatening. It is important to consider this
diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may
occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to
drug discontinuation alone. However, in moderate to severe cases, appropriate therapy with a
suitable oral antibacterial agent effective against C. difficile should be considered. Fluids,
electrolytes and protein replacement should be provided when indicated. Drugs which delay
peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the
condition and should not be used.
Prolonged use of antibiotics may promote the overgrowth of non-susceptible organisms,
including fungi. Should superinfection occur, appropriate measures should be taken.
Check the following before use
In streptococcal infections, therapy must be sufficient to eliminate the organism otherwise the
sequelae of streptococcal disease may occur. Cultures should be taken following completion of
treatment to determine whether streptococci have been eradicated.
In prolonged therapy with penicillin and particularly with high-dosage schedules, periodic
evaluation of the renal and haematopoietic systems is recommended.
Fluids, electrolytes and protein replacement therapy should be provided when indicated.
Use in pregnancy
Category A - Drugs which have been taken by a large number of pregnant women and women of
child-bearing age without any proven increase in the frequency of malformations or other direct
or indirect harmful effects on the foetus having been observed.
Although generally considered to be safe, BICILLIN L-A should be used during pregnancy only if
clearly needed.
Use in lactation
Soluble penicillin is excreted in breast milk. The effect on the infant, if any, is not known.
Caution should be used when BICILLIN L-A is administered to a nursing woman.
Page: 4 of 8
Pediatric Use
(See INDICATIONS and DOSAGE AND ADMINISTRATION sections.)
Geriatric Use
Clinical studies of benzylpenicillin did not include sufficient numbers of subjects aged 65 and
over to determine whether they respond differently from younger subjects. Other reported clinical
experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end
of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac
function, and of concomitant disease or other drug therapy. This drug is known to be substantially
excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with
impaired renal function (see PHARMACOLOGY). Because elderly patients are more likely to
have decreased renal function, care should be taken in dose selection, and it may be useful to
monitor renal function.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been conducted with this drug.
Interaction with other drugs
Tetracycline may antagonise the bactericidal effect of penicillin and concurrent use of these drugs
should be avoided.
The rate of excretion of the penicillins is decreased by concomitant administration of probenecid
which prolongs, as well as increases, blood levels of the penicillins.
Effects on laboratory tests
Penicillins can interfere with the copper sulphate reagent method of testing for glycosuria,
resulting in falsely elevated or falsely decreased readings. Such interference does not occur with
the glucose oxidase method.
ADVERSE REACTIONS
As with other penicillins, untoward reactions of the sensitivity phenomena are likely to occur,
particularly in individuals who have previously demonstrated hypersensitivity to penicillins or in
those with a history of allergy, asthma, hay fever, or urticaria.
The following adverse reactions have been reported:
General: Hypersensitivity reactions including the following: skin eruptions (maculopapular to
exfoliative dermatitis), urticaria, laryngeal oedema, fever, eosinophilia; other serum sickness-like
reactions (including chills, fever, oedema, arthralgia and prostration), and
anaphylactic/anaphylactoid reaction (including shock and death).
Page: 5 of 8
Fever and eosinophilia may frequently be the only reaction observed.
Gastrointestinal: Pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may
occur during or after antibacterial treatment. (See PRECAUTIONS section.)
Haematologic: Haemolytic anaemia, leucopenia, thrombocytopenia
Neurologic: Neuropathy
Urogenital: Nephropathy, acute interstitial nephritis
As with other treatments for syphilis, the Jarisch-Herxheimer reaction has been reported.
The following adverse events have been temporally associated with parenteral administration of
benzylpenicillin:
Body as a Whole: Hypersensitivity reactions including allergic vasculitis, pruritus, fatigue,
asthenia, and pain; aggravation of existing disorder; headache.
Cardiovascular: Cardiac arrest; hypotension; tachycardia; palpitations; pulmonary hypertension;
pulmonary embolism; vasodilation; vasovagal reaction; cerebrovascular accident; syncope.
Gastrointestinal: Nausea, vomiting; blood in stool; intestinal necrosis.
Haematological: Lymphadenopathy.
Injection Site: Injection site reactions including pain, inflammation, lump, abscess, necrosis,
edema, haemorrhage, cellulitis, hypersensitivity, atrophy, ecchymosis, and skin ulcer.
Neurovascular reactions including warmth, vasospasm, pallor, mottling, gangrene, numbness of
the extremities, cyanosis of the extremities, and neurovascular damage.
Metabolic: Elevated BUN, creatinine, and SGOT.
Musculoskeletal: Joint disorder; periostitis; exacerbation of arthritis; myoglobinuria;
rhabdomyolysis.
Nervous System: Nervousness; tremors; dizziness; somnolence; confusion; anxiety; euphoria;
transverse myelitis; seizures; coma. A syndrome manifested by a variety of CNS symptoms such
as severe agitation with confusion, visual and auditory hallucinations, and a fear of impending
death (Hoigne's syndrome), has been reported after administration of benzylpenicillin procaine
and, less commonly, after injection of the combination of benzylpenicillin benzathine and
benzylpenicillin procaine. Other symptoms associated with this syndrome, such as psychosis,
seizures, dizziness, tinnitus, cyanosis, palpitations, tachycardia, and/or abnormal perception in
taste, also may occur.
Respiratory: Hypoxia; apnoea; dyspnoea.
Skin: Diaphoresis.
Page: 6 of 8
Special Senses: Blurred vision; blindness.
Urogenital: Neurogenic bladder; haematuria; proteinuria; renal failure; impotence; priapism.
DOSAGE AND ADMINISTRATION
The stated volume of 2.3mL is a theoretical volume based on potency at the time of manufacture.
Use a concentration of 442mg/mL when measuring part doses.
Streptococcal (Group A) upper respiratory infections (for example, pharyngitis)
A single injection of 900 mg (1,200,000 Units) for adults.
A single injection of 675 mg (900,000 Units) for older children.
A single injection of 225 mg to 450 mg (300,000 to 600,000 Units) for infants and for children
under 27 kg.
Venereal infections
Syphilis - Primary, secondary and latent - 1.8 g ((2,400,000 Units) (1-dose). Late (tertiary
including neurosyphilis) - 1.8 g at 7-day intervals for three doses.
Congenital (with normal CSF) - under 2 years of age: 37.5 mg (50,000 Units)/kg body weight;
ages 2-12 years; adjust dosage based on adult dosage schedule.
Yaws, bejel and pinta - 900 mg (1,200,000 Units) (single injection).
Prophylaxis - for rheumatic fever and glomerulonephritis
Following an acute attack, benzathine benzylpenicillin (parenteral) may be given in doses of
900 mg (1,200,000 Units) once a month or 450 mg (600,000 Units) every 2 weeks.
TO ADMINISTER
Because of the high concentration of suspended material in this product, the needle may be
blocked if the injection is not made at a slow, steady rate.
Administer by DEEP, INTRAMUSCULAR INJECTION in the upper, outer quadrant of the
buttock. In infants and small children, the midlateral aspect of the thigh may be preferable.
When doses are repeated, vary the injection site.
Method of administration is the same as with conventional syringe. Remove needle cover by
grasping it securely; twist and pull. Introduce needle into patient, aspirate by pulling back slightly
on the plunger, and inject.
Discard any unused portion.
Page: 7 of 8
OVERDOSAGE
There have been no reported overdoses with BICILLIN L-A. Penicillin in overdosage has the
potential to cause neuromuscular hyperirritability and convulsive seizures. This is particularly so
if the penicillin is given intravenously or to patients with renal failure.
PRESENTATION
BICILLIN L-A benzathine benzylpenicillin injection is supplied as follows:
2.3 mL size, containing 900 mg (1,200,000 Units) benzathine benzylpenicillin per pre-filled
syringe. (The stated volume of 2.3mL is a theoretical volume based on potency at the time of
manufacture. Use a concentration of 442mg/mL when measuring part doses.)
STORAGE
Store at 2 to 8oC. Refrigerate, do not freeze.
MEDICINES CLASSIFICATION
Prescription Only Medicine.
NAME AND ADDRESS
Pfizer New Zealand Ltd
P O Box 3998
Auckland, New Zealand
Toll Free Number: 0800 736 363
DATE OF PREPARATION
08 June 2012
 Registered Trade Mark
Page: 8 of 8
Lidocaine-Claris
Lidocaine Injection BP, Lidocaine Hydrochloride Ph Eur 1% (10 mg/ml) and 2% (20 mg/ml)
Presentation
Proprietary name and description
Lidocaine-Claris is a clear, colourless, particle-free, sterile, isotonic, pH adjusted solution of
Lidocaine Hydrochloride Ph Eur conforming to Lidocaine Injection BP. There are six
presentations in two concentrations and three ampoule or vial sizes:
- 10 mg/ml (1%)
Lidocaine Hydrochloride Ph Eur 20 mg in 2 ml, 50 mg in 5 ml and 200 mg in 20 ml;
- 20 mg/ml (2%)
Lidocaine Hydrochloride Ph Eur 40 mg in 2 ml, 100 mg in 5 ml and 400 mg in 20 ml.
Uses
Pharmacotherapeutic group
N01BB02: member of N01BB - amides, a subset of N01B – anaesthetics, local.
Actions
Lidocaine is used to provide anaesthesia by reversible nerve blockade at various sites in the body
and in the control of dysrhythmias. It has a rapid onset of action (about one minute following
intravenous injection and fifteen minutes following intramuscular injection) and rapidly spreads
through the surrounding tissues. The effect lasts about ten to twenty minutes and about sixty to
ninety minutes following intravenous and intramuscular injection respectively.
Pharmacokinetics
The concentration of lidocaine in the blood will be determined by its rate of absorption from
the site of injection, the rate of tissue distribution and the rate of metabolism and excretion.
Absorption
The systemic absorption of lidocaine is determined by the site of injection, the dosage and its
pharmacological profile. The maximum blood concentration occurs following intercostal
nerve blockade followed in order of decreasing concentration, the lumbar epidural space,
brachial plexus site and subcutaneous tissue. The total dose injected regardless of the site is
the primary determinant of the absorption rate and blood levels achieved. There is a linear
relationship between the amount of lidocaine injected and the resultant peak anaesthetic
blood levels.
The lipid solubility and vasodilator activity will also influence its rate of absorption. This is
seen in the epidural space where lidocaine is absorbed more rapidly than prilocaine. Lidocaine
shows complete and biphasic absorption from the epidural space with half-lives of the two
phases in the order of 9.3 min and 82 min respectively. The slow absorption is the ratelimiting factor in the elimination of lidocaine, which explains why the apparent terminal
Please refer to the Medsafe website (www.medsafe.govt.nz) for the most recent version of
this prescribing information.
Page 1 of 12
Lidocaine-Claris
half-life is longer after epidural administration. Absorption of lidocaine from the
subarachnoid space is monophasic with an absorption half-life of 71 min.
Distribution
Lidocaine is distributed throughout the total body water and the volume of distribution at
steady state is 91 litres. Lidocaine is 65% protein-bound (mainly to alpha-1-acid
glycoprotein) in plasma.
Lidocaine is distributed less rapidly than prilocaine (an amide drug of similar potency and
duration of action) but equally as with mepivacaine. Its distribution is throughout all body
tissues. In general, the more highly perfused organs will show higher concentrations of
lidocaine. The highest percentage of this drug will be found in skeletal muscle. This is
because of the mass of muscle rather than a particular affinity.
Lidocaine readily crosses the placenta and equilibrium with regard to the unbound
concentration is rapidly reached. The degree of plasma protein binding in the foetus is less
than in the mother, which results in lower total plasma concentrations in the foetus.
Lidocaine is excreted in breast milk, but in such small quantities that there is no risk of
affecting the child with therapeutic doses.
Biotransformation
Lidocaine undergoes enzymatic degradation primarily in the liver. Some degradation may take
in tissues other than liver. The main pathway involves oxidative de-ethylation to
monoethylglycinexylidide (MEGX), glycinexylidide (GX), followed by subsequent hydrolysis
to 2,6-xylidine and 4-hydroxy-2,6-xylidine. MEGX has a convulsant activity similar to that of
lidocaine and a somewhat longer half-life. GX lacks convulsant activity and has a half-life of
about 10 h. The N-dealkylation to MEGX, is considered to be mediated by both CYP1A2 and
CYP3A4.
The metabolite 2,6-xylidine is converted to 4-hydroxy-2,6-xylidine by CYP2A6 and the latter
is the major urinary metabolite in man. Only 3% of lidocaine is excreted unchanged. About
70% appears in the urine as 4-hydroxy-2,6-xylidine.
Elimination
Lidocaine has a total plasma clearance of 0.95 litres/min, a terminal half-life of 1.6 h and an
estimated hepatic extraction ratio of 0.65. Its rate of clearance from the blood can be described
by a two or three compartment model. There is a rapid disappearance (alpha) phase which is
believed to be related to uptake by rapidly equilibrating tissues (i.e. tissues with a high
vascular perfusion). The slower phase is related to distribution, to slowly equilibrating tissues
(Betaphase) and to its metabolism and excretion (Gamma phase).
The renal clearance is inversely related to its protein binding affinity and the pH of the urine.
This suggests by the latter that excretion of lidocaine occurs by non-ionic diffusion.
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Lidocaine-Claris
Special patient groups
The terminal half-life in neonates (3.2 h) is approximately twice that of adults, whereas
clearance is similar (10.2 ml/min kg).
Indications
Lidocaine solutions are indicated for the production of local or regional anaesthesia by the
following techniques: local infiltration; minor or major nerve blocks; epidural block;
arthroscopy; intravenous regional anaesthesia.
Dosage and administration
Adults and children above 12 years
The following table is a guide to dosage for the more commonly used techniques in the
average adult. The figures reflect the expected average dose range needed. Standard
textbooks should be consulted for factors affecting specific block techniques and for
individual patient requirements.
The clinician's experience and knowledge of the patient's physical status are of importance in
calculating the required dose. The lowest dose required for adequate anaesthesia should be
used (refer to Warnings and precautions). Individual variations in onset and duration occur.
Table 1 Dosage recommendations (without adrenaline)
Type of block
Concentration (mg/ml)
Surgical anaesthesia
Lumbar epidural
administration [1]
Thoracic epidural
administration [1]
Caudal epidural block [1]
IV regional (Bier´s block)
a) upper limb [2]
b) lower limb [2]
i.
thigh tourniquet
ii.
calf tourniquet
Intra-articular block [3]
Dose
Onset
(min)
(mg)
20
15 to 25
300 to 500
15 to 20
1.5 to 2
15
20
10
20
10 to 15
10 to 15
20 to 30
15 to 25
150 to 225
200 to 300
200 to 300
300 to 500
10 to 20
10 to 20
15 to 30
15 to 30
1 to 1.5
1.5 to 2
1 to 1.5
1.5 to 2
5
40
5
5
5
10
Field block (eg. minor nerve blocks and infiltration)
Infiltration
5
10
Digital block
10
Intercostals (per nerve)
10
15
[Maximal number of nerves
blocked at same time should
be ≤8]
Retrobulbar
20
10
Peribulbar
Pudendal (each side)
10
60
40
≤60
≤40
≤80
≤40
1 to 5
2 to 5
2 to 4
10 to 15 until tourniquet
release
300 10 to 15 until tourniquet
200 10 to 15 release
≤300
5 to 10 30 to 60 minutes
≤400
5 to 10 after washout
200
≤400
≤400
10 to 50
20 to 50
30 to 60
1 to 2
1 to 2
2 to 5
3 to 5
3 to 5
1.5 to 2
2 to 3
1.5 to 2
1 to 2
2 to 3
4
80
10 to 15
100 to 150
10 100
1.5 to 2
1.5 to 2
5 to 10
1.5 to 2
1.5 to 2
1.5 to 2
Duration of
effect (h)
(ml)
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Lidocaine-Claris
Type of block
Major nerve block
Paracervical (each side)
Brachial plexus: axillary
Supraclavicular, interscalene
and subclavian perivascular
Sciatic
3 in 1 (femoral, obturator and
lateral cutaneous)
Concentration
(mg/ml)
Dose
10
10
15
10
15
15
20
10
15
Onset
(min)
(ml)
(mg)
10
40 to 50
30 to 50
30 to 40
20 to 30
15 to 20
15 to 20
30 to 40
30
100
400 to 500
450 to 600
300 to 400
300 to 450
225 to 300
300 to 400
300 to 400
450
Duration of
effect (h)
3 to 5
15 to 30
15 to 30
15 to 30
15 to 30
15 to 30
15 to 30
15 to 30
15 to 30
1 to 1.5
1.5 to 2
1.5 to 3
1.5 to 2
1.5 to 3
2 to 3
2 to 3
1.5 to 2
2 to 3
Remarks:
1) Dose includes test dose
2) Do not deflate tourniquet within 20 min of injection
3) There have been post marketing reports of chondrolysis in patients receiving postoperative intra-articular continuous infusion of local anaesthetics. Lidocaine is not approved
for this indication (refer to Warnings and precautions).
≤ = up to
In general, surgical anaesthesia (eg. epidural administration) requires the use of the higher
concentrations and doses. When a less intense block is required, the use of a lower
concentration is indicated. The volume of drug used will affect the extent and spread of
anaesthesia.
In order to avoid intravascular injection, aspiration should be repeated prior to and during
administration of the main dose, which should be injected slowly or in incremental doses, at a
rate of 100 to 200 mg/min, while closely observing the patient’s vital functions and
maintaining verbal contact. When an epidural dose is to be injected, a preceding test dose of 3
to 5 ml short-acting local anaesthetic, containing adrenaline is recommended. An inadvertent
intravascular injection may be recognized by a temporary increase in heart rate and an
accidental intrathecal injection by signs of a spinal block. If toxic symptoms occur, the
injection should be stopped immediately.
Table 2 Dosage recommendations in children aged 1 to 12 years old (without adrenaline)
Type of block
Caudal epidural
Concentration
(mg/ml)
10
Volume
(ml)
0.5
Dose
(mg/kg)
5
Onset
(min)
Duration of
effect (h)
10 to 15
1 to 1.5
Consider both age and weight for calculation of dosages.
The doses in Table 2 should be regarded as guidelines for use in paediatrics. Individual
variations occur. In children with a high body weight a gradual reduction of the dosage is
often necessary and should be based on the ideal body weight. Standard textbooks should be
consulted for factors affecting specific block techniques and for individual patient
requirements.
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Lidocaine-Claris
Contraindications
- Known hypersensitivity to local anaesthetics of the amide type.
- Complete heart block.
- Hypovolaemia.
Warnings and precautions
General
Lidocaine should be administered by persons with resuscitative skills and equipment.
Resuscitation equipment must be available at all times. When performing major blocks or
using large doses, an IV cannula should be inserted before the local anaesthetic is injected.
Clinicians should have received adequate and appropriate training in the procedure to be
performed and should be familiar with the diagnosis and treatment of side effects, systemic
toxicity or other complications. (refer to Overdosage)
Lidocaine should be used with caution in patients with myasthenia gravis, epilepsy,
congestive heart failure, bradycardia or respiratory depression, including where agents are
known to interact with lidocaine either to increase its availability or additive effects e.g.
phenytoin or prolong its elimination e.g. hepatic or end renal insufficiency where the
metabolites of lidocaine may accumulate.
Patients being treated with anti-arrhythmic drugs class III (eg. amiodarone) should be under
close surveillance and ECG monitoring considered, since cardiac effects may be additive
(refer to Interactions).
There have been post-marketing reports of chondrolysis in patients receiving postoperative
intra-articular continuous infusion of local anaesthetics. The majority of reported cases of
chondrolysis have involved the shoulder joint. Due to multiple contributing factors and
inconsistency in the scientific literature regarding mechanism of action, causality has not
been established. Intra-articular continuous infusion is not an approved indication.
Intramuscular lidocaine may increase creatinine phosphokinase concentrations which can
interfere with the diagnosis of acute myocardial infarction. Lidocaine has been shown to be
porphyrinogenic in animals and should be avoided in persons suffering from porphyria.
The effect of lidocaine may be reduced if it is injected into inflamed or infected areas.
Hypokalaemia, hypoxia and disorder of acid-base balance should be corrected before
treatment with intravenous lidocaine begins.
Lidocaine solution for injection is not recommended for use in neonates. The optimum serum
concentration of lidocaine required to avoid toxicity, such as convulsions and cardiac
arrhythmias, in this age group is not known.
Dosage reduction may be required in patients presenting impaired hepatic function, cardiac
failure or during prolonged administration to patients with renal failure.
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Risks of certain procedures
Certain local anaesthetic procedures may be associated with serious adverse reactions,
regardless of local anaesthetic drug used.
Central nerve blocks may cause cardiovascular depression, especially in the presence of
hypovolaemia, and therefore epidural anaesthesia should be used with caution in patients
with impaired cardiovascular function.
Epidural anaesthesia may lead to hypotension and bradycardia. This risk can be reduced by
preloading the circulation with crystalloidal or colloidal solutions. Hypotension should be
treated promptly.
Paracervical block can sometimes cause foetal bradycardia or tachycardia and careful
monitoring of the foetal heart rate is necessary (refer to Pregnancy and lactation).
Injections in the head and neck regions may be made inadvertently into an artery causing
cerebral symptoms even at low doses.
Retrobulbar injections may rarely reach the cranial subarachnoid space, causing
serious/severe reactions including cardiovascular collapse, apnoea, convulsions and
temporary blindness.
Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular
motor dysfunction. The primary causes include trauma and/or local toxic effects on muscles
and/or nerves.
The severity of such tissue reactions is related to the degree of trauma, the concentration of
the local anaesthetic and the duration of exposure of the tissue to local anaesthetic. For this
reason, as with all local anaesthetic, the lowest effective concentration and dose of local
anaesthetic should be used.
Pregnancy and lactation
Use in pregnancy
Assigned Category A in the Australian Categorisation of risk system. Category A refers to
medicines which have been taken by a large number of pregnant women and women of
childbearing age without any proven increase in the frequency of malformations or other
direct or indirect harmful effects on the foetus having been observed.
It is reasonable to assume that a large number of pregnant women and women of childbearing age have been given lidocaine. No specific disturbances to the reproductive process
have so far been reported, e.g. no increased incidence of malformations.
Lidocaine readily crosses the placental barrier after epidural or intravenous administration to
the mother. The ratio of umbilical to maternal venous concentration is 0.5 to 0.6. The foetus
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appears to be capable of metabolising lidocaine at term. The elimination half life in the
newborn of the drug received in utero is about three hours, compared with 100 minutes in the
adult. Elevated lidocaine levels may persist in the newborn for at least 48 hours after
delivery. Foetal bradycardia or tachycardia , neonatal bradycardia, hypotonia or respiratory
depression may occur. Foetal adverse effects due to local anaesthetics, such as foetal
bradycardia, seem to be most apparent in paracervical block anaesthesia. Such effects may be
due to high concentrations of anaesthetic reaching the foetus.
Use in lactation
Small amounts of lidocaine are secreted into breast milk and the possibility of an allergic
reaction in the infant, albeit remote, should be borne in mind when using lidocaine in nursing
mothers.
Effects on ability to drive and use machinery
This medicine is likely to have mild to moderate effects on the ability to drive or operate
machinery. Besides the direct anaesthetic effect, local anaesthetics may have a very mild
effect on mental function and coordination even in the absence of overt CNS toxicity and
may temporarily impair locomotion and alertness.
Major motor nerve block occurs e.g. brachial plexus, epidural, spinal block may result in a
loss of sensation resulting from nerve block to areas of muscle co-ordination or balance.
Advice is that for general anaesthesia as sedative/hypnotic drugs are often used during nerve
blockade.
Adverse effects
The adverse reaction profile of lidocaine is similar to those of other amide local anaesthetics.
Adverse reactions caused by the drug per se are difficult to distinguish from the physiological
effects of the nerve block (eg. decrease in blood pressure, bradycardia), events caused
directly (eg. nerve trauma) or indirectly (eg. epidural abscess) by the needle puncture.
Adverse reactions that are usually dose related include nervousness, blurred vision, dizziness,
bradycardia, hypotension, tremor, nausea, vomiting, drowsiness, speech disturbances,
perioral numbness, muscle twitching, confusion, vertigo or tinnitus, psychosis, seizures and
respiratory depression. Others include metallic taste, rash, sinus arrest, atrioventricular block,
urticaria and anaphylactoid reactions.
Table of adverse drug reactions
Common (from 1 in 100 to 1 in 10)
Vascular disorders: hypotension, hypertension
Gastrointestinal disorders: nausea, vomiting
Nervous system disorders: paraesthesia, dizziness
Cardiac disorders: bradycardia
Page 7 of 12
Lidocaine-Claris
Uncommon (from 1 in 1,000 to 1 in 100)
Nervous system disorders: signs and symptoms of CNS toxicity (convulsions, paraesthesia
circumoral, numbness of the tongue, hyperacusis, visual disturbances, tremor, tinnitus,
dysarthria, CNS depression)
Rare (below 1 in 1,000)
Cardiac disorders: cardiac arrest, cardiac arrhythmias
Immune system disorders: allergic reactions, anaphylactic reaction/shock.
Respiratory disorders: respiratory depression
Nervous system disorders: neuropathy, peripheral nerve injury, arachnoiditis
Eye disorders: diplopia
Acute systemic toxicity
Systemic toxic reactions primarily involve the central nervous system (CNS) and the
cardiovascular system (CVS). Such reactions are caused by high blood concentrations of a
local anaesthetic, which may appear due to (accidental) intravascular injection, overdose or
exceptionally rapid absorption from highly vascularised areas (refer to Overdose). CNS
reactions are similar for all amide local anaesthetics, while cardiac reactions are more
dependent on the drug, both quantitatively and qualitatively. Signs of toxicity in the central
nervous system generally precede cardiovascular toxic effects, unless the patient is receiving
a general anaesthetic or is heavily sedated with drugs such as benzodiazepine or barbiturate.
Central nervous system toxicity is a graded response with symptoms and signs of escalating
severity. The first symptoms are usually, circumoral paraesthesia, numbness of the tongue,
light-headedness, hyperacusis, tinnitus and visual disturbances. Dysarthria, muscular
twitching or tremors are more serious and precede the onset of generalized convulsions.
These signs must not be mistaken for a neurotic behaviour. Unconsciousness and grand mal
convulsions may follow which may last from a few seconds to several minutes. Hypoxia and
hypercarbia occur rapidly following convulsions due to the increased muscular activity,
together with the interference with respiration and possible loss of functional airways. In
severe cases apnoea may occur. Acidosis, hyperkalaemia, hypocalcaemia and hypoxia
increase and extend the toxic effects of local anaesthetics.
Recovery is due to redistribution of the local anaesthetic drug from the central nervous
system and subsequent metabolism and excretion. Recovery may be rapid unless large
amounts of the drug have been injected.
Cardiovascular system toxicity may be seen in severe cases and is generally preceded by
signs of toxicity in the central nervous system. In patients under heavy sedation or receiving a
general anaesthetic, prodromal CNS symptoms may be absent. Hypotension, bradycardia,
arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of
local anaesthetics, but in rare cases cardiac arrest has occurred without prodromal CNS effects.
In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where
the block is given during general anaesthesia.
Page 8 of 12
Lidocaine-Claris
Treatment
If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped
immediately and CNS symptoms (convulsion, CNS depression) must be promptly treated with
appropriate airway/respiratory support and the administration of anticonvulsant drugs.
If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be
instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment
of acidosis are of vital importance.
If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with
intravenous fluids, vasopressor, chronotropic and or inotropic agents should be considered.
Children should be given doses commensurate with age and weight.
INTERACTIONS
Lidocaine toxicity is enhanced, by the co-administration of cimetidine and propranolol
requiring a reduction in the dosage of lidocaine. Both drugs decrease hepatic blood flow.
Also, cimetidine depresses microsomial activity. Ranitidine produces a small reduction in
lidocaine clearance. Potentially toxic plasma concentrations may occur when lidocaine is
given in repeated high doses over a long time period. However, such interactions should be of
no clinical importance following short term treatment with lidocaine at recommended doses.
Increase in serum levels of lidocaine may also occur with anti-viral agents (e.g. amprenavir,
atazanavir, darunavir, lopinavir).
Hypokalaemia caused by diuretics may antagonize the action of lidocaine if administered
concomitantly (refer to Warnings and precautions).
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents
structurally related to amide-type local anaesthetics (e.g. anti-arrhythmics, such as mexiletine
and tocainide), since the systemic toxic effects are additive. Specific interaction studies with
lidocaine and class III antiarrhythmic drugs (e.g. amiodarone) have not been performed, but
caution is advised.
There may be an increased risk of ventricular arrhythmia in patients treated concurrently with
antipsychotics which prolong or may prolong the QT interval (e.g. pimozide, sertindole,
olanzapine, quetiapine, zotepine), prenylamine, adrenaline (if accidently injected
intravenously) or 5HT3 antagonists (e.g. tropisetron, dolasetron).
Concomitant use of quinupristin/dalfopristin may increase lidocaine levels with a subsequent
increased risk of ventricular arrhythmias and therefore should be avoided.
There may be an increased risk of enhanced and prolonged neuromuscular blockade in
patients treated concurrently with muscle relaxants (e.g. suxamethonium).
Cardiovascular collapse has been reported following the use of bupivacaine in patients on
treatment with verapamil and timolol; lidocaine is structurally related to bupivacaine.
Page 9 of 12
Lidocaine-Claris
Dopamine and 5 hydroxytryptamine reduce the convulsant threshold to lidocaine.
Narcotics are probably proconvulsants and this would support the evidence that lidocaine
reduces the seizure threshold to fentanyl in man.
Opioid-antiemetic combination sometimes used for sedation in children could reduce the
convulsant threshold to lidocaine and increase the CNS depressant effect.
While adrenaline when used in conjunction with lidocaine might decrease vascular
absorption, it greatly increase the danger of ventricular tachycardia and fibrillation if
accidentally injected intravenously.
OVERDOSAGE
Accidental intravascular injections of local anaesthetics may cause immediate (within
seconds to a few minutes) systemic toxic reactions. In the event of overdose, systemic
toxicity appears later (15 to 60 minutes after injection) due to the slower increase in local
anaesthetic blood concentration.
Signs and symptoms
Central nervous system toxicity presents with symptoms of increasing severity. Patients may
present initially with circumoral paraesthesia, numbness of the tongue, light-headedness,
hyperacusis and tinnitus. Visual disturbance and muscular tremors or muscle twitching are
more serious and precede the onset of generalised convulsions. These signs must not be
mistaken for neurotic behaviour. Unconsciousness and grand mal convulsions may follow,
which may last from a few seconds to several minutes. Hypoxia and hypercapnia occur
rapidly following convulsions due to increased muscular activity, together with the
interference with normal respiration and loss of the airway. In severe cases, apnoea may
occur. Acidosis increases the toxic effects of local anaesthetics.
Effects on the cardiovascular system may be seen in severe cases. Hypotension, bradycardia,
arrhythmia and cardiac arrest may occur as a result of high systemic concentrations, with
potentially fatal outcome.
Recovery occurs as a consequence of redistribution of the local anaesthetic drug from the
central nervous system and metabolism and may be rapid unless large amounts of the drug
have been injected.
Treatment
If signs of acute systemic toxicity appear, injection of the anaesthetic should be stopped
immediately.
Treatment will be required if convulsions and CNS depression occurs. The objectives of
treatment are to maintain oxygenation, stop the convulsions and support the circulation. A
Page 10 of 12
Lidocaine-Claris
patent airway should be established and oxygen should be administered, together with assisted
ventilation (mask and bag) if necessary. The circulation should be maintained with infusions
of plasma or intravenous fluids. Where further supportive treatment of circulatory depression
is required, use of a vasopressor agent may be considered although this involves a risk of
CNS excitation. Convulsions may be controlled by the intravenous administration of
diazepam or thiopentone sodium, bearing in mind that anti-convulsant drugs may also
depress respiration and the circulation. Prolonged convulsions may jeopardize the patient’s
ventilation and oxygenation and early endotracheal intubation should be considered. If
cardiac arrest should occur, standard cardiopulmonary resuscitation procedures should be
instituted. Continual optimal oxygenation and ventilation and circulatory support as well as
treatment of acidosis are of vital importance.
Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.
PHARMACEUTICAL PRECAUTIONS
Incompatibilities
Lidocaine has been found to be incompatible when mixed with amphotericin, methohexitone
and glyceryl trinitrate. It is not advisable to mix lidocaine with other agents.
Storage conditions
Unopened container
Store at or below 25°C. Do not refrigerate or freeze.
Opened container
Use immediately. Discard any residue.
MEDICINE CLASSIFICATION
Prescription Medicine
PACKAGE QUANTITIES
2 ml and 5 ml ampoules – packs of 25 ampoules
20 ml vials – single vial packs.
FURTHER INFORMATION
Compatibility
Lidocaine Claris injection is compatible with the following sterile diluents: 0.9% w/v sodium
chloride injection; 5% w/v glucose intravenous infusion; sodium chloride intravenous
infusion with glucose intravenous infusion; lactated Ringer's (Hartmann's) solution. Solutions
prepared in these diluents are stable for up to 48 hours.
Page 11 of 12
Lidocaine-Claris
List of inactive ingredients
Sodium chloride, water for injections (pH adjusted from 5.0 to 7.0). Sodium content is 2.75
mg/ml (0.119 mmol/ml). This preparation does not contain antioxidants or antimicrobial
agents.
Primary packaging materials
Vial stopper is composed entirely of siliconised synthetic bromobutyl rubber.
NAME AND ADDRESS
Multichem NZ Limited
8 Apollo Drive,
Rosedale,
North Shore City 0632
Auckland
Telephone: (09) 488 0330
DATE OF PREPARATION
7 March 2014
Page 12 of 12
Intramuscular Injection of Bicillin with Lignocaine added (> 30kg)
You will need:





1.2mu prefilled Bicillin syringe (with Bicillin needle)
2% Lignocaine ampoule
X1 1ml syringe
25g 1” needle
BUZZY®
Process:
Ensure an aseptic non touch technique is used throughout procedure.
 2 RNs independently double check the pre-filled Bicillin syringe and Lignocaine
ampoule
 Administering RN draws up 0.25ml of 2% Lignocaine into a 1ml syringe
 Checking RN confirms right volume in syringe
 Attach 25g 1” needle to the 1ml syringe containing Lignocaine
 Remove cap from pre-filled Bicillin syringe and draw back plunger to allow space for
Lignocaine
 Add Lignocaine to the pre-filled Bicillin syringe
 Discard empty Lignocaine needle/syringe in sharps bin
 Push plunger up gently so there is no air in the Lignocaine/Bicillin syringe
 Attach Bicillin needle (with needle guard) and warm injection with hands
 Locate site for VG injection (see below)
 Press activated BUZZY® directly on injection site and leave for 1 minute
 Slide BUZZY® 2-5cm proximal to site
 Use distraction while administering (non-procedural talk/eye spy/breathing)
 Administer Lignocaine/Bicillin to client slowly. Give first portion containing
Lignocaine and wait a few seconds then give remaining Bicillin (leave BUZZY®
vibrating until needle is removed).
Note: Discard unused Lignocaine at the end of the day.
Administration:
Gluteus Medius Muscle
 This site is recommended in adults and children over seven months old as it is the
largest muscle in the young child.
 Potential complications are limited as it is free from nerves and major vascular
structures.
 Site is easily palpable and accessible in both thin and obese patients.
 The muscle is accessible in the supine, prone or side lying position.
 Subcutaneous tissue is thinner over this muscle and has a consistent thickness of
adipose over it ensuring that the needle will penetrate the muscle.
Version 1
Version 1
Intramuscular Injection of Bicillin with Lignocaine added
For clients < 30kg
You will need:






1.2mu prefilled Bicillin syringe (with Bicillin needle)
2% Lignocaine ampoule
X1 1ml syringe
X1 3ml syringe
X2 23g 1” needle
BUZZY®
Process:
Ensure an aseptic non touch technique is used throughout procedure.
 2 RNs independently double check the pre-filled Bicillin syringe and Lignocaine
ampoule
 Using a 3ml syringe pull the plunger back to 1.15ml
o Decant the Bicillin from the prefilled syringe into the 3ml syringe using a 23g
needle filling from plunger end of 3ml syringe first to avoid air bubbles
 Administering RN draws up 0.25ml of 2% Lignocaine into a 1ml syringe
 Checking RN confirms right volume in syringe
 Attach 23 (or 25)g 1” needle to the 1ml syringe containing Lignocaine
 Add Lignocaine to the 3ml Penicillin filled syringe
 Discard empty Lignocaine needle/syringe in sharps bin
 Push plunger up gently so there is no air in the Lignocaine/Bicillin syringe
 Attach Bicillin needle (with needle guard) and warm injection with hands
 Locate site for VG injection (see below)
 Press activated BUZZY® directly on injection site and leave for 1 minute
 Slide BUZZY® 2-5cm proximal to site
 Use distraction while administering (non-procedural talk/eye spy/breathing)
 Administer Lignocaine/Bicillin to client slowly. Give first portion containing
Lignocaine and wait a few seconds then give remaining Bicillin (leave BUZZY®
vibrating until needle is removed).
Note: Discard unused Lignocaine at the end of the day.
Administration:
Gluteus Medius Muscle
 This site is recommended in adults and children over seven months old as it is the
largest muscle in the young child.
 Potential complications are limited as it is free from nerves and major vascular
structures.
 Site is easily palpable and accessible in both thin and obese patients.
Version 1


Version 1
The muscle is accessible in the supine, prone or side lying position.
Subcutaneous tissue is thinner over this muscle and has a consistent thickness of
adipose over it ensuring that the needle will penetrate the muscle.
79
Sore Throat Clinics
Appendix
|NHC 2013
80
OVERVIEW
Around 50 South Auckland children are affected by Rheumatic Fever each year, the largest number of cases of any DHB in New Zealand. New Zealand children, particularly Māori and Pacific children, have one of the highest rates of rheumatic fever in the developed world. Rheumatic fever is a serious illness that is preventable. It mainly occurs in children (aged 5‐19 years) after a Group A Streptococcal (GAS) throat infection. For some children an autoimmune response will occur where the body will attack its own tissue: heart, brain and joints. In adult life it may develop into chronic heart disease and require heart surgery. The Ministry of Health has invested over $40million into reducing the rates of rheumatic fever in Counties Manukau. Counties Manukau Health (CMH) is committed to reducing Acute Rheumatic fever rates in the district and acknowledges the complexity of preventing this disease as well as the wide range of activities and investment which will be needed if a significant reduction in cases is to be achieved. An overall reduction in ARF incidence of two thirds is needed in order to achieve the Better Public Service target by 2016/17. In order to achieve this goal several interventions have been put in place. Services have been implemented in primary and intermediate schools as well as primary care clinics. SERVICES
The National Hauora Coalition is the lead contractor for Mana Kidz. This successful programme is the largest initiative in New Zealand to combat the silent childhood illness of rheumatic fever. It is spread across four communities; Otara, Mangere, Manurewa and Papakura covering 61 schools, and 25,000 children. Each comprehensive clinic has a registered nurse and whānau support worker. These health teams are based in schools Monday to Friday attending to rheumatic fever prevention services. Mana Kidz is a proactive initiative, which strives to improve health outcomes for Tamariki across Counties Manukau. The National Hauora Coalition has set up these clinics in partnership with the Counties Manukau District Health Board and with the support of local providers: Kidz First, East Tāmaki Health Care, Otara Union, Health Star Pacific, Turuki Health Care, Te Hononga O Tāmaki Me Hoturoa, ProCare and Papakura Marae. 81
Mana Kidz is not only the largest rheumatic fever initiative in New Zealand, but also an example of primary health organisations working together in an alliance to improve the health and wellbeing of tamariki. 82
What is Mana Kidz?
Mana Kidz is the name for the school‐based health service in Counties Manukau. All school clinics are led by Registered Nurses from either Health or General Practice with help from skilled Whanau Support Workers (WSWs). Mana Kidz is governed by the Child Health Alliance, an alliance forum with a focus on improving the health of children in South Auckland which includes membership from health providers and key organisations that fund and/or provide health care to children living in the Counties Manukau area. Currently, dedicated Mana Kidz teams are working in 61 schools in South Auckland providing comprehensive school based, nurse led health services for children in identified schools. This has been accomplished in conjunction with the rheumatic fever prevention response and has enabled teams to deliver sore throat checks, skin assessments and treatments five days a week. The Mana Kidz nurses also manage school health referrals such as hearing and vision follow up and other child health issues which have historically been managed by Public Health Nurses. This includes home visiting. Mana Kidz Nurses are a highly skilled group of nurses with a population health perspective who are able to deal with a range of health issues. Enabling these RNs, through extra training and support, to work independently under standing orders is both empowering for them as a workforce, and for the population they serve through improved access to much needed health care. Another key strength is the emphasis on empowering families and individuals by providing them with knowledge on a myriad of health issues and encouraging, supporting and motivating them to achieve good antibiotic adherence and positive health outcomes. The delivery of this aspect of care is undoubtedly one of the most challenging, but the potential benefits are immeasurable. The Mana Kidz model of nurse‐led care is easily transferable to primary care response where an innovative approach is needed to effect change in the RF rates. The utilisation of specially trained nurses operating at the top of their scope within primary care is not new, but has not been implemented on a large scale or with a clear set of guidelines, standing orders, and a dedicated supported training pathway such as this. “Sometimes the questions are complicated and the answers are simple.” ― Dr. Seuss Rheumatic fever:
the neglected disease
Key concepts
The problem
■■ New Zealand continues to have high rates of
Pacific peoples have the highest rate of rheumatic fever
rheumatic fever, particularly among Pacific
in New Zealand and one of the highest rates in the world.
peoples
In 2009, there were 53 notified cases of rheumatic fever
■■ 80% of cases occur in young people aged less
than 15 years
■■ The majority of areas with a high incidence of
rheumatic fever are in the North Island
■■ Acute rheumatic fever can be prevented by
among Pacific peoples in New Zealand, a rate of 23 per
100 000. This is over six times the overall rate for all New
Zealanders of 3.5 per 100 000 (a total of 140 cases).1
New Zealand stands out from most other developed
countries in continuing to have high rates of acute
effective treatment of Group A streptococcal
rheumatic fever (ARF) and rheumatic heart disease (RHD).
throat infection
It is estimated that 97% of cases of RHD worldwide occur
■■ Management of people presenting with sore
throat should be guided by age, ethnicity and
in developing countries and in the indigenous populations
of countries such as New Zealand and Australia.2
location
■■ Guidelines have been developed for the
diagnosis and management of sore throat and
acute rheumatic fever and also for primary and
secondary prevention of rheumatic fever
Since 1984, ARF has been a notifiable disease in New
Zealand. However, it continues to be under-notified despite
increasing rates each year.3, 4
There is significant geographical variation in the rates of
ARF in New Zealand, with the highest rates in the North
Island, e.g. Tairawhiti, Hawke’s Bay and Northland.1,5
However, clusters of cases occur in a number of
communities across New Zealand.
Best Practice Tip: Check the incidence of rheumatic
fever in your DHB area. A map of New Zealand showing
rates per DHB is available in the Heart Foundation
Rheumatic Fever Guidelines (see sidebar).
BPJ | Issue 32 | 15
The majority of cases of ARF (approximately 80%) occur
in areas with a high incidence of rheumatic fever, should
in young people aged less than 15 years. The high rates
have a throat swab taken.
1
of ARF in Pacific peoples have been widely attributed to
socioeconomic factors such as overcrowding, poverty and
If the child has any of the following clinical features,
poor nutrition, but also to delayed diagnosis and treatment
empirical antibiotics should be prescribed:6
of streptococcal throat infection.
Group A streptococcal throat infection
Appropriate diagnosis and treatment of streptococcal sore
throat in high risk populations is required to reduce the
▪▪ Tonsillar swelling or exudate
▪▪ Anterior cervical lymphadenopathy
▪▪ No cough or coryza (which may suggest viral cause)
▪▪ Temperature ≥38ºC
incidence of ARF. A guideline for the management of sore
throats in New Zealand (see sidebar) has been developed
If none of the clinical features are present, wait for the
to assist with targeted treatment of streptococcal throat
results of the throat swab. If the swab is positive for
infection and includes algorithms for individual and
group A streptococcus, a ten day course of antibiotics,
household management.
e.g. penicillin V, amoxicillin or erythromycin, should be
prescribed.
Community pharmacists, particularly those in areas of
high ARF incidence, can assist by encouraging patients
with sore throat to see their GP.
Acute rheumatic fever and rheumatic heart disease
ARF arises from an autoimmune response to group A
Approach to treatment of sore throat in high risk groups
streptococcal throat infection. On average there is a
A key message from the Auckland Regional Public Health
latent period of three weeks between the initial infection
Service is to: “Think differently about sore throats in
and the development of symptoms of ARF. The majority
different population groups”.
of people with ARF are very unwell, in considerable pain
6
and require hospitalisation for confirmation of diagnosis
All children presenting with sore throat who are of Pacific
and treatment. ARF causes a widespread inflammatory
or Māori ethnicity, aged three years and over and who live
response that affects the heart, joints, skin and brain.
The Heart Foundation Rheumatic Fever Guidelines
The Heart Foundation of New Zealand has developed a
The full guidelines are available from the Heart Foundation
three part guideline for rheumatic fever;
website: www.heartfoundation.org.nz Keyword search:
1. Diagnosis, management and secondary prevention
2. Group A streptococcal sore throat management
3. Proposed rheumatic fever primary prevention
programme
These guidelines provide key information including:
▪▪ A geographical map of rheumatic fever incidence
▪▪ Guidelines for the management of sore throat
▪▪ Clinical features and diagnosis criteria for rheumatic
fever
16 | BPJ | Issue 32
Rheumatic fever
The heart (specifically the mitral and/or aortic valves) is
It has been estimated that over 60% of patients with ARF
the only organ that suffers long term damage, particularly
will develop RHD,9 which remains a significant cause of
after recurrent attacks of ARF. In some people ARF may
premature death in New Zealand (responsible for up to
be silent and symptomless, but still affects the heart i.e.
200 deaths each year).10 Adult patients may present with
causing subclinical carditis.4, 7
RHD that is a legacy of ARF from decades previously.
ARF is diagnosed clinically because there is no single
The difficulties
diagnostic test available. Diagnosis is based on the Jones
Not all streptococcal throat infections cause symptoms
criteria although these may not be sensitive enough to
and many children with sore throat do not present to
detect ARF in populations with a high incidence such as
primary care. Therefore there should be a low threshold
Pacific peoples.
for swabbing and treating sore throats in people who live
8
in areas of high incidence of ARF.
A modified version of the Jones criteria and a full
description of the clinical features of the major and minor
Pacific people are often stoical, putting up with a sore throat
manifestations of ARF are detailed in the Heart Foundation
or a sore joint and not presenting for medical care. Pacific
guidelines for rheumatic fever (see sidebar). Criteria for
families may prefer to use traditional health remedies
diagnosing ARF include the presence of two major, or one
rather than visit a doctor. Children may present later, so
major and two minor, manifestations, plus a preceding
in high incidence areas antibiotics should be prescribed
group A streptococcal infection. Major manifestations
empirically rather than waiting for swab results (if the
include carditis, polyarthritis, chorea, erythema
child has a sore throat and clinical features as detailed
marginatum and subcutaneous nodules. In New Zealand,
previously). A sore, swollen joint in a child should never
evidence of subclinical carditis on echocardiogram
be ignored and a possible diagnosis of ARF should always
is also accepted as a major manisfestation. Minor
be considered.
8
manifestations include fever, raised CRP, polyarthralgia
and prolonged P-R interval on ECG. If these signs are not
Populations that are transient are likely to be more at
present but there is strong clinical suspicion, ARF remains
risk. There may be a lack of continuity within primary
a possible diagnosis.
care which can result in delayed diagnosis or treatment
8
or stopping antibiotics needed for secondary prevention.
Diagnostic certainty may vary according to location and
Irregular school attendance may jeopardise school-based
ethnicity. It is recommended that a lower threshold for
detection programmes. Multiple caregivers may result
diagnosis be applied to people who:
in a child attending multiple GPs. Secondary prevention
8
▪▪ Are in high risk groups (such as Māori and Pacific
peoples)
▪▪ Live in lower socioeconomic areas
▪▪ Have delayed presentation
▪▪ Have atypical clinical features at presentation
programmes are also only effective with consistent longterm follow up.
The solutions
Targeted interventions are important. New Zealand-wide
approaches include:
▪▪ Ongoing awareness and education about the Heart
Refer all patients with suspected ARF to hospital. Clinical
Foundation rheumatic fever treatment guidelines
follow-up of patients and their close contacts, and the
for all medical care staff both at a primary and
ongoing use of prophylactic antibiotics after an attack of
secondary care level. The goal is for a reduced
ARF are important in preventing recurrence of ARF and
incidence of ARF through effective treatment of sore
RHD.
throat.
BPJ | Issue 32 | 17
▪▪ Secondary prevention programmes to prevent
Any child who tested positive for group A Streptococcus
recurrence in people who have had confirmed ARF
received a ten day course of antibiotics. This campaign
or RHD. These programmes rely on effective follow
has raised public awareness and has increased the
up to ensure regular administration of prophylactic
number of parents requesting throat swabs for children
antibiotics over a minimum of ten years.
with sore throat.
School-wide regular throat swabbing programmes have
More information is available from:
successfully reduced the incidence of ARF in some
www.toiteorapublichealth.govt.nz/Rheumatic_Fever_
regions. The use of portable echocardiograms to detect
GP
previously undiagnosed RHD in school children has also
been initiated in some areas.
The “Say Aah” campaign in Flaxmere, Hawkes Bay, is
fronted by All Black Israel Dagg. This campaign aims to
Solutions aimed at improving housing, reducing
obtain parental permission to take throat swabs from all
overcrowding and improving the socioeconomic situation
school children in Flaxmere, an area with a rheumatic
of Pacific peoples will require a longer time frame and a
fever rate of 32 per 10 000.
co-ordinated approach with other sectors, e.g. education,
welfare and housing, at both local and national levels.
In 2002, a successful community based primary
prevention programme for rheumatic fever was initiated
Some recent regional approaches include:
in Whangaroa, Northland. For more information on
The Opotiki Rheumatic Fever prevention project led
this programme, see “How a community controlled the
by Te Ao Hou PHO was initiated in October 2009. The
Streptococcus”, BPJ 13 (May, 2008).
message was: “sore throats matter”, and the project
involved community health workers visiting primary
schools, three times a week, to take throat swabs (with
parental consent) from children who reported sore throat.
For further information about rheumatic fever see
“Why we still need to think of rheumatic fever”, BPJ 13
(May, 2008).
References
1. ESR. Public Health Surveillance. Notifiable and Other Diseases in
6. Auckland Regional Public Health Service (ARPHS). Sore throats
New Zealand. Annual Surveillance Report. ESR, 2009. Available
and acute rheumatic fever: advice for GPs and Practice Nurses.
from www.surv.esr.cri.nz (Accessed Oct, 2010).
Available from: www.arphs.govt.nz/Guidelines/SoreThroats_ARF.
asp (Accessed Oct, 2010).
2. White H, Walsh W, Brown A et al. Rheumatic Heart Disease in
Indigenous Populations. Heart Lung Cir 2010;19:273-81.
3. Loring B. Rheumatic Fever in the Bay of Plenty and Lakes District
Health Boards. A review of the evidence and recommendations
7.
Tubridy-Clark M, Carapetis JR. Subclinical carditis in rheumatic
fever: A systematic review. Int J Cardiol 2007;119(1):54-8.
8. Heart Foundation of New Zealand (HFNZ). New Zealand guidelines
for action. Summary Report. 2008. Available from: www.
for rheumatic fever. 1. Diagnosis, management and secondary
toiteorapublichealth.govt.nz/vdb/document/150 (Accessed Oct,
prevention. HFNZ, 2006. Available from www.heartfoundation.org.
2010).
nz (Accessed Oct, 2010).
4. Wilson N. Rheumatic heart disease in indigenous populations –
New Zealand experience. Heart Lung Circ 2010;19:282-8.
5. Heart Foundation of New Zealand (HFNZ). New Zealand guidelines
for rheumatic fever. 2. Group A Streptococcal Sore throat
9. Carapetis JR, Steer AC, Mulholland EK, Weber M. The global
burden of group A streptococcal diseases. Lancet Infect Dis
2005;5(11):665-732.
10. Ministry of Health. New Zealand mortality statistics: 2006-2009.
Management. HFNZ, 2008. Available from: www.heartfoundation.
Ministry of Health. Wellington, 2010. Available from: www.moh.
org.nz (Accessed Oct, 2010).
govt.nz (Accessed Oct, 2010).
18 | BPJ | Issue 32
Standing Order
Guidelines
2012
These guidelines are issued by the Ministry of Health and represent
the Ministry’s view as to the matters contained in the Medicines
(Standing Order) Regulations 2002. They do not constitute legal
advice as to the regulations. Users are encouraged to seek their
own legal advice on such matters.
Citation: Ministry of Health. 2012. Standing Order Guidelines.
Wellington: Ministry of Health.
Published in June 2012 by the
Ministry of Health
PO Box 5013, Wellington 6145, New Zealand
ISBN 978-0-478-39329-3
HP 5482
This document is available at www.health.govt.nz
Contents
1
Introduction and purpose
1
2
Exclusions
2
3
Issuer
3
4
People working under standing orders
4
5
Medicines
5
6
Contents of a standing order
6
7
Period for which the standing order applies
7
8
Record keeping
8
9
Competency, including training
9
10 Countersigning and audit of standing orders
10
11
Review of standing orders
11
12
Availability of standing orders
12
13
Enforcement
13
Checklist for use of standing orders
14
Appendix 1: Standing order template guide
18
Standing Order Guidelines
iii
1
Introduction and purpose
1.
A standing order is a written instruction issued by a medical practitioner or
dentist. It authorises a specified person or class of people (eg, paramedics,
registered nurses) who do not have prescribing rights to administer and/or
supply specified medicines and some controlled drugs. The intention is for
standing orders to be used to improve patients’ timely access to medicines; for
example, by authorising a paramedic in an emergency or a registered nurse in a
primary health care setting.
2.
Currently, medical practitioners and dentists are the only prescribers who can
issue standing orders.
3.
The purpose of these guidelines is to provide guidance for health professionals
working with standing orders, to assist issuers to comply with the regulations
when developing a standing order, and to assist people administering and/or
supplying under standing orders.
4.
The use of standing orders is governed by the Medicines (Standing Order)
Regulations 2002 (Standing Order Regulations). This regulation sits within the
broader health regulatory regime that includes:
5.

the Medicines Act 1981 and Medicines Regulations 1984

the Misuse of Drugs Act 1975 and Regulations 1977

the Health Practitioners Competence Assurance Act 2003

the Health and Disability Commissioner (Code of Health and Disability
Services Consumers’ Rights) Regulations 1996.
The above legislation can be accessed online at www.legislation.govt.nz. Hard
copies can be purchased from Bennetts Government Bookshop (Wellington),
phone (04) 499 3433 or by ordering online at www.bennetts.co.nz.
1
2
Exclusions
6.
A standing order does not allow a person to generate a prescription and provide
it to a patient to take to a pharmacy to be dispensed (with the prescription signed
later by the issuer of the standing order). Pharmacies cannot lawfully dispense
unsigned prescriptions. Nor does a standing order allow a person to provide a
patient with a prescription that has been ‘pre-signed’ by the medical practitioner
or dentist who issued the standing order.
2
3
7.
8.
Issuer
To issue a standing order a person must be one of the following:
(a)
an individual practitioner1 in practice
(b)
a practitioner who is an employer of a practitioner or a person permitted to
supply or administer a medicine under a standing order
(c)
a practitioner who exercises managerial control over a practitioner or a
person permitted to supply or administer a medicine under a standing order
(d)
a practitioner who is authorised by a group of practitioners or a group of
people permitted to supply or administer a medicine under a standing order
on their behalf.
Standing orders are a significant and specific authorisation from the issuer. It is
important to clearly specify the issuer of each standing order within an individual
general practice or hospital ward/department. The issuer retains overall
responsibility to:

ensure the legislative requirements for the standing order are met

ensure that anyone operating under the standing order has the appropriate
training and competency to fulfil the role

countersign, audit and review the standing order.
NOTE: Many of the duties (eg, countersigning, annual review) can only be performed
by the issuer who originally issued the standing order. If the issuer leaves the
organisation or goes on leave for an extended period, a new standing order will be
necessary.
1
The Standing Order Regulations define a practitioner as a medical practitioner or dentist.
3
4 People working under
standing orders
9.
A person who is permitted to administer and/or supply medicines under a
standing order must be engaged in the delivery of a health service. They may
include, for example:

registered nurses

paramedics

New Zealand Defence Force medical personnel.
10.
To meet regulatory requirements, a person working under standing orders must
have the competency and training to be able to make an assessment that the
standing order applies to the presenting patient, the competency to administer
and/or supply the medicine, and the knowledge to assess the contraindications
and/or exclusions. See ‘Section 9: Competency, including training’.
11.
All staff potentially affected by the standing order should be identified in the
development of the standing order. It is recommended that the standing order be
developed in consultation with the staff who will be expected to work under that
standing order, or representatives of those staff.
12.
A standing order permits or empowers people to administer and/or supply
medicines; it cannot require them to do so. In every case it will be a matter of
professional judgement by the person concerned as to whether to administer
and/or supply medicines pursuant to a standing order. This subject is not covered
in detail in these guidelines. The employer or health organisation should have a
written policy relating to the standing orders that records the agreement of the
management, issuers and those who will administer and/or supply medicines
under that standing order. Working under standing orders may be part of the
person’s duties as an employee or independent contractor, or may be governed by
contract.
4
5
13.
Medicines
The following medicines can be administered and/or supplied in accordance with
a standing order:

prescription medicines

restricted medicines (pharmacist-only medicines)

pharmacy-only medicines

controlled drugs listed in Part 1 of Schedule 2 to the Misuse of Drugs Act 1975
which are exempt under Misuse of Drugs Regulation 22 and Part 3 of
Schedule 2 to the Misuse of Drugs Act 1975

controlled drugs listed in Parts 2 to 7 of Schedule 3 of the Misuse of Drugs Act
1975.
Note: the Immunisation Handbook 2011 sets out who can administer vaccines
and in what circumstances a standing order is required:
www.health.govt.nz/publication/immunisation-handbook-2011 (Section 2.1, page
38).
14.
Medicines and controlled drugs to be administered and/or supplied must be
available on-site. Requirements for the labelling, packing, storage and handling of
medicines are specified in the Medicines Regulations 1984. The labelling,
packing, storage and handling requirements relating to medicines must be
understood and complied with prior to issuing a standing order.
15.
If a standing order includes medicines that require reconstitution, the issuer
should ensure the availability of the necessary equipment (eg, accurate measuring
vessels) and/or training.
5
6 Contents of a standing order
16.
The regulations require that the standing order includes:

an explanation of why the standing order is required

the circumstances in which the standing order applies – for example, a
paramedic in an emergency or a registered nurse running a specified school
clinic

the class of people able to administer and/or supply under the standing order
– for example, paramedics, registered nurses

the competency requirements of the person administering and/or supplying a
medicine under a standing order (see ‘Section 9: Competency, including
training’ for further information)

the treatment of condition/s to which the standing order applies – for
example, urinary tract infection, asthma

the medicines that may be supplied or administered under the standing order

the indications for which the medicine is to be administered and the
recommended dose or dose range for those indications

the number of dose(s) of the medicine for which the standing order is valid

the contraindications and/or exclusions for the medicines, the validated
reference charts for dose calculation (if required) and the monitoring of a
medicine (if required)

the method of administration

whether countersigning is required and, if countersigning is required, the
timeframe for countersigning

the clinical documentation to be recorded

the period for which the standing order applies (see ‘Section 7: Period for this
the standing order applies’ below).
These requirements are included in ‘Appendix 1: Standing order template guide’.
17.
If a standing order lists more than one medicine for the treatment of a condition,
clear guidance must be provided about which medicine is preferred in what
circumstances. For example, medication A for children aged 5–12 years;
medication B for pregnant women; medication C for non-pregnant adults.
NOTE: It is recommended that the standing order lists a medicine by its generic name
rather than the trade name. This will avoid the need to update the standing order every
time the trade name of the available product changes.
6
7
18.
19.
Period for which the
standing order applies
The standing order must specify the period for which it applies. If it is not
appropriate to state a specific period, then the standing order must state that it is
to apply until it is either:

replaced by a new standing order covering the same subject matter or

cancelled in writing by the issuer.
Whatever the specified period for the standing order, it must be reviewed by the
issuer at least annually (see also ‘Section 11: Review of standing orders’). The
standing order must specify the required review date. Following review, the
standing order should be re-signed and dated.
7
8 Record keeping
20.
A person who administers and/or supplies a medicine under a standing order
must document the assessment and treatment of the patient (including any
adverse reactions) in the clinical record and, if necessary, any monitoring or
follow-up of the patient’s treatment.
21.
The name of the person administering and/or supplying under the standing
order, and the date and time of administration and/or supply should also be
recorded in the clinical record.
8
9 Competency, including
training
22.
The legislation requires the standing order to specify the level of competency,
including training, required to administer and/or supply a medicine under a
standing order where the registration authority has not set the level of
competency (or where there is no registration authority). Generally registration
authorities do not set specific competencies required to administer and/or supply
a medicine under a standing order. Therefore the required level of competency,
including any specific training requirements, should be specified in all standing
orders.
23.
The issuer must, at least once a year, review the competency of each person
permitted to administer and/or supply medicine under the standing order if the
level has not be set by the registration authority.
NOTE: Clearly defining the specific competency and training requirements in a
standing order is particularly important where there is the potential for a significant
adverse event to occur. For example, the medicine Warfarin can cause serious bleeding.
To administer it correctly, a person must calculate the required dose from a range based
on blood results. In addition to completing the in-house training on the organisation’s
standing order policy and procedures, assessed competency through peer and/or case
review could be set as an additional requirement before a health professional can work
independently under the standing order.
9
10 Countersigning and audit of
standing orders
24.
The requirements for countersigning standing orders changed in August 2011.
Previously the issuing prescriber was required to countersign every
administration and/or supply of a medicine under a standing order. Now, the
issuer has the option of either countersigning every administration and/or supply
of a medicine or specifying that countersigning is not required. This change
means the issuer can specify different countersigning requirements for people
administering and/or supplying under standing orders commensurate with the
level of competency and expertise of the individuals.
25.
The requirement for countersigning must be clearly described within each
standing order. The issuer of the standing order must decide, and specify:

whether (and under what circumstances) countersigning is or is not required

in cases where countersigning is required, the period within which the issuer
must countersign.
26.
If countersigning is not required, or required less frequently than once a month,
the issuer must, at least once a month, audit a sample of the records of
administration and/or supply under the standing order.
27.
If a single medical practitioner or dentist has issued a number of standing orders
for different conditions or medicines, then that issuer will be required to audit a
sample from each standing order.
28.
Audit sample sizes should be, as a minimum:

50 percent of administration and/or supply records if there are 20 or fewer in
total

20–30 percent of administration and/or supply records if they are in range of
21–100

15–20 percent of administration and/or supply records if there are over 100.
29.
If any administration and/or supply records are found to be non-compliant with
the standing order, it is recommended that the sample size is doubled.
30.
The results of the audit should be recorded along with any required changes or
improvements in relation to the standing order documentation, processes or
training to be undertaken. Prompt action should be taken to address any issues
identified.
10
11 Review of standing orders
31.
The issuer must review the standing order at least once a year. The issuer must
consider whether the standing order continues to be necessary and whether the
terms used are appropriate. If the issuer considers that some of the terms of the
standing order are no longer appropriate and require either amending or deleting,
then any material variations, deletions or additions to the standing order, made
as a result of a review, must be dated and signed by the issuer. All staff potentially
affected by amendments or deletions should be identified and consulted on the
changes.
32.
The issuer must ensure that there is a process in place for monitoring and
reviewing the correct operation of the standing order and, in particular, any
adverse incidents that occur. The issuer must also ensure that there is a process
for document control so that, following a review, all obsolete copies are replaced
with new versions of the standing order.
11
12 Availability of standing
orders
33.
The regulations require that the issued standing order is made available to:

every person permitted to administer and/or supply a medicine under the
standing order

an employer of any practitioner, whether or not he or she is the issuer

any affected practitioner who is not the issuer

any person affected by the standing order

the Director-General of Health, on request.
34.
Standing orders should be made available to anyone on request.
12
13 Enforcement
35.
It is an offence to fail to meet the requirements of the Medicines (Standing Order)
Regulations. The Ministry of Health may, from time to time, audit any standing
order.
13
Checklist for use of standing
orders
1.
Has the need for a standing order been established?
(a)
Does the standing order explain why the standing order is necessary?
(b)
Has the scope (coverage) of the standing order been specified?
(c)
Do you have processes in place for monitoring and reviewing the standing
order?
2.
Has the best person to issue the standing order been identified?
(a)
Is the person you have identified as issuer one of the following:
i.
an individual practitioner in practice
ii.
a practitioner who is an employer of a practitioner or a person
permitted to supply or administer a medicine under a standing order
or
iii.
a practitioner who exercises managerial control over a practitioner or a
person permitted to supply or administer a medicine under a standing
order
or
iv.
a practitioner who is authorised by a group of practitioners or a group
of people permitted to supply or administer a medicine under a
standing order on their behalf
or
(b)
Does the standing order name the issuer?
14
3.
Has the class of people permitted to administer and/or supply a
medicine under a standing order been determined?
(a)
Does the standing order describe the class of people permitted to administer
and/or supply a medicine under a standing order?
(b)
Is the class of people you have identified limited to people engaged in the
delivery of a health service?
(c)
Has the registration authority of the class of people set any competencies?
(d)
If the registration authority has set levels of competency, including training,
for the classes of people administering and/or supplying medicines under the
standing order, are there any additional competencies required, including
any training to be undertaken?
(e)
If the registration authority has not set any level of competency, or there is
no registration authority, does the standing order specify the levels of
competency, including training, required of the class of people permitted to
administer and/or supply medicines under the standing order?
(f)
Does the class of people you have identified have the required competencies
to administer and/or supply?
(g)
Have the people who will work under the standing order, or their
representatives, been involved in the development process?
4.
Does the standing order specify the class of people (eg, adults,
children aged 5 to 12 years) to whom medicines can be administered?
5.
Does the standing order specify the circumstances in which it applies?
6.
Which treatment/s are included in the standing order?
(a)
Does the standing order specify the treatment/s and condition/s to which the
order applies?
15
7.
Which medicines will be administered and/or supplied under the
standing order?
(a)
Does the standing order list the medicines that may be administered and/or
supplied under the standing order?
(b)
For each medicine that is listed, have you recorded all of the following:
i.
indications for which the medicine is to be administered
ii.
the recommended dose or dose range for those indications
iii.
the number of doses the standing order allows
iv.
the contraindications and/or exclusions for the medicine
v.
the validated reference charts for calculation of dose (if required)
vi.
the method of administration
vii.
the documentation required in clinical notes.
8.
Does the standing order specify whether or not countersigning is
required?
(a)
If countersigning is required, does the standing order specify the period,
shorter than a month, within which the issuer will countersign the
administration and/or supply of the medicines?
(b)
If countersigning is not required, has a process been established to
document, at a minimum, a monthly audit of a sample of the records of
administration and/or supply?
9.
Does the standing order define the terms it uses?
10.
Is the standing order in writing?
11.
Is the standing order signed and dated by the issuer?
16
or
Processes
12.
Have you developed a process for the issuer to review the competency
of any person working under the standing order who does not have
levels of competency set by a registration authority for acting under a
standing order?
13.
Have you developed a process for at least an annual review of the
standing order?
14.
Have you developed a process for monitoring and reviewing the correct
operation of the standing order and, in particular, any adverse
incidents that occur?
15.
Is a copy of the standing order available to every person operating
under the standing order, any person affected by the standing order, an
employer of any practitioner, or any practitioner who is not the issuer?
17
Appendix 1:
Standing order template guide
Issued: 00/00/0000
Review date: 00/00/0000
Medicine Standing Order Title Name the condition you are treating under this standing
order – eg, urinary tract infection (UTI), scabies.
A standing order covers the treatment of a specified
condition. This may involve directions for several different
medicines with clear indications for the use of each
medicine.
Rationale
Explain why the standing order is necessary.
Organisation/clinic
Name and address of the organisation where the standing
order is being used.
Scope (the condition and
patient group)
eg, for the treatment of UTI in females over 12 years of age.
Medicine/s
Name, strength and dose form.
Dosage instructions for each
medicine
eg, 300 mg at night for 3 days.
Route of administration
eg, oral, deltoid intramuscular or deep subcutaneous
injection.
Indication/circumstances for
activating the standing order
eg, to provide post-coital (or emergency) oral contraception
to clients in a school clinic or for the treatment of a UTI (with
frequency, urgency and/or dysuria and positive dipstick test)
without complicating factors.
Precautions and exclusions
that apply to this standing
order
eg, pregnancy, breastfeeding, allergies, contraindications.
Name or class of health professional (eg, registered nurses).
Persons authorised to
administer the standing order
Competency/training
requirements for the
person(s) authorised to
administer
18
eg, prior to administering paracetamol under this standing
order the registered nurse is required to undergo the inhouse training on the policy, procedure and documentation
requirements for standing orders. A record of this training will
be kept.
Countersigning and audit
The standing order must specify whether countersigning is
or is not required for every administration and/or supply (and
under what circumstances).
Note: The standing order must be either individually
countersigned or included in the monthly audit by the issuer.
If countersigning is required, define the timeframe (eg, within
24 hours of administration); if countersigning is not required,
define the audit sample (eg, 20% of standing order
treatments once a month).
Definition of terms used in
standing order
eg, dysuria is pain or difficulty on urination.
Additional information
Documentation (administration/supply information – including
validated dose reference charts); initial and ongoing
assessment requirements.
Note any supporting documents, eg, policy, guidelines or
decision support tools, attached to this standing order.
Signed by issuer:
Name:
Title:
Date:
Medical practitioner or dentist
Notes:
This standing order is not valid after the review date. The review date is one year after the date that the
order was signed by the issuer.
The organisational standing order policy and procedure must be signed by management, the issuer and
every person operating under standing orders, and attached to the standing order.
19
83
Workbook developed by:
Tracy McKee - Clinical Leader, Mana Kidz
[email protected]
027 309 6707
and
Liz Pillay – Clinical Nurse Educator, Mana Kidz
[email protected]
021 408 669

Workbook – Standing orders for registered nurses in primary care

Transcription

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