Acarbose —(Precose)

Transcription

Acarbose —(Precose)

Acarbose—(Precose)
International Brand Names
Glibose (Taiwan); Glicobase (Italy); Glucobay (Argentina, Austria, Bangladesh,
Belgium, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador,
El Salvador, England, Germany, Greece, Guatemala, Honduras, Hungary, India, Israel, Italy, Japan, Korea, Malaysia,
Mexico, Netherlands, Nicaragua, Norway, Pakistan, Panama, Peru, Poland, Portugal, Spain, Sweden, Switzerland);
Gluconase (Philippines); Glumida (Spain); Prandase (Canada, Israel); Rebose (India)
# Drug Class ..........................
a Glucosidase inhibitor; Antidiabetic agents; Oral hypoglycemics
# Indications .........................
Diabetes mellitus, type II
# Mechanism .........................
An oral pancreatic a amylase and intestinal a glucoside hydrolase
inhibitor that delays bowel carbohydrate metabolism, slowing the
postprandial rise in glucose
# Dosage with Qualifiers .......
Diabetes mellitus, type II begin 25mg (50mg if >60kg);
thereafter, 50 100mg PO ac tid based on glucose levels
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Contraindications hypersensitivity to drug or class,
DKA, cirrhosis, intestinal obstruction or malabsorption
syndromes
Caution renal dysfunction
# Maternal Considerations .....
Acarbose is the subject of a large ongoing trial to determine
whether its use can reduce or delay the onset of type II
diabetes in patients with impaired glucose intolerance.
The preliminary results indicate benefit. There are no adequate
reports or well controlled studies of acarbose in pregnant
women. There is a single report of 6 pregnant women with
impaired glucose tolerance treated with acarbose. Glucose levels
returned to normal, and the pregnancies were reportedly
uncomplicated.
Side effects include intestinal discomfort consisting of pain,
diarrhea, flatulence, elevated LFTs, and jaundice.
# Fetal Considerations ...........
There are no adequate reports or well controlled studies in
human fetuses. Only 2% of the oral dose is absorbed. Rodent
studies are reassuring, revealing no evidence of teratogenicity or
IUGR despite the use of doses almost 10 higher than those used
clinically.
# Breastfeeding Safety ..........
There is no published experience in nursing women. It is
unknown whether acarbose enters human breast milk. A single
rat study suggests acarbose might alter the composition of breast
milk by inhibiting lipogenesis. Less than 2% of acarbose is
bioavailable. It is unlikely any would be excreted into the milk
and or absorbed by the neonate.
# Drug Interactions ................
Some drugs tend to produce hyperglycemia. They include
thiazides and similar class diuretics, corticosteroids,
phenothiazines, thyroid products, estrogens, oral contraceptives,
phenytoin, nicotinic acid, sympathomimetics, calcium channel
blocking drugs, and isoniazid. Women taking both acarbose and
one of these drugs should be monitored closely for loss of glucose
control. Discontinuation of such drugs may lead to hypoglycemia.
Intestinal adsorbents (e.g., charcoal) and digestive enzyme such as
amylase and pancreatin may reduce the effect of acarbose and
should not be taken together.
Acarbose may alter digoxin bioavailability when they are
co administered.
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http://www.us.elsevierhealth.com/product.jsp?isbn=9781416040132
# References .........................
Hanefeld M, Schaper F, Koehler C. Cardiovasc Drugs Ther 2008;
22:225 31.
Mercer SW, Williamson DH. Biochem J 1987; 242:235 43.
Product information. Precose, Bayer Corp., 1997.
Zarate A, Ochoa R, Hernandez M, Basurto L. Ginecol Obstet Mex
2000; 68:42 5.
# Summary ...........................
Pregnancy Category: B
Lactation Category: S (likely)
Insulin and diet regulation remain the standard treatments for
glucose intolerance during pregnancy.
There is a growing interest in the use of oral hypoglycemic
agents during pregnancy, and acarbose is a candidate for
future study in this area.
Acebutolol—(ACB; Alol; Beloc; Diasectral; Espesil; Lupar;
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Neptal; Rhotral; Sectral; Sectral LP; Wesfalin)
International Brand Name ACB (New Zealand, Singapore); Acecor (Italy); Diasectral (Denmark, Finland);
Espesil (Finland); Flebutol (Venezuela); Grifobutol (Chile); Monitan (Canada); Prent (Germany, Italy, Portugal);
Rhotral (Canada); Sectral (Belgium, Bulgaria, Canada, Czech Republic, England, France, Hong Kong, Ireland, Italy,
Malaysia, Netherlands, Poland, South Africa, Spain, Switzerland, Taiwan); Sectral LP (France)
# Drug Class ..........................
Antiarrhythmics, class II; Antiarrhythmics, ventricular;
Antihypertensives; b Blocker
# Indications .........................
Chronic hypertension, ventricular arrhythmias
# Mechanism .........................
Cardioselective partial b adrenoceptor antagonist
Hypertension begin 400 800mg PO qd; max 1200mg/d
Ventricular arrhythmia begin 200 400mg/d; typical dose, 600
1200mg/d
Contraindications hypersensitivity, CHF, heart block,
hypotension, pulmonary disease
Caution diabetes mellitus, hepatic or renal dysfunction
There are no adequate reports or well controlled studies of
acebutolol in pregnant women. Acebutolol was significantly less
successful than either labetalol or a methyldopa in controlling
chronic arterial hypertension >90mmHg in one small
randomized trial. The rates of pregnancy complications among
the 3 groups of women were similar.
Side effects include CHF, bronchospasm, fatigue, dizziness,
headache, constipation, and diarrhea.
There are no adequate reports or well controlled studies
in human fetuses. Acebutolol and its main metabolite,
N acetylacebutolol, cross the placenta with a 0.6:0.8 M:F ratio.
A prospective study of acebutolol’s hemodynamic and renal
impact on neonates after chronic in utero exposure found
hemodynamic failure in 5/11 children delivered of treated
mothers. Exposed neonates had significantly less early neonatal
diuresis, absence of a significant rise in the GFRs, and reduced
sodium and calcium balances. The direct effect of the drug on the
glomerular and tubular functions and/or the renal arteriolar
vasomotoricity could explain these effects.
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Acebutolol and N acetylacebutolol are concentrated in
breast milk (M:P ratios 2:9 for acebutolol and 2:25 for
N acetylacebutolol), though symptoms of neonatal b blockade
are rarely reported. A neonate might receive pharmacologically
active amounts of acebutolol if the daily maternal dosage exceeds
400mg and/or renal function in the mother is impaired. However,
the American Academy of Pediatrics considers acebutolol
permissible with breastfeeding.
Catecholamine depleting drugs, such as reserpine, may have an
additive effect when given with b blockers.
Women treated with both acebutolol and catecholamine
depletors should be observed closely for bradycardia or
hypotension that may present as vertigo, syncope/presyncope, or
orthostatic hypotension without compensatory tachycardia.
Women receiving b blockers should be warned that hypertensive
responses may follow the combined use of b blockers and
a adrenergic agonists, including those in OTC cold remedies
and vasoconstrictive nasal drops.
NSAIDs may blunt the antihypertensive effect of b blockers.
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# References .........................
Boutroy MJ, Bianchetti G, Dubruc C, et al. Eur J Clin Pharmacol
1986; 30:737 9.
Committee on Drugs, American Academy of Pediatrics. Pediatrics
1994; 93:137 50.
Lardoux H, Blazquez G, Leperlier E, Gerard J. Arch Mal Coeur
Vaiss 1988; 81(Spec No):137 40.
Yassen H, Boutroy MJ, Monin P, Vert P. Arch Fr Pediatr 1992;
49:351 5.
# Summary ...........................
Pregnancy Category: B (1st trimester), D (2nd and 3rd
trimesters)
Lactation Category: S
There are alternative agents for which there is more experience
during pregnancy and lactation.
Consider withholding oral acebutolol therapy for 12h prior to
the anticipated delivery to minimize the risk to the neonate.
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Acetaminophen—(APAP; Acephen; Aceta; Acetaminophen
Uniserts; Anapark; Apacet; Asidon; Calip; Dapacin; Ed-Apap;
Feverall; Genapap; Genebs; Mapap; Maranox; Neopap;
Oraphen-PD; Panadol; Redutemp; Ridenol; Silapap; Tapanol;
Tempra; Tylenol; Uni-Ace)
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International Brand Name Abenol (Canada); Acamol (Chile, Israel); Acamoli Forte suppositories for Kids
(Israel); Acet (Malaysia, Philippines); Acetalgin (Switzerland); Acetam (Peru); Acetamol (Italy); ACET suppositories
(Singapore); Adorem (Colombia); Afebrin (Hong Kong, Indonesia, Philippines); Algiafin (Chile); Alphagesic (Indonesia);
Alvedon (Sweden); Amol (Israel); A Mol (Thailand); Anaflon (Germany); Analgiser (Israel); Apirex (France); Arfen
(Malaysia, South Africa); Atamel (Peru); Benuron (Japan); Ben U Ron (Belgium, Germany, Portugal, Switzerland);
Biogesic (Indonesia, Philippines, Thailand); Biogesic Suspension (Hong Kong); Bodrex (Indonesia); Brenal (Philippines);
Calapol (Indonesia); Calodol (Philippines); Calpol (India, Ireland, Israel, Japan, Puerto Rico, South Africa, Thailand);
Causalon (Argentina); Cemol (Thailand); Christamol (Hong Kong); Claradol (Morocco); Clocephen (Philippines); Crocin
(India); Daga (Thailand); Datril (Mexico, Venezuela); Depyretin (Taiwan); Dirox (Argentina); Dismifen (Mexico); Dolex
(Uruguay); Dolex 500 (Colombia, Uruguay); Doliprane (France, Morocco); Dolitabs (France); Dolofen (Colombia);
Dolomol (Israel); Dolorol (South Africa); Dolotemp (Mexico); Doltem (Peru); Drilan (Philippines); Dymadon (Australia);
Efferalgan 500 (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Israel, Nicaragua, Panama);
Efferalganodis (France); Eraldor (Ecuador); Expandol (France); Fervex (Brazil); Flurinol (Philippines); Fortolin (China);
Gelocatil (Spain); Geluprane 500 (France); Gunaceta (Indonesia); Kamolas (Indonesia); Kyofen (Colombia); Lemgrip
(Belgium); Lotemp (Thailand); Malidens (India); Mebinol (Peru); Meforagesic (Philippines); Metagesic (Philippines);
Mexalen (Austria, Czech Republic, Hungary); Milidon 500 (Singapore); Minopan (Korea); Mypara (Thailand); Nalgesik
(Indonesia); Napa (Singapore); Napamol (South Africa); Naprex (Indonesia); NEBS (Japan); Nektol 500 (Philippines);
Nilapur (Indonesia); Pacemol (Brazil, Singapore); Pacimol (India); Pamol (Denmark, New Zealand); Panadol (Belgium,
Brazil, Bulgaria, Chile, England, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Italy, Korea, Netherlands, South
Africa, Switzerland, Taiwan, Thailand, Uruguay); Panadol Actifast (Malaysia, Singapore); Panamax (Australia); Panodil
(Denmark, Norway, Sweden); Paracet (Norway); Parageniol (Paraguay); Paragin (Thailand); Paralgin (Australia); Paralief
(Ireland); Paramidol (Peru); Paramol (Israel, Taiwan); Parapaed (Germany); Parapaed Junior (New Zealand); Parapaed Six
Plus (New Zealand); Paratabs (New Zealand); Parvid (Philippines); Paximol (Singapore); Pedipan (Korea); Penral Night
(Korea); Pinex (Norway); Poro (Malaysia); Predimol (India); Puernol (Italy); Raperon (Korea); Rapidol (Chile); Reliv
(Sweden); Remedol (Puerto Rico); Revanin (South Africa); Rhinapen elixir (Korea); Roxamol Gelcaps (Israel); Salzone
(South Africa); Saridon (Colombia); Serimol (Hong Kong); Setamol (Australia); Sinedol (Dominican Republic); Taganopain
(Korea); Tamifen (Ecuador); Tempra (Belgium, Canada, Costa Rica, Ecuador, El Salvador, Greece, Guatemala, Honduras,
Indonesia, Japan, Mexico, Nicaragua, Panama, Spain, Thailand); Tempte (Taiwan); Temzzard (Mexico); Termofren
(Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama); Turpan (Indonesia);
Tylenol (Australia, Austria, Brazil, Bulgaria, Canada, China, France, Germany, Hong Kong, Israel, Japan, Korea, Mexico,
Philippines, Portugal, Spain, Switzerland, Thailand, Venezuela); Tylenol Extra Fuerte (Paraguay, Peru); Tylex (Costa Rica,
Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama); Winadol (Colombia, Venezuela);
Winasorb (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama);
Xebramol (Thailand); Zetifen (Philippines); Zolben (Venezuela); Zydinol (Philippines)
# Drug Class ..........................
Analgesics, non narcotic; Antipyretics; NSAID
# Indications .........................
Mild pain, fever, menstrual cramps, osteoarthritis, tension headache
# Mechanism .........................
Nonspecific cyclooxygenase inhibitor
Pain and/or fever
650 1000mg PO/PR q4 6h; max 4g/d
NOTE: included in many combinations.
Contraindications hypersensitivity to drug or class
Caution hepatic or renal dysfunction, chronic alcohol use,
G6PD deficiency, PKU
Acetaminophen is component of a long list of OTC medications.
It is metabolized in the liver and excreted by the kidneys. During
the 1st trimester, the mean t/2 is significantly lower and oral
clearance is significantly higher compared to nonpregnant control
subjects. Only during pregnancy is weight related to clearance,
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suggesting the dose may need to be adjusted in obese women.
Ibuprofen provides more rapid relief of perineal pain after
vaginal delivery. Up to 2=3 of pregnant women ingest
acetaminophen some time during gestation. In one recent RCT,
acetaminophen plus oxycodone was superior to patient
controlled morphine for the relief of post cesarean pain. There
are no obvious differences in clearance at term. Chronic abuse
and overdose are the most common problems. The damage
appears secondary to free radical toxicity with consumption of
glutathione. N acetylcysteine is the treatment of choice for acute
overdose. In one prospective case control study, use of prenatal
ibuprofen, naproxen, and aspirin, but not acetaminophen,
increased the risk of spontaneous abortion by 80% (adjusted
hazard ratio 1.8 [95% CI 1.0 3.2]). The association was stronger
if the initial use occurred around conception or if the use lasted
more than a week.
Side effects include hepatotoxicity, nephrotoxicity,
agranulocytosis, pancytopenia, hemolytic anemia, pancreatitis,
rash, angioedema, and urticaria.
human fetuses. Acetaminophen crosses the human placenta,
reaching steady state in the isolated perfused model within 1h.
The F:M ratio for acetaminophen approximated 0.12 in the
pregnant ewe, and neither sulfate or glucuronide metabolites
crossed. Acetaminophen use during labor to treat the fever of
chorioamnionitis is associated with improved fetal umbilical
blood gases, presumably by reducing fetal oxygen demand as the
maternal core temperature declines. Although it was previously
suggested that exposure to acetaminophen was associated with
clubfoot and digital abnormalities, these reports are not sustained
in large series. However, there appears to be a link between it and
gastroschisis and small bowel atresia, but not cardiac
ventriculoseptal defects. Unlike aspirin, acetaminophen has no
antiplatelet activity and does not pose a hemorrhagic risk to the
fetus.
Acetaminophen is excreted in low concentrations into breast
milk. The amount of the drug administered to the mother
estimated to be available to the neonate ranges from 0.04% to
0.23%, and it is generally considered compatible with
breastfeeding.
Tramadol may increase the risk of acetaminophen toxicity.
Local anesthetics may increase the risk of methemoglobinemia.
# References .........................
Beaulac Baillargeon L, Rocheleau S. Eur J Clin Pharmacol 1994;
46:451 4.
Cleves MA, Savell VH Jr, Raj S, et al; National Birth Defects
Prevention Study. Birth Defects Res Part A Clin Mol Teratol
2004; 70:107 13.
Committee on Drugs, American Academy of Pediatrics. Pediatrics
1994; 93:137 50.
Davis KM, Esposito MA, Meyer BA. Am J Obstet Gynecol
2006;194:967 71.
Kamandetdecha R, Tanninandorn Y. J Med Assoc Thai 2008;
91:282 6.
Kirshon B, Moise KJ Jr, Wasserstrum N. J Reprod Med 1989;
34:955 9.
Li DK, Liu L, Odouli R. BMJ 2003; 327:368 73.
Rayburn W, Shukla U, Stetson P, Piehl E. Am J Obstet Gynecol
1986; 155:1353 6.
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Wang LH, Rudolph AM, Benet LZ. J Pharmacol Exp Ther 1986;
238:198 205.
Weigand UW, Chou RC, Maulik D, Levy G. Pediatr Pharmacol
(New York) 1984; 4:145 53.
Werler MM, Mitchell AA, Hernandez Diaz S, Honein MA.
Am J Obstet Gynecol 2005;193:771 7.
Werler MM, Sheehan JE, Mitchell AA. Am J Epidemiol 2002;
155:26 31.
# Summary ...........................
Pregnancy Category: B
Acetaminophen is used throughout pregnancy for analgesia
and to reduce fever.
Like most drugs, it should be used during the 1st trimester
only when clearly necessary.
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Acetazolamide—(Acetadiazol; Acetamide; Azomid;
Dehydratin; Diamox; Diamox Sequels; Diamox Sodium; Ederen;
Glauconox; Inidrase; Nephramid; Oratrol)
International Brand Name Acetadiazol (Mexico); Albox (Japan); Apo Acetazolamide (Malaysia);
Carbinib (Portugal); Cetamid (Philippines); Defiltran (Germany); Diamox (Argentina, Bangladesh, Brazil, Bulgaria,
Canada, Chile, Czech Republic, Ecuador, Germany, Greece, Hungary, Korea, Mexico, Pakistan, Peru, Poland, Portugal,
Slovenia, South Africa, Turkey, Venezuela); Diamox Sustets (Colombia); Diluran (Czech Republic); Diural (Uruguay);
Diuramid (Germany, Poland); Edemox (Spain); Genephamide (Peru); Glaucomed (Colombia); Glaucomide (New Zealand);
Glaupax (Denmark, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Thailand); Huma Zolamide (Hungary);
Ledamox (Japan); Lediamox (Portugal); Ledimox (Japan, Portugal); Stazol (Paraguay)
# Drug Class ..........................
Carbonic anhydrase inhibitors; Diuretics
# Indications .........................
Glaucoma, open and closed angle; altitude sickness, prevention
and treatment; epilepsy; CHF; drug induced edema; urinary
alkalinization
# Mechanism .........................
Carbonic anhydrase inhibitor
Glaucoma 125 250mg PO/IV bid to qid
Altitude sickness 250 500mg PO bid beginning 48h before ascent
Epilepsy 375 1000mg (8 30mg/kg/d) PO qd if sole agent; begin
250mg qd if with other agents
Congestive heart failure 250 375mg PO/IV qd (for best results,
take on alternate days)
Drug induced edema 250 375mg PO/IV qd (for best results,
take on alternate days)
Urinary alkalinization 5mg/kg PO/IV bid or tid to maintain
alkaline urine pH
hyponatremia, hypokalemia, depressed respiratory function,
cirrhosis, hyperchloride acidosis, adrenocortical insufficiency
Caution hepatic and/or renal dysfunction
acetazolamide in pregnant women. Pregnancy is not known to
alter the impact, efficacy, and dosing of acetazolamide.
Side effects include aplastic anemia, Stevens Johnson syndrome,
toxic epidermal necrolysis, fulminant hepatitis, paresthesias, loss
of appetite, taste changes, dyspepsia, and polyuria.
6
human fetuses. Acetazolamide apparently crosses the human
placenta. There is no suggestion of teratogenicity in humans
despite a long clinical experience. A single case report documents
a preterm infant whose mother was treated for glaucoma
throughout pregnancy with oral acetazolamide. When renal
tubular acidosis developed, acetazolamide was detected in the
child’s serum, confirming transplacental passage. In some rodents,
acetazolamide is teratogenic (skeletal abnormalities consisting
variably of ossification defects or some form of postaxial forelimb
ectrodactyly in rats, urinary malformations in mice when
combined with amiloride). The prevalence of defects is enhanced
when combined with ibuprofen.
Acetazolamide is not concentrated in the milk, and the neonatal
exposure is <0.5% of the maternal dose. It is generally considered
compatible with breastfeeding.
Acetazolamide may modify phenytoin metabolism and increase
serum level of phenytoin. By decreasing the GI absorption of
primidone, it may decrease serum concentrations of primidone.
Acetazolamide reduces urinary excretion of quinidine and may
enhance its effect. It increases lithium excretion.
Acetazolamide may elevate cyclosporine levels.
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# References .........................
Academy of Pediatrics. Pediatrics 1994; 93:137 50.
Lee GS, Liao X, Cantor RM, Collins MD. Birth Defects Res A
Clin Mol Teratol 2006;76:19 28.
Nakatsuka T, Komatsu T, Fujii T. Teratology 1992; 45:629 36.
Ozawa H, Azuma E, Shindo K, et al. Eur J Pediatr 2001;
160:321 2.
# Summary ...........................
Pregnancy Category: C
Acetazolamide should be used during pregnancy and lactation
only if the benefit justifies the potential perinatal risk.
Acetohexamide—(Dimelin; Dimelor; Dymelor;
Gamadiabet; Ordimel; Toyobexin)
International Brand Name
Dimelin (Japan); Dimelor (South Africa, Taiwan); Toyobexin (Japan)
# Drug Class ..........................
Carbonic anhydrase inhibitors; Oral hypoglycemics;
Sulfonylureas
# Indications .........................
Diabetes mellitus, type II
# Mechanism .........................
Acutely stimulates the release of pancreatic insulin and thus
requires islet activity
Diabetes mellitus, type II begin 250mg/d before breakfast in
women not receiving another hypoglycemic agent; increase by
250 500mg every 5 7d until desired control
ketoacidosis, type I diabetes mellitus
Caution pregnancy
7
acetohexamide in pregnant women, and no publications within
the last 3 decades. Some oral hypoglycemic drugs are associated
with an increased risk of CV death compared to diet and insulin
control of glucose.
Side effects include hypoglycemia, cholestatic jaundice, GI upset,
allergic skin reactions, SIADH, hemolytic anemia, various
cytopenias, and hepatic porphyria.
human fetuses. Although acetohexamide apparently crosses the
placenta, there are no reports of teratogenicity in humans.
Prolonged neonatal hypoglycemia associated with hyperinsulinism
is reported. Differences in the extent of the placental transport of
various sulfonylureas are reported. Embryotoxicity is noted in
rodent studies.
There is no published experience in nursing women. It is
unknown whether acetohexamide enters human breast milk as
other sulfonylureas do.
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The hypoglycemic action of sulfonylureas can be enhanced by
some drugs, including NSAIDs and other drugs that are highly
protein bound, salicylates, sulfonamides, chloramphenicol,
probenecid, coumarins, MAOIs, and b blockers. Women treated
with both should be observed closely for hypoglycemia.
Thiazides and other diuretics, corticosteroids, phenothiazines,
thyroid products, estrogens, oral contraceptives, phenytoin,
nicotinic acid, sympathomimetics, calcium channel blockers, and
isoniazid tend to produce hyperglycemia and may lead to loss of
control or hypoglycemia when withdrawn.
Severe hypoglycemia was reported following concurrent use of
oral miconazole and oral hypoglycemic agents. It is not known
whether this interaction occurs with IV, topical, and vaginal
preparations of miconazole.
# References .........................
Kemball ML, McIver C, Milner RD, et al. Arch Dis Child 1970;
45:696 701.
# Summary ...........................
Pregnancy Category: C
Lactation Category: U
Insulin and diet regulation remain the standard treatments for
glucose intolerance during pregnancy.
There is growing interest in the use of oral hypoglycemic
agents during pregnancy, and acetohexamide might be a
candidate for future study. If a patient is maintained on
acetohexamide during pregnancy, she should be switched to
insulin 1 2w prior to delivery in hopes of reducing the risk of
neonatal hypoglycemia secondary to hyperinsulinism.
8

Acarbose —(Precose)

Transcription

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