Glucobay

Glucobay

acarbose

Manufacturer:

Bayer

Distributor:

Zuellig
Full Prescribing Info
Contents
Acarbose.
Description
Acarbose (Glucobay) 50 mg tablets: 1 tablet contains 50 mg acarbose.
Acarbose (Glucobay) 100 mg tablets: 1 tablet contains 100 mg acarbose.
Excipients/Inactive Ingredients: Microcrystalline cellulose; Silica, colloidal anhydrous; magnesium stearate; maize starch.
Action
Pharmacology: Pharmacodynamics: In all species tested acarbose exerts its activity in the intestinal tract. The action of acarbose is based on inhibition of the intestinal enzymes (α-glucosidases) involved in the degradation of disaccharides, oligosaccharides and polysaccharides. This leads to a dose-dependent delay in the digestion of these carbohydrates. Most importantly, glucose derived from carbohydrates is released and taken up into the blood more slowly. In this way acarbose postpones and reduces the postprandial rise in blood glucose. As a result of the balancing effect on the uptake of glucose from the intestine, the blood glucose fluctuations over the day are reduced and the mean blood glucose values decrease.
Pharmacokinetics: Absorption and Bioavailability: The bioavailability is 1-2% only. This extremely low systemically available percentage of inhibitory substance is desirable because acarbose acts only locally in the intestine. Thus, this low bioavailability has no relevance for the therapeutic effect.
Indications/Uses
Additional therapy in association with diet in patients with diabetes mellitus.
Prevention of onset of Type 2 Diabetes in individuals with confirmed impaired glucose tolerance*, in combination with diet and exercise.
Dosage/Direction for Use
Recommended usual dose for additional therapy in association with diet in patients with diabetes mellitus: The dosage must be adjusted by the doctor to suit each patient, because efficacy and tolerability vary from one individual to another.
Dosage regimen: Unless otherwise prescribed the recommended dosage is as follows: Initially 3x 1 tablet of 50 mg Acarbose (Glucobay)/day or; 3x ½ tablet of 100 mg Acarbose (Glucobay)/day; up to 3x 2 tablets of 50 mg Acarbose (Glucobay )/day or; 3x 1 tablet of 100 mg Acarbose (Glucobay)/day.
A further increase in dosage to 3x 200 mg Acarbose (Glucobay)/day may occasionally be necessary.
The dose may be increased after 4-8 weeks, and if patients show an inadequate clinical response in the later course of the treatment. If distressing complaints develop inspite of strict adherence to the diet, the dose should not be increased further, and if necessary should be somewhat reduced. The average dose is 300 mg Acarbose (Glucobay)/day (corresponding to 3x 2 tablets of Acarbose (Glucobay) tablets 50 mg/day, or 3x 1 tablet of Acarbose (Glucobay) tablets 100 mg/day).
Recommended usual dose for the prevention of type 2 diabetes in patients with impaired glucose tolerance: Recommended dose: 3x 100 mg/day.
Treatment should be initiated with a dose of 50 mg once daily and escalated to 3x 100 mg/day within 3 months.
Method of administration: Acarbose (Glucobay) tablets are effective only if swallowed whole with a little liquid directly before the meal or be chewed with the first few mouthfuls of the meal.
Contraindications
Hypersensitivity to acarbose and/or to inactive constituents.
Chronic intestinal disorders associated with distinct disturbances of digestion and absorption.
States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld's syndrome, major hernias, intestinal obstructions, and intestinal ulcers).
Acarbose (Glucobay) is contraindicated in patients with severe renal impairment (creatinine clearance <25 mL/min).
Special Precautions
Asymptomatic liver enzyme elevations may occur in individual cases. Therefore liver enzyme monitoring should be considered during the first 6 to 12 months of treatment. In evaluable cases these changes were reversible on discontinuation of Acarbose (Glucobay) therapy.
Safety and efficacy of Acarbose (Glucobay) in patients under 18 years of age have not been established.
Use In Pregnancy & Lactation
Pregnancy: Glucobay should not be administered during pregnancy, as no information from controlled clinical studies is available on its use in pregnant women.
Lactation: After administration of radiolabeled acarbose to lactating rats, a small quantity of the radioactivity was found in milk. There are as yet no corresponding findings in humans. However, as drug-induced effects of acarbose in milk have not been excluded in babies in principle, it is advisable not to prescribe Glucobay during the breastfeeding period.
Adverse Reactions
The frequencies of ADRs reported with Glucobay based on placebo-controlled studies sorted by CIOMS III categories of frequency (placebo-controlled studies in clinical trial database: Glucobay N=8595; placebo N=7278; status: 10 Feb 2006) are summarized in the table as follows:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000).
The ADRs identified only during post-marketing surveillance (status: 31 Dec 2005), and for which a frequency could not be estimated are listed under "not known".

Click on icon to see table/diagram/image

In addition events reported as liver disorder, abnormal hepatic function and liver injury have been received especially from Japan.
Individual cases of fulminant hepatitis with fatal outcome have been reported in Japan. The relationship to Glucobay is unclear.
If the prescribed diabetic diet is not observed, the intestinal side effects may be intensified.
If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.
In patients receiving the recommended daily dose of Glucobay 150-300 mg/day, rarely clinically relevant abnormal liver function tests (3 times above upper limit of normal range) were observed. Abnormal values may be transient under ongoing Glucobay therapy.
Drug Interactions
Sucrose (cane sugar) and foods containing sucrose often cause abdominal discomfort or even diarrhea during treatment with Acarbose (Glucobay) tablets as a result of increased carbohydrate fermentation in the colon.
Acarbose has an antihyperglycaemic effect, but does not itself induce hypoglycaemia.
If Acarbose (Glucobay) tablets are prescribed in addition to drugs containing sulphonylureas or metformin, or in addition to insulin, a fall of the blood glucose values into the hypoglycaemic range may necessitate a suitable decrease in the sulphonylurea, metformin or insulin dose. In individual cases hypoglycaemic shock may occur.
If acute hypoglycaemia develops it should be borne in mind that sucrose (cane sugar) is broken down into fructose and glucose more slowly during treatment with Acarbose (Glucobay); for this reason sucrose is unsuitable for a rapid alleviation of hypoglycaemia and glucose should be used instead.
In individual cases Acarbose (Glucobay) may affect digoxin bioavailability, which may require dose adjustment of digoxin.
Because they may possibly influence the action of Acarbose (Glucobay) tablets, simultaneous administration of cholestyramine, intestinal adsorbents and digestive enzyme products should be avoided.
The concomitant administration of Acarbose (Glucobay) and oral neomycin may lead to enhanced reductions of post prandial blood glucose and to an increase in the frequency and severity of gastro-intestinal side-effects. If the symptoms are severe, a temporary dose reduction of Acarbose (Glucobay) may be considered.
Caution For Usage
Instructions for use/handling: At storage conditions up to 25°C and below 60% relative humidity the unpacked tablets can be stored for up to two weeks. At higher temperatures and/or higher relative humidity, discoloration can occur in tablets that are not in the pack. The tablets should therefore only be removed from the foil or bottle immediately prior to use.
Incompatibilities: None.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
A10BF01 - acarbose ; Belongs to the class of alpha glucosidase inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Tab 50 mg x 100's. 100 mg x 100's.
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