Capribose

CAPRIBOSE 50: Each tablet contains: Acarbose 50 mg. CAPRIBOSE 100: Each tablet contains: Acarbose 100 mg.

Pharmacology: The active ingredient of CAPRIBOSE is Acarbose, a pseudotetrasaccharide of microbial origin. Acarbose exerts its activity in the intestinal tract. The action is based on the inhibition of 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.

Additional therapy associated 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.
Unless otherwise prescribed, the recommended dosage is as follows: Initially 3 x 1 tablet of 50 mg CAPRIBOSE/day or 3 x ¹/₂  tablet of 100 mg CAPRIBOSE/day. Subsequently 3 x 2 tablet of 50 mg CAPRIBOSE/day or 3 x 1 tablet of 100 mg CAPRIBOSE/day up to 3 x 2 tablet of 100 mg CAPRIBOSE/day.
Doses 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 in spite 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 CAPRIBOSE/ day (corresponding to 2 tablets of CAPRIBOSE 50 or 1 tablet CAPRIBOSE 100, 3 times daily).
Elderly (> 65 years): No alteration of dosage or dosing frequency is recommended with regard to the age of the patients.
Hepatic Impairment: There is no dose adjustment for patients with a history of impaired liver function.
Administration: CAPRIBOSE is only effective if swallowed whole with a little liquid directly before meals or chewed with the first mouthful of meal.
No limit to the length of time for which CAPRIBOSE can be used is envisaged. The limitation on dosage is due to the secondary effects of carbohydrate malabsorption, in particular distention, flatulence, and loose stools. Some adaptation to these effects occurs in the first few weeks of use. The optimal therapeutic dose is established by minimizing whilst reducing postprandial glycaemic rises.

When CAPRIBOSE is taken with drinks and/or meals containing carbohydrates (disaccharides, oligosaccharides or polysaccharides), then overdosage can lead to meteorism, flatulence and diarrhea.
In the event of CAPRIBOSE tablets being taken in an overdose independently of food, excessive intestinal symptoms need not be anticipated.
In case of overdosage, any carbohydrate-containing beverage or food (disaccharides, oligosaccharides or polysaccharides) should not be given for the next 4-6 hours.

Hypersensitivity to Acarbose.
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 obstruction and ulcer.
Patients with severe renal impairment (creatinine clearance < 25 mL/min).
Inflammatory bowel disease, e.g. ulcerative colitis and Chron's disease, partial intestinal obstruction or in patients predisposed to intestinal obstruction or ileus.
Since the information on its effects and tolerability in children and adolescents is still insufficient, Acarbose should not be used in patients under 18 years.

Symptomatic increase of liver enzyme may occur in several cases. Therefore, examination of liver enzyme should be done during the first 6-12 months of treatment. In the evaluated case, this change is reversible after discontinuation of Acarbose therapy.
Diabetic diet should be adhered during the administration of Acarbose.

Acarbose should not be administered during pregnancy as no information is available on its use in pregnant woman.
Since the effect of Acarbose in breast milk has not been excluded, Acarbose should not be administered during lactation.

Blood and Lymphatic System Disorders: Thrombocytopenia.
Immune System Disorders: Allergic reaction (rash, erythema, exanthema, urticaria).
Vascular Disorders: Oedema.
Gastrointestinal Disorsers: Flatulence, diarrhea, gastrointestinal and abdominal pains, nausea, vomiting, dyspepsia, subileus/ ileus pneumonia cytoidis intestinalis.
Hepatobiliary Disorder: Transient increase in liver enzymes, jaundice, hepatitis.
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 150-300 mg Acarbose/day, rarely clinically relevant abnormal liver function test (three times above upper limit of normal range) were observed (see Precautions).
Abnormal values may be transient under ongoing CAPRIBOSE therapy.

Sucrose and food containing often cause abdominal discomfort or even diarrhea during treatment with Acarbose as a result of increased carbohydrate fermentation in the colon.
Acarbose has an antihyperglycemic effect but does not itself induce hypoglycaemia.
If Acarbose is 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 sulphonylureas, metformin, or insulin dose. In individual cases hypoglycaemic shock may occur.
If acute hypoglycaemia develops it should be borne in mind that sucrose is broken down into fructose and glucose more slowly during treatment with Acarbose; for this reason sucrose is unsuitable for a rapid alleviation of hypoglycaemia and glucose should be used instead.
In individual cases Acarbose may affect digoxin bioavailability, which may require dose adjustment of digoxin.
Because they may possibly influence the action of Acarbose, simultaneous administration of cholestyramine, intestinal adsorbents, and digestive enzyme products should be avoided. No interaction was observed with dimeticone/simeticone.
Drugs that tend to result in hyperglycaemia and may lead to loss of blood glucose control include diuretics (thiazides, furosemide), corticosteroids , phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics and isoniazid. If these drugs are given to patients who are receiving Acarbose, the patients should be closely monitored for loss of blood glucose control.
Due to neomycin induced malabsorption of carbohydrate, concomitant administration of neomycin may lead to an enhanced reduction of post prandial blood glucose and to an increase in the frequency and severity of gastrointestinal adverse reactions. If the symptoms are severe, a temporary dose reduction of Acarbose may be warranted.

Store below 30°C, away from light.

Antidiabetic Agents

A10BF01 - acarbose ; Belongs to the class of alpha glucosidase inhibitors. Used in the treatment of diabetes.

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