Eclid

Eclid

acarbose

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Acarbose.
Action
Pharmacology: Acarbose is an alpha-glucosidase inhibitor antidiabetic agent. Acarbose does not enhance insulin secretion. Acarbose is a reversible, competitive inhibitor of pancreatic alpha-amylase and membrane bound intestinal alpha-glucosidase hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidase hydrolyzes oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine.
In diabetic patients, inhibition of these enzymes results in delayed carbohydrate breakdown and glucose absorption and a lowering of postprandial hyperglycemia.
As a result of balancing effect on the uptake of glucose from the intestine, the blood glucose fluctuation over the day are reduced and the mean blood glucose values decreases.
Indications/Uses
Additional therapy in association with diet in patients with diabetes mellitus.
Dosage/Direction for Use
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: Initial Dose: 3x1 tablet of acarbose 50 mg/day or 3x ½ tablet of acarbose 100 mg/day.
Subsequent Dose: 3x2 tablet of acarbose 50 mg/day or 3x1 tablet of acarbose 100 mg/day up to 3x2 tablet of acarbose 100 mg/day.
The dose may be increased after 4-8 weeks, and if the patient 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 acarbose/day (corresponding to 3x2 tablet acarbose 50 mg/day, or 3x1 tablet acarbose 100 mg/day).
Elderly (Above 65 years): No alteration of dosage or dosing frequency is recommended with regard to the age of the patients.
Hepatic Impairment: No dose adjustment is required in patients with pre-existing impaired hepatic function.
Administration: Acarbose 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.
No limit to the length of time for which acarbose can be used is envisaged. The limitation on dosage is due to the secondary effects of carbohydrate malabsorption, in particular distension, flatulence, and loose stools. Some adaptations to these effects occurs in the first few weeks of use. The optimal therapeutic dose is established by minimizing while reducing postprandial glycemic issues.
Overdosage
When acarbose tablets are taken with drinks and/or meals considering carbohydrates (disaccharides, oligosaccharides, or polysaccharides), overdosage can lead to meteorism, flatulence, and diarrhea. If an overdose of acarbose is taken without food excessive intestinal symptoms are unlikely. In cases of overdosage, the patient should not be given drinks or meals containing carbohydrates (disaccharides, oligosaccharides, or polysaccharides) for the next 4-6 hours.
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 hernia, intestinal obstructions, and intestinal ulcers).
Inflammatory bowel disease, such as ulcerative colitis and Crohn's disease, partial intestinal obstruction or in patients predisposed to intestinal obstruction or ileus.
Acarbose should not be used in patients with severe renal impairment (creatinine clearance <25 mL/min).
Use in pregnancy & lactation: Acarbose should not be administered during pregnancy, as no information is available on its use in pregnant women.
After administration of radiolabeled acarbose in lactating rats, a small quantity of the radioactivity was found in the 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 acarbose during the breast-feeding period.
Use in children: Since the information on its effects and tolerability in children and adolescents is still insuficient, acarbose should not be used in patients under 18 years of age.
Special Precautions
A symptomatic liver enzyme elevations may occur in individual cases. Therefore, liver enzyme monitoring should be considered during the first 6-12 months of treatment. In evaluated cases, these changes were reversible on discontinuation of acarbose therapy.
Strict adherence to a diabetic diet is still imperative when taking acarbose.
Adverse Reactions
Adverse Events Observed in Controlled Clinical Trials: Very commonly, flatulence. Commonly, diarrhea and abdominal pain. Uncommonly, nausea.
If the prescribed diabetic diet is not observed, the individual 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 were clinically relevant abdominal liver function tests (three times above upper limit of normal range) were observed (see Precautions). Abnormal values may be transient with ongoing acarbose therapy.
Adverse Events From Spontaneous Reports: Very rarely, hypersensitive skin reactions may occur e.g. rash, erythema, exanthema, and urticaria.
Very rarely, edema were observed.
Very rarely, ileus may occur.
Very rarely, cases of jaundice and/or hepatitis and suspected liver damage have been reported.
Individual cases of fulminant hepatitis with fatal outcomes have been reported in Japan. The relationship to acarbose is unclear.
There have been occasional reports of sleepiness, weakness, dizziness, headache and vertigo.
Drug Interactions
Sucrose (cane sugar) and foods containing sucrose 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 hypoglycemia. If acarbose is prescribed in addition in drugs containing sulphonylureas, metformin, or insulin, a fall of the blood glucose values into the hypoglycemic 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; for this reason, sucrose is unsuitable for a rapid alteration of hypoglycemia 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 antacids, cholestyramine, intestinal adsorbents, and digestive enzyme products should be avoided.
No interactions was observed with dimethicone/simethicone.
Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include diuretics (thiazides, furosemide), corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and isoniazid. When such drugs are administered to patient receiving acarbose, the patient 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 postprandial 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 dose may warranted.
Storage
STORE AT TEMPERATURE BELOW 30°C. PROTECT FROM LIGHT.
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 5 x 10's. 100 mg x 5 x 10's.
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