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GLYSET (MIGLITOL): PRESCRIBING INFORMATION
Glyset tablets contain miglitol, an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Miglitol is a desoxynojirimycin derivative, and is chemically known as 3,4,5-piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, [2R-(2alpha,3beta,4alpha,5beta)]-. It is a white to pale-yellow powder with a molecular weight of 207.2. Miglitol is soluble in water and has a pKa of 5.9. Its empirical formula is C8H17NO5.
Glyset (Miglitol) is available as 25 mg, 50 mg and 100 mg tablets for oral use. The inactive ingredients are starch, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80.
Glyset clinical pharmacology
Glyset clinical studies
INDICATIONS AND USAGE
Miglitol (Glyset) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glyset tablets are contraindicated in patients with:
Chronic intestinal diseases associated with marked disorders of digestion or absorption, or with conditions that may deteriorate as a result of increased gas formation in the intestine
Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to intestinal obstruction
Hypersensitivity to the drug or any of its components.
Glyset drug interactions
USE IN SPECIAL POPULATIONS
Glyset use in special populations
Glyset adverse reactions
Unlike sulfonylureas or insulin, an overdose of Glyset (Miglitol) tablets will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort. Because of the lack of extra-intestinal effects seen with Miglitol (Glyset), no serious systemic reactions are expected in the event of an overdose.
DOSAGE AND ADMINISTRATION
Glyset dosage and administration
Glyset (Miglitol) tablets are available as 25 mg, 50 mg, and 100 mg white, round, film-coated tablets. The tablets are debossed with the word "Glyset" on one side and the strength on the other side.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)
Manufactured by Bayer and distributed by Pfizer pharmaceutical companies and its divisions.
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