GLYSET- miglitol tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MIGLITOL (UNII: 0V5436JAQW) (MIGLITOL - UNII:0V5436JAQW)

Available from:

Pharmacia & Upjohn Company LLC

INN (International Name):

MIGLITOL

Composition:

MIGLITOL 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - Diabetic ketoacidosis - Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to intestinal obstruction - 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 - Hypersensitivity to the drug or any of its components.

Product summary:

GLYSET Tablets are available as 25 mg, 50 mg, and 100 mg tablets. Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

GLYSET- MIGLITOL TABLET, FILM COATED
PHARMACIA & UPJOHN COMPANY LLC
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GLYSET (MIGLITOL) TABLETS
For Oral Use
DESCRIPTION
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-(2α,3β,4α, 5β)]-. It is a
white to pale-yellow
powder with a molecular weight of 207.2. Miglitol is soluble in water
and has a pK of 5.9.
Its empirical formula is C H
NO and its chemical structure is as follows:
GLYSET is available as 25 mg, 50 mg and 100 mg tablets for oral use.
The inactive
ingredients are starch, microcrystalline cellulose, magnesium
stearate, hypromellose,
polyethylene glycol, titanium dioxide, and polysorbate 80.
CLINICAL PHARMACOLOGY
Miglitol is a desoxynojirimycin derivative that delays the digestion
of ingested
carbohydrates, thereby resulting in a smaller rise in blood glucose
concentration
following meals. As a consequence of plasma glucose reduction, GLYSET
Tablets reduce
levels of glycosylated hemoglobin in patients with Type II
(non-insulin-dependent)
diabetes mellitus. Systemic nonenzymatic protein glycosylation, as
reflected by levels of
glycosylated hemoglobin, is a function of average blood glucose
concentration over
time.
MECHANISM OF ACTION
In contrast to sulfonylureas, GLYSET does not enhance insulin
secretion. The
antihyperglycemic action of miglitol results from a reversible
inhibition of membrane-
bound intestinal α-glucoside hydrolase enzymes. Membrane-bound
intestinal α-
glucosidases hydrolyze oligosaccharides and disaccharides to glucose
and other
monosaccharides in the brush border of the small intestine. In
diabetic patients, this
enzyme inhibition results in delayed glucose absorption and lowering
of postprandial
hyperglycemia.
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Because its mechanism of action is different, the effect of GLYSET to
enhance glycemic
control is additive to that of