MIGLITOL tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Westminster Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Miglitol 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:

Miglitol tablets are available as 25 mg, 50 mg, and 100 mg white to off-white, circular, biconvex film-coated tablets, debossed with the logo-mark "OP" on one side and the product code on the other side, as indicated below. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIGLITOL- MIGLITOL TABLET, COATED
WESTMINSTER PHARMACEUTICALS, LLC
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MIGLITOL TABLETS
For Oral Use
DESCRIPTION
Miglitol Tablets, 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-(2a,3ß,4a, 5ß)]-. 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:
Miglitol tablets are available as 25 mg, 50 mg, and 100 mg tablets for
oral use. The
inactive ingredients are corn starch, microcrystalline cellulose,
magnesium stearate,
hypromelloses, polyethylene glycols, 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,
miglitol 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, miglitol tablets do 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.
Because its mechanism of action is different, the effect of miglitol
tablets to enhance
glycemic control is additive to that o