MIGLITOL tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries Inc.

INN (International Name):

Miglitol

Composition:

Miglitol 25 mg

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:

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. Strength NDC Tablet Identification Bottles of 100 : Front Back 25 mg 57664-684-88 OP 25 50 mg 57664-685-88 OP 26 100 mg 57664-686-88 OP 27 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured by: Orient Pharma Co., Ltd. Yunlin, Taiwan Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Rev. 03/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIGLITOL- MIGLITOL TABLET, COATED
SUN PHARMACEUTICAL INDUSTRIES INC.
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MIGLITOL TABLETS
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
pKa 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 of sulfonylure