ACARBOSE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACARBOSE (UNII: T58MSI464G) (ACARBOSE - UNII:T58MSI464G)

Available from:

Strides Pharma Science Limited

INN (International Name):

ACARBOSE

Composition:

ACARBOSE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acarbose Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Acarbose Tablets are contraindicated in patients with known hypersensitivity to the drug. Acarbose Tablets are contraindicated in patients with diabetic ketoacidosis or cirrhosis. Acarbose Tablets are also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, Acarbose Tablets are contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

Product summary:

Acarbose Tablets are available as 25 mg, 50 mg or 100 mg, circular biconvex tablets. Each tablet strength is white to yellow-tinged in color. The 25 mg tablet is engraved with 'P210' on one side and '25' on the other side. The 50 mg tablet is engraved with 'P211' on one side and '50' on the other side. The 100 mg tablet is engraved with 'P212' on one side and '100' on the other side. Acarbose Tablets are available in bottles of 100 and bottles of 1000. Store at 20˚ to 25˚C (68˚ to 77˚F) [see USP Controlled Room Temperature]. Protect from moisture. Keep container tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACARBOSE - ACARBOSE TABLET
STRIDES PHARMA SCIENCE LIMITED
----------
ACARBOSE TABLETS
DESCRIPTION
Acarbose Tablets are an oral alpha-glucosidase inhibitor for use in
the management of
type 2 diabetes mellitus. Acarbose is an oligosaccharide which is
obtained from
fermentation processes of a microorganism, Actinoplanes utahensis, and
is chemically
known as O-4,6-dideoxy-
4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-
cyclohexen-1-yl]amino]- α-D-glucopyranosyl-(1 →
4)-O-α-D-glucopyranosyl-(1 → 4)-D-
glucose. It is a white to off-white powder with a molecular weight of
645.6. Acarbose is
soluble in water and has a pK of 5.1. Its empirical formula is C
H
NO
and its
chemical structure is as follows:
Acarbose Tablets are available as 25 mg, 50 mg and 100 mg for oral
use. The inactive
ingredients are starch, microcrystalline cellulose, magnesium
stearate, and colloidal
silicon dioxide.
CLINICAL PHARMACOLOGY
Acarbose is a complex oligosaccharide 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,
Acarbose Tablets
reduce levels of glycosylated hemoglobin in patients with type 2
diabetes mellitus.
Systemic non-enzymatic 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, Acarbose Tablets do not enhance insulin
secretion. The
antihyperglycemic action of acarbose results from a competitive,
reversible inhibition of
pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside
hydrolase
enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to
oligosaccharides in
a
25
43
18
the lumen of the small intestine, while the membrane-bound intestinal
alpha-glucosidases
hydrolyze oligosaccharides, trisaccharides, and disaccharides to
glucose and other
monosaccharides in the brush border of the small intestine. In
diabetic patients, this
enzym