ACARBOSE- acarbose tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

ACARBOSE

Composition:

ACARBOSE 50 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 also 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 50 mg tablets are supplied as round, white to off-white, biconvex tablets, debossed with product identification “54” over “737” on one side and plain on the other side. Bottle of 42 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. For bottles, keep container tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACARBOSE- ACARBOSE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
ACARBOSE TABLETS
RX ONLY
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 molecular formula is C
H
NO
and its
chemical structure is as follows:
Acarbose Tablets are available for oral administration containing 25
mg, 50 mg or 100 mg acarbose.
Each tablet contains the following inactive ingredients: colloidal
silicon dioxide, magnesium stearate,
microcrystalline cellulose and corn starch.
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 reduces 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 does not enhance insulin
secretion. The antihyperglycemic action
of acarbose results from a competitive, reversible inhibition of
pancreatic alpha-amylase and
a
25
43
18
membrane-bound intestinal alpha-glucoside hydrolase enzymes.
Pancreatic alpha-amylase hydrolyzes
complex starches to oligosaccharides in 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 th