ACARBOSE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

ACARBOSE

Composition:

ACARBOSE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acarbose tablets, USP 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, USP are supplied as follows: For 25 mg: White to off white, round, biconvex tablets, debossed with "HP" on one side and "147" on other side. For 50 mg: White to off white, round, biconvex tablets, debossed with "HP" and "148" on one side and plain on other side. For 100 mg: White to off white, round, biconvex tablets, debossed with "HP" and "149" on one side and plain on other side. Acarbose Tablets, USP 25 mg/50 mg/100 mg are available in Bottles of 100, 500 & 1,000. Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Protect from moisture. For bottles, keep container tightly closed. Manufactured by: RA CHEM PHARMA LIMITED Hyderabad – 500 076, INDIA Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 01/2020 OR Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG(3784) 40211 Revised: 06/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACARBOSE- ACARBOSE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
ACARBOSE TABLETS, USP
DESCRIPTION
Acarbose Tablets, USP 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, USP are available as 25 mg, 50 mg and 100 mg tablets
for oral use.
The inactive ingredients are starch (corn 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.
a
25
43
18
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
the lumen of the small intestine, while the membrane-bound intestinal
alpha-glucosidases
hydrolyze oligosaccharides, trisaccharides, and disaccharides to
glucose and other
monosaccharides i