ACARBOSE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Virtus Pharmaceuticals LLC

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 25 mg are white to yellowish, round biconvex tablets marked "318 " on one face and "cor " on the other face. They are supplied as follows: Bottles of 100 NDC 69543-120-10 Bottles of 1000 NDC 69543-120-11 Acarbose Tablets 50 mg are white to yellowish, round biconvex tablets marked "319 " on one face and "cor " on the other face. They are supplied as follows: Bottles of 100 NDC 69543-121-10 Bottles of 1000 NDC 69543-121-11 Acarbose Tablets 100 mg are white to yellowish, round biconvex tablets marked "320 " on one face and "cor " on the other face. They are supplied as follows: Bottles of 100 NDC 69543-122-10 Bottles of 1000 NDC 69543-122-11 Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from moisture. Keep container tightly closed. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rev: May 2018 Distributed By: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 1-888-848-3593 Manufactured By: Bluepharma Indústria Farmacêutica, S.A. S. Martinho do Bispo 3045-016 Coimbra, Portugal

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACARBOSE- ACARBOSE TABLET
VIRTUS PHARMACEUTICALS LLC
----------
ACARBOSE TABLETS
25 MG, 50 MG AND 100 MG
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-[[(1_S_,4_R_,5_S_,6_S_)-
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 tablets for
oral use. The inactive
ingredients are corn starch, magnesium stearate, microcrystalline
cellulose 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 the lumen of the small
intestine, while the membrane-bound
intestinal alpha-glucosidases hydrolyze oligosaccharides,
trisaccharides, and disaccharides to glucose
a
25
43
18
and other monosaccharides in the brush border of the sma