PRECOSE- acarbose tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

ACARBOSE

Composition:

ACARBOSE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PRECOSE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. PRECOSE is contraindicated in patients with known hypersensitivity to the drug. Precose is contraindicated in patients with diabetic ketoacidosis or cirrhosis. PRECOSE is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, PRECOSE is 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:

PRECOSE is available as 25 mg, 50 mg or 100 mg round, unscored tablets. Each tablet strength is white to yellow-tinged in color. The 25 mg tablet is coded with the word “PRECOSE” on one side and “25” on the other side. The 50 mg tablet is coded with the word “PRECOSE” and “50” on the same side. The 100 mg tablet is coded with the word “PRECOSE” and “100” on the same side. PRECOSE is available in bottles of 100 and 50 mg strength in unit dose packages of 100. Strength NDC Tablet Identification Bottles of 100: 25 mg 50419-863-51 PRECOSE   25 50 mg 50419-861-51 PRECOSE   50 100 mg 50419-862-51 PRECOSE 100 Unit Dose Packages of 100: 50 mg 50419-861-48 PRECOSE   50 Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Germany ©2015 Bayer HealthCare Pharmaceuticals Inc. 3/15

Authorization status:

New Drug Application

Summary of Product characteristics

PRECOSE- ACARBOSE TABLET
BAYER HEALTHCARE PHARMACEUTICALS INC.
----------
PRECOSE
(ACARBOSE TABLETS)
DESCRIPTION
PRECOSE (acarbose tablets) is 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 pKa of 5.1. Its
empirical formula is C
H NO and its
chemical structure is as follows:
PRECOSE is available as 25 mg, 50 mg and 100 mg tablets 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, PRECOSE 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, PRECOSE does 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 in the brush border of the small intestine.
In diabetic patients, this enzyme
i