ACARBOSE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Hikma Pharmaceuticals USA Inc.

Designación común internacional (DCI):

ACARBOSE

Composición:

ACARBOSE 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Acarbose Tablets, USP 25 mg tablets are supplied as round, white to off-white, biconvex tablets, debossed with product identification “54” over “311” on one side and plain on the other side. NDC 0054-0140-25: Bottle of 100 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. NDC 0054-0141-25: Bottle of 100 Tablets NDC 0054-0141-20: 10x10 Unit-Dose 100 mg tablets are supplied as round, white to off-white, biconvex tablets, debossed with product identification “54” over “251” on one side and plain on the other side. NDC 0054-0142-25: Bottle of 100 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. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000234/01 Revised February 2023

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ACARBOSE- ACARBOSE TABLET
HIKMA PHARMACEUTICALS USA INC.
----------
ACARBOSE TABLETS, USP
RX ONLY
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
645.60. 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, USP are available for oral administration containing
25 mg, 50 mg or
100 mg acarbose, USP. 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
a
25
43
18
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 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