ACARBOSE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Aphena Pharma Solutions - Tennessee, LLC

INN (الاسم الدولي):

ACARBOSE

تركيب:

ACARBOSE 50 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Acarbose 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. Strength NDC Tablet Identification Bottles of 100: 25 mg 47781-340-01 Precose 25 50 mg 47781-341-01 Precose 50 100 mg 47781-342-01 Precose 100 Do not store above 25°C (77°F). Protect from moisture. Keep container tightly closed. Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Germany Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 Rev. 3/2015

الوضع إذن:

New Drug Application Authorized Generic

خصائص المنتج

ACARBOSE- ACARBOSE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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ACARBOS E
DESCRIPTION
Acarbose 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:
Acarbose tablets are available as 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, 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
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
25
43
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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
inhibition results in a delay