GLIMEPIRIDE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)

Доступна с:

Rebel Distributors Corp

ИНН (Международная Имя):

GLIMEPIRIDE

состав:

GLIMEPIRIDE 2 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (See DOSAGE AND ADMINISTRATION section ).   Glimepiride tablets are contraindicated in patients with 1. Known hypersensitivity to the drug. 2. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. 

Обзор продуктов:

Glimepiride tablets USP, 1 mg are green, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “320” separating “3” and “20” with bisect line scoring on the other side and are supplied in bottles of 120. Bottles of 120                                      NDC 21695-746-72 Glimepiride tablets USP, 2 mg are green, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “321” separating “3” and “21” with bisect line scoring on the other side and are supplied in bottles of 30 and 90. Bottles of 30                                       NDC 21695-746-30 Bottles of 90                                      NDC 21695-746-90 Glimepiride tablets USP, 4 mg are blue, oval, flat bevelled edged, uncoated tablets embossed “RDY” on one side and “322” separating “3” and “22” with bisect line scoring on the other side and are supplied in bottles of 30, 60 and 90. Bottles of 30                                       NDC 21695-747-30 Bottles of 60                                      NDC 21695-747-60 Bottles of 90                                     NDC 21695-747-90 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in well-closed containers with safety closures.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

GLIMEPIRIDE- GLIMEPIRIDE TABLET
REBEL DISTRIBUTORS CORP
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GLIMEPIRIDE TABLETS USP
DESCRIPTION
Glimepiride tablets USP, are an oral blood-glucose-lowering drug of
the sulfonylurea class.
Glimepiride is a white to yellowish-white, crystalline, odorless to
practically odorless powder
formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral
administration. Glimepiride tablets
contain the active ingredient glimepiride and the following inactive
ingredients: lactose monohydrate,
magnesium stearate, microcrystalline cellulose, povidone and sodium
starch glycolate. In addition,
glimepiride 1 mg tablets contain ferric oxide red, glimepiride 2 mg
tablets contain lake blend green
(contains D&C yellow # 10 aluminium lake and FD&C blue #1/ brilliant
blue FCF aluminium lake) and
glimepiride 4 mg tablets contain lake blend blue (contains D&C yellow
# 10 aluminium lake and FD&C
blue # 1/ brilliant blue FCF aluminium lake).
Chemically, glimepiride is identified as
1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-
carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea.
The CAS Registry Number is 93479-97-1
The structural formula is:
Molecular Formula: C
H N O S
Molecular Weight: 490.62
Glimepiride is practically insoluble in water.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The primary mechanism of action of glimepiride in lowering blood
glucose appears to be dependent on
stimulating the release of insulin from functioning pancreatic beta
cells. In addition, extrapancreatic
effects may also play a role in the activity of sulfonylureas such as
glimepiride. This is supported by
both preclinical and clinical studies demonstrating that glimepiride
administration can lead to increased
sensitivity of peripheral tissues to insulin. These findings are
consistent with the results of a long-term,
randomized, placebo-controlled trial in which glimepiride therapy
improved postprandial insulin/C-
peptide responses and overall glycemic control without producing
clinically meaningful increases in
fasting insulin/C-pe