GLIMEPIRIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

STAT Rx USA LLC

INN (국제 이름):

GLIMEPIRIDE

구성:

GLIMEPIRIDE 4 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 ). Glimepiride tablets are contraindicated in patients with - Known hypersensitivity to the drug. - Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

제품 요약:

Bottles of 30 - NDC # 42549-498-30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

GLIMEPIRIDE - GLIMEPIRIDE TABLET
STAT RX USA LLC
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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
USP contain the active ingredient glimepiride and the following
inactive ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone,
and sodium starch glycolate. In
addition, glimepiride tablets USP 1 mg contain ferric oxide red,
glimepiride tablets USP 2 mg contain
ferric oxide yellow and FD&C Blue #2 aluminum lake, and glimepiride
tablets USP 4 mg contain FD&C
Blue #2 aluminum 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-peptide levels. However, as with other
sulfonylureas, the mechanism by which
glimepiride lowers blood glucose during long-term administration has
not been clear