GLIMEPIRIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

STAT Rx USA LLC

INN (International Adı):

GLIMEPIRIDE

Kompozisyon:

GLIMEPIRIDE 2 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Glimepiride Tablets, USP 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, USP 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. The safety and efficacy of glimepiride were evaluated in an active-controlled, single-blind (patients only), 24-week trial involving 272 pediatric patients, ranging from 8 to 17 years of age, with Type 2 diabetes. Glimepiride (n=135) was administered at 1 mg initially, and then titrated up to 2, 4 or 8 mg (mean last dose 4 mg) until the therapeutic goal of self-monitored fasting blood glucose less than  7.0 mmol/L (less than 126 mg/dL) was achieved. The active comparator metformin (n=137) was administered at 500 mg twice daily initially and titrated up to 1000 mg twice daily (mean last dose 1365 mg). The profile of adverse rea

Ürün özeti:

Glimepiride Tablets, USP are available in the following strengths and package sizes: 2 mg (green, round, flat faced, beveled edge tablets de-bossed with I on the left side of bisect and G on right side of bisect on one side and “204” on the other). Bottles of 30 -  NDC 42549-499-30 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA  30501

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

GLIMEPIRIDE - GLIMEPIRIDE TABLET
STAT RX USA LLC
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GLIMEPIRIDE TABLETS, USP 2 MG
DESCRIPTION
Glimepiride Tablets, USP are an oral blood-glucose-lowering drug of
the sulfonylurea class.
Glimepiride, USP 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, USP and the following
inactive ingredients: lactose
monohydrate, magnesium stearate, povidone, and sodium starch
glycolate. In addition, Glimepiride 1-mg
tablets contain Ferric Oxide (Iron Oxide Red), Glimepiride 2-mg
tablets contain Ferric Oxide (Iron
Oxide Yellow), and FD and C Blue #2 Aluminum Lake, and Glimepiride
4-mg tablets contain FD and 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: C24H34N4O5S
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