GLIMEPIRIDE- glimepiride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 

Product summary:

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 30     NDC 35356-896-30 Bottles of 60     NDC 35356-896-60 Bottles of 90     NDC 35356-896-90 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. 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. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in well-closed containers with safety closures.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIMEPIRIDE- GLIMEPIRIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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