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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
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Glimepiride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
There is currently no drug history available for this drug.
Glimepiride is an oral sulfonylurea that contains the active ingredient glimepiride. 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 (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride, USP is a white, crystalline, odorless to practically odorless powder and is practically insoluble in water.
The structural formula is:
Glimepiride tablets, USP contain the active ingredient glimepiride, USP and the following inactive ingredients:lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. In addition, the 2 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake and the 4 mg also contains D&C Red No. 27 Aluminum Lake.