Amaryl
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
AMARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)].
AMARYL should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
History
There is currently no drug history available for this drug.
Other Information
AMARYL 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 is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water.
The structural formula is:
AMARYL tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose (hydrous), sodium starch glycolate, povidone, microcrystalline cellulose, and magnesium stearate. In addition, AMARYL 1 mg tablets contain Ferric Oxide Red, AMARYL 2 mg tablets contain Ferric Oxide Yellow and FD&C Blue #2 Aluminum Lake, and AMARYL 4 mg tablets contain FD&C Blue #2 Aluminum Lake.
Sources
Amaryl Manufacturers
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Sanofi-aventis U.s. Llc
![Amaryl (Glimepiride) Tablet [Sanofi-aventis U.s. Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amaryl | Sanofi-aventis U.s. Llc
2.1 Recommended DosingAMARYL should be administered with breakfast or the first main meal of the day.
The recommended starting dose of AMARYL is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5, 8.6)].
After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient's glycemic response. Uptitration should not occur more frequently than every 1–2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5, 8.6)].
The maximum recommended dose is 8 mg once daily.
Patients being transferred to AMARYL from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1–2 weeks and should be appropriately monitored for hypoglycemia.
When colesevelam is coadministered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced. Therefore, AMARYL should be administered at least 4 hours prior to colesevelam.
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