Label Changes for:
Amaryl (glimepiride) tablets
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Concomitant Administration of Colesevelam
- Colesevelam can reduce the maximum plasma concentration and total exposure of glimepiride when the two are coadministered. However, absorption is not reduced when glimepiride is administered 4 hours prior to colesevelam. Therefore, AMARYL should be administered at least 4 hours prior to colesevelam.
- Drugs that may potentiate the hypoglycemic action of sulfonylureas: disopyramide, fluoxetine, and quinolones added
- persons allergic to other sulfonamide derivatives may develop an allergic reaction to glimepiride
- hypoglycemia may be difficult to recognize in patients with autonomic neuropathy
- hypersensitivity reactions worsening: dyspnea, fall in blood pressure, and shock