Label Changes for:

Amaryl (glimepiride) tablets

October 2013

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)  

 

October 2013

DRUG INTERACTIONS

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.

 

June 2009

 

CLINICAL PHARMACOLOGY

Drug Interactions
  • Drugs that may potentiate the hypoglycemic action of sulfonylureas: disopyramide, fluoxetine, and quinolones added

WARNINGS

  • persons allergic to other sulfonamide derivatives may develop an allergic reaction to glimepiride

PRECAUTIONS

  • hypoglycemia may be difficult to recognize in patients with autonomic neuropathy 

ADVERSE REACTIONS

  • hypersensitivity reactions worsening: dyspnea, fall in blood pressure, and shock

 

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