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- AMARYL is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1.1).
- Important Limitations of Use:
- • Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1.1).
- Common adverse reactions in clinical trials (≥5% and more common than with placebo) include hypoglycemia, headache, nausea, and dizziness (6.1)
- Certain medications may affect glucose metabolism, requiring AMARYL dose adjustment and close monitoring of blood glucose (7.1).
- Miconazole: Severe hypoglycemia can occur when AMARYL and oral miconazole are used concomitantly. (7.2).
- Cytochrome P450 2C9 interactions: Inhibitors and inducers of cytochrome P450 2C9 may affect glycemic control by altering glimepiride plasma concentrations (7.3).
- Colesevelam: Coadministration may reduce glimepiride absorption. AMARYL should be administered at least 4 hours prior to colesevelam (2.1, 7.4).
Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications (5.1).
• Hypersensitivity Reactions: Postmarketing reports include anaphylaxis, angioedema and Stevens-Johnson Syndrome. Promptly discontinue AMARYL, assess for other causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes (5.2).
• Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative. (5.3). Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives (5.4).
• Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with AMARYL or any other anti-diabetic drug (5.5).
