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Label Changes for:

Avandaryl (rosiglitazone maleate and glimepiride) Tablets

March 2015

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

March 2015

CONTRAINDICATIONS

  • AVANDARYL is contraindicated in patients with a history of a hypersensitivity reaction to rosiglitazone or glimepiride or any of the product’s ingredients.
  • Patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to AVANDARYL. Do not use AVANDARYL in patients who have a history of an allergic reaction to sulfonamide derivatives. Reported hypersensitivity reactions include cutaneous eruptions with or without pruritis as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome, dyspnea) [see Warnings and Precautions (5.9) and Adverse Reactions (6.3)].

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
  • There have been postmarketing reports of hypersensitivity reactions in patients treated with glimepiride, including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, promptly discontinue <insert drug name>, assess for other potential causes for the reaction, and institute alternative treatment for diabetes.

DRUG INTERACTIONS

Drugs Affecting Glucose Metabolism section edited

ADVERSE REACTIONS

Post-Marketing Experience

Glimepride

added the following bullet:

  • Thrombocytopenia (including severe cases with platelet count less than 10,000/µL) and thrombocytopenic purpura
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