Thiazolidinediones (Rosiglitazone)
WARNINGS AND PRECAUTIONS-
- Cardiac Failure
- Myocardial Ischemia
- Myocardial Ischemic Events in Large Long-Term Prospective Randomized Controlled Trials
- Congestive Heart Failure and Myocardial Ischemia During Coadministration With Insulin
- Weight Gain
Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients.
After initiation of Thiazolidinediones, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction must be considered.
Limitations of Use:
- It should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
- Coadministration with insulin is not recommended.
- Use with nitrates is not recommended.
DOSAGE AND ADMINISTRATION
Start at 4 mg daily in single or divided doses; do not exceed 8 mg daily.
• Dose increases should be accompanied by careful monitoring for adverse events related to fluid retention.
• Do not initiate AVANDIA if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels.
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