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Cordarone (amiodarone HCl) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- added: acute respiratory distress syndrome in the post-operative setting
HMG-CoA reductase inhibitors:
- Limit the dose of simvastatin in patients on amiodarone to 20 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as amiodarone may increase the plasma concentration of these drugs.
- drug rash with eosinophilia and systemic symptoms (DRESS)