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U.S. Department of Health and Human Services

Safety

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Nexterone (Amiodarone Hydrochloride) Premixed Injection for Intravenous Use

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011

 

Summary View

 

DRUG INTERACTIONS

HMG-CoA Reductase Inhibitors (revised)
  • The use of HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with amiodarone has been associated with reports of myopathy/rhabdomyolysis.
  • 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.