Label Changes for:

Cordarone (amiodarone HCl) 200 mg Tablets

April 2009

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Brand (Generic) Name

Sections Modified

Cordarone (amiodarone HCl) 200 mg Tablets

PRECAUTIONS

  • Drug Interactions
    • HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with amiodarone
      • Added "When co-administered with amiodarone, lower starting and maintenance doses of these agents should be considered."

ADVERSE REACTIONS

  • Postmarketing Reports
    • urticaria
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