Medication Guide App

Label Changes for:

Cordarone (amiodarone HCl) Tablets

December 2014

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)

December 2014

PRECAUTIONS

Thyroid Abnormalities
  • Hypothyroidism has been reported in 2 to 10% of patients receiving amiodarone and may be primary or subsequent to resolution of preceding amiodarone-induced hyperthyroidism. This condition may be identified by clinical symptoms and elevated serum TSH levels. Cases of severe hypothyroidism and myxedema coma, sometimes fatal, have been reported in association with amiodarone therapy. In some clinically hypothyroid amiodarone-treated patients, free thyroxine index values may be normal. Manage hypothyroidism by reducing the dose of or discontinuing Cordarone and considering the need for thyroid hormone supplement.

ADVERSE REACTIONS

Postmarketing Reports
  • In Postmarketing surveillance…acute pancreatitis…bullous dermatitis…and dry mouth…

 

January 2014

ADVERSE REACTIONS

Postmarketing Reports
  • added: acute respiratory distress syndrome in the post-operative setting

 

November 2011

PRECAUTIONS

Drug Interactions
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.

 

December 2010

ADVERSE REACTIONS

Postmarketing Reports
  • drug rash with eosinophilia and systemic symptoms (DRESS)

 

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