Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- added...The risk of exacerbation may be increased when other risk factors are present such as electrolytic disorders or use of concomitant antiarrhythmics or other interacting drugs (See “Drug Interactions, Other reported interactions with amiodarone”).
- added...Correct hypokalemia, hypomagnesemia or hypocalcemia whenever possible before initiating treatment with CORDARONE, as these disorders can exaggerate the degree of QTc prolongation and increase the potential for TdP. Give special attention to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhe or in patients receiving concomitant diuretics and laxatives, systemic corticosteroids, amphotericin B (IV) or other drugs affecting electrolyte levels.
- Sentence edited...Elevations in liver enzymes (aspartate aminotransferase and alanine aminotransferase) can occur.
The following sections have undergone significant edits:
- Pharmacodynamic interactions
- Pharmocokinetic interactions
- Effects of other medicinal products on amiodarone
- Effects of amiodarone on other medicinal products
- 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.
- In Postmarketing surveillance…acute pancreatitis…bullous dermatitis…and dry mouth…
- 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)