Cordarone (amiodarone HCl) Tablets October 2008
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008
|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 of Changes to Contraindications and Warnings
The following sentence has been added to the end of the first paragraph:
Post-marketing reports describe cases of pulmonary toxicity in patients treated with low doses of Cordarone; however, reports suggest that the use of lower loading and maintenance doses of Cordarone are associated with a decreased incidence of Cordarone-induced pulmonary toxicity.
Implantable Cardiac Devices:
In patients with implanted defibrillators or pacemakers, chronic administration of antiarrhythmic drugs may affect pacing or defibrillating thresholds. Therefore, at the inception of and during amiodarone treatment, pacing and defibrillation thresholds should be assessed.
Label approved 10/17/2008 is not available on this site.