Medication Guide App

Label Changes for:

Cordarone (amiodarone HCl) Tablets

October 2008

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

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 View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

  • Pulmonary Toxicity
    • First Paragraph
  • Implantable Cardiac Devices (new)

WARNINGS

Pulmonary Toxicity:

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. 

Hide
(web4)