Drugs
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Amiodarone hydrochloride (marketed as Cordarone and Pacerone) Information
Amiodarone is a cardiac drug that is indicated for the management of life-threatening recurrent ventricular fibrillation (VF) or hemodynamically-unstable ventricular tachycardia (VT) refractory to other antiarrhythmic agents, or in patients intolerant of other agents used for these conditions.
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
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Related Information
FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone
5/6/2011Letter to Stakeholders: Communication on certain needleless pre-filled glass syringes
11/17/2010- Information for Healthcare Professionals: Simvastatin (marketed as Zocor), Ezetimibe/Simvastatin (marketed as Vytorin), Niacin extended-release/Simvastatin (marketed as Simcor), used with Amiodarone (Cordarone, Pacerone)
8/8/2008 Information on Simvastatin/Amiodarone Information for Healthcare Professionals: Amiodarone (marketed as Cordarone)
5/2005Cordarone Medication Guide (PDF - 159KB)
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Labeling and Regulatory History from Drugs@FDA
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Contact FDA
1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
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