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MULTAQ(R) (dronedarone) for Atrial Fibrillation or Atrial Flutter Now Available in the United States
Date:7/28/2009

ment with MULTAQ can be initiated in an outpatient setting. Most common adverse reactions are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and cutaneous rash.

Important Safety Information

MULTAQ is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.

MULTAQ is also contraindicated in second- or third-degree atrioventricular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker), bradycardia <50 bpm, QTc Bazett interval greater than or equal to 500 ms and severe hepatic impairment.

MULTAQ should not be given to patients who are or may become pregnant (Category X) or nursing.

MULTAQ should not be coadministered with strong CYP 3A inhibitors or medicinal products that prolong the QT interval.

In patients with new or worsening heart failure, the suspension or discontinuation of MULTAQ should be considered.

Serum creatinine levels increase by about 0.1mg/dL following MULTAQ treatment initiation. The elevation has a rapid onset, reaches a plateau after 7 days and is reversible after discontinuation.

Hypokalemia and hypomagnesemia may occur with concomitant administration of potassium-depleting diuretics. Potassium levels should be maintained in the normal range pre and during administration.

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SOURCE sanofi-aventis
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