dronedarone
Multaq	Pharmaceutical company: Sanofi-Aventis www.sanofi-avantis.com

Pharmacologic classification: benzofuran derivative
Therapeutic classification: antiarrhythmic
Pregnancy risk category: X

AVAILABLE FORMS
Tablets: 400 mg

INDICATIONS AND DOSAGES
Reduce the risk of hospitalization in patients with a recent episode of paroxysmal or persistent atrial fibrillation or flutter who have cardiovascular risk factors, such as age older than 70 years, diabetes, hypertension, stroke, left atrial diameter greater than 50 mm, or left ventricular ejection fraction less than 40%, who are in normal sinus rhythm or who will be cardioverted—
Adults: 400 mg P.O. b.i.d. with morning and evening meals.

CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients with New York Heart Association Class IV heart failure or Class II to III heart failure with recent decompensation requiring hospitalization or referral to a heart failure clinic. Contraindicated in pregnancy, second- or third-degree AV block or sick sinus syndrome (unless a functioning pacemaker is in place), bradycardia less than 50 beats/minute, severe hepatic impairment, QTc interval 500 ms or greater, or PR interval greater than 280 ms. Contraindicated with concomitant use of CYP3A inhibitors, and drugs or herbal preparations that prolong QT interval.
   Use cautiously in patients with new or worsening heart failure.

INTERACTIONS
Drug-drug. Beta blockers: May cause bradycardia. Initially, give low doses of the beta blocker and increase only after monitoring the ECG for tolerance.
Calcium channel blockers (verapamil, diltiazem): May cause additive effects. Reduce initial doses of calcium channel blockers; increase doses only after monitoring ECG for tolerance.
CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, erythromycin: May increase dronedarone levels. Use together is contraindicated.
CYP3A inducers (rifampin, phenobarbital, carbamazepine, phenytoin): May decrease dronedarone levels. Use together is contraindicated.
CYP3A substrates (sirolimus, tacrolimus): May increase levels of these drugs. Monitor drug levels.
CYP2C9 substrates (warfarin, losartan): May increase levels of metabolites. Monitor patient closely and monitor INR in patient taking warfarin.
CYP2D6 substrates (tricyclic antidepressants, serotonin reuptake inhibitors): May increase levels of these drugs. Monitor drug levels.
Digoxin: May increase digoxin levels and increase electrophysiologic effects of dronedarone. Avoid use together; if unable, decrease digoxin dose by 50%.
Drugs that prolong QT interval (phenothiazines, tricyclic antidepressants, macrolide antibiotics, Class I and III antiarrhythmics): May further increase QT interval leading to torsades de pointe, a potentially fatal arrhythmia. Use together is contraindicated.
Statins (simvastatin): May increase statin levels. Use together cautiously.
Drug-herb. St John's wort: May decrease drug levels. Discourage use together.
Drug-food. Grapefruit juice: May increase drug levels. Discourage use together.

ADVERSE REACTIONS
CNS: asthenia.
CV: bradycardia, heart failure, QT prolongation.
GI: abdominal pain, diarrhea, dyspepsia, nausea, vomiting.
Skin: allergic dermatitis, dermatitis, eczema, pruritis, rash.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING.

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