Generic Name and Formulations:
Dronedarone 400mg; tabs.

Company:
Sanofi Aventis

Indications for MULTAQ:
To reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.

Adult Dose for MULTAQ:
≥18yrs: 400mg twice daily (AM & PM) with meals.

Children's Dose for MULTAQ:
<18yrs: not established.

Pharmacological Class:
Antiarrhythmic.

Rems:
YES

Contraindications:
Permanent AF (normal sinus rhythm will not or cannot be restored). Symptomatic heart failure (HF) with recent decompensation requiring hospitalization or NYHA Class IV HF. 2nd- or 3rd-degree AV block or sick sinus syndrome, unless paced. Bradycardia (<50bpm). Concomitant strong CYP3A inhibitors (eg, ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, ritonavir). Concomitant agents that can cause QTc prolongation (eg, phenothiazines, tricyclics, certain oral macrolide antibiotics, Class I and III antiarrhythmics). Liver or lung toxicity related to previous amiodarone use. QTc Bazett interval ≥500ms. PR interval >280ms. Severe hepatic impairment. Pregnancy (Cat.X) (use effective contraception). Nursing mothers.

Warnings/Precautions:
Increased risk of death, stroke, or HF in decompensated HF or permanent AF. Monitor cardiac rhythm every 3 months during therapy. Ensure appropriate antithrombotic therapy before starting. Discontinue if worsening HF develops and requires hospitalization or if pulmonary toxicity is confirmed. Monitor hepatic enzymes during 1st 6 months of therapy; discontinue if hepatic injury develops. Maintain normal serum K+ and Mg2+ levels. Monitor renal function periodically.

Interactions:
See Contraindications. Avoid concomitant antiarrhythmics, rifampin, other CYP3A inducers (eg phenobarbital, carbamazepine, phenytoin, St. John's wort), grapefruit juice. Consider discontinuing digoxin; if continued, reduce digoxin dose by ½, and monitor. Avoid doses >10mg once daily of simvastatin. Reduce dose and monitor Ca+ channel blockers, β-blockers (bradycardia), other CYP2D6 substrates. Verapamil, diltiazem increase dronedarone levels. Dronedarone increases verapamil, diltiazem, nifedipine levels. May potentiate dabigatran and other P-gP substrates, some statins, sirolimus, tacrolimus, other narrow-therapeutic range CYP3A substrates: adjust dose and monitor. Monitor other CYP3A or CYP2D6 substrates (eg, SSRIs, tricyclics). Monitor INR with warfarin.

Adverse Reactions:
Diarrhea, nausea, abdominal pain, vomiting, asthenia; increased serum creatinine, liver injury, QT prolongation, interstitial lung disease.

Metabolism:
Hepatic (CYP3A); >98% protein bound.

Elimination:
Fecal (primarily), renal.

Generic Availability:
NO

How Supplied:
Tabs—60, 180, 500