• Reduces the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.

Contraindicated in:

• New York Heart Association Class IV HF or New York Heart Association Class II–III HF with recent decompensation requiring hospitalization
• Permanent AF
• Second- or third-degree heart block or sick sinus syndrome (unless a pacemaker is present)
• Heart rate <50 bpm
• Concurrent use of strong CYP3A inhibitors or drugs/herbal products that prolong the QT interval
• Liver or lung toxicity related to previous amiodarone use
• QTc interval 500 msec
• PR interval >280 msec
• Concurrent use of Class I or III antiarrhythmics including amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, and sotalol; must be discontinued prior to treatment
• Severe hepatic impairment
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• New/worsening HF
• Hypokalemia or hypomagnesemia (may ↑ risk of arrhythmias)
• Mild or moderate hepatic impairment
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.
• Geri: Appears on Beers list. Worse outcomes in patients with permanent atrial fibrillation or HF. Avoid use in older adults with permanent AF or HF.

CV: HF, QTc interval prolongation.

Derm: photosensitivity.

GI: abdominal pain, diarrhea, vomiting, nausea, taste abnormality, HEPATOTOXICITY.

GU: ACUTE RENAL FAILURE, renal impairment.

Neuro: weakness.

Resp: PNEUMONITIS, PULMONARY FIBROSIS.

Misc: ANGIOEDEMA.

Drug-Drug:

• Concurrent use of strong CYP3A inhibitors including ketoconazole, itraconazole, voriconazole, cyclosporine, clarithromycin, nefazodone, and ritonavir or QT interval prolonging drugs, including phenothiazines, tricyclic antidepressants, and other Class I and III antiarrhythmics, ↑ risk of serious adverse cardiovascular reactions; concurrent use contraindicated.
• Concurrent use of CYP3A4 inducers, including rifampin, phenobarbital, carbamazepine, or phenytoin↓ levels and effectiveness; avoid concurrent use.
• ↑digoxin levels and the risk of toxicity (discontinue or ↓ dose of digoxin by 50% before treatment and monitor carefully).
• May ↑ dabigatran levels and risk of bleeding; ↓ dabigatran dose to 75 mg twice daily in patients with moderate renal impairment (CCr 30–50 mL/min); avoid concurrent use in severe renal impairment (CCr 15–30 mL/min).
• May ↑ warfarin levels and risk of bleeding; closely monitor INR.
• Concurrent use of diltiazem, verapamil, digoxin, or beta-blockers↑ risk of bradycardia (initiate at lower dose and ↑ only after ECG evaluation).
• May ↑ levels and risk of toxicity of tricyclic antidepressants, and SSRIs.
• May ↑ levels and risk of toxicity of some statins; do not exceed simvastatin dose of 10 mg/day.
• Concurrent use with CYP3A substrates, including sirolimus and tacrolimus may ↑ risk of serious adverse reactions; monitor and adjust dosage carefully.

Drug-Natural Products:

• St. John’s wort ↓ blood levels and may ↓ effectiveness; avoid concurrent use.

Drug-Food:

• Grapefruit juice may ↑ levels and the risk of toxicity; avoid concurrent ingestion.

• Tablets: 400 mg;

• PO (Adults): 400 mg twice daily.

Multaq

• Has several antiarrhythmic properties; prolongs PR and QTc intervals.

• Suppression of AF.

Therapeutic Classification: antiarrhythmics

Pharmacologic Classification: benzofurans

Absorption: Poor bioavailability (4%) due to extensive first-pass hepatic metabolism (4%); food ↑ bioavailability (15%).

Distribution: Unknown.

Protein Binding: >98%.

Metabolism/Excretion: Undergoes extensive first-pass hepatic metabolism; mostly by the CYP3A isoenzyme. 6% excreted in urine as metabolites, 84% was excreted in feces as metabolites. Minimal elimination as unchanged drug.

Half-life: 13–19 hr.

(antiarrhythmic effect)

†Steady state blood levels are attained at 4–8 days.

†Peak levels after individual doses.

• Instruct patient to take dronedarone as directed. Do not stop taking dronedarone, even if feeling better, without consulting health care professional. If a dose is missed, omit and take next dose at regularly scheduled time; do not double dose. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Advise patient to avoid grapefruit juice during therapy; may increase drug levels.
• Advise patient to notify health care professional if signs and symptoms of HF (weight gain, dependent edema, increasing shortness of breath), hepatic injury, or pulmonary toxicity occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's wort.
• Rep: May cause fetal harm. Caution females of reproductive potential to use effective contraception, to avoid breastfeeding during therapy, and to notify health care professional promptly if pregnancy is planned or suspected.

droe-NED-a-rone

NDC Code^*

• 0024- sanofi-aventis U.S. LLC
  • 0024-4142- Multaq
    • 0024-4142-06- 8 BLISTER PACK in 1 BOX (0024-4142-06) > 6 TABLET, FILM COATED in 1 BLISTER PACK

• 0024- sanofi-aventis U.S. LLC
  • 0024-4142- Multaq
    • 0024-4142-10- 10 BLISTER PACK in 1 BOX (0024-4142-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• 0024- sanofi-aventis U.S. LLC
  • 0024-4142- Multaq
    • 0024-4142-50- 500 TABLET, FILM COATED in 1 BOTTLE (0024-4142-50)

• 0024- sanofi-aventis U.S. LLC
  • 0024-4142- Multaq
    • 0024-4142-60- 60 TABLET, FILM COATED in 1 BOTTLE (0024-4142-60)

• 55154- Cardinal Health
  • 55154-8104- Multaq
    • 55154-8104-2- 1260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2)