Usual Adult Dose for Atrial Fibrillation

400 mg orally 2 times a day with a meal

Use: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

Usual Adult Dose for Atrial Flutter

400 mg orally 2 times a day with a meal

Use: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Contraindicated

Precautions

US BOXED WARNINGS:

• HEART FAILURE: Dronedarone is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. Dronedarone doubles the risk of death in these patients.

ATRIAL FIBRILLATION (AF): Dronedarone is contraindicated in patients in atrial fibrillation (AF) who cannot be cardioverted into normal sinus rhythm. Dronedarone doubles the risk of death, stroke, and hospitalization for heart failure in patients with permanent AF.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer with food.
• Grapefruit juice should be avoided.

Monitoring:
Cardiovascular: Periodic assessment of heart failure risks or worsening of preexisting NYHA Class I heart failure.
Hepatic: Liver function tests should be performed at baseline and periodically during treatment.
Metabolic: Potassium or magnesium deficiency should be corrected prior to starting treatment.
Renal: Serum creatinine should be monitored prior to and 7 days after treatment initiation.

General: Doses greater than 400 mg daily are not considered more effective and are less well tolerated.