II. Indications
III. Contraindications
- NYHA Class IV Heart Failure (or recent hospitalization for decompensated, symptomatic CHF)
- Chronic or persistent Atrial Fibrillation (patient should be in sinus rhythm when initiated)
- Second or third degree AV Block or Sick Sinus Syndrome (without Pacemaker)
- Significant Bradycardia (Heart Rate <50 bpm)
- QTc Prolongation > 500 ms
- Severe Hepatic Impairment
- Concurrent use of agents with significant Drug Interactions (esp. CYP3A4 Inhibitors, other Antiarrhythmics, see below)
IV. Mechanism
- Class III Antiarrhythmic
V. Precautions
- Significantly increased mortality in patients with CHF or with chronic, persistent Atrial Fibrillation
- Proarrhythmic
- Correct Hypomagnesemia and Serum Potassium abnormalities prior to infusion
VI. Dosing: Adults with Atrial Fibrillation Rhythm Control
- Dronedarone 400 mg orally twice daily with breakfast and dinner
VII. Drug Interactions
- Concurrent use of other Antiarrhythmics (Class I or Class III)
- Agents affecting AV Node (e.g. Calcium Channel Blockers, Beta Blockers)
- CYP3A4 Inhibitors (e.g. Clarithromycin, Ketoconazole, Ritonavir)
- CYP3A4 Inducers (Carbamazepine, Phenytoin, Rifampin)
- Simvastatin (limit dose to 10 mg)
- Increases levels and effects of other drugs
- Warfarin (increases INR)
- Dabigatran
- CYP3A4 Substrates (e.g. Tacrolimus, Sirolimus)
VIII. Adverse Effects
- Hepatotoxicity
- QTc Prolongation
- Increased Serum Creatinine >10%
- Occurs early in medication course and resolves when medication is stopped
- Gastrointestinal Effects (Diarrhea, Nausea, Vomiting)
IX. Safety
- Pregnancy Category X
- Avoid in Lactation
X. Resources
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