| TAH Drug Code | OMUL |
|---|---|
| Indications | Paroxysmal or persistent atrial fibrillation: To reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF |
| Dosing | 400 mg twice daily with meals |
| Hepatic Impairment | Dose adjustment required |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Hypersensitivity to dronedarone or any component of the formulation; permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored); symptomatic heart failure (heart failure with recent [within the last 4 weeks] decompensation requiring hospitalization or NYHA Class III or IV symptoms); liver or lung toxicity related to previous amiodarone use; second-degree or third-degree atrioventricular block or sick sinus syndrome (except when used in conjunction with a functioning artificial pacemaker); bradycardia <50 bpm; concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, ritonavir); concomitant use of drugs or herbal products known to prolong the QT interval increasing the risk for torsade de pointes (eg, phenothiazine antipsychotics, tricyclic antidepressants, certain oral macrolide antibiotics, class I and III antiarrhythmics); QTc (Bazett) interval ?500 msec or PR interval >280 msec; severe hepatic impairment; pregnancy; breastfeeding |
| Adverse Effects | Common: Abdominal pain (4%), Diarrhea (9%), Indigestion (2%), Nausea (5%), Vomiting (2%), Asthenia (7%), Serum creatinine above reference range (51%) Serious: Congestive heart failure, Prolonged QT interval (28%), Hepatotoxicity, Liver failure, Acute renal failure, Renal failure, Interstitial lung disease |
| Pregnancy | Human (and Animal) Data Suggest Risk |
| Lactation | No (Limited) Human Data - Potential Toxicity |
| More Info | UpToDate |