Classes
DEA Class; Rx
Common Brand Names; Multaq
- Antidysrhythmics, III
Description
Antiarrhythmic agent similar in efficacy to amiodarone
Used to reduce hospitalization risk for AF in patients in sinus rhythm with history of paroxysmal or persistent AF
Contraindicated in certain patients with heart failure or permanent AF
Indications
Indicated for reduction in the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.
Contraindications
Hypersensitivity
Permanent AF in patients in whom normal sinus rhythm cannot be restored
Symptomatic HF with recent decompensation requiring hospitalization, or symptoms of NYHA class IV HF due to doubled risk of death
Concomitant strong CYP3A4 inhibitors (eg, grapefruit juice, itraconazole, clarithromycin, erythromycin)
Symptomatic HF with recent decompensation requiring hospitalization
NYHA class IV HF
Referral to HF program
2nd or 3rd degree heart block or sick sinus syndrome (unless used with functioning pacemaker)
Bradycardia <50 bpm
QTc interval >500 ms or PR interval >280 ms
Coadministration with drugs that prolong QT interval may cause torsade de Pointes-type ventricular tachycardia (eg, phenothiazine, TCAs, macrolide antibiotics, class I and III antiarrhythmic agents [amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol])
Liver toxicity related to previous use of amiodarone
Severe hepatic impairment (ie, Child-Pugh Class C)
Pregnancy (category X)
Breastfeeding women
Adverse Effects
- QTc prolongation (28%)
- Early increase in SCr of >10% (51%)
- Diarrhea (9%)
- Asthenia (7%)
- Nausea (5%)
- Skin reactions (eg, rash, pruritus, eczema, allergic dermatitis) (5%)
- Abdominal pain (4%)
- Bradycardia (3%)
- Vomiting (2%)
- Dyspepsia (2%)
- New/worsening HF
- Hepatic injury
- Cardiac failure
- Pulmonary fibrosis
- Interstitial lung disease including pneumonitis and PF
- Anaphylactic reactions (eg, angioedema)
- Vasculitis (eg, leukocytoclastic vasculitis)
- Interstitial lung disease, including pneumonitis and pulmonary fibrosis, have been reported
- Atrial flutter with 1:1 atrioventricular conduction
- Photosensitivity
- Dysgeusia
Warnings
Increased risk of stroke, particularly in first two weeks of therapy; should only be initiated in patients in sinus rhythm who are receiving appropriate antithrombotic therapy
Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis reported; onset of dyspnea or non-productive cough may be related to pulmonary toxicity; carefully evaluate patients clinically; if pulmonary toxicity confirmed, discontinue therapy
Postmarketing cases of increased INR with or without bleeding events have been reported in warfarin-treated patients initiated on dronedarone; monitor INR after initiating in patients taking warfarin
Potassium levels should be within normal range prior to administration of therapy and maintained in normal range during administration; increased risk of hypomagnesemia/hypokalemia with potassium-depleting diuretics
Dronedarone induces moderate prolongation of the QT interval; monitor; if QTc Bazett interval is ≥500 ms, discontinue therapy
Marked increase in serum creatinine, prerenal azotemia, and acute renal failure, often in the setting of heart failure or hypovolemia, reported; typically reversible when drug discontinued; monitor renal function
Small increase in SCr following initiation; elevation has a rapid onset, reaches plateau after 7 days, and is reversible upon discontinuation
Women of childbearing potential must exercise caution while on therapy and must be counseled on appropriate contraceptive choices
Pregnancy and Lactation
Pregnancy category: X
Lactation: Unknown if distributed in breast milk; contraindicated
Maximum Dosage
800 mg/day PO.
800 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Dronedarone
tablet
- 400mg