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Dronedarone

    Brands

    DEA Class; Rx

    Common Brand Names; Multaq

    • Antidysrhythmics, III

    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

    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.

    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

    • 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

    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 category: X

    Lactation: Unknown if distributed in breast milk; contraindicated

    Adults

    800 mg/day PO.

    Geriatric

    800 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Dronedarone

    tablet

    • 400mg