Multaq

Dronedarone HCl

Maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients w/ paroxysmal or persistent atrial fibrillation.

Adult Recommended dose: 400 mg bd.

Should be taken with food: Avoid grapefuit juice.

Hypersensitivity. 2nd- or 3rd-degree AV block, complete bundle branch block, distal block, sinus node dysfunction, atrial conduction defects or sick sinus syndrome (except when used w/ a pacemaker); bradycardia <50 bpm; permanent atrial fibrillation w/ an atrial fibrillation duration ≥6 mth (or duration unknown) & attempts to restore sinus rhythm no longer considered by the physician; patients in unstable hemodynamic conditions; history of or current heart failure or left ventricular systolic dysfunction; patients w/ liver or lung toxicity related to previous use of amiodarone; co-administration w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone & ritonavir; co-administration w/ torsades de pointes inducers eg, phenothiazines, cisapride, bepridil, TCAs, terfenadine, certain oral macrolides (eg, erythromycin), class I & III antiarrhythmics; co-administration w/ dabigatran; QTc Bazett interval ≥500 msec; severe hepatic impairment; severe renal impairment (CrCl <30 mL/min).

Should only be prescribed after alternative treatment options have been considered. Regularly assess cardiac, hepatic & pulmonary function. Perform ECGs serially, at least every 6 mth. Carefully evaluate patients for symptoms of CHF. Discontinue treatment if patients develop permanent atrial fibrillation, heart failure, or left ventricular systolic dysfunction. Monitor clinical signs of heart failure & ECG on a regular basis in patients w/ CAD. Reports of hepatocellular liver injury; increases in plasma creatinine; interstitial lung disease including pneumonitis & pulmonary fibrosis. Perform liver function tests prior to treatment initiation, after 1 wk & after 1 mth following treatment initiation, then repeatedly mthly for 6 mth, at mth 9 & 12, & periodically thereafter. W/draw treatment in case of confirmed ALT ≥3 x ULN. Periodically monitor renal function. Any K or Mg deficiency should be corrected before initiation & during dronedarone therapy. May induce a moderate QTc Bazett prolongation (about 10 msec), related to prolonged repolarisation. Concomitant use w/ digoxin; β-blockers or Ca antagonists; vit K antagonists; statins. Not recommended w/ potent CYP3A4 inducers. Do not take w/ grapefruit juice. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Monitor clinical signs of heart failure & ECG on a regular basis in patients ≥75 yr w/ co-morbidities. Safety & efficacy in childn <18 yr have not yet been established.

CHF; increased blood creatinine, prolonged QTc Bazett. Bradycardia; diarrhoea, vomiting, nausea, abdominal pain, dyspepsia; liver function test abnormalities; rashes (including generalised, macular, maculopapular); pruritus; fatigue, asthenia.

Potential risk of proarrhythmia w/ medicinal products inducing torsades de pointes eg, phenothiazines, cisapride, bepridil, TCAs, certain oral macrolides (eg, erythromycin), terfenadine & class I & III antiarrhythmics. Increased exposure w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, telithromycin, clarithromycin or nefazodone; grapefruit juice. Pharmacokinetic & possible pharmacodynamic interaction w/ Ca antagonists; β-blockers; digoxin. Possible increased exposure w/ moderate/weak CYP3A4 inhibitors. Decreased exposure w/ potent CYP3A4 inducers eg, phenobarb, carbamazepine, phenytoin or St. John's Wort. Increased AUC_0-24 & C_max of dabigatran. Increased exposure of statins; rivaroxaban; apixaban; edoxaban. Increased plasma conc of immunosuppressants (tacrolimus, sirolimus, everolimus, cyclosporine). Increased INR in patients concomitantly taking oral anticoagulants.

Cardiac Drugs

C01BD07 - dronedarone ; Belongs to class III antiarrhythmics.

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