Multaq

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

Adult 400 mg bd, taken as 1 tab w/ morning meal & 1 tab w/ evening meal.

Should be taken with food: Swallow whole w/ water during a meal.

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 in conjunction w/ a functioning 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 & lung toxicity related to previous use of amiodarone. QTc Bazett interval ≥500 msec. Co-administration w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone, ritonavir; medicinal products inducing torsades de pointes eg, phenothiazines, cisapride, bepridil, TCAs, terfenadine, certain oral macrolides (eg, erythromycin), class I & III antiarrhythmics; dabigatran. 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 for symptoms of CHF. Discontinue treatment if patients develop permanent atrial fibrillation, heart failure, or left ventricular systolic dysfunction. Regularly monitor clinical signs of heart failure & ECG in patients w/ CAD or in elderly patients ≥75 yr w/ multiple co-morbidities. Reports of hepatocellular liver injury, including life-threatening acute liver failure. Perform LFTs prior to treatment initiation, after 1 wk & after 1 mth following treatment initiation, then repeated mthly for 6 mth, at mth 9 & 12, & periodically thereafter. W/draw treatment in case of confirmed ALT levels ≥3 x ULN. Risk of increases in plasma creatinine. Measure plasma creatinine values prior to & 7 days after treatment initiation. Periodically monitor renal function. Antiarrhythmic medicinal products may be ineffective or may be arrhythmogenic in patients w/ hypokalemia. Correct any K or Mg deficiency before initiation of & during dronedarone therapy. May induce a moderate QTc Bazett prolongation (about 10 msec), related to prolonged repolarisation. Reports of ILD including pneumonitis & pulmonary fibrosis. Discontinue treatment in case of confirmed pulmonary toxicity. Concomitant use w/ digoxin; β-blockers or Ca antagonists; vit K antagonists; statins. Not recommended w/ potent CYP3A4 inducers. Avoid grapefruit juice beverages while taking dronedarone. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Ability to drive & use machines may be affected by adverse reactions eg, fatigue. Not recommended during pregnancy & in women of childbearing potential not using contraception. Women of childbearing potential should use effective contraception during treatment & for 7 days after the final dose. Women should not breastfeed during treatment & for 7 days after the final dose. 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; LFT 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, nefazodone; moderate CYP3A4 inhibitors eg, erythromycin, Ca antagonists (eg, diltiazem, verapamil); grapefruit juice (CYP3A4 inhibitor). Decreased exposure w/ potent CYP3A4 inducers eg, rifampicin, phenobarb, carbamazepine, phenytoin, St. John's wort. Increased exposure of CYP3A4 substrates eg, dabigatran, statins, Ca antagonists, immunosuppressants (eg, tacrolimus, sirolimus, everolimus, cyclosporine); β-blockers metabolized by CYP2D6; P-gp substrates eg, digoxin; CYP3A4 & P-gp substrates eg, rivaroxaban, apixaban, edoxaban. Reports of INR elevations after starting dronedarone in patients taking oral anticoagulants.

Cardiac Drugs

C01BD07 - dronedarone ; Belongs to class III antiarrhythmics.

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