Multaq ® tablets are indicated for the maintenance of sinus rhythm after successful cardioversion in clinically stable adult patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, Multaq ® should only be prescribed after consideration of alternative treatment approaches.
Composition
The active substance is dronedarone (one tablet contains dronedarone hydrochloride equivalent to 400 mg dronedarone).
Excipients: hypromellose, corn starch, crospovidone (type A), poloxamer, lactose, colloidal anhydrous silica, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), polyethylene glycol, carnauba wax.
Contraindication
Hypersensitivity to the active substance or to any of the excipients; II or III degree block, complete bundle branch block, distal block, sinus node dysfunction, atrial conduction disorders or sick sinus syndrome (except when used simultaneously with a functioning pacemaker); bradycardia <50 beats per minute; persistent atrial fibrillation (AF) with AF duration ≥ 6 months (or of unknown duration), if the physician has decided to discontinue attempts to restore sinus rhythm; unstable hemodynamics; history of heart failure or left ventricular systolic dysfunction; toxic liver or lung damage associated with previous use of amiodarone; Concomitant use with potent cytochrome P450 (CYP) 3A4 inhibitors such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir; medicinal products that induce torsades de pointes tachycardia, e.g. phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine and certain oral macrolides (e.g. erythromycin), class I and III antiarrhythmics; QTc interval defined by Bazett's formula: ≥ 500 ms; severe hepatic impairment; severe renal impairment (creatinine clearance < 30 ml/minute); concomitant use with dabigatran.
Method of application
Treatment should be initiated and carried out only under the supervision of a specialist.
Treatment with Multak ® can be started on an outpatient basis.
Before starting the use of Multaq®, treatment with class I or III antiarrhythmic agents (flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) should be discontinued.
Data on the optimal transition from amiodarone to Multaq ® are still limited. It should be borne in mind that the effect of amiodarone after discontinuation of its use may last for a long time due to its long half-life. If a transition to Multaq ® is planned, it should be carried out under the supervision of a specialist.
The recommended dose for adults is 400 mg twice a day. Take one tablet in the morning and one in the evening with meals.
It is recommended to swallow the tablet whole with water. The tablet can be divided into two equal parts.
Multak ® tablets should not be taken with grapefruit juice.
If a dose is missed, patients should take the next dose as scheduled; the dose should not be doubled.
Application features
Pregnant women
There is currently no adequate evidence for the use of dronedarone in pregnant women. Dronedarone is contraindicated in pregnant women. Women of childbearing potential should use effective contraception during treatment with Dronedarone.
It is not known whether dronedarone and its metabolites are excreted in human milk. Available pharmacodynamic/toxicological data from animal studies have shown the presence of dronedarone and its metabolites in human milk. A risk to the newborn/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Multaq® therapy taking into account the benefit of breast-feeding for the child and the need for therapy for the woman.
Dronedarone did not affect fertility in animal studies.
Children
There is no experience with use in children and adolescents (under 18 years of age). There are no relevant data.
Drivers
The effect of the drug "Multak ®" on the ability to drive vehicles or operate other mechanisms is absent or insignificant. However, the ability to drive vehicles or operate other mechanisms may be affected by undesirable reactions, such as increased fatigue.
Overdose
It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis or hemofiltration).
There is no specific antidote. In case of overdose, treatment should be supportive and aimed at relieving symptoms.
Side effects
The most common reason for discontinuation of Multaq ® therapy was gastrointestinal disorders (3.2% of patients versus 1.8% in the placebo group). In all studies, the most common side effects observed with dronedarone 400 mg twice daily were diarrhea, nausea and vomiting, fatigue, and asthenia.
Storage conditions
Store in the original packaging at a temperature below 30 °C, out of the reach of children.
Shelf life - 3 years.
