Multaq 400mg 60 tablets — Made in France — Free Delivery

Brand: VEVICU
Product Code: Multaque
Availability: In Stock

$71.99

Description

Product description

Multaq® tablets are indicated for maintaining 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 used after consideration of alternative treatment approaches.

Compound

The active substance is dronedarone (one tablet contains dronedarone hydrochloride in terms of dronedarone 400 mg).

Excipients: hypromellose, corn starch, crospovidone (type A), poloxamer, lactose monohydrate, anhydrous colloidal silicon dioxide, magnesium stearate; shell: hypromellose, titanium dioxide (E 171), polyethylene glycol, carnauba wax.

Contraindications

hypersensitivity to the active substance or to any of the excipients;
II or III degree blockade, complete bundle branch block, distal block, sinus node dysfunction, atrial conduction disturbances, or sick sinus syndrome (unless used simultaneously with a functioning pacemaker);
bradycardia < 50 beats per minute;
persistent atrial fibrillation (AF) with AF duration ≥ 6 months (or duration unknown), if the physician has decided to stop attempts to restore sinus rhythm;
unstable hemodynamics;
heart failure or left ventricular systolic dysfunction in history or at present;
toxic damage to the liver or lungs associated with previous use of amiodarone;
simultaneous use with potent inhibitors of cytochrome P450 (CYP) 3A4, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir;
preparations that cause torsades de pointes tachycardia, eg phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine and certain oral macrolides (eg erythromycin), class I and III antiarrhythmics;
QTc interval determined using Bazett's formula: ≥ 500 ms;
severe liver failure;
severe renal failure (creatinine clearance < 30 ml/minute);
concomitant use with dabigatran.

Mode of application

Treatment should be started and carried out only under the supervision of a specialist.

Treatment with Multaq® can be started on an outpatient basis.

Before starting the use of Multaq®, treatment with class I or III antiarrhythmic preparations (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 stopping its use may continue for a long time due to its long half-life. If it is planned to switch to Multaq®, then it must be carried out under the supervision of a specialist.

The recommended dose for adults is 400 mg twice daily. Take one tablet in the morning and evening with meals.

It is recommended to swallow the tablet whole with water. The tablet can be divided into two equal parts.

Do not take Multaq® tablets with grapefruit juice.

If a dose is missed, patients should take the next dose according to a specific schedule and should not double the dose.

Application features

pregnant

So far, there is no adequate evidence for the use of dronedarone in pregnant women. Dronedarone is contraindicated in pregnant women. Women of childbearing age should use effective contraception during treatment with dronedarone.

It is not known whether dronedarone and its metabolites are excreted in breast milk. Available pharmacodynamic/toxicological data from animal studies have shown the presence of dronedarone and its metabolites in breast milk. A risk to neonates/infants cannot be excluded. The decision to stop breastfeeding or stop/withhold treatment with Multaq® should be made taking into account the benefits of breastfeeding for the baby and the need for treatment for the woman.

Dronedarone did not affect fertility in animal studies.

Children

There is no experience of use in children and adolescents (under 18 years of age). Relevant data not available.

Drivers

The effect of the preparation "Multaq®" on the ability to drive vehicles or work with other mechanisms is absent or insignificant. However, the ability to drive vehicles or operate other mechanisms may be affected by adverse reactions, such as increased fatigue.

Overdose

It is not known whether dronedarone and/or its metabolites can be excreted 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, when receiving dronedarone 400 mg twice daily, the most commonly observed side effects 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.

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