Product image of Multaq (Dronedarone) supplied by GNH India

Multaq

Active Ingredient:
Dronedarone
Origin:
EU

Multaq (Dronedarone)

Dronedarone, the active ingredient in Multaq, is a Class III antiarrhythmic presented as a 400 mg tablet for oral use. It is employed to maintain sinus rhythm in adults with atrial fibrillation or atrial flutter, helping to reduce recurrence of these arrhythmias.

GNH India supplies Multaq as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution across EU and other regulated markets. The company adheres to stringent quality standards and provides regulatory documentation for global procurement.

Manufacturer / TM Owner

Sanofi Winthrop Industrie

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Indications & Clinical Uses

  • Multaq (dronedarone) is used in the management of cardiac rhythm disorders, specifically atrial arrhythmias.
  • Atrial fibrillation: helps maintain sinus rhythm and reduces recurrence of episodes.
  • Atrial flutter: used to sustain normal rhythm after cardioversion or to prevent recurrence.
  • Paroxysmal atrial fibrillation: supports rhythm control in patients with intermittent episodes.

How It Works

  • Dronedarone blocks multiple cardiac ion channels, inhibiting potassium (IKr), sodium (INa) and calcium (ICaL) currents while also exerting non‑adrenergic anti‑adrenergic effects. This multichannel inhibition prolongs the cardiac action potential, extending repolarisation and the refractory period, which stabilises myocardial excitability and reduces the likelihood of re‑entrant arrhythmias. By doing so, it helps maintain a regular heart rhythm without the tissue accumulation seen with some older agents.

Side Effects

Dronedarone may be associated with a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea
  • Diarrhea
  • Abdominal pain
  • Fatigue
  • Dizziness
  • Headache

Serious or Rare Side Effects

  • Severe liver injury (hepatitis, hepatic failure)
  • Pulmonary toxicity (interstitial lung disease)
  • QT interval prolongation leading to torsades de pointes
  • Heart failure exacerbation
  • Severe skin reactions (Stevens‑Johnson syndrome)

Precautions & Warnings

  • Before initiating dronedarone, several safety considerations should be evaluated.
  • Contraindication in severe heart failure: avoid use in patients with NYHA class III/IV heart failure.
  • Monitor liver function: obtain baseline hepatic enzymes and repeat periodically during therapy.
  • Avoid in permanent atrial fibrillation: drug is not indicated for patients with continuous AF.
  • Drug interactions: review concomitant medications, especially strong CYP3A4 inhibitors.
  • Pregnancy and lactation: safety not established; use only if potential benefit justifies risk.
  • Store at ambient temperature: keep tablets below 25 °C in the original container, protected from moisture and light.

Avoid Interactions

Dronedarone interacts with several medicines; awareness of the interaction level guides clinical management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, HIV protease inhibitors): may increase dronedarone exposure and toxicity.
  • Digoxin: dronedarone raises digoxin levels, risking toxicity.
  • Amiodarone: combined use increases risk of pulmonary and hepatic adverse effects.

Moderate Interactions (Monitor Closely)

  • Diltiazem or verapamil: may enhance dronedarone’s effect on cardiac conduction.
  • Warfarin: dronedarone can elevate INR, requiring closer anticoagulation monitoring.
  • Statins metabolised by CYP3A4 (e.g., simvastatin, atorvastatin): may increase statin concentrations, monitor for myopathy.

Frequently Asked Questions

Multaq contains dronedarone, a Class III antiarrhythmic indicated to maintain sinus rhythm in adult patients with atrial fibrillation or atrial flutter. It is prescribed to reduce the frequency of arrhythmic episodes and to support rhythm control after cardioversion.

Dronedarone exerts a multichannel blocking effect, inhibiting potassium, sodium and calcium ion currents in cardiac myocytes. This prolongs the action potential and refractory period, stabilising electrical activity and preventing re‑entrant circuits that trigger atrial arrhythmias.

The specific dose of Multaq is determined by the prescribing clinician based on the patient’s clinical condition, renal and hepatic function, and concomitant therapies. The prescriber will select the appropriate regimen and any dose adjustments required.

Safety of dronedarone in pregnancy and lactation has not been established. The product is generally avoided unless the potential therapeutic benefit justifies the potential risk to the fetus or infant. Consultation with a specialist is recommended.

To request Multaq, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Both dronedarone and amiodarone belong to the Class III antiarrhythmic family, but dronedarone lacks the iodine moiety found in amiodarone, resulting in a lower risk of thyroid and pulmonary toxicity. However, amiodarone may be more potent in some patients, while dronedarone is generally preferred when a better safety profile is desired.

Multaq tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack to protect from moisture and light. Keep the container tightly closed and out of reach of children.

Multaq is taken orally as a tablet, usually with a glass of water. It can be taken with or without food, but patients should follow the prescribing physician’s instructions regarding timing and any required fasting periods.

Serious adverse events include severe liver injury, pulmonary toxicity, QT‑interval prolongation that may lead to torsades de pointes, exacerbation of heart failure, and rare severe skin reactions such as Stevens‑Johnson syndrome. Patients should be monitored closely for any signs of these conditions.

Multaq is contraindicated in patients with permanent atrial fibrillation, severe (NYHA class III/IV) heart failure, recent decompensated heart failure, significant hepatic impairment, and in those taking strong CYP3A4 inhibitors. It should also be avoided in individuals with known hypersensitivity to dronedarone.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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