dronedarone hydrochloride at a glance
Medicine class
Multichannel antiarrhythmic, classified principally as class III
Main role
Maintaining sinus rhythm after successful cardioversion for paroxysmal or persistent atrial fibrillation
Specialist oversight
Treatment is initiated and monitored under specialist supervision
Administration
Swallow the tablet whole with water during a meal and avoid grapefruit juice
Important monitoring
Regular ECG, liver and kidney checks are required
What is dronedarone hydrochloride used for?
The selected product is licensed for a restricted atrial-fibrillation population.
Maintenance of sinus rhythm after successful cardioversion in clinically stable adults with paroxysmal or persistent atrial fibrillation.
It is considered only after alternative treatment options have been assessed.
It is not licensed for permanent atrial fibrillation.
How does dronedarone hydrochloride work?
Dronedarone blocks several potassium, sodium and calcium currents and reduces adrenergic effects on the heart. This slows conduction and reduces susceptibility to the disorganised electrical activity responsible for atrial fibrillation.
dronedarone hydrochloride preparations and strengths
Tablet
Route: Oral
Strengths: 400 mg
How to take dronedarone hydrochloride
Follow the specialist’s instructions and do not change or stop treatment without clinical advice.
Swallow the film-coated tablet whole with water during a meal.
The tablet cannot be divided into equal portions.
Avoid grapefruit and grapefruit juice because they can substantially increase dronedarone exposure.
Tell doctors and pharmacists before starting prescribed, over-the-counter or herbal products.
dronedarone hydrochloride side effects
Common or expected effects
- Diarrhoea, nausea, vomiting, abdominal pain or indigestion
- Tiredness or weakness
- Slow heartbeat
- Rash or itching
- Changes in liver-function tests
- An expected early increase in blood creatinine
Get urgent medical advice
- New or worsening breathlessness, ankle swelling or rapid weight gain, which may indicate heart failure
- Persistent dry cough or breathlessness, which may indicate inflammatory or fibrotic lung disease
- Yellow skin or eyes, dark urine, itching or sustained new abdominal pain, which may indicate liver injury
- Fainting, severe dizziness or symptoms of a very slow or abnormal heartbeat
- Facial or throat swelling, breathing difficulty or collapse from a severe allergic reaction
- Unexplained muscle pain, weakness or dark urine when also taking a statin
dronedarone hydrochloride in pregnancy
Dronedarone is not recommended during pregnancy. Pregnancy should be excluded before treatment where relevant, and effective contraception is required during treatment and for seven days after the final tablet. Contact the specialist promptly if pregnancy occurs rather than stopping treatment independently.
dronedarone hydrochloride while breastfeeding
Breastfeeding is not advised during treatment or for seven days after the final tablet. It is unknown whether dronedarone enters human milk, and a risk to the infant cannot be excluded. Discuss the options with the specialist.
dronedarone hydrochloride interactions
Dronedarone has important interactions affecting its levels, bleeding risk, heart rate or rhythm. A full medicines review is needed before treatment and whenever medicines change.
Dabigatran
Contraindicated because dronedarone substantially increases dabigatran exposure and may increase bleeding risk.
Potent CYP3A4 inhibitors, including clarithromycin, azole antifungals and ritonavir
Contraindicated because they can greatly increase dronedarone exposure.
Class I or III antiarrhythmics and other QT-prolonging medicines
Contraindicated because of additive conduction, QT and dangerous ventricular-arrhythmia risks.
Common questions about dronedarone hydrochloride
Answers are fully visible for fast scanning and source review.
What is dronedarone hydrochloride used for?
It helps maintain sinus rhythm after successful cardioversion in selected clinically stable adults with paroxysmal or persistent atrial fibrillation.
Can it be used for permanent atrial fibrillation?
No. Permanent atrial fibrillation is a contraindication, and treatment should be discontinued if the condition becomes permanent.
Why must it be taken with food?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.