- Active ingredient
- dronedarone
- Strength
- 400mg
- Form
- tablet
- Manufacturer
- andalous pharma
- Route
- oral.solid
Uses
Dronedarone is an antiarrhythmic agent indicated to reduce the risk of cardiovascular hospitalization in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.
Do not use if
Contraindicated in permanent atrial fibrillation, symptomatic heart failure with recent decompensation or NYHA Class IV, second- or third-degree AV block or sick sinus syndrome (without pacemaker), bradycardia below 50 bpm, severe hepatic impairment, and concurrent use of strong CYP3A inhibitors.
Side effects
Common adverse effects include diarrhea, nausea, abdominal pain, vomiting, and elevated serum creatinine. Serious risks include hepatotoxicity, pulmonary toxicity, new or worsening heart failure, and QT prolongation.
Warnings
Black box warning: increased risk of death, stroke, and heart failure in patients with decompensated heart failure or permanent atrial fibrillation. Monitor liver function and pulmonary function periodically. Avoid in pregnancy.
How it works
Dronedarone exhibits electrophysiological properties of all four Vaughan-Williams classes, including sodium, potassium, and calcium channel blockade as well as non-competitive alpha and beta-adrenergic inhibition, though the relative contribution of each class to its clinical effect is unknown.
Storage
Store at room temperature 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F).