Droniva
Generic Name
Dronedarone
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Dronedarone (Droniva) is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.
Uses & Indications
Dosage
Adults
400 mg twice daily with meals (e.g., one tablet with breakfast and one with evening meal).
Elderly
No specific dosage adjustment is recommended for elderly patients.
Renal_impairment
No dosage adjustment is needed for patients with mild to moderate renal impairment. Not studied in severe renal impairment (CrCl < 30 mL/min).
How to Take
Dronedarone tablets should be taken orally, twice daily with meals. Do not crush or chew the tablets.
Mechanism of Action
Dronedarone blocks multiple ion channels (potassium, sodium, calcium) involved in cardiac repolarization and depolarisation, and also has anti-adrenergic properties. It prolongs the cardiac action potential and refractory period.
Pharmacokinetics
Onset
Steady state plasma concentrations reached within 4-5 days of twice-daily dosing.
Excretion
Mainly excreted via the feces (about 84% of an oral dose), with only a small portion (about 6%) excreted renally.
Half life
The terminal elimination half-life of dronedarone is approximately 25-30 hours, and for its active metabolite, it's about 20-25 hours.
Absorption
Approximately 70-80% absorbed, but absolute bioavailability is about 4% due to extensive first-pass metabolism. Bioavailability is increased significantly when taken with food.
Metabolism
Extensively metabolized, primarily by cytochrome P450 3A4 (CYP3A4) and through direct glucuronidation.
Side Effects
Contraindications
- Severe heart failure (NYHA Class IV, or Class II-III with a recent decompensation requiring hospitalization or referral to a specialized HF clinic).
- Second- or third-degree atrioventricular (AV) block or sick sinus syndrome (unless used in conjunction with a functioning pacemaker).
- Bradycardia less than 50 beats per minute.
- QTc interval prolongation (> 500 ms).
- Severe hepatic impairment.
- Hypersensitivity to dronedarone or any excipients.
- Concomitant use of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, telithromycin).
- Concomitant use of drugs that prolong the QT interval and are known to cause Torsade de Pointes (e.g., phenothiazines, tricyclic antidepressants, certain macrolide antibiotics).
- Patients with permanent atrial fibrillation.
Drug Interactions
Digoxin
Increases digoxin exposure, reduce digoxin dose by approximately half.
Warfarin
Potentiates the anticoagulant effect of warfarin, requiring careful INR monitoring.
Statins (e.g., simvastatin, lovastatin)
Increases statin exposure, consider lower statin doses or alternative statins.
Strong CYP3A inducers (e.g., rifampin, phenytoin)
Significantly decrease dronedarone exposure, avoid concomitant use.
Strong CYP3A inhibitors (e.g., ketoconazole, ritonavir)
Significantly increase dronedarone exposure, contraindicated.
Beta-blockers, Calcium Channel Blockers (non-dihydropyridine)
Increased risk of bradycardia and AV block.
QT-prolonging drugs (e.g., phenothiazines, tricyclic antidepressants, certain antibiotics)
Increased risk of Torsade de Pointes, contraindicated.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms may include bradycardia, prolonged QT interval. Management is symptomatic and supportive. Monitor ECG and vital signs.
Pregnancy & Lactation
Pregnancy Category C. Dronedarone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in animal milk; avoid breastfeeding during treatment.
Side Effects
Contraindications
- Severe heart failure (NYHA Class IV, or Class II-III with a recent decompensation requiring hospitalization or referral to a specialized HF clinic).
- Second- or third-degree atrioventricular (AV) block or sick sinus syndrome (unless used in conjunction with a functioning pacemaker).
- Bradycardia less than 50 beats per minute.
- QTc interval prolongation (> 500 ms).
- Severe hepatic impairment.
- Hypersensitivity to dronedarone or any excipients.
- Concomitant use of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, telithromycin).
- Concomitant use of drugs that prolong the QT interval and are known to cause Torsade de Pointes (e.g., phenothiazines, tricyclic antidepressants, certain macrolide antibiotics).
- Patients with permanent atrial fibrillation.
Drug Interactions
Digoxin
Increases digoxin exposure, reduce digoxin dose by approximately half.
Warfarin
Potentiates the anticoagulant effect of warfarin, requiring careful INR monitoring.
Statins (e.g., simvastatin, lovastatin)
Increases statin exposure, consider lower statin doses or alternative statins.
Strong CYP3A inducers (e.g., rifampin, phenytoin)
Significantly decrease dronedarone exposure, avoid concomitant use.
Strong CYP3A inhibitors (e.g., ketoconazole, ritonavir)
Significantly increase dronedarone exposure, contraindicated.
Beta-blockers, Calcium Channel Blockers (non-dihydropyridine)
Increased risk of bradycardia and AV block.
QT-prolonging drugs (e.g., phenothiazines, tricyclic antidepressants, certain antibiotics)
Increased risk of Torsade de Pointes, contraindicated.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms may include bradycardia, prolonged QT interval. Management is symptomatic and supportive. Monitor ECG and vital signs.
Pregnancy & Lactation
Pregnancy Category C. Dronedarone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in animal milk; avoid breastfeeding during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, depending on manufacturer
Availability
Available in pharmacies and hospitals
Approval Status
FDA Approved
Patent Status
Patent expired for innovator drug
Clinical Trials
The ATHENA trial, a large-scale randomized, placebo-controlled study, demonstrated Dronedarone's efficacy in reducing cardiovascular hospitalization or death from any cause in patients with AF or atrial flutter.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) should be performed prior to treatment, at 2 weeks, 1 month, and monthly for 6 months, then periodically thereafter.
- Serum creatinine should be monitored prior to treatment, at 2 weeks, and periodically thereafter.
- Electrolytes (potassium, magnesium) should be corrected prior to initiation and monitored periodically during treatment.
- ECG should be performed prior to treatment and periodically to monitor QTc interval.
Doctor Notes
- Careful patient selection is paramount due to black box warnings; ensure patients do not have permanent AFib or severe decompensated heart failure.
- Strictly monitor LFTs, renal function, electrolytes, and ECG (for QTc prolongation) before and during treatment.
- Be aware of significant drug-drug and drug-food interactions, especially with strong CYP3A inhibitors/inducers and grapefruit juice.
Patient Guidelines
- Take Droniva exactly as prescribed by your doctor, usually twice daily with meals.
- Do not stop taking Droniva suddenly without consulting your doctor, as this may worsen your condition.
- Report any signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe nausea/vomiting) or heart failure (e.g., shortness of breath, swelling in legs/feet, rapid weight gain) to your doctor immediately.
- Avoid grapefruit and grapefruit juice while taking Droniva.
Missed Dose Advice
If a dose is missed, the patient should take the next scheduled dose. Do not take a double dose to make up for a missed dose.
Driving Precautions
Dronedarone may cause dizziness or visual disturbances. Patients should be cautioned about operating machinery or driving until they know how the drug affects them.
Lifestyle Advice
- Maintain a heart-healthy diet and regular exercise routine as advised by your healthcare provider.
- Limit alcohol intake as it can contribute to atrial fibrillation.
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