Droniva
Generic Name
Dronedarone
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| droniva 150 mg tablet | ৳ 700.00 | N/A |
Description
Overview of the medicine
Dronedarone is an antiarrhythmic drug used to maintain normal sinus rhythm and reduce cardiovascular hospitalization risk in patients with paroxysmal or persistent atrial fibrillation or flutter who are in sinus rhythm or who will be cardioverted.
Uses & Indications
Dosage
Adults
The recommended dose of dronedarone is 400 mg twice daily (e.g., two 150 mg tablets and one 100 mg tablet if available, or one 400 mg tablet if available). It should be taken with meals, in the morning and evening.
Elderly
No specific dose adjustment is generally required for elderly patients, but monitoring for adverse effects should be meticulous.
Renal_impairment
No dose adjustment is necessary for patients with mild to moderate renal impairment. Avoid use in patients with severe renal impairment (creatinine clearance < 30 mL/min).
How to Take
Take orally, with meals (preferably breakfast and dinner). Swallow the tablet whole with water; do not crush or chew.
Mechanism of Action
Dronedarone blocks multiple ion channels (potassium, sodium, calcium) involved in cardiac repolarization and excitability. It prolongs the action potential duration, effective refractory period, and QT interval without significant effect on sinus node function.
Pharmacokinetics
Onset
Steady state plasma concentrations are reached within 4-8 days of administration. Antiarrhythmic effects are gradual.
Excretion
Primarily excreted in the feces (84%), with a minor portion eliminated via urine (6%).
Half life
The apparent terminal half-life of dronedarone and its active metabolite (N-debutyl dronedarone) is approximately 24 hours.
Absorption
Oral bioavailability is low (4%) in the fasted state, but increases to 15% when taken with food. Peak plasma concentration reached in 3-6 hours.
Metabolism
Extensively metabolized by CYP3A4, with the main active metabolite being N-debutyl dronedarone.
Side Effects
Contraindications
- Permanent atrial fibrillation (increased risk of death, stroke, and heart failure)
- Severe heart failure (NYHA Class IV or recent decompensation requiring hospitalization)
- Second or third-degree AV block, sick sinus syndrome (unless with a functioning pacemaker)
- Bradycardia (<50 bpm)
- Severe hepatic impairment
- Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) and drugs that prolong QT interval and could lead to Torsade de Pointes
- QTc interval > 500 ms
- Known hypersensitivity to dronedarone or any component of the formulation
Drug Interactions
Digoxin
Increases digoxin plasma concentration; reduce digoxin dose and monitor levels.
Warfarin/Oral anticoagulants
Increases INR in patients on warfarin. Monitor INR/PT frequently and adjust anticoagulant dose as needed.
Statins (e.g., simvastatin, lovastatin)
Dronedarone inhibits CYP3A4-mediated metabolism of statins, leading to increased statin exposure. Consider lower statin doses.
Beta-blockers/Calcium channel blockers (non-dihydropyridine)
Increased risk of bradycardia and AV block. Use with caution, monitor ECG and heart rate.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin)
Contraindicated due to significant increase in dronedarone exposure, leading to increased risk of QT prolongation.
CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, St. John's Wort)
Decrease dronedarone exposure, potentially reducing efficacy. Co-administration should be avoided.
QT-prolonging drugs (e.g., phenothiazines, tricyclic antidepressants, certain antibiotics)
Co-administration may further prolong the QT interval, increasing the risk of Torsade de Pointes. Avoid concomitant use.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date.
Overdose
Symptoms of overdose may include bradycardia, sinus arrest, AV block, and QT prolongation. Hepatic injury has also been reported. Management is supportive: monitor ECG, vital signs, and liver function. Hemodialysis is unlikely to remove dronedarone due to high protein binding.
Pregnancy & Lactation
Dronedarone is contraindicated in pregnancy due to potential for fetal harm (animal studies showed embryo-fetal toxicity). Avoid breastfeeding during treatment, as it is unknown if dronedarone is excreted in human milk.
Side Effects
Contraindications
- Permanent atrial fibrillation (increased risk of death, stroke, and heart failure)
- Severe heart failure (NYHA Class IV or recent decompensation requiring hospitalization)
- Second or third-degree AV block, sick sinus syndrome (unless with a functioning pacemaker)
- Bradycardia (<50 bpm)
- Severe hepatic impairment
- Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) and drugs that prolong QT interval and could lead to Torsade de Pointes
- QTc interval > 500 ms
- Known hypersensitivity to dronedarone or any component of the formulation
Drug Interactions
Digoxin
Increases digoxin plasma concentration; reduce digoxin dose and monitor levels.
Warfarin/Oral anticoagulants
Increases INR in patients on warfarin. Monitor INR/PT frequently and adjust anticoagulant dose as needed.
Statins (e.g., simvastatin, lovastatin)
Dronedarone inhibits CYP3A4-mediated metabolism of statins, leading to increased statin exposure. Consider lower statin doses.
Beta-blockers/Calcium channel blockers (non-dihydropyridine)
Increased risk of bradycardia and AV block. Use with caution, monitor ECG and heart rate.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin)
Contraindicated due to significant increase in dronedarone exposure, leading to increased risk of QT prolongation.
CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, St. John's Wort)
Decrease dronedarone exposure, potentially reducing efficacy. Co-administration should be avoided.
QT-prolonging drugs (e.g., phenothiazines, tricyclic antidepressants, certain antibiotics)
Co-administration may further prolong the QT interval, increasing the risk of Torsade de Pointes. Avoid concomitant use.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date.
Overdose
Symptoms of overdose may include bradycardia, sinus arrest, AV block, and QT prolongation. Hepatic injury has also been reported. Management is supportive: monitor ECG, vital signs, and liver function. Hemodialysis is unlikely to remove dronedarone due to high protein binding.
Pregnancy & Lactation
Dronedarone is contraindicated in pregnancy due to potential for fetal harm (animal studies showed embryo-fetal toxicity). Avoid breastfeeding during treatment, as it is unknown if dronedarone is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, depending on manufacturer specifications.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Generic available
Clinical Trials
Key clinical trials (e.g., EURIDIS, ADONIS, ATHENA, PALLAS) have evaluated dronedarone. ATHENA showed reduced risk of cardiovascular hospitalization or death. PALLAS, however, demonstrated increased mortality in permanent AF patients, leading to a black box warning.
Lab Monitoring
- ECG (before and periodically during treatment to monitor heart rate, PR, QRS, and QTc intervals)
- Liver function tests (ALT, AST, bilirubin) prior to treatment, at 1 week, 1 month, and monthly for the first 6 months, then periodically thereafter
- Serum creatinine (before treatment and periodically during treatment)
- Serum potassium and magnesium (correct hypokalemia/hypomagnesemia before initiating treatment and monitor periodically)
Doctor Notes
- Prior to initiating dronedarone, confirm the patient does NOT have permanent AF, decompensated heart failure, or severe hepatic impairment.
- Perform baseline ECG, liver function tests, serum creatinine, potassium, and magnesium. Monitor these parameters regularly during treatment.
- Educate patients on symptoms of heart failure and liver injury, and emphasize the importance of compliance and avoiding contraindicated drugs/foods.
Patient Guidelines
- Take Droniva-150-mg-tablet exactly as prescribed by your doctor, always with food.
- Do not stop taking the medicine or change your dose without consulting your doctor, as this can worsen your condition.
- Report any new or worsening symptoms of heart failure (e.g., shortness of breath, sudden weight gain, swelling in ankles/feet) or liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting) immediately.
- Avoid grapefruit juice while taking this medication.
Missed Dose Advice
If you miss a dose, do not take a double dose to make up for it. Simply take the next dose at your regularly scheduled time. Do not take more than two doses per day.
Driving Precautions
Dronedarone may cause dizziness, fatigue, or visual disturbances. If you experience these effects, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy lifestyle, including a balanced diet and regular exercise, as advised by your doctor.
- Limit or avoid alcohol consumption, as it can affect heart rhythm and interact with your medication.
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