Cordarone
Generic Name
Amiodarone 100 mg Tablet
Manufacturer
Sanofi
Country
France (originator)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| cordarone 100 mg tablet | ৳ 10.10 | ৳ 101.00 |
Description
Overview of the medicine
Cordarone 100 mg Tablet contains Amiodarone, an antiarrhythmic drug used to treat and prevent various types of irregular heartbeats (arrhythmias), including ventricular and supraventricular arrhythmias. It is often reserved for severe cases due to its complex side effect profile.
Uses & Indications
Dosage
Adults
Loading dose: Typically 600-800 mg/day (orally) for 1-3 weeks or until initial response. Maintenance dose: 100-400 mg/day, usually starting with 200 mg/day and reducing to 100 mg/day or less based on response and tolerability.
Elderly
Lower initial and maintenance doses may be appropriate due to increased sensitivity and potential for adverse effects. Careful monitoring is recommended.
Renal_impairment
No dose adjustment is generally needed for renal impairment as amiodarone is minimally excreted renally. However, caution is advised in severe cases.
How to Take
Take orally, generally once daily. May be taken with or without food, but should be taken consistently (e.g., always with food) to maintain stable drug levels and minimize gastrointestinal upset. Swallow tablets whole.
Mechanism of Action
Amiodarone primarily works by blocking potassium channels, leading to a prolongation of the action potential duration and refractory period in cardiac tissues. It also has alpha- and beta-adrenergic blocking properties, and affects sodium and calcium channels, making it a broad-spectrum antiarrhythmic.
Pharmacokinetics
Onset
Oral: Days to weeks for full antiarrhythmic effect. IV: Hours.
Excretion
Primarily biliary/fecal; very little renal excretion. Undergoes enterohepatic recirculation.
Half life
Very long and highly variable (25-110 days, average 53 days) due to extensive tissue accumulation.
Absorption
Slow, erratic, and variable oral bioavailability (35-65%) due to first-pass metabolism.
Metabolism
Primarily hepatic via CYP3A4 to desethylamiodarone (DEA), an active metabolite. Both amiodarone and DEA are substrates and inhibitors of various CYP enzymes.
Side Effects
Contraindications
- Severe sinus bradycardia
- Second- or third-degree AV block or sick sinus syndrome (unless with a functional pacemaker)
- Cardiogenic shock
- Known hypersensitivity to amiodarone or iodine
- Severe hepatic impairment
- Thyroid dysfunction (unless treated prior to initiation)
- Concomitant use with drugs that prolong QT interval and are associated with torsades de pointes
Drug Interactions
Digoxin
Increases serum digoxin levels, leading to potential digoxin toxicity. Digoxin dose should be reduced.
Fentanyl
Increased risk of bradycardia, hypotension, and decreased cardiac output.
Warfarin
Significantly enhances the anticoagulant effect of warfarin, increasing risk of bleeding. Requires substantial warfarin dose reduction and close INR monitoring.
Statins (especially Simvastatin)
Increases statin levels, leading to increased risk of myopathy/rhabdomyolysis. Simvastatin dose should be limited or alternative statin used.
Beta-blockers/Calcium channel blockers (e.g., Diltiazem, Verapamil)
Increased risk of bradycardia, AV block, and hypotension.
Drugs that prolong QT interval (e.g., Sotalol, Quinidine, Fluoroquinolones)
Increased risk of torsades de pointes and other ventricular arrhythmias.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Overdose symptoms may include severe bradycardia, hypotension, liver injury, worsening arrhythmias, and cardiac arrest. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered soon after acute oral overdose. Continuous ECG and vital sign monitoring are essential, and cardiac pacing may be required for severe bradycardia.
Pregnancy & Lactation
Pregnancy Category D. Amiodarone crosses the placenta and can cause fetal toxicity, including congenital goiter and hypothyroidism, due to its high iodine content. It is excreted into breast milk in significant amounts and can harm a nursing infant, including thyroid dysfunction. Therefore, it is generally not recommended during pregnancy or lactation unless the benefits clearly outweigh the risks in life-threatening situations.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific details on packaging.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies worldwide
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety profile of amiodarone for various types of arrhythmias over decades. Ongoing research continues to optimize its use, explore its long-term effects, and manage its side effect profile.
Lab Monitoring
- Baseline and regular (e.g., every 3-6 months) liver function tests (LFTs)
- Baseline and regular (e.g., every 3-6 months) thyroid function tests (TFTs), including TSH
- Serum electrolytes (potassium, magnesium) periodically
- Baseline and annual chest X-ray and pulmonary function tests (PFTs)
- Electrocardiogram (ECG) regularly to monitor QT interval and rhythm
- Ophthalmic examination (baseline and if vision changes occur)
Doctor Notes
- Amiodarone has a complex pharmacological profile and significant potential for severe organ toxicities (pulmonary, hepatic, thyroid, ocular). Careful patient selection and rigorous monitoring are essential.
- Baseline and regular follow-up for LFTs, TFTs, ECG, chest X-ray, and ophthalmic examination are mandatory throughout therapy.
- Educate patients thoroughly on potential side effects, especially symptoms of pulmonary, hepatic, and thyroid toxicity, and the importance of reporting them promptly.
- Consider drug-drug interactions carefully, especially with warfarin, digoxin, beta-blockers, and certain statins. Dose adjustments are frequently required.
Patient Guidelines
- Take your medication exactly as prescribed; do not stop taking it or change your dose without consulting your doctor.
- Avoid exposure to direct sunlight and use protective clothing and high-SPF sunscreen, as amiodarone can cause severe photosensitivity.
- Report any new or worsening symptoms immediately to your doctor, especially shortness of breath, cough, yellowing of skin/eyes, unexplained weight changes, or vision disturbances.
- Avoid grapefruit juice and grapefruit products while on this medication.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Amiodarone may cause visual disturbances (e.g., blurred vision, halos), dizziness, or tremors which could impair your ability to drive or operate machinery safely. Exercise caution and avoid such activities if you experience these symptoms.
Lifestyle Advice
- Maintain a healthy diet and regular exercise routine as advised by your doctor to support cardiovascular health.
- Avoid smoking and excessive alcohol consumption, as these can negatively impact heart health and drug efficacy.
- Regularly monitor your pulse and report any significant changes to your healthcare provider.
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