Amiodarone Uses, Dosage, Side Effects & Warnings | DrugsAtlas
Authoritative Clinical Reference
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Therapeutic Class
Antiarrhythmic
Subclass
Class III Antiarrhythmic (Potassium Channel Blocker)
Speciality
Cardiology
Schedule (India)
Schedule H
Routes
Oral, Intravenous
Formulations
- Tablets: 100 mg, 200 mg
- Injection: 150 mg/3 mL (50 mg/mL) ampoule
Adult indications
INDICATIONS + DOSING ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Ventricular Tachyarrhythmias (VT/VF, particularly in structural heart disease)
A. Intravenous Route (Acute/Emergency Setting)
| Parameter | Recommendation |
|---|---|
|
Starting dose (Loading)
|
150 mg IV over 10 minutes (dilute in 100 mL 5% dextrose) |
|
Titration
|
1 mg/min for 6 hours → then 0.5 mg/min for 18 hours |
|
Usual maintenance dose
|
Convert to oral therapy after stabilization |
|
Maximum dose
|
2.2 g IV in first 24 hours |
B. Oral Route (Maintenance/Chronic Therapy)
| Parameter | Recommendation |
|---|---|
|
Starting dose (Loading)
|
800ā1200 mg/day in 2ā3 divided doses for 1ā2 weeks |
|
Titration
|
Reduce by 200 mg every 5ā7 days based on response |
|
Usual maintenance dose
|
200ā400 mg once daily |
|
Maximum dose
|
600 mg/day (short-term); 400 mg/day preferred for chronic use |
Clinical Notes:
- Adjust dosing based on rhythm control response and safety parameters
- Long half-life (40ā55 days) necessitates loading phase
- ECG monitoring mandatory during IV administration
2. Supraventricular Tachyarrhythmias (Atrial Fibrillation ā rhythm control in structural heart disease or LV dysfunction)
| Parameter | Recommendation |
|---|---|
|
Starting dose (Loading)
|
600ā800 mg/day in divided doses for 1 week |
|
Titration
|
Reduce by 200 mg every 5ā7 days |
|
Usual maintenance dose
|
100ā400 mg once daily |
|
Maximum dose
|
400 mg/day for long-term use |
Clinical Notes:
- Initiate only when cardioversion is planned or in recurrent AF
- Preferred in patients with heart failure or structural heart disease where other antiarrhythmics are contraindicated
- Not first-line for lone AF
3. Prevention of Recurrent VT/VF in ICD Patients (Adjunct to Device Therapy)
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
400 mg/day in divided doses for 1ā2 weeks |
|
Titration
|
Reduce based on ICD interrogation and arrhythmia burden |
|
Usual maintenance dose
|
100ā200 mg once daily |
|
Maximum dose
|
400 mg/day |
Clinical Notes:
- Used to reduce frequency of appropriate ICD shocks
- Lower maintenance doses preferred to minimize toxicity
Secondary Indications ā Adults (Off-label, if any)
| Indication | Dose | Duration | Supervision | Label Status | Evidence Basis |
|---|---|---|---|---|---|
| Acute rate control in atrial fibrillation (when beta-blockers/CCBs contraindicated) | 150 mg IV over 10ā15 min, then 1 mg/min × 6 hours, then 0.5 mg/min | Until rate controlled | Specialist/ICU only |
OFF-LABEL
|
RCTs in acute AF; not first-line per ICMR/API guidelines |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
Supraventricular Tachycardia (SVT) or Ventricular Tachycardia
A. Intravenous Route (ICU/Specialist Setting Only)
| Parameter | Recommendation |
|---|---|
|
Starting dose (Loading)
|
5 mg/kg IV over 20ā60 minutes (dilute in D5W) |
|
Titration
|
May repeat loading dose; total up to 15 mg/kg/day |
|
Usual maintenance dose
|
5ā15 mcg/kg/min continuous infusion |
|
Maximum dose
|
15 mg/kg/day OR 1.5 mg/kg/day maintenance |
B. Oral Route (After Stabilization)
| Parameter | Recommendation |
|---|---|
|
Starting dose (Loading)
|
10ā15 mg/kg/day in 2ā3 divided doses for 5ā10 days |
|
Titration
|
Reduce gradually based on arrhythmia control |
|
Usual maintenance dose
|
5ā10 mg/kg/day in 1ā2 divided doses |
|
Maximum dose
|
200ā400 mg/day (weight and age dependent) |
Age Restrictions:
- NOT recommended below 1 year of age except under paediatric cardiology supervision in tertiary care
Safety Monitoring:
- Baseline: ECG (QTc), LFTs, TFTs, chest X-ray
- Ophthalmology examination if use exceeds 6 months
- Monitor growth parameters
Secondary Indications ā Paediatric Doses (Off-label, if any)
| Indication | Dose | Duration | Supervision | Label Status | Evidence Basis |
|---|---|---|---|---|---|
| Fetal tachyarrhythmia (via maternal administration) | Individualized maternal dosing | Until delivery/resolution | Maternal-fetal medicine + Paediatric cardiology |
OFF-LABEL
|
Case series from Indian referral centres |
Renal Adjustments
| Renal Function | Recommendation |
|---|---|
| All stages of renal impairment | No dose adjustment required |
| Haemodialysis | Not dialyzable (large volume of distribution); no supplemental dose needed |
| Peritoneal dialysis | No dose adjustment required |
Hepatic adjustment
Contraindications
- Sinus node dysfunction (unless permanent pacemaker in situ)
- Second-degree or third-degree AV block (unless permanent pacemaker in situ)
- Severe sinus bradycardia (<50 bpm, symptomatic)
- Known hypersensitivity to amiodarone or iodine
- Severe thyroid dysfunction (overt hyperthyroidism or hypothyroidism)
- Pregnancy (except for life-threatening arrhythmias ā see Pregnancy section)
- Concurrent use of drugs causing torsades de pointes with no monitoring capability
Cautions
- Pre-existing pulmonary disease ā increased risk of amiodarone-induced pulmonary toxicity
- Thyroid disorders ā can cause both hypothyroidism and hyperthyroidism
- Hepatic dysfunction ā hepatotoxicity risk even with normal baseline LFTs
- Baseline QT prolongation ā risk of torsades de pointes
- Electrolyte abnormalities ā correct hypokalaemia and hypomagnesaemia before initiation
- Photosensitivity ā advise sun protection measures
- Corneal microdeposits ā usually asymptomatic but may cause visual halos
- Elderly patients ā increased sensitivity to all adverse effects
- Concurrent use of other negative chronotropes
Pregnancy
| Parameter | Recommendation |
|---|---|
|
Risk category/Safety statement
|
Avoid ā crosses placenta; associated with fetal thyroid dysfunction, goitre, growth restriction, and neurodevelopmental concerns |
|
Preferred alternatives
|
Beta-blockers (metoprolol, propranolol) or digoxin depending on arrhythmia type |
|
When it may be used
|
Life-threatening arrhythmias refractory to safer alternatives; specialist decision only |
|
Monitoring
|
Maternal: ECG, LFTs, TFTs; Fetal: serial ultrasound for growth, thyroid size, cardiac function |
Lactation
| Parameter | Recommendation |
|---|---|
|
Compatibility
|
Not recommended ā significant excretion into breast milk |
|
Preferred alternatives
|
Propranolol, sotalol (if appropriate for indication) |
|
Expected drug levels in milk
|
Moderate to high; infant receives significant iodine load |
|
Infant monitoring
|
If unavoidable: monitor infant TFTs, weight gain, feeding patterns, cardiac status |
Elderly
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
100ā200 mg/day oral; lower IV loading doses may be considered |
|
Titration
|
Slower titration recommended; assess response over weeks |
|
Extra risks
|
Enhanced susceptibility to bradycardia, hypotension, thyroid dysfunction, pulmonary toxicity, hepatotoxicity; falls risk with hypotension; polypharmacy interactions common |
Major drug interactions
| Interacting Drug | Effect/Mechanism | Recommendation |
|---|---|---|
| Digoxin | Increased digoxin levels (inhibits P-glycoprotein) |
Reduce digoxin dose by 50%; monitor levels
|
| Warfarin | Increased INR (CYP2C9 inhibition) |
Reduce warfarin by 30ā50%; monitor INR frequently
|
| Simvastatin | Increased myopathy/rhabdomyolysis risk (CYP3A4 inhibition) |
Limit simvastatin to ≤20 mg/day; consider alternative statin
|
| QT-prolonging drugs (fluoroquinolones, macrolides, azole antifungals, antipsychotics, ondansetron) | Additive QT prolongation; risk of torsades de pointes |
Avoid combination or ensure ECG monitoring
|
| Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) | Increased amiodarone levels and toxicity |
Avoid or reduce amiodarone dose
|
| Grapefruit juice | Increased amiodarone absorption and levels |
Avoid concurrent intake
|
Moderate drug interactions
| Interacting Drug | Effect/Mechanism | Recommendation |
|---|---|---|
| Beta-blockers | Additive bradycardia and AV block | Use with caution; monitor heart rate and ECG |
| Diltiazem, Verapamil | Additive negative chronotropic and dromotropic effects | Monitor for bradycardia; avoid high doses |
| Phenytoin | Increased phenytoin levels (CYP2C9 inhibition) | Monitor phenytoin levels; adjust dose if needed |
| Rifampicin | Decreased amiodarone efficacy (CYP3A4 induction) | Monitor for loss of arrhythmia control |
| Ciclosporin | Increased ciclosporin levels | Monitor ciclosporin levels |
| Aluminium/magnesium antacids | May reduce oral amiodarone absorption | Separate administration by 2 hours |
| Fentanyl | Enhanced cardiovascular depression | Use with caution in perioperative settings |
Common Adverse effects
- Corneal microdeposits (>90% with long-term use; usually asymptomatic, may cause visual halos)
- Photosensitivity and blue-grey skin discolouration
- Bradycardia
- Nausea, anorexia, constipation
- Hypothyroidism (more common) or hyperthyroidism
- Elevated hepatic transaminases (usually asymptomatic)
- Tremor, ataxia, peripheral neuropathy
- Sleep disturbances
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Serious Adverse effects
| Adverse Effect | Clinical Action |
|---|---|
| Pulmonary toxicity (pneumonitis, fibrosis) | Potentially fatal; discontinue immediately; may require corticosteroids |
| Hepatotoxicity (transaminases >3× ULN or clinical hepatitis) | Discontinue; monitor for recovery |
| Torsades de pointes | Rare but life-threatening; discontinue; correct electrolytes; may need pacing |
| Optic neuritis/neuropathy | Can cause permanent vision loss; discontinue immediately |
| Thyroid storm (amiodarone-induced thyrotoxicosis) | Medical emergency; specialist management required |
| Severe bradycardia/sinus arrest/complete heart block | May require pacing; discontinue if possible |
| Stevens-Johnson Syndrome/TEN | Discontinue immediately; supportive care |
Monitoring requirements
| Timing | Parameters |
|---|---|
|
Baseline (before initiation)
|
ECG (rhythm, QTc), LFTs, TFTs (TSH, free T4, free T3), chest X-ray, serum potassium and magnesium, pulmonary function tests if respiratory symptoms |
|
After initiation (first 3ā6 months)
|
ECG: after loading and at 1, 3 months; LFTs: monthly for 3 months then 3-monthly; TFTs: at 3 months |
|
Long-term (chronic use)
|
TFTs and LFTs: every 6 months; ECG: every 6 months; Chest X-ray: annually or with symptoms; Ophthalmology: annually or if visual symptoms; Pulmonary function/HRCT: if new respiratory symptoms |
Brands in India
| Brand Name | Manufacturer | Formulation |
|---|---|---|
| Cordarone | Sanofi | Tablets 200 mg, Injection |
| Cordarone X | Pfizer | Tablets 200 mg |
| Amiodon | Samarth | Tablets 100 mg, 200 mg |
| Duron | Intas | Tablets 200 mg |
| Eurythmic | Micro Labs | Tablets 100 mg, 200 mg; Injection |
| Aldarone | Alkem | Tablets 200 mg |
Note: Also available as hospital-supply generics
Price range (INR)
| Formulation | Approximate Price |
|---|---|
| Unidentifiedcccc | ā¹4ā10 per tablet |
| Tablet 200 mg | ā¹6ā15 per tablet |
| Injection 150 mg/3 mL | ā¹40ā90 per ampoule |
Note: Not currently under DPCO/NLEM price control. Prices vary between government and private supply chains.
Clinical pearls
- Loading is mandatory: Due to extremely long half-life (40ā55 days) and high volume of distribution, adequate loading is essential before maintenance.
- Thyroid vigilance: Contains ~37% iodine by weight; inhibits peripheral T4→T3 conversion. Both hypo- and hyperthyroidism can occur ā hyperthyroidism is more dangerous and may require thyroidectomy.
- Pulmonary toxicity is unpredictable: Not strictly dose-dependent; can occur at any dose. Annual chest X-ray and immediate evaluation for new respiratory symptoms essential.
- Drug interactions are extensive: Always review concomitant medications. Reduce digoxin by 50% and warfarin by 30ā50% when initiating amiodarone.
- Effects persist after stopping: Due to tissue accumulation, adverse effects and drug interactions may persist for weeks to months after discontinuation.
- Preferred in structural heart disease: Amiodarone is the antiarrhythmic of choice for VT/VF and AF in patients with heart failure or significant LV dysfunction where other agents are contraindicated.
Version
RxIndia v1.0 ā 01 Apr 2025
Reference
-
- CDSCO approved prescribing information
- Indian Pharmacopoeia / National Formulary of India
- API Textbook of Medicine
- Harrison's Principles of Internal Medicine
- AIIMS Pharmacology Department protocols
- ICMR Guidelines on Atrial Fibrillation and Ventricular Arrhythmia Management
- Cardiological Society of India practice recommendations
- Select RCTs/meta-analyses (for off-label IV rate control indication)
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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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