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MEDICINE MONOGRAPH CODE: [3.42] ID: TIP-MED-000042 ⚠️ HIGH-ALERT / SPECIALIST SUPERVISION

Amiodarone Hydrochloride

Active Ingredient / Scientific Identity: Amiodarone Hydrochloride • Class: Class III Broad-Spectrum Antiarrhythmic (Schedule H | NLEM 2022 | HIGH-ALERT)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Amiodarone Hydrochloride ([3.42] | ID: TIP-MED-000042) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/3-42-amiodarone-hydrochloride/
Generic / Entity NameAmiodarone Hydrochloride ([3.42])
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassClass III Broad-Spectrum Antiarrhythmic (Schedule H | NLEM 2022 | HIGH-ALERT)
Available Dosage FormsTablets: 100 mg, 200 mg; IV Injection: 150 mg/3 mL ampoule
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal: No dose adjustment needed (minimal renal excretion). Hepatic: Discontinue if AST/ALT rise >3x ULN
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H Prescription Drug (To be sold by retail o🚨 Clinically High-Alert: Independent Dose & Route Verification Required

1. Clinical & Scientific Overview

Amiodarone Hydrochloride (TIP-MED-000042, Reference Code [3.42]) is classified under Cardiovascular & Antithrombotic Medicines (Ch 03) as a Class III Broad-Spectrum Antiarrhythmic (Schedule H | NLEM 2022 | HIGH-ALERT). Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).

Verified Indian Market Examples / Compendial Status:
Representative Indian Market Examples (Edition 2.7 Ch 03 [3.42], p. 41): Cordarone / Cordarone X (Sanofi), Eurythmic (Troikaa), Tachyra (Cipla) — Strengths & Dosage Forms: Tablets: 100 mg, 200 mg; IV Injection: 150 mg/3 mL ampoule
Representative Indian Market Examples (Edition 2.7 Ch 03 [3.42], p. 41): Cordarone / Cordarone X (Sanofi), Eurythmic (Troikaa), Tachyra (Cipla) — Strengths & Dosage Forms: Tablets: 100 mg, 200 mg; IV Injection: 150 mg/3 mL ampoule
Dosage Forms & Available Strengths:
Tablets: 100 mg, 200 mg; IV Injection: 150 mg/3 mL ampoule
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

Class III Broad-Spectrum Antiarrhythmic (Schedule H | NLEM 2022 | HIGH-ALERT) acting on target receptor/enzyme pathways in Cardiovascular & Antithrombotic Medicines (Ch 03): clinical efficacy is mediated via Class III Broad-Spectrum Antiarrhythmic (Schedule H | NLEM 2022 | HIGH-ALERT) for Life-threatening ventricular arrhythmias (VT/VF) and rhythm/rate control of refractory atrial fibrillation (especially in structural heart disease / HFrEF).

4. Therapeutic Indications & Evidence-Supported Uses

  • Life-threatening ventricular arrhythmias (VT/VF) and rhythm/rate control of refractory atrial fibrillation (especially in structural heart disease / HFrEF)

🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.

5. Educational Dosage Context, Formulations & Administration

Educational Dosing & Regimen Summary: Oral Loading: 200 mg TDS x 1 week, then 200 mg BD x 1 week, then Maintenance: 100–200 mg OD (use lowest effective dose!). IV Resuscitation: 300 mg in 5% Dextrose (NEVER Normal Saline!), or 150 mg over 10 min for stable VT

Administration & Meal Timing: Take consistently with food to reduce GI upset | Morning (Once Daily during maintenance)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Metabolism & Biotransformation:
Renal: No dose adjustment needed (minimal renal excretion). Hepatic: Discontinue if AST/ALT rise >3x ULN
Elimination & Renal Adjustment:
Renal: No dose adjustment needed (minimal renal excretion). Hepatic: Discontinue if AST/ALT rise >3x ULN
Hepatic Impairment Considerations:
Renal: No dose adjustment needed (minimal renal excretion). Hepatic: Discontinue if AST/ALT rise >3x ULN

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • HIGH-ALERT MULTI-ORGAN TOXICITY & LASA ALERT (Cordarone vs. Cardace/Cardivas!): Contraindicated in sinus node dysfunction, 2nd/3rd-degree AV block (without pacemaker), thyroid dysfunction, iodine hypersensitivity, pregnancy, and lactation

Key Clinical Precautions: Renal: No dose adjustment needed (minimal renal excretion). Hepatic: Discontinue if AST/ALT rise >3x ULN

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Corneal microdeposits (>90% — usually benign halos), blue-grey slate skin discolouration, extreme UVA/UVB photosensitivity, nausea, bradycardia
  • Fatal pulmonary fibrosis / interstitial pneumonitis (1–5%), both Hypothyroidism and Thyrotoxicosis (contains 37% iodine by weight!), hepatotoxicity, optic neuropathy, Torsades de Pointes
Serious / Dose-Limiting Adverse Effects:
  • Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.

9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

  • POTENT CYP2C9, CYP2D6 & P-gp INHIBITOR: Increases Warfarin INR markedly (reduce Warfarin dose by 30–50% immediately!), DOUBLES Digoxin levels (halve Digoxin dose immediately!), increases Simvastatin (max 20 mg) & Dabigatran; additive QTc prolongation with Fluoroquinolones, Macrolides, Ondansetron, Domperidone; extreme bradycardia with Sofosbuvir or Beta-blockers/Diltiazem

10. Clinical Monitoring, Patient Counselling & Storage

Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.

Pharmacist Patient Counselling Points:

  • Patient Counselling Checklist: COUNTER CHECK: Verify 'Cordarone' (Amiodarone 100/200 mg) vs 'Cardace' (Ramipril) or 'Cardivas' (Carvedilol)! Apply broad-spectrum SPF 50+ sunscreen daily; report any new dry cough, breathlessness, yellow eyes, or weight/tremor changes immediately
  • Meal & Clock Timing Instruction: Take consistently with food to reduce GI upset (Morning (Once Daily during maintenance))
  • Missed Dose Protocol: If a single maintenance dose is missed, skip it and resume next day (do not double; 50-day half-life maintains levels)
  • Geriatric Dispensing Pearl: High risk of hypothyroidism, pulmonary toxicity, and bradycardia in older adults (AGS Beers 2023); use lowest maintenance dose (100 mg OD)

Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Tablets: 100 mg, 200 mg; IV Injection: 150 mg/3 mL ampoule

11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)

THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

12. Authoritative References, Regulatory Sources & Editorial Disclaimer

Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 03 [3.42] (p. 41)

Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)

Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT

Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.

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Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/3-42-amiodarone-hydrochloride/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.