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MEDICINE MONOGRAPH CODE: [7.18] ID: TIP-MED-000120

Indomethacin

Active Ingredient / Scientific Identity: Indomethacin • Class: Potent Indole Acetic Acid Non-Selective COX Inhibitor (Schedule H)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Indomethacin ([7.18] | ID: TIP-MED-000120) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/7-18-indomethacin/
Generic / Entity NameIndomethacin ([7.18])
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassPotent Indole Acetic Acid Non-Selective COX Inhibitor (Schedule H)
Available Dosage FormsCapsules: 25 mg, 50 mg IR; 75 mg SR; Suppositories: 50 mg, 100 mg
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal: Contraindicated in moderate-to-severe CKD (eGFR <45 mL/min). Hepatic: Contraindicated in cirrhosis
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H Prescription Drug (To be sold by retail o✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Indomethacin (TIP-MED-000120, Reference Code [7.18]) is classified under Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07) as a Potent Indole Acetic Acid Non-Selective COX Inhibitor (Schedule H). 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 07 [7.18], p. 87): Indocap / Indocap SR (Jagsonpal), Microcid (Micro Labs), Indometh — Strengths & Dosage Forms: Capsules: 25 mg, 50 mg IR; 75 mg SR; Suppositories: 50 mg, 100 mg
Representative Indian Market Examples (Edition 2.7 Ch 07 [7.18], p. 87): Indocap / Indocap SR (Jagsonpal), Microcid (Micro Labs), Indometh — Strengths & Dosage Forms: Capsules: 25 mg, 50 mg IR; 75 mg SR; Suppositories: 50 mg, 100 mg
Dosage Forms & Available Strengths:
Capsules: 25 mg, 50 mg IR; 75 mg SR; Suppositories: 50 mg, 100 mg
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

Potent Indole Acetic Acid Non-Selective COX Inhibitor (Schedule H) acting on target receptor/enzyme pathways in Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07): clinical efficacy is mediated via Potent Indole Acetic Acid Non-Selective COX Inhibitor (Schedule H) for Acute gouty arthritis flare (in young/non-elderly adults without CV/GI/renal disease), ankylosing spondylitis, hemicrania continua / paroxysmal hemicrania.

4. Therapeutic Indications & Evidence-Supported Uses

  • Acute gouty arthritis flare (in young/non-elderly adults without CV/GI/renal disease), ankylosing spondylitis, hemicrania continua / paroxysmal hemicrania

🇮🇳 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: Acute Gout: 50 mg PO TDS with food for 2–3 days, then taper over 3–5 days (Max 150–200 mg/day). Ankylosing Spondylitis: 25 mg BD–TDS or 75 mg SR OD–BD

Administration & Meal Timing: MUST be taken immediately AFTER a full meal or with milk + a Proton-Pump Inhibitor (Pantoprazole/Rabeprazole) | With Breakfast, Lunch & Dinner (IR) or Morning/Bedtime with food (75 mg SR)

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: Contraindicated in moderate-to-severe CKD (eGFR <45 mL/min). Hepatic: Contraindicated in cirrhosis
Elimination & Renal Adjustment:
Renal: Contraindicated in moderate-to-severe CKD (eGFR <45 mL/min). Hepatic: Contraindicated in cirrhosis
Hepatic Impairment Considerations:
Renal: Contraindicated in moderate-to-severe CKD (eGFR <45 mL/min). Hepatic: Contraindicated in cirrhosis

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • HIGHEST CNS & GI TOXICITY AMONG NSAIDs: Contraindicated in older adults (>=65 yr), epilepsy, Parkinson's disease, severe psychiatric disorders/depression (crosses BBB causing severe frontal headache, vertigo, confusion, & psychosis!), peptic ulcer, CKD (eGFR <45 mL/min), Heart Failure, and 3rd trimester of pregnancy

Key Clinical Precautions: Renal: Contraindicated in moderate-to-severe CKD (eGFR <45 mL/min). Hepatic: Contraindicated in cirrhosis

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Severe frontal throbbing headache (25–50% of patients!), dizziness, vertigo, confusion/somnolence, nausea, dyspepsia
  • Peptic ulcer perforation/haemorrhage, acute kidney injury, hyperkalaemia (induces hyporeninaemic hypoaldosteronism!), agranulocytosis/aplastic anaemia, psychosis/hallucinations
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

  • Triamterene + Indomethacin = CONTRAINDICATED (acute anuric renal failure!); Probenecid doubles Indomethacin levels; blunts Furosemide, Thiazides, and ACEi/ARBs; increases Lithium, Digoxin, and Methotrexate toxicity; high bleed risk with Warfarin/DOACs/SSRIs

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: Always take right after a meal with a stomach-protecting PPI; may cause a throbbing front headache or dizziness (do not drive if dizzy); stop immediately if stomach pain or black stools occur
  • Meal & Clock Timing Instruction: MUST be taken immediately AFTER a full meal or with milk + a Proton-Pump Inhibitor (Pantoprazole/Rabeprazole) (With Breakfast, Lunch & Dinner (IR) or Morning/Bedtime with food (75 mg SR))
  • Missed Dose Protocol: Skip if missed; never double dose
  • Geriatric Dispensing Pearl: STRICTLY AVOID Indomethacin in older adults >=65 years (AGS Beers 2023: highest CNS delirium/dizziness and GI/renal toxicity of any NSAID; use Colchicine or short-course Prednisolone for elderly gout instead!)

Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Capsules: 25 mg, 50 mg IR; 75 mg SR; Suppositories: 50 mg, 100 mg

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 07 [7.18] (p. 87)

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/7-18-indomethacin/, 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.