1. Clinical & Scientific Overview
Etoricoxib (TIP-MED-000108, Reference Code [7.6]) is classified under
Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07) as a Selective Cyclooxygenase-2 (COX-2) Inhibitor (Coxib NSAID).
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).
Representative Indian Market Examples (Edition 2.7 Ch 07 [7.6], p. 81): Nucoxia (Zydus), Etoshine (Sun Pharma), Etorica (Micro Labs), Retoz (Dr. Reddy's), Brutaflam; In FDC with Thiocolchicoside: Nucoxia-MR, Etoshine-MR; With Paracetamol: Nucoxia-P — Strengths & Dosage Forms: Oral Film-Coated Tablets: 60 mg, 90 mg, 120 mg
Oral Film-Coated Tablets: 60 mg, 90 mg, 120 mg
3. Mechanism of Action & Pharmacodynamics
Selective Cyclooxygenase-2 (COX-2) Inhibitor (Coxib NSAID) acting on target receptor/enzyme pathways in Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07): clinical efficacy is mediated via Selective Cyclooxygenase-2 (COX-2) Inhibitor (Coxib NSAID) for Osteoarthritis (60 mg OD); Rheumatoid Arthritis and Ankylosing Spondylitis (60–90 mg OD); Acute Gouty Arthritis and Acute Dental Surgery Pain (120 mg OD strictly limited to maximum 8 days!)..
4. Therapeutic Indications & Evidence-Supported Uses
- Osteoarthritis (60 mg OD)
- Rheumatoid Arthritis and Ankylosing Spondylitis (60–90 mg OD)
- Acute Gouty Arthritis and Acute Dental Surgery Pain (120 mg OD strictly limited to maximum 8 days!)
🇮🇳 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: General Adult Reference: Osteoarthritis: 60 mg once daily. Rheumatoid Arthritis / Ankylosing Spondylitis: 60 mg–90 mg once daily. Acute Gout Flare: 120 mg once daily for a maximum of 8 days only! Use lowest effective dose for shortest duration. Follow physician prescription.
Administration & Meal Timing: With or without food (onset of acute pain relief is faster when taken without food, though may be taken after meals if mild dyspepsia occurs). | Once daily (long 22-hour half-life provides full 24-hour analgesia).
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Just as nephrotoxic as traditional NSAIDs! Contraindicated if CrCl <30 mL/min; avoid in moderate CKD. Hepatic: Child-Pugh A (mild): max 60 mg once daily; Child-Pugh B (moderate): max 60 mg every alternate day (or 30 mg OD); Child-Pugh C (severe): contraindicated.
Renal: Just as nephrotoxic as traditional NSAIDs! Contraindicated if CrCl <30 mL/min; avoid in moderate CKD. Hepatic: Child-Pugh A (mild): max 60 mg once daily; Child-Pugh B (moderate): max 60 mg every alternate day (or 30 mg OD); Child-Pugh C (severe): contraindicated.
Renal: Just as nephrotoxic as traditional NSAIDs! Contraindicated if CrCl <30 mL/min; avoid in moderate CKD. Hepatic: Child-Pugh A (mild): max 60 mg once daily; Child-Pugh B (moderate): max 60 mg every alternate day (or 30 mg OD); Child-Pugh C (severe): contraindicated.
7. Contraindications, Precautions & High-Risk Warnings
- STRICTLY CONTRAINDICATED in Uncontrolled Hypertension (BP persistently >140/90 mmHg), Ischaemic Heart Disease (IHD / Angina / prior MI / Stent), Peripheral Arterial Disease, Cerebrovascular Disease (Stroke / TIA), and Congestive Heart Failure (NYHA II–IV)! (Selective COX-2 blockade suppresses endothelial prostacyclin PGI2 while leaving platelet thromboxane TXA2 unopposed—creating a prothrombotic state and dose-dependent hypertension!). Also contraindicated in active peptic ulcer, inflammatory bowel disease, and CrCl <30 mL/min.
Key Clinical Precautions: Renal: Just as nephrotoxic as traditional NSAIDs! Contraindicated if CrCl <30 mL/min; avoid in moderate CKD. Hepatic: Child-Pugh A (mild): max 60 mg once daily; Child-Pugh B (moderate): max 60 mg every alternate day (or 30 mg OD); Child-Pugh C (severe): contraindicated.
8. Adverse Effects Profile
- Hypertension (dose-related blood pressure surge, especially at 90–120 mg), pedal oedema/fluid retention, dizziness, headache, mild dyspepsia, aphthous stomatitis, ALT/AST elevation.
- Myocardial infarction, ischaemic stroke, hypertensive crisis, acute heart failure, acute kidney injury (COX-2 is constitutively expressed in the renal macula densa—etoricoxib is JUST AS NEPHROTOXIC as non-selective NSAIDs like diclofenac!), GI perforation/bleed (lower risk than non-selective NSAIDs, but advantage is lost if patient also takes low-dose Aspirin!).
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Antagonises all antihypertensives (ACEIs, ARBs, CCBs, diuretics) and causes 'Triple Whammy' AKI
- Increases Warfarin INR by ~13%
- Increases plasma ethinylestradiol and lithium levels
- Co-administration with low-dose Aspirin (75 mg) negates the GI-sparing benefit of etoricoxib (still requires a PPI!)
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: Clarify two widespread misconceptions at the counter: (1) Although Etoricoxib (Nucoxia/Etoshine) is gentler on the stomach lining than Voveran, it is NOT safe for the kidneys or heart and frequently pushes blood pressure up—check BP regularly while taking it; (2) If prescribed the strong 120 mg tablet for acute gout, never continue it beyond 8 days.
- Meal & Clock Timing Instruction: With or without food (onset of acute pain relief is faster when taken without food, though may be taken after meals if mild dyspepsia occurs). (Once daily (long 22-hour half-life provides full 24-hour analgesia).)
- Missed Dose Protocol: Take as soon as remembered on the same day; never take two tablets in 24 hours.
- Geriatric Dispensing Pearl: Before dispensing Etoricoxib to an elderly CGHS beneficiary from an orthopaedic slip, always cross-check their cardiology medication list—if they have a coronary stent, prior heart attack, stroke, heart failure, or CKD, hold and contact the physician to substitute a safer modality (paracetamol, topical NSAID, or intra-articular therapy).
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Oral Film-Coated Tablets: 60 mg, 90 mg, 120 mg
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 07 [7.6] (p. 81)
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.
13. Related Reference Monographs, Educational Guides & Visual Concept
💊 Related Pharmacological / Category Profiles
- [7.8] Pregabalin — Gabapentinoid; Presynaptic Voltage-Gated Calcium Channel Alpha-2-
- [7.9] Gabapentin — Gabapentinoid; Voltage-Gated Calcium Channel Alpha-2-Delta (α2δ)
- [7.10] Allopurinol — Xanthine Oxidase Inhibitor (Purine Analogue; Metabolised to Activ
- [7.11] Febuxostat — Non-Purine Selective Xanthine Oxidase Inhibitor; Urate-Lowering A
