1. Clinical & Scientific Overview
Celecoxib (TIP-MED-000119, Reference Code [7.17]) is classified under
Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07) as a Selective Cyclooxygenase-2 (COX-2) Inhibitor — Diaryl-Substituted Pyrazole Sulfonamide (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).
Representative Indian Market Examples (Edition 2.7 Ch 07 [7.17], p. 87): Celact (Sun), Zycel (Zydus), Cobix (Cipla), Celebrex (Pfizer) — Strengths & Dosage Forms: Capsules: 100 mg, 200 mg
Capsules: 100 mg, 200 mg
3. Mechanism of Action & Pharmacodynamics
Selective Cyclooxygenase-2 (COX-2) Inhibitor — Diaryl-Substituted Pyrazole Sulfonamide (Schedule H) 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 — Diaryl-Substituted Pyrazole Sulfonamide (Schedule H) for Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute musculoskeletal pain (lower incidence of gastroduodenal ulcers than non-selective NSAIDs at 200 mg/day, PRECISION trial).
4. Therapeutic Indications & Evidence-Supported Uses
- Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute musculoskeletal pain (lower incidence of gastroduodenal ulcers than non-selective NSAIDs at 200 mg/day, PRECISION trial)
🇮🇳 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: Osteoarthritis: 200 mg PO OD (or 100 mg BD). Rheumatoid Arthritis / AS: 100–200 mg PO BD (Max 400 mg/day; use lowest effective dose)
Administration & Meal Timing: May be taken with or without food (take with food for 200 mg BD doses to improve absorption and comfort) | Morning (OD) or Morning & Evening (BD)
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Avoid if eGFR <30 mL/min. Hepatic: Reduce dose by 50% in moderate hepatic impairment (Child–Pugh B); contraindicated in Child–Pugh C
Renal: Avoid if eGFR <30 mL/min. Hepatic: Reduce dose by 50% in moderate hepatic impairment (Child–Pugh B); contraindicated in Child–Pugh C
Renal: Avoid if eGFR <30 mL/min. Hepatic: Reduce dose by 50% in moderate hepatic impairment (Child–Pugh B); contraindicated in Child–Pugh C
7. Contraindications, Precautions & High-Risk Warnings
- CONTRAINDICATED in Sulfonamide ('Sulfa') Allergy (Celecoxib contains a benzenesulfonamide moiety — unlike Etoricoxib!), established ischaemic heart disease (MI/angina), cerebrovascular disease (stroke/TIA), peripheral arterial disease, NYHA II–IV Heart Failure, active GI bleed, CKD (eGFR <30 mL/min), and Child–Pugh C cirrhosis
Key Clinical Precautions: Renal: Avoid if eGFR <30 mL/min. Hepatic: Reduce dose by 50% in moderate hepatic impairment (Child–Pugh B); contraindicated in Child–Pugh C
8. Adverse Effects Profile
- Dyspepsia, abdominal pain, mild peripheral oedema, blood pressure elevation, dizziness
- Atherothrombotic cardiovascular events (MI, stroke), heart failure decompensation, GI ulceration/bleeding (especially if combined with low-dose Aspirin!), acute kidney injury, SJS/TEN
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- CYP2C9 INHIBITED BY FLUCONAZOLE: Fluconazole doubles Celecoxib plasma levels -> halve Celecoxib dose! Celecoxib inhibits CYP2D6 -> increases Metoprolol, Nebivolol, Amitriptyline, and Dextromethorphan levels; increases Lithium and Warfarin INR; co-administration with low-dose Aspirin negates much of Celecoxib's GI-sparing advantage (add 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: COUNTER ALLERGY CHECK: Ask every patient about 'Sulfa' (Sulfonamide) allergy before dispensing Celecoxib (Celact/Zycel)! If the patient also takes Aspirin 75 mg for heart protection, a stomach protector (Pantoprazole) is still required
- Meal & Clock Timing Instruction: May be taken with or without food (take with food for 200 mg BD doses to improve absorption and comfort) (Morning (OD) or Morning & Evening (BD))
- Missed Dose Protocol: Take PRN or skip missed dose; never double dose
- Geriatric Dispensing Pearl: If an oral NSAID cannot be avoided in an older adult without CV/renal disease, Celecoxib 100–200 mg/d + PPI has the lowest GI bleed rate, but monitor BP, eGFR, and HF signs closely
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: 100 mg, 200 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 [7.17] (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.
13. Related Reference Monographs, Educational Guides & Visual Concept
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