1. Clinical & Scientific Overview
Aceclofenac (TIP-MED-000105, Reference Code [7.3]) is classified under
Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07) as a Non-Steroidal Anti-Inflammatory Drug (NSAID); Phenylacetic Acid Derivative (Preferential COX-2 Inhibitor, Prodrug of 4'-Hydroxyaceclofenac & Diclofenac).
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).
Voveran (Novartis), Dynapar (Troikka), Reactin (Cipla)
Oral Film-Coated Tablets: 100 mg; Sustained/Controlled-Release (SR/CR) Tablets: 200 mg
3. Mechanism of Action & Pharmacodynamics
Non-Steroidal Anti-Inflammatory Drug (NSAID); Phenylacetic Acid Derivative (Preferential COX-2 Inhibitor, Prodrug of 4'-Hydroxyaceclofenac & Diclofenac) acting on target receptor/enzyme pathways in Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07): clinical efficacy is mediated via Non-Steroidal Anti-Inflammatory Drug (NSAID); Phenylacetic Acid Derivative (Preferential COX-2 Inhibitor, Prodrug of 4'-Hydroxyaceclofenac & Diclofenac) for Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute lumbago (low back pain), dental pain, and postoperative musculoskeletal inflammation..
4. Therapeutic Indications & Evidence-Supported Uses
- Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute lumbago (low back pain), dental pain, and postoperative musculoskeletal inflammation
🇮🇳 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: 100 mg twice daily (morning and evening after meals), or 200 mg SR/CR once daily (Maximum 200 mg/day). Follow physician prescription.
Administration & Meal Timing: Take WITH or immediately AFTER food with a full glass of water. | Twice daily after breakfast and dinner (for 100 mg IR) or once daily after dinner (for 200 mg SR/CR).
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Contraindicated in severe CKD (eGFR <30 mL/min); avoid in moderate CKD (eGFR 30–59 mL/min). Hepatic: Reduce initial dose to 100 mg once daily in mild-to-moderate hepatic impairment; contraindicated in severe liver disease.
Renal: Contraindicated in severe CKD (eGFR <30 mL/min); avoid in moderate CKD (eGFR 30–59 mL/min). Hepatic: Reduce initial dose to 100 mg once daily in mild-to-moderate hepatic impairment; contraindicated in severe liver disease.
Renal: Contraindicated in severe CKD (eGFR <30 mL/min); avoid in moderate CKD (eGFR 30–59 mL/min). Hepatic: Reduce initial dose to 100 mg once daily in mild-to-moderate hepatic impairment; contraindicated in severe liver disease.
7. Contraindications, Precautions & High-Risk Warnings
- Same cardiovascular, renal, and gastrointestinal contraindications as Diclofenac! (Because aceclofenac is partially metabolised to diclofenac in vivo, it is contraindicated in established IHD, heart failure, stroke, PAD, active peptic ulcer, eGFR <30–45 mL/min, pregnancy 3rd trimester, and Dengue).
Key Clinical Precautions: Renal: Contraindicated in severe CKD (eGFR <30 mL/min); avoid in moderate CKD (eGFR 30–59 mL/min). Hepatic: Reduce initial dose to 100 mg once daily in mild-to-moderate hepatic impairment; contraindicated in severe liver disease.
8. Adverse Effects Profile
- Dyspepsia, abdominal pain, nausea, diarrhoea, dizziness, mild elevation of hepatic transaminases (slightly better upper GI tolerability than conventional diclofenac/piroxicam, but ulcer risk remains significant).
- GI ulceration and haemorrhage, acute kidney injury, cardiovascular thrombotic events, Stevens-Johnson syndrome, hepatotoxicity.
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Blunts antihypertensive efficacy of ACE inhibitors, ARBs, beta-blockers, and diuretics ('Triple Whammy' AKI risk)
- Increases bleeding risk with aspirin, clopidogrel, DOACs, warfarin, and steroids
- Increases lithium, digoxin, and methotrexate toxicity
- Combined with fluoroquinolones (ciprofloxacin), increases CNS seizure risk
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: Zerodol-P and Zerodol-SP are among the top-selling prescription tablets in Indian orthopaedic OPDs. Remind patients that '-P' and '-SP' already contain 325 mg of Paracetamol, to take them strictly after meals, and to stop using them as soon as acute joint pain resolves rather than refilling them monthly like a blood pressure pill.
- Meal & Clock Timing Instruction: Take WITH or immediately AFTER food with a full glass of water. (Twice daily after breakfast and dinner (for 100 mg IR) or once daily after dinner (for 200 mg SR/CR).)
- Missed Dose Protocol: Take after food if remembered; skip if close to next dose. Never double.
- Geriatric Dispensing Pearl: Ensure gastroprotection (Pantoprazole 40 mg OD) if prescribed short-term to an elderly patient, and strictly screen out use in CGHS beneficiaries with CKD, heart failure, or coronary stents.
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: 100 mg; Sustained/Controlled-Release (SR/CR) Tablets: 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 [7.3] (p. 80)
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
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- [7.6] Etoricoxib — Selective Cyclooxygenase-2 (COX-2) Inhibitor (Coxib NSAID)
- [7.7] Tramadol Hydrochloride — Weak Centrally Acting Mu-Opioid Receptor Agonist & Serotonin/Nore
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