1. Clinical & Scientific Overview
Mefenamic Acid (TIP-MED-000118, Reference Code [7.16]) is classified under
Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07) as a Anthranilic Acid (Fenamate) COX-1 / COX-2 Inhibitor & Prostaglandin Receptor Antagonist (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 [7.16], p. 86): Meftal-250 / Meftal-500 / Meftal-P (Blue Cross), Ponstan (Pfizer); FDCs: Meftal-Spas (+ Dicyclomine 10 mg), Trapic-MF (+ Tranexamic Acid 500 mg) — Strengths & Dosage Forms: Tablets: 250 mg, 500 mg; Paediatric Suspension: 100 mg/5 mL
Tablets: 250 mg, 500 mg; Paediatric Suspension: 100 mg/5 mL
3. Mechanism of Action & Pharmacodynamics
Anthranilic Acid (Fenamate) COX-1 / COX-2 Inhibitor & Prostaglandin Receptor Antagonist (Schedule H) acting on target receptor/enzyme pathways in Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07): clinical efficacy is mediated via Anthranilic Acid (Fenamate) COX-1 / COX-2 Inhibitor & Prostaglandin Receptor Antagonist (Schedule H) for Primary dysmenorrhoea (uniquely blocks both prostaglandin synthesis AND uterine myometrial PGE2/PGF2a receptors!), heavy menstrual bleeding (with Tranexamic Acid), acute dental/musculoskeletal pain, refractory pyrexia.
4. Therapeutic Indications & Evidence-Supported Uses
- Primary dysmenorrhoea (uniquely blocks both prostaglandin synthesis AND uterine myometrial PGE2/PGF2a receptors!), heavy menstrual bleeding (with Tranexamic Acid), acute dental/musculoskeletal pain, refractory pyrexia
🇮🇳 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: Adults: 500 mg PO initial dose, then 250–500 mg TDS after meals for 3–5 days (Max 1500 mg/day for <=7 days)
Administration & Meal Timing: Take immediately AFTER meals with a full glass of water | Three times daily after Meals for 3–5 Days during menstruation or acute pain
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Contraindicated if eGFR <30–45 mL/min or in dehydrated febrile children. Hepatic: Avoid in active liver disease
Renal: Contraindicated if eGFR <30–45 mL/min or in dehydrated febrile children. Hepatic: Avoid in active liver disease
Renal: Contraindicated if eGFR <30–45 mL/min or in dehydrated febrile children. Hepatic: Avoid in active liver disease
7. Contraindications, Precautions & High-Risk Warnings
- IPC / CDSCO PvPI SAFETY ALERT (2023): Mefenamic acid carries a documented alert for DRESS Syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms)! Contraindicated in peptic ulcer, inflammatory bowel disease, CKD (eGFR <45 mL/min), Heart Failure, post-CABG, and 3rd trimester of pregnancy
Key Clinical Precautions: Renal: Contraindicated if eGFR <30–45 mL/min or in dehydrated febrile children. Hepatic: Avoid in active liver disease
8. Adverse Effects Profile
- Diarrhoea (very characteristic of fenamates — if diarrhoea occurs, STOP Mefenamic Acid immediately!), dyspepsia, nausea, dizziness
- DRESS syndrome (fever, widespread morbilliform rash, facial oedema, lymphadenopathy, eosinophilia, hepatitis/nephritis 2–8 weeks after exposure — PvPI Alert!), haemolytic anaemia, seizures in overdose, GI bleeding, AKI
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Potentiates Warfarin and DOAC bleeding; increases Lithium and Methotrexate toxicity; Triple Whammy AKI with ACEi/ARB + Diuretic; avoid combining with other NSAIDs
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: Take after food for a maximum of 5–7 days; stop immediately if you develop diarrhoea, skin rash, fever, or swollen glands (CDSCO PvPI safety alert); never give to a dehydrated child
- Meal & Clock Timing Instruction: Take immediately AFTER meals with a full glass of water (Three times daily after Meals for 3–5 Days during menstruation or acute pain)
- Missed Dose Protocol: Use PRN during painful menses; do not exceed 7 days
- Geriatric Dispensing Pearl: Avoid in older adults due to high GI diarrhoea/ulcer and renal toxicity risk
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: 250 mg, 500 mg; Paediatric Suspension: 100 mg/5 mL
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 [7.16] (p. 86)
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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