1. Clinical & Scientific Overview
Ketorolac Tromethamine (TIP-MED-000117, Reference Code [7.15]) is classified under
Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07) as a Potent Pyrrolizine Carboxylic Acid Non-Selective COX Inhibitor Analgesic (Schedule H | HIGH-ALERT).
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 [7.15], p. 86): Ketorol / Ketorol DT (Dr. Reddy's), Torolac (Lupin), Cadolac (Cadila) — Strengths & Dosage Forms: Dispersible / Film-Coated Tablets: 10 mg; IM/IV Injection: 30 mg/mL; Ophthalmic Solution: 0.4%, 0.5%
Dispersible / Film-Coated Tablets: 10 mg; IM/IV Injection: 30 mg/mL; Ophthalmic Solution: 0.4%, 0.5%
3. Mechanism of Action & Pharmacodynamics
Potent Pyrrolizine Carboxylic Acid Non-Selective COX Inhibitor Analgesic (Schedule H | HIGH-ALERT) acting on target receptor/enzyme pathways in Pain, Inflammation, Rheumatology & Gout Medicines (Ch 07): clinical efficacy is mediated via Potent Pyrrolizine Carboxylic Acid Non-Selective COX Inhibitor Analgesic (Schedule H | HIGH-ALERT) for Short-term management (<=5 days ONLY!) of moderate-to-severe acute postoperative pain, acute dental pulpitis/post-extraction pain, or acute renal colic.
4. Therapeutic Indications & Evidence-Supported Uses
- Short-term management (<=5 days ONLY!) of moderate-to-severe acute postoperative pain, acute dental pulpitis/post-extraction pain, or acute renal colic
🇮🇳 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: Oral (Adults <65 yr & >=50 kg): 10 mg PO q6h PRN (Max 40 mg/day). IM/IV: 15–30 mg q6h (Max 60–120 mg/day; max 60 mg/day if >=65 yr or <50 kg). MAXIMUM COMBINED (IV/IM + PO) DURATION: 5 DAYS!
Administration & Meal Timing: Disperse 10 mg DT tablet in half a glass of water and take immediately AFTER food | Every 6 Hours PRN after food for Max 5 Days
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Contraindicated in moderate-to-severe renal impairment (SCr >1.5 mg/dL or eGFR <45 mL/min). Hepatic: Avoid in severe liver disease
Renal: Contraindicated in moderate-to-severe renal impairment (SCr >1.5 mg/dL or eGFR <45 mL/min). Hepatic: Avoid in severe liver disease
Renal: Contraindicated in moderate-to-severe renal impairment (SCr >1.5 mg/dL or eGFR <45 mL/min). Hepatic: Avoid in severe liver disease
7. Contraindications, Precautions & High-Risk Warnings
- CONTRAINDICATED for chronic pain or mild osteoarthritis, use >5 days, peptic ulcer/GI bleed history, suspected/confirmed cerebrovascular bleeding, pre-operative prophylaxis, labour/delivery, advanced renal impairment, and concurrent use with any other NSAID or Aspirin
Key Clinical Precautions: Renal: Contraindicated in moderate-to-severe renal impairment (SCr >1.5 mg/dL or eGFR <45 mL/min). Hepatic: Avoid in severe liver disease
8. Adverse Effects Profile
- Epigastric pain, dyspepsia, nausea, headache, drowsiness, dizziness, injection-site pain
- Severe GI haemorrhage or perforation (can occur without warning symptoms!), acute kidney injury / renal failure, anaphylaxis/bronchospasm, post-operative wound bleeding
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Strictly contraindicated with Probenecid (triples Ketorolac AUC!), Pentoxifylline, other NSAIDs/Aspirin, and Anticoagulants (Warfarin, DOACs, Heparin); increases Lithium and Methotrexate toxicity; Triple Whammy AKI with ACEi/ARB + Diuretic
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 QUANTITY AUDIT: Ketorol DT is only for severe short-term dental or post-surgery pain for a maximum of 5 days (never >4 tablets/day); do not take with Ibuprofen, Diclofenac, or Aceclofenac; stop immediately if stomach pain or black stools occur
- Meal & Clock Timing Instruction: Disperse 10 mg DT tablet in half a glass of water and take immediately AFTER food (Every 6 Hours PRN after food for Max 5 Days)
- Missed Dose Protocol: Take PRN for severe pain; stop as soon as pain subsides and never exceed 4 tablets/day or 5 days
- Geriatric Dispensing Pearl: Avoid in older adults >=65 years (AGS Beers 2023: extreme risk of asymptomatic GI perforation/bleeding and AKI)
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Dispersible / Film-Coated Tablets: 10 mg; IM/IV Injection: 30 mg/mL; Ophthalmic Solution: 0.4%, 0.5%
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 [7.15] (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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