Formulary
Ketorolac trometamol: Indications, Dosing, Side Effects and Interactions
Ketorolac trometamol clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 6 min read
Ketorolac trometamol: Indications, Dosing, Side Effects and Interactions
Ketorolac trometamol clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Short-term management of moderate to severe acute postoperative pain only**
- **Adult** (By Intramuscular Injection, Or By Intravenous Injection): (body-weight 50 kg and above) Initially 10 mg, then 10-30 mg every 4-6 hours as required for maximum duration of treatment 2 days, frequency may be increased to up to every 2 hours during initial postoperative period; maximum 90 mg per day.
- **Elderly** (By Intramuscular Injection, Or By Intravenous Injection): Initially 10 mg, then 10-30 mg every 4-6 hours as required for maximum duration of treatment 2 days, frequency may be increased to up to every 2 hours during initial postoperative period; maximum 60 mg per day.
**Prophylaxis and reduction of inflammation and associated symptoms following ocular surgery**
- **Adult** (To The Eye): (consult product literature).
**Short-term management of moderate to severe acute postoperative pain only for ketorolac trometamol**
- **Child 16-17 years (body-weight up to 50 kg)** (By intramuscular injection, or by intravenous injection): Initially 10 mg, then 10-30 mg every 4-6 hours as required for maximum duration of treatment 2 days, frequency may be increased to up to every 2 hours during initial postoperative period; maximum 60 mg per day.
- **Child 16-17 years (body-weight 50 kg and above)** (By intramuscular injection, or by intravenous injection): Initially 10 mg, then 10-30 mg every 4-6 hours as required for maximum duration of treatment 2 days, frequency may be increased to up to every 2 hours during initial postoperative period; maximum 90 mg per day.
- **Child 6 months-15 years** (By intravenous injection): Initially 0.5-1 mg/kg (max. per dose 15 mg), then 500 micrograms/kg every 6 hours (max. per dose 15 mg) as required for maximum duration of treatment 2 days; maximum 60 mg per day.
**Prophylaxis and reduction of inflammation and associated symptoms following ocular surgery for ketorolac trometamol**
- **Child** (To the eye): (consult product literature).
Cautions
General cautions: May mask symptoms of infection Specific cautions: When used by eye Bleeding tendency (increased risk of ocular tissue bleeding, including hyphaema); concomitant use of ocular corticosteroids; corneal epithelial breakdown (if evidence of, then discontinue immediately); may slow or delay wound healing; patients at increased risk of corneal side-effects With intramuscular use Allergic disorders; cardiac impairment (NSAIDs may impair renal function); cerebrovascular disease; connective-tissue disorders; elderly (risk of serious side-effects and fatalities); heart failure; history of gastro-intestinal disorders (e.g. ulcerative colitis, Crohn's disease); ischaemic heart disease; peripheral arterial disease; risk factors for cardiovascular events; uncontrolled hypertension With intravenous use Allergic disorders; cardiac impairment (NSAIDs may impair renal function); cerebrovascular disease; connective-tissue disorders; elderly (risk of serious side-effects and fatalities); heart failure; history of gastro-intestinal disorders (e.g. ulcerative colitis, Crohn's disease); ischaemic heart disease; peripheral arterial disease; risk factors for cardiovascular events; uncontrolled hypertension Cautions, further information Concomitant use of ocular corticosteroids When used by eye: Concomitant use of ocular formulations containing NSAIDs with ocular formulations containing corticosteroids may increase the risk of corneal healing problems, leading to corneal melt or scarring and loss of vision. M Patients at increased risk of corneal side-effects When used by eye: Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases, rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk of corneal side-effects which may become sight threatening. M
Contraindications
With intramuscular use Active or history of gastro-intestinal bleeding; active or history of gastro-intestinal ulceration; coagulation disorders; complete or partial syndrome of nasal polyps; confirmed or suspected cerebrovascular bleeding; dehydration; following operations with high risk of haemorrhage or incomplete haemostasis; haemorrhagic diatheses; history of gastro-intestinal bleeding related to previous NSAID therapy; history of gastro-intestinal perforation related to previous NSAID therapy; hypovolaemia; severe heart failure With intravenous use Active or history of gastro-intestinal bleeding; active or history of gastro-intestinal ulceration; coagulation disorders; complete or partial syndrome of nasal polyps; confirmed or suspected cerebrovascular bleeding; dehydration; following operations with high risk of haemorrhage or incomplete haemostasis; haemorrhagic diatheses; history of gastro-intestinal bleeding related to previous NSAID therapy; history of gastro-intestinal perforation related to previous NSAID therapy; hypovolaemia; severe heart failure
Side effects
General side-effects: Common or very common Headache; hypersensitivity Specific side-effects: Common or very common When used by eye (topical) Eye discomfort; eye disorders; eye infection; eye inflammation; keratic deposits; retinal haemorrhage; vision disorders Uncommon When used by eye (topical) Dry eye Frequency not known When used by eye (topical) Asthma exacerbated; bronchospasm With parenteral use Agranulocytosis; angioedema; anxiety; aplastic anaemia; appetite decreased; asthenia; asthma; azotaemia; bradycardia; burping; chest pain; concentration impaired; confusion; constipation; Crohn's disease aggravated; depression; diarrhoea; dizziness; drowsiness; dry mouth; dyspnoea; electrolyte imbalance; embolism and thrombosis; euphoric mood; fever; flank pain; fluid retention; flushing; gastrointestinal discomfort; gastrointestinal disorders; haemolytic anaemia; haemorrhage; hallucination; hearing loss; heart failure; hepatic disorders; hyperhidrosis; hyperkinesia; hypertension; hypotension; infertility female; malaise; meningitis aseptic (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible); musculoskeletal disorder; myalgia; nausea; nephritis tubulointerstitial; nephropathy; neutropenia; oedema; optic neuritis; oral disorders; pallor; palpitations; pancreatitis; paraesthesia; perforation; photosensitivity reaction; platelet aggregation inhibition; psychotic disorder; pulmonary oedema; renal impairment; respiratory disorders; seizure; severe cutaneous adverse reactions (SCARs); skin reactions; sleep disorders; taste altered; thinking abnormal; thirst; thrombocytopenia; tinnitus; ulcer; urinary disorders; vertigo; visual impairment; vomiting; weight increased; wound haemorrhage Side-effects, further information Cardiovascular and gastrointestinal side-effects For information about cardiovascular and gastrointestinal side-effects, and a possible exacerbation of symptoms in asthma, see Non-steroidal anti-inflammatory drugs. When used by eye (topical) Prolonged use can cause epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration and corneal perforation which might be sight-threatening. Discontinue if corneal epithelial breakdown occurs and monitor closely.
Interactions
**Other interactions (3):**
- ACULAR has been safely administered with systemic and ophthalmic medications such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, mydriatics, local anaesthetics and...
- Topical corticosteroids are also known to slow or delay healing.
- Concomitant use of topical NSAIDs and topical corticosteroids may increase the potential for healing problems (see section 4.4).
Pregnancy
Important safety information For ketorolac trometamol MHRA/CHM advice: NSAIDs: potential risks following prolonged use after 20 weeks of pregnancy (June 2023) With intramuscular use or intravenous use: See Non-steroidal anti-inflammatory drugs .
Breast feeding
With intramuscular use or intravenous use: Amount too small to be harmful.
Hepatic impairment
With intramuscular use or intravenous use: Manufacturer advises caution-may increase risk of renal impairment; avoid in hepatic failure.
Renal impairment
With intramuscular use or intravenous use: In general, for NSAIDs the MHRA advises to avoid where possible; if necessary, use with caution (risk of fluid retention and further renal impairment, including renal failure). For ketorolac , avoid if serum creatinine greater than 160 micromol/litre. M Dose adjustments With intramuscular use or intravenous use: Max. 60 mg daily if serum creatinine 160 micromol/litre or less. M
Medicinal forms
Solution,Drops
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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