Generic Medicine Info
Hypersensitivity to ketorolac, aspirin or other NSAIDs. History of bronchospasm, asthma, rhinitis, urticaria or other allergic-type reactions associated with aspirin or NSAID therapy. active or history of peptic ulceration, gastrointestinal bleeding or perforation, confirmed or suspected cerebrovascular bleeding, haemorrhagic diathesis, incomplete haemostasis, high risk of bleeding; severe heart failure, risk of renal failure due to volume depletion or dehydration, treatment of pain in the setting of CABG, or prophylactic analgesic prior to any major surgery, labour and delivery. Moderate to severe renal and severe hepatic impairment. Pregnancy (3rd trimester). Concomitant use with aspirin or NSAIDs, probenecid, pentoxifylline.
Special Precautions
Patients with inflammatory disease (e.g. ulcerative colitis, Crohn's disease), coagulation disorders, increased risk for gastrointestinal bleeding (e.g. smoking, use of alcohol) or CV thrombotic events (e.g. MI, stroke), hypertension, oedema, diabetes mellitus, SLE, asthma, hypovolaemia, low body weight (<50 kg). Debilitated patients. Mild renal and hepatic impairment. Elderly. Pregnancy (1st and 2nd trimester) and lactation. Concomitant use of corticosteroids, SSRIs, antiplatelets, anticoagulants, diuretics, or ACE inhibitors. Ophthalmic: Patients with complicated ocular surgery or repeat ocular surgery (within a short timeframe), corneal epithelial defects, corneal denervation, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis. Patient Counselling This drug may cause drowsiness, dizziness and blurred vision, if affected do not drive or operate machinery. Oral therapy is only indicated for use as continuation following parenteral treatment. Ophthalmic: Remove contact lenses prior to instillation and may reinsert after at least 15 minutes. Monitoring Parameters Monitor blood pressure, CBC, chemistry profile, LFT, renal function (e.g. serum creatinine, BUN, urine output), signs and symptoms of bleeding or gastrointestinal effects (e.g. bleeding, abdominal pain).
Adverse Reactions
Significant: Renal papillary necrosis, acute renal failure, interstitial nephritis, nephrotic syndrome, hypertension, fluid retention, hyperkalaemia. Rarely, blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia). Ophthalmic: Keratitis, corneal thinning, erosion, ulceration or perforation. Ear and labyrinth disorders: Tinnitus. Eye disorders: Blurred vision, increased intraocular pressure, conjunctival hyperaemia, lacrimation, corneal infiltrates, eye or eyelid oedema, eye irritation, pain, inflammation or infection. Gastrointestinal disorders: Abdominal pain, dyspepsia, nausea, flatulence, constipation, diarrhoea, heartburn, vomiting, stomatitis. Injury, poisoning and procedural complications: Injection site pain. Investigations: Elevated liver enzymes. Nervous system disorders: Headache, drowsiness, dizziness. Respiratory, thoracic and mediastinal disorders: Nasal discomfort, rhinalgia. Skin and subcutaneous tissue disorders: Rash, pruritus, purpura.
Potentially Fatal: Gastrointestinal bleeding, ulceration or perforation, CV thrombotic events (e.g. myocardial infarction, stroke), bronchospasm, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Rarely, severe hepatic reactions (e.g. jaundice, fulminant hepatitis, hepatic necrosis, hepatic failure).
ROUTE(S) : IM / IV / Ophth / Parenteral: C
ROUTE(S) : Nasal: C prior to 30 weeks gestation
ROUTE(S) : Nasal: D starting at 30 weeks gestation
Drug Interactions
Increased risk of bleeding with other NSAIDs, corticosteroids, SSRIs, anticoagulants, antiplatelet agents (e.g. aspirin), and pentoxifylline. Increased plasma concentration with probenecid, lithium, cardiac glycosides (e.g. digoxin) and methotrexate. May enhance nephrotoxicity with ACE inhibitors, angiotensin II antagonists, ciclosporin, and diuretics. Increased risk of seizure with antiepileptic drugs (e.g. phenytoin, carbamazepine). Hallucination may occur when used with psychoactive drugs (e.g. fluoxetine, thiothixene, alprazolam). May enhance adverse effect (e.g. apnoea) of nondepolarizing muscle relaxants.
CIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) / Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories
ATC Classification
M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
S01BC05 - ketorolac ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
Disclaimer: This information is independently developed by CIMS based on ketorolac from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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