Novell Pharma


Averroes Pharma
Concise Prescribing Info
Ketorolac tromethamine
Short-term management of moderate to severe acute post-op pain.
Dosage/Direction for Use
Initially 10 mg IM or IV bolus, then 10-30 mg every 4-6 hr as required for 2 days. Not to exceed total daily dose: 90 mg in non-elderly & 60 mg in elderly.
Hypersensitivity to NSAIDs or aspirin. History of peptic ulceration or GI bleeding, haemorrhagic diathesis, confirmed or suspected cerebrovascular bleeding, asthma. Operations associated w/ high risk of haemorrhage. Hypovolaemia or dehydration. Co-administration w/ other NSAIDs, anticoagulant ie, low-dose heparin. Moderate or severe renal impairment. Pregnancy, labour, delivery or lactation. Childn <16 yr.
Special Precautions
Not to be used for epidural or spinal inj. Anaphylactic reactions. Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity & if GI bleeding or ulceration occurs. Not to be used in patients w/ coagulation disorders & post-op patients w/ high risk of haemorrhage or incomplete haemostasis. History of inflammatory bowel disease eg, ulcerative colitis, Crohn’s disease; PUD; GI toxicity; HTN &/or mild to moderate CHF; asthma & w/ complete or partial nasal polyps syndrome, angioedema & bronchospasm. Patients w/ SLE & mixed connective tissue disorders. Established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease; risk factors for CV disease; cardiac decompensation; strict clinical haemostasis eg, cosmetic or day-case surgery, prostate resection, tonsillectomy. Correct vol depletion & monitor serum urea, creatinine & urine output. Avoid concomitant use w/ NSAIDs ie, COX-2 selective inhibitors. Concomitant use w/ oral corticosteroids, SSRIs or anti-platelets eg, aspirin; diuretics; methotrexate. Not to be used w/ anticoagulants eg, warfarin. May affect ability to drive & use machines. Renal & hepatic impairment or history of kidney disease. Not recommended in women of childbearing potential. Elderly. Childn.
Adverse Reactions
GI disorders; aseptic meningitis; thrombocytopenia; hypersensitivity reactions; anorexia, hyperkalaemia, hyponatraemia; psychiatric, nervous system & skin & subcutaneous tissue disorders; abnormal vision, visual disturbances, optic neuritis; tinnitus, hearing loss, vertigo; renal & urinary disorders; palpitations, bradycardia, cardiac failure; HTN, hypotension, haematoma, flushing, pallor, post-op wound haemorrhage; female infertility; asthma, dyspnoea, pulmonary oedema; hepatitis, cholestatic jaundice, liver failure; myalgia, functional disorder; excessive thirst, asthenia, oedema, inj site reactions & pain, fever, chest pain; prolonged bleeding time, increased creatinine & serum urea, abnormal liver function tests.
Drug Interactions
Risk of serious NSAID-related adverse events w/ acetylsalicylic acid or other NSAIDs. Enhanced anticoagulant effect w/ warfarin. Increased risk of bleeding w/ low-dose heparin, dextrans; oxpentifylline; anti-platelet agents, SSRIs. Increased plasma lithium conc. Increased plasma conc & t½ w/ probenecid. Reduced mifepristone effects. Increased risk of GI ulceration or bleeding w/ corticosteroids. Reduced methotrexate clearance. Reduced effect of diuretics & anti-hypertensives. Increased risk of nephrotoxicity w/ ciclosporin, tacrolimus. Increased risk of acute renal insufficiency w/ ACE inhibitors &/or angiotensin II receptor antagonists. Increased plasma cardiac glycoside levels. Increased risk of developing convulsions w/ quinolones. Increased risk of haematological toxicity w/ zidovudine, ibuprofen.
ATC Classification
M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Xevolac soln for inj 10 mg/mL
6 × 1's
Xevolac soln for inj 30 mg/mL
6 × 1's
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