Ketovex

Ketovex

ketorolac

Manufacturer:

Mount Mettur

Distributor:

Sannovex

Marketer:

Pharma-Surrey
Concise Prescribing Info
Contents
Ketorolac trometamol
Indications/Uses
Short-term management of moderate to severe acute post-op pain.
Dosage/Direction for Use
IM/IV bolus inj over no <15 sec Adult Initially 10 mg, followed by 10-30 mg every 4-6 hr. May be given every 2 hr in initial post-op period if needed. Total daily dose: Not to exceed 90 mg. Max duration: Not to exceed 2 days. Elderly, renally-impaired patient & patient <50 kg Total daily dose: Not to exceed 60 mg. Patient receiving parenteral ketorolac & converted to ketorolac oral tab Total combined daily dose: Not to exceed 90 mg (60 mg for elderly, renally-impaired patient & patient <50 kg). Oral component: Not to exceed 40 mg on day of change in formulation.
Contraindications
Hypersensitivity to ketorolac, other NSAIDs & in patients whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions. Patients w/ history of asthma; active peptic ulcer or any history of GI bleeding, ulceration or perforation; severe heart failure, hepatic & renal failure; suspected or confirmed cerebrovascular bleeding, who have had operations w/ high risk of haemorrhage or incomplete haemostasis & those at high risk of bleeding eg, those w/ haemorrhagic diatheses including coagulation disorders; complete or partial syndrome of nasal polyps, angioedema or bronchospasm. Prophylactic analgesia prior to surgery & as intra-operatively. Neuraxial (epidural or intrathecal) administration. Concomitant use w/ anticoagulants including warfarin & low dose heparin (2,500-5,000 u 12 hrly); ASA or other NSAIDs (including COX-2 selective inhibitors); oxpentifylline; probenecid or lithium salts. Moderate or severe renal impairment (serum creatinine >160 µmol/L) or patients at risk for renal failure due to vol depletion or dehydration. Pregnancy, labour, delivery or lactation. Childn <16 yr.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; clinical signs & symptoms consistent w/ liver disease develop or if systemic manifestations occur. Not to be used in patients w/ coagulation disorders; who have had operations w/ high risk of haemorrhage or incomplete haemostasis; history of asthma & w/ complete or partial syndrome of nasal polyps, angioedema & bronchospasm. High risk of serious GI toxicity especially when used outside licensed indications &/or for prolonged periods. Pain relief may not occur in some patients until upwards of 30 min after IV or IM administration. GI bleeding, ulceration or perforation. Potentially increased risk of aseptic meningitis in patients w/ SLE & mixed connective tissue disorders. Patients w/ hepatopathy or high risk of epilepsy; history of inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease); history of HTN &/or heart failure; cardiac decompensation, HTN or similar conditions; uncontrolled HTN, CHF, established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease; conditions leading to reduction in blood vol &/or renal blood flow. Concomitant use w/ oral corticosteroids, SSRIs or anti-platelet agents eg, aspirin; other drug therapy interfering w/ haemostasis; MTX. Contains ethanol. Renal impairment or history of kidney disease. Not recommended in women attempting to conceive. Elderly.
Drug Interactions
Increased risk of GI adverse events (eg, ulceration & bleeding) w/ anticoagulants; oral glucocorticoids. Possible additive side effects w/ any other NSAID eg, ASA & ibuprofen. Decreased clearance & increased plasma levels & terminal t1/2 w/ probenecid. Reduced diuretic response to furosemide. Inhibited renal lithium clearance. Reduced clearance of MTX. May increase risk of renal impairment particularly in vol-depleted patients w/ ACE inhibitors.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB15 - ketorolac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Ketovex soln for inj 30 mg/mL
Packing/Price
10 × 1's (P98/ampoule)
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