INDICATION:
Torax® injections and tablets are indicated for the short-term management of moderate to
severe acute post-operative pain.
DOSAGE & ADMINISTRATION:
Ketorolac tromethamine is for administration by intramuscular or bolus
intravenous injection. The recommended initial dose of Ketorolac is 10 mg, followed by 10 to 30 mg
every four to six hours as required. A total daily dose of 90 mg for non-elderly and 60 mg for the elderly,
renally-impaired patients and patients less than 50 kg should not be exceeded. The maximum duration
of treatment should not exceed two days. Ketorolac tablets are recommended for short-term use only
(up to 7 days) and are not recommended for chronic use. 10mg every 4 to 6 hours as required. Doses
exceeding 40 mg per day are not recommended. For patients receiving parenteral Ketorolac
tromethamine and who are converted to Ketorolac tromethamine oral tablets, the total combined daily
dose should not exceed 90 mg (60 mg for the elderly, renally-impaired patients and patients less than 50
kg) and the oral component should not exceed 40 mg on the day the change of formulation is made.
Patients should be converted to oral treatment as soon as possible.
SIDE EFFECTS:
Commonly occurring side-effects are nausea, vomiting, gastro-intestinal bleeding,
melaena, peptic ulcer, pancreatitis, anxiety, drowsiness, dizziness, headache, hallucination, excessive
thirst, inability to concentrate, insomnia, malaise, fatigue, pruritus, urticaria, skin photosensitivity,
Lyell’s syndrome, Stevens Johnson syndrome, flushing, bradycardia, hypertension, palpitations, chest
pain, infertility in female, dyspnoea, asthma, pulmonary oedema, fever & pain at injection site.
CONTRAINDICATION: Ketorolac tromethamine is contraindicated in patients having hypersensitivity to
this drug or other NSAIDs and those patients in whom aspirin or other prostaglandin synthesis inhibitors
induce allergic reactions. It is also contraindicated in a history of peptic ulcer or gastro-intestinal
bleeding, moderate or severe renal impairment (serum creatinine> 160 micromol/l), a history of asthma,
children under 16 years of age. Ketorolac tromethamine is contra-indicated as prophylactic analgesia
before surgery due to inhibition of platelet aggregation and is contra-indicated intraoperatively because
of the increased risk of bleeding. It is also contraindicated during pregnancy, labor, delivery or lactation.
DRUG INTERACTIONS:
Ketorolac tromethamine should not be used with other NSAIDs or in patients
receiving aspirin because of the potential for additive side-effects. Care should be taken when
administering Ketorolac tromethamine with anti-coagulants since co-administration may cause an
enhanced anti-coagulant effect. Ketorolac tromethamine and other non-steroidal anti-inflammatory
drugs can reduce the anti-hypertensive effect of beta-blockers and may increase the risk of renal
impairment when administered concurrently with ACE inhibitors, particularly in volume depleted
patients. Caution is advised when methotrexate is administered concurrently, since some prostaglandin
synthesis inhibiting drugs have been reported to reduce the clearance of methotrexate, and thus
possibly enhance its toxicity. Probenecid should not be administered concurrently with Ketorolac
tromethamine because of increases in ketorolac plasma level and half-life.
PRECAUTION:
Patients over the age of 65 years may be at a greater risk of experiencing adverse events
than younger patients. Ketorolac tromethamine can cause gastro-intestinal irritation, ulcers or bleeding
in patients with or without a history of previous symptoms. Bronchospasm may be precipitated in
patients with a history of asthma. Since ketorolac tromethamine and its metabolites are excreted
primarily by the kidney, patients with moderate to severe impairment of renal function (serum
creatinine greater than 160 micromol/l) should not receive. Fluid retention and oedema have been
reported with the use of Ketorolac tromethamine.
USE IN PREGNANCY & LACTATION:
Safety in human pregnancy has not been established. Ketorolac has
been detected in human milk at low levels. Ketorolac is therefore contraindicated during pregnancy,
labour or delivery, or in mothers who are breast feeding.
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