Therapeutic Group: NSAIDs
Torafix® 10 mg Tablet: Each film-coated tablet contains
Ketorolac Tromethamine USP 10 mg.
Torafix® is a potent analgesic agent of NSAID class. Its
mode of action is to inhibit the cyclo-oxygenase enzyme system and hence
prostaglandin synthesis and it demonstrates a minimal anti-inflammatory effect
at its analgesic dose. Plasma half-life is on average 5.3 hours in young adults
and 7 hours in elderly patients (mean age 72). More than 99% of the ketorolac
tromethamine in plasma is protein-bound over a wide concentration range.
Short-term management of moderate to severe acute pain
that requires analgesia at the opioid level.
Adult: Tablet- 10 mg 4-6 hourly, maximum 7 days.
Children (≥2 years): Tablet- Not established
Nausea, dyspepsia, gastro-intestinal pain/bleeding,
vomiting, haemorrhage, perforation, headache, sweating, dry mouth, acute renal
failure, hyponatremia, bradycardia, hypertension, asthma, bronchospasm, rash,
postoperative wound haemorrhage, abnormalities of liver function tests.
Use with other NSAIDs, coagulation disorder,
hypertension, mild to moderate congestive heart failure, impaired renal
function, asthma, liver dysfunction, skin rash or any other sign of
hypersensitivity. Patients receiving oral corticosteroids, warfarin, SSRIs or
antiplatelets.
Concurrent treatment with probenecid is contraindicated
because of increases in Ketorolac Tromethamine plasma level and half-life.
Concurrent treatment with lithium is contraindicated because there is a
possible inhibition of renal lithium clearance, increased plasma lithium
concentration, and potential lithium toxicity. Ketorolac Tromethamine should
not be used with other NSAIDs because of the potential for additive side
effects. There is an increased risk of renal impairment when Ketorolac
Tromethamine is administered concurrently with ACE inhibitors, particularly in
volume-depleted patients.
Doses of 360 mg given intramuscularly over an 8-hour
interval for five consecutive days have caused abdominal pain and peptic ulcers
which have healed after discontinuation of dosing. Two patients recovered from
unsuccessful suicide attempts. One patient experienced nausea after 210 mg
Ketorolac, and the other hyperventilation after 300 mg Ketorolac.
Store at temperature not exceeding 30° C in a dry place.
Protect from light & moisture.
Torafix® 10 mg Tablet: Each box contains 3x10's film
coated tablets in Alu-Alu blister strips.