Indications
Toramax (Ketorolac tromethamine) is indicated for the short-term (<5 days) management of moderately severe acute pain that requires analgesia at the opioid level, (usually in postoperative setting). Therapy should always be started with Toramax (Ketorolac tromethamine) IM/IV injection and Toramax (Ketorolac tromethamine) oral is to be used only as continuation treatment, if necessary. Combined use of Toramax (Ketorolac tromethamine) IM/IV and oral is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses.
Pharmacology
Toramax (Ketorolac tromethamine) is a potent analgesic agent of the non-steroidal, anti-inflammatory class (NSAID). 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. Toramax (Ketorolac tromethamine) is not an anesthetic agent and possesses no sedative or anxiolytic properties; therefore, it is not recommended as a pre-operative medication for the support of anesthesia when these effects are required. It is not an opioid and has no known effects on opioid receptors. Toramax (Ketorolac tromethamine) was rapidly and completely absorbed following oral administration with a mean peak plasma concentration of 0.87 μg/ml occurring an average of 50 minutes after a single 10 mg dose. The terminal plasma half-life was on average 5.4 hours in young adults and 6.2 hours in elderly patients (mean age 72). The total clearance in elderly patients was slightly lower than that in young adults. The pharmacokinetics of Toramax (Ketorolac tromethamine) in man following single or multiple doses are linear. Steady-state plasma levels are achieved after dosing every 6 hours for one day. No changes in clearance occur with continued dosing. The primary route of excretion of Toramax (Ketorolac tromethamine ) and its metabolites is renal: 91.4% (mean) of a given dose being found in the urine and 6.1% (mean) in the feces. More than 99% of the Toramax (Ketorolac tromethamine) in plasma is protein-bound over a wide concentration range.
Dosage & Administration
Adults: The usual oral dose of Toramax (Ketorolac tromethamine).is 10 mg every 4 to 6 hours for pain as required. Doses exceeding 40 mg per day are not recommended. The maximum duration of treatment with the oral formulation is 5 days for post-surgical patients and 7 days for patients with musculoskeletal pain.
Patients Under 50 kg, over 65 years of age: The lowest effective dose is recommended.
Interaction
Toramax (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 Toramax (Ketorolac tromethamine) with anti-coagulants since co-administration may cause an enhanced anti-coagulant effect. Toramax (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 Toramax (Ketorolac tromethamine) because of increases in ketorolac plasma level and half-life.
Contraindications
- History of peptic ulcer or gastrointestinal bleeding,
- Suspected or confirmed cerebrovascular bleeding,
- Hemorrhagic diatheses, including coagulation disorders,
- Patients with hypersensitivity to Toramax (Ketorolac tromethamine )or other NSAIDs and Patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions (severe anaphylactic-like reactions have been observed in such patients),
- Patients with the complete or partial syndrome of nasal polyps, angio-edema or bronchospasm,
- Concurrent treatment with other NSAIDs, oxpentifylline, probenecid or lithium salts,
- Hypovolemia from any cause, or dehydration,
- moderate or severe renal impairment (serum creatinine >160 μmol/l),
- A history of asthma,
- Patients who have had operations with a high risk of hemorrhage or incomplete hemostasis,
- Patients on anticoagulants including low-dose heparin (2,500-5,000 units 12-hourly),
- During pregnancy, labor, delivery or lactation,
Side Effects
Commonly occurring side-effects are nausea, vomiting, gastro-intestinal bleeding, melaena, peptic ulcer, pancreatitis, anxiety, drowsiness, dizziness, headache, hallucinations, 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, dyspnea, asthma, pulmonary edema, fever, injection site pain.
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