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Ket Ketorolac Tromethamine 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 Ket (Ketorolac Tromethamine) because of increases in Ket plasma level and half-life. DESCRIPTION Ket (Ketorolac Tromethamine) is a non-narcotic analgesic belonging to the non-steroidal anti-inflammatory drug (NSAID) class of medicines with analgesic, anti-inflammatory and antipyretic properties. Ket (Ketorolac Tromethamine) inhibits the cyclo-oxygenase enzyme system and hence synthesis of prostaglandins. It is considered to be a peripherally-acting analgesic. It does not have known effects on opiate receptors. It has no intrinsic effects on respiration and does not exacerbate opioid-related respiratory depression or sedation. PRECAUTIONS INDICATIONS Patients over the age of 65 years may be at a greater risk of experiencing adverse events than younger patients. Ket (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 Ket (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 the drug. Fluid retention and oedema have been reported with the use of Ket (Ketorolac Tromethamine). Ket (Ketorolac Tromethamine) is indicated for the short-term management of moderate to severe acute pain following surgical procedures. PREGNANCY & LACTATION DOSAGE & ADMINISTRATION Pregnancy category C. Ket (Ketorolac Tromethamine) is not recommended for use during pregnancy, labour and delivery. Adult (Under 65 years of age) The usual recommended initial intramuscular dose is 10 mg to 30 mg, followed by 10 mg to 30 mg at 4 to 6 hourly intervals, up to a maximum daily dose of 90 mg. The usual oral dose of Ket (Ketorolac Tromethamine) is 10 mg every 4 to 6 hours, as required. Doses exceeding 40 mg per day are not recommended. Ket (Ketorolac Tromethamine) is not recommended for treatment of nursing mothers. PACKAGING Ket tablet: Each box contains 20's tablet in alu-alu blister pack. Each filmcoated tablet contains Ketorolac Tromethamine USP 10 mg. Elderly (65 years of age and older) An initial intramuscular dose of 10 mg to 15 mg, followed by 10 mg to 15 mg at 4 to 6 hourly intervals, up to a maximum daily dose of 60 mg. Ket 30 injection: Each box contains 5 x 1 ml ampoules in blister pack. Each ampoule contains Ketorolac Tromethamine USP 30 mg. The usual oral dose of Ket (Ketorolac Tromethamine) in the elderly is 10 mg every 6 to 8 hours. Daily doses of 30 mg to 40 mg per day should not be exceeded. The use of Ket (Ketorolac Tromethamine) tablets is recommended for the shortest possible time. PHARMACEUTICAL PRECAUTIONS The total duration of Ket (Ketorolac Tromethamine) administration should not exceed 5 days because adverse effects may increase with prolonged usage. WARNING Store in a cool & dry place, below 30OC. Protect from light & moisture. Keep out of the reach of children. Note: When converting from parenteral to oral administration, total combined dose on the day of converting should not exceed 90 mg (60 mg in the elderly and patients weighing less than 50 kg) of which the oral component should not exceed 40 mg. 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, flushing, bradycardia, hypertension, palpitations, chest pain, infertility in female, dyspnoea, asthma, pulmonary oedema, fever, injection side pain. CONTRAINDICATIONS Ket (Ketorolac Tromethamine) is contraindicated in patients with severe heart failure, dehydration or hypovolaemia from any other cause, 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 and haemorrhagic diatheses including coagulation disorders. Ket (Ketorolac Tromethamine) is also contraindicated for children under 16 years of age. It is contraindicated as prophylactic analgesia before surgery due to inhibition of platelet aggregation and is contraindicated intraoperatively because of the increased risk of bleeding. DRUG INTERACTIONS Ket (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 Ket (Ketorolac Tromethamine) with anticoagulants since co-administration may cause an enhanced anti-coagulant effect. Ket (Ketorolac Tromethamine) and other non-steroidal antiinflammatory 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