COMPOSITION
Lacor 10 Tablet: Each tablet contains Ketorolac Tromethamine USP 10 mg.
PHARMACOLOGY
Ketorolac Tromethamine is a drug of pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drug (NSAID). Chemically it is known as 5 benzoyle-2,3-dihydro-1H-pyrroligine-1-carboxylic acid, compound with 2 – amino-2-(hydroxymethyl)-1,3-propanediol (1:1). Ketorolac Tromethamine inhibits synthesis of prostaglandins and may be considered as a peripherally acting analgesic. The biological activity of Ketorolac Tromethamine is associated with the S-form. Pharmacokinetic property of Ketorolac Tromethamine is linear. It is highly protein bound and is largely metabolized in liver. The products of metabolism and some unchanged drugs are excreted in the urine.
INDICATION
Lacor (Ketorolac Tromethamine) tablet is indicated for short-term management of moderate to severe acute post-operative pain.
DOSAGE AND ADMINISTRATION
Lacor (Ketorolac Tromethamine) tablets are recommended for short-term use only (up to 7 days) and are not recommended for chronic use. 10 mg every 4 to 6 hours as required. Dose exceeding 40 mg daily is not recommended.
CONTRAINDICATION
Lacor (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. Lacor (Ketorolac Tromethamine) is contraindicated as prophylactic analgesia before surgery due to inhibition of platelet aggregation and is contraindicated intraoperatively because of the increased risk of bleeding. It is also contraindicated during pregnancy, labor, delivery or lactation.
SIDE EFFECTS
Commonly occurring side effects are nausea, vomiting, gastrointestinal bleeding, melaena, peptic ulcer, pancreatitis, anxiety, drowsiness, dizziness, headache, hallucinations, excessive thirst, inability to concentrate, insomnia, malaise, fatigue, pruritis, urticaria, skin photosensitivity etc.
DRUG INTERACTION
Lacor (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 Lacor (Ketorolac Tromethamine) with anti-coagulants since co-administration may cause an enhanced anti-coagulant effect. Lacor (Ketorolac Tromethamine) and other NSAIDs can reduce the anti-hypertensive effect of beta-blockers and may increase the risk of renal impairment when administered concurrently with ACE inhibitors. Probenecid should not be administered concurrently with Lacor (Ketorolac Tromethamine) because of increases in ketorolac plasma level and half-life.
USE IN PREGNANCY AND LACTATION
Safety in human pregnancy has not been established. Lacor (Ketorolac Tromethamine) has been detected in human milk at low levels. Lacor (Ketorolac Tromethamine) is therefore contraindicated during pregnancy, labour or delivery, or in mothers who are breast feeding.
STORAGE PRECAUTIONS
Store at a cool & dry place, protect from light & moisture. Keep out of the reach of children.
PACKING
Lacor 10 Tablet: Box containing 10 X 2 tablets in Alu-Alu pack.