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ETOGESIC SR (Etodolac USP 600 mg) Sustained Release Tablet Description Etodolac belongs to a class of drug called non-steroidal anti inflammatory drugs (NSAIDs) that exhibits anti-inflammatory, analgesic and antipyretic activities. It works by reducing the levels of prostaglandins which are chemicals that are responsible for pain, fever and tenderness that occur with inflammation. Studies in human cell models have confirmed that Etodolac is selective for the inhibition of Cox-2. Experiments shows that Etodolac is more potent than other NSAIDs. Composition Each sustained release tablet contains Etodolac USP 600 mg. Indication Acute and long-term use in the management of signs and symptoms of 1. Rheumatoid arthritis including Juvenile Idiopathic arthritis, 2. Osteoarthritis For the management of acute pain Acute gout. Dosage & Administration Adults & Over 18 years : Etogesic 600 mg tablet once daily. Children : For the treatment of Juvenile idiopathic Arthritis : One tablet daily in those weighing 31 to 45 kg. Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Or as directed by the physician. Side Effects Common side effects associated with Etodolac are disturbances of the gut such as indigestions, diarrhoea, constipation, nausea, vomiting or abdominal pain. Others are flatulence, stomatitis, headache, dizziness, visual disturbances, skin rash, insomnia, drowsiness, confusion, depression, tinnitus, oedema, dysponea, ulceration or bleeding in the stomach or intestines, kidney & liver or blood disorders. Contraindication Etodolac is contraindicated in patients with known hypersensitivity to Etodolac. Etodolac should be avoided by patients with a history of asthma attacks, hives or other allergic reactions to aspirin or other NSAIDs. Precaution Etodolac is used with caution in patients taking blood thinning medications (anticoagulants), such as warfarin. It also should be avoided by patients with peptic ulcer disease or poor kidney function. Use in Pregnancy & Lactation Pregnancy : There are no adequate and well controlled studies in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation : It is not known whether Etodolac is excreted in human milk and as such its use in nursing mothers should be avoided. Drug Interaction Etodolac should not be used in combination with painkilling doses of aspirin or any other NSAID taken by mouth, e.g. ibuprofen, as this increases the risk of side effects on the stomach and intestines. There may be an increased risk of ulceration or bleeding from the gut if Etodolac is taken with corticosteroids such as prednisolone. When Etodolac is administered with ACE inhibitors, e.g. enalapril it can reduces its antihypertensive effect. Supply Each box contains 2 x 10 tablets in blister strips. Store in a cool & dry place, protected from light. Keep all medicines out of reach of children. * Further information is available on request. FOR HEALTH, VIGOUR AND HAPPINESS . Dhamrai, Dhaka, Bangladesh. 071254 Over dose Lethargy, drowsiness, nausea, vomiting & epigastric pain etc.