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Edopain Etodolac USP 600 mg extended release tablet Presentation Edopain capsule: Each capsule contains Etodolac BP 300 mg. Edopain 600 ER tablet: Each extended release tablet contains Etodolac USP 600 mg. Description Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities. The mechanism of action of Etodolac, like that of other NSAIDs related to prostaglandin synthesis inhibition. Indications and Uses For acute and long-term use in the management of signs and symptoms - 1. Osteoarthritis 2. Rheumatoid arthritis For the management of acute pain Acute gout Contraindications Etodolac is contraindicated in patients with known hypersensitivity to Etodolac. Etodolac should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking Aspirin or other NSAIDs. Dosage And Administration Adults and over 18 years: Edopain capsule: 600 mg daily in 1-2 divided doses Edopain 600 ER tablet: Once daily Precautions Etodolac should be given with caution in patients with severe hepatic reactions, pre-existing asthma, fluid retention, hypertension or heart failure. If clinical sings and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash etc.), it should be discontinued. Side Effects The common side effects of Etodolac involve the gastrointestinal system. It can cause abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, nausea, GI ulcers, vomiting. Other events including abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus etc. 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. A decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother. Overdosage Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain which are generally reversible with supportive care. Commercial Pack Edopain : Each box contains 3 blister strips of 10 capsules. Edopain 600 ER : Each box contains 2 blister strips of 10 tablets. ; Other Pediatric Safety and effectiveness in pediatric patients below the age of 18 years have not been established. |
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