Dr. Reddy's gets CDSCO panel conditional nod to manufacture, market Nimesulide Granules
New Delhi: Stressing that the drug product should only be made available with a prescription from a Registered Medical Practitioner, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has granted approval to pharmaceutical major Dr. Reddy's Laboratories to manufacture and market Nimesulide Granules for Oral Suspension 100mg for "Short-term treatment of inflammatory conditions including joint disorders such as rheumatoid arthritis, post-operative painful conditions and fever".
The approval is subjected to condition that the drug product should be available only under prescription of a Registered Medical Practitioner. Furthermore, the expert panel stated that the prescription should contain clearly displayed Medical Council Registration No. of the Physician.
Nimesulide is a relatively COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Its approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years old.
Nimesulide is generally well tolerated, but side effects can include headache, dizziness, somnolence, gastrointestinal upset, nausea, abdominal discomfort, diarrhea, peripheral edema and hypersensitivity reactions. Due to concerns about the risk of hepatotoxicity, nimesulide has been withdrawn from market in many countries. However, the mechanism of nimesulide hepatotoxicity is not known, but likely to be due to an idiosyncratic reaction to an intermediate of its metabolism. Nimesulide is extensively metabolized by the liver.
The therapeutic effects of Nimesulide are the result of its complete mode of action which targets a number of key mediators of the inflammatory process such as: COX-2 mediated prostaglandins, free radicals, proteolytic enzymes and histamine.
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