TGP Diclofenac Sodium

TGP Diclofenac Sodium





TGP Pharma


Euro Generics
Full Prescribing Info
Diclofenac sodium.
Each film-coated tablet contains: Diclofenac (as Sodium) 100 mg.
Diclofenac Sodium is a potent nonsteroidal, anti-inflammatory agent with analgesic and antipyretic properties. By virtue of its analgesic, antipyretic and anti-inflammatory properties together with its excellent tolerability marks a major advance in the treatment of rheumatic and or inflammatory conditions. Diclofenac inhibits cyclooxygenase activity with a reduction in the tissue production of prostaglandins such as PGE1 and PGE2.
Diclofenac sodium is enteric-coated (acid-resistant coating) with the result that the active constituent is not released until it has passed through the stomach.
Diclofenac sodium tablet has got many advantages. Because the frequency of drug administration is reduced, patient compliance can be improved and drug administration be made more convenient as well.
For the relief of painful and inflammatory conditions due to rheumatoid arthritis, tendinitis, osteoarthritis, bursitis, and other articular or periarthritic disorders.
Dosage/Direction for Use
Adult: One tablet once a day after meals. Diclofenac sodium SR should not be fragmented, nor should they be chewed. If necessary, the daily dose can be increased to 150 mg by taking in addition, either of 2 diclofenac sodium 25 mg tablet/capsule or 1 diclofenac sodium 50 mg tablet/capsule, or suppositories.
To be dispensed on physician's prescription.
Diclofenac sodium is contraindicated in peptic ulcer, previous sensitivity to Diclofenac Sodium and in asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other nonsteroidal anti-inflammatory agents with prostaglandin synthesis inhibiting activity.
Special Precautions
Precaution should be taken in patients with symptoms/history of gastro-intestinal disease, impaired hepatic, cardiac or renal function, pregnancy, porphyria and patients who are taking diuretics, anticoagulant, or anti-diabetics. During prolonged treatment, periodical monitoring of liver function should be carried out and blood counts are recommended. Possibility of hypersensitivity reactions to sodium disulphite particularly in patients with asthma.
Adverse Reactions
Occasional gastrointestinal disorders, headache, dizziness or vertigo, rash, elevation of SGOT/SGPT, rare peptic ulcer, gastro-intestinal bleeding, hepatitis, hypersensitivity reactions. In isolated cases, disturbances of sensation, erythema multiforme, purpura, abnormalities of renal function, blood dyscrasias may occur.
Store at temperatures not exceeding 30°C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
TGP Diclofenac Sodium FC tab 100 mg
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