Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Roussel
SURGAM 200 TABLETS SURGAM 300 TABLETS SURGAM SA CAPSULES SCHEDULING STATUS S3 PROPRIETARY NAME (and dosage form) SURGAM 200 TABLETS SURGAM 300 TABLETS SURGAM SA CAPSULES COMPOSITION Surgam 200 tablets Each tablet contains 200 mg of tiaprofenic acid . Surgam 300 tablets Each tablet contains 300 mg of tiaprofenic acid. Surgam SA Each capsule contains 300 mg tiaprofenic acid in a controlled release form. PHARMACOLOGICAL CLASSIFICATION A.3.1 Anti-inflammatory agents. PHARMACOLOGICAL ACTION Surgam (tiaprofenic acid) is a molecule of non-steroidal structure with anti-inflammatory and analgesic properties. Surgam is an inhibitor of prostaglandin biosynthesis. Surgam has been shown not to cause suppression of proteoglycan synthesis. Pharmacokinetics: Tablets 200 mg and 300 mg Following oral administration, maximum serum concentration is attained after ± 1 hour. Drug elimination half-life is within the range of 1,5 - 2,5 hours. Surgam penetrates the synovial membrane and is retained at relatively constant levels within the synovial fluid throughout an eight-hour period. Surgam SA Following oral administration of the controlled release form, the maximum serum concentration is comparable with that of the standard 300 mg tablet. The maximum serum concentration is prolonged for periods of 6 to 8 hours. INDICATIONS Surgam is indicated for disorders where inflammatory conditions are dominant as in: ¾ ¾Rheumatic disorders: including rheumatoid arthritis, osteoarthritis, epicondylitis. ¾ ¾Trauma: including fractures, lacerations, sprains. ¾ Post-operative trauma: including dental, orthopaedic, gynaecological procedures and meniscectomy. CONTRA-INDICATIONS Surgam is contra-indicated in patients with gastro-duodenal ulcers. Surgam should Read the complete document