Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Merckp
ARCANAFENAC® 25 mg Tablets ARCANAFENAC® 50 mg Tablets ARCANAFENAC® Injection SCHEDULING STATUS: Schedule 3 PROPRIETARY NAME (and dosage form): ARCANAFENAC ® 25 mg Tablets ARCANAFENAC ® 50 mg Tablets ARCANAFENAC ® Injection COMPOSITION: Enteric coated tablets containing 25 mg (50 mg) diclofenac sodium. Each 3 mL ampoule contains 75 mg diclofenac sodium with 4% benzyl alcohol as a preservative. PHARMACOLOGICAL CLASSIFICATION: A 3.1 - Anti-rheumatics (anti-inflammatory agents). PHARMACOLOGICAL ACTION: Diclofenac sodium is a non-steroidal compound with analgesic anti-flammatory, antirheumatic and antipyretic properties. Diclofenac sodium is eliminated principally by metabolism and subsequent urinary and biliary excretion of glucuronide and sulphate conjugates of the metabolites. The principal metabolite in man is the 4-hydroxy derivative of diclofenac sodium. The amount excreted in urine accounts for 20 - 30% of the dose and that in bile for 10 - 20%. The mean terminal elimination half-life is 1,2 to 1,8 hours. Tablets: A single 50 mg dose of enteric coated tablets results in maximum plasma concentrations of about 1500 ng/mL at 1,5 to 2 hours after ingestion. INDICATIONS: Tablets: Rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis. Treatment of post traumatic pain and inflammation. Symptomatic treatment of primary dysmenorrhoea. Injection: For use as initial therapy for inflammatory and degenerative rheumatic diseases. Painful conditions due to inflammation of non-rheumatic origin and acute attacks of gout. CONTRA-INDICATIONS: Patients with a history of active gastro-intestinal bleeding or peptic ulceration. Severe hepatic or renal impairment. Contra-indicated in aspirin-sensitive patients, and in patients hypersensitive to any of the ingredients in these products. WARNINGS: Serious Read the complete document