Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
DICLOFLAM BLACKCURRANT SCHEDULING STATUS: S3 Except when intended for the emergency treatment of acute gout attacks and when intended for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days. S2 PROPRIETARY NAME (and dosage form): DICLOFLAM BLACKCURRANT (DISPERSIBLE TABLET) COMPOSITION Each DICLOFLAM BLACKCURRANT dispersible tablet contains 46,5 mg of diclofenac free acid, equivalent to 50,0 mg of diclofenac sodium. PHARMACOLOGICAL CLASSIFICATION A 3.1 Antirheumatics (anti-inflammatory agents) PHARMACOLOGICAL ACTION Diclofenac is a non-steroidal anti-inflammatory compound (NSAID) with analgesic, antipyretic and anti-inflammatory activities. It causes decreased formation of prostaglandins and thromboxanes through inhibition of the activity of the enzyme cyclo-oxygenase. Prostaglandins play a major role in the causation of inflammation, pain and fever and the inhibition of prostaglandin synthesis may have an important bearing on diclofenac’s mechanism of action. Diclofenac inhibits platelet aggregation in vitro. Pharmacokinetics: Diclofenac is well absorbed after oral administration. Peak plasma concentrations are reached within approximately 1 hour. Administration with food slows the rate but does not alter the extent of absorption. There is a substantial first-pass effect (only 50% of diclofenac is available systemically). Diclofenac is extensively bound to plasma proteins (99%) and its plasma half-life is 1 to 2 hours. Diclofenac is metabolised in the liver by a cytochrome P-450 isozyme of the CYP2C subfamily and excreted in the form of metabolites via the kidneys (approximately 60%) and faeces (approximately 30%). Less than 1% is excreted in unchanged form. INDICATIONS DICLOFLAM BLACKCURRANT is indicated as short Read the complete document