资料单张
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
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