(and dosage form):
Each capsule contains 300 mg Azapropazone.
A 3.1 Antirheumatics (anti-flammatory agents).
Azapropazone is a pyrazole derivative which has analgesic, anti-flammatory and antipyretic actions.
It is indicated for use in the treatment of rheumatoid arthritis, osteo-arthritis and gout.
It is contra-indicated for use in patients with a history of active ulcers of the gastro-intestinal tract.
It should not be given during the first three months of pregnancy.
The administration of Rheumox is contra-indicated in patients with porphyria.
Azapropazone may enhance the activity of coumarin anticoagulants.
DOSAGE AND DIRECTIONS FOR USE:
The usual dose is 1200 mg per day, given as 600 mg twice daily. This may be reduced to 900 mg for maintenance therapy or increased to 1800 mg if required. Azapropazone is principally excreted unchanged by the kidney. In patients over 65 years of age, whose renal function may be reduced, it is therefore suggested that the starting dose be 300 mg in the morning and 600 mg at night. In patients much older than this, a suitable starting regimen is 600 mg at night or 300 mg twice daily. This dosage can be subsequently adjusted since some elderly patients have excellent renal function.
In acute gout, 2,4 g may be given in divided doses during the first 24 hours, followed by 1,8 g daily until the attack is resolving, then reduced to 1,2 g daily until symptoms have disappeared.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances, allergic skin rashes and photosensitivity, headache, vertigo, oedema and kidney impairment may occur. Gastro-intestinal bleeding and angioedema have been reported.
Azapropazone should be given with caution to patients with acute gastritis or peptic ulceration, impaired renal function, or with a history of blood disorders.
Very rarely, fibrosing alveolitis and Coomb's positive hamemolytic anaemia have been reported in association with Rheumox therapy. Should either occur, therapy should be discontinued.
Azapropazone may increase the hypoglycaemic effect of sulphonylureas, as well as blood-phenytoin concentrations. Fatal toxicity has occurred when given concurrently with methotrexate.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". In acute overdosage the stomach should be emptied by inducing emesis or by aspiration and lavage. Patients with mild intoxication should be encouraged to drink plenty of fluids. In patients with more severe intoxication, forced alkaline diuresis may be required and should be continued till the plasma concentration is less than 350 micrograms per mL in adults, then I.V. fluids can be stopped and the patients encouraged to take fluids by mouth. Plasma electrolytes, especially potassium and the acid-base balance should be monitored regularly. Acidaemia must be corrected by infusion of sodium bicarbonate before starting forced diuresis. In the presence of cardiac or renal impairment or in severe intoxication, haemodialysis or peritoneal dialysis may be necessary. Acute allergic reactions may be treated, if necessary, by administration of adrenalin, corticosteroids and an antihistamine.
Opaque shiny capsules.
Dark orange cap and pale orange body printed with "RHEUMOX" and "CE".
Capsules of 300 mg in bottles of 30's, 100's and 500's.
Store below 25°C and protect from light. Keep container tightly closed.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF APPLICANT:
Continental Ethicals (Pty) Ltd, 7 Fairclough Road, PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 February 1986.
Tradepack P E
First displayed on this site December 1995
Current: September 2004
Source: Pharmaceutical Industry
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