Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
ALLOPURINOL
Roussel Laboratories Limited
300 mg Milligram
Tablets
1988-07-25
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol Tablets 300mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg of Allopurinol For excipients, see 6.1 3 PHARMACEUTICAL FORM Tablets White biconvex tablets about 11mm in diameter. One face is marked with ‘AP’, a breakline and ‘300’, the reverse carries the Roussel logo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. In the management of conditions of excess body urate, including gout, neoplastic disease and associated treatment, enzyme disorders such as the Lesch – Nyhan Syndrome, renal calculi, renal failure, diuretic therapy and psoriasis. 2. In the prophylaxis and treatment of calcium renal lithiasis in patients with raised serum or urinary uric acid. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION DOSAGE: Adults: The usual daily dose is 300mg as a single dose with increments, as indicated by monitoring of serum and/or urinary uric acid, to the level necessary for optimum control, seldom in excess of 900mg. Dosage higher than 300mg should be given in divided doses not exceeding 300mg at any one time. Children: The usual daily dose is 10 to 20 mg/kg b.w. To avoid an acute attack of gouty arthritis in the initial stages of treatment, colchicine or other appropriate agents should be given for at least a month. When used in neoplasia allopurinol therapy should be commenced before cytotoxics. In renal insufficiency, dosage requirements must be reduced if creatinine clearance is less than 20ml/minute. CREATININE CLEARANCE DOSAGE 10-20 ml/min 100 to 200mg daily <10ml/min 100mg daily or at longer intervals IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 25/08/2005_ _CRN 2014137_ _page number: 1_ If frequent renal dialysis is require Lesen Sie das vollständige Dokument