Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
ALLOPURINOL
Ranbaxy Ireland Limited
100 Milligram
Tablets
1987-04-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol Tablets BP 100 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Allopurinol 100.00mg Excipient: Also includes lactose monohydrate, 160 mg per tablet. For a full list of excipients, see section section 6.1 3 PHARMACEUTICAL FORM Tablet Circular, white, biconvex tablets about 9.5 mm in diameter, marked AP over 100 on one side and R on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Allopurinol is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical risk (e.g. treatment of malignancy potentially leading to acute uric acid nephropathy). The main clinical conditions where urate/uric acid deposition may occur are: o Idiopathic gout o Uric acid lithiasis o Acute uric acid nephropathy o Neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously, or after cytotoxic therapy o Certain enzyme disorders which lead to overproduction of urate, for example - hypoxanthine-guanine phosphoribosyltransferase, including Lesch-Nyhan syndrome - gluclose phosphatase including glycogen storage disease - phosphoribosylpyrophosphate synthetase - phosphoribosylpyrophosphate amidotransferase - adenine phosphoribosyltransferase Allopurinol is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltranferase Allopurinol is indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed. IRISH MEDICINES BOARD _______________________________ Lue koko asiakirja