Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ALLOPURINOL
GLAXO WELLCOME INDONESIA - Indonesia
ALLOPURINOL
300 MG
TABLET
DUS, 3 BLISTER @ 10 TABLET
GLAXO WELLCOME INDONESIA - Indonesia
2019-01-21
Page 1 of 9 ZYLORIC™ ALLOPURINOL 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing either 100 mg or 300 mg allopurinol. 2. PHARMACEUTICAL FORM Tablets. 3. CLINICAL PARTICULARS 3.1 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: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously, or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate, for example: - hypoxanthine-guanine phosphoribosyltransferase, including Lesch-Nyhan syndrome; - glucose-6-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. 3.2 DOSAGE AND ADMINISTRATION The dosage should be adjusted by monitoring serum urate concentrations and urinary urate/uric acid levels at appropriate intervals. Allopurinol may be taken orally once a day after a meal. It is well tolerated, especially after food. Should the daily dosage exceed 300 mg and gastrointestinal intolerance be manifested, a divided dose regimen may be appropriate. ADULTS Allopurinol should be introduced at low dosage e.g. 100 mg/day to reduce the risk of adverse reactions and increased onl Preberite celoten dokument