ZYLORIC

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

ALLOPURINOL

제공처:

GLAXO WELLCOME INDONESIA - Indonesia

INN (International Name):

ALLOPURINOL

복용량:

100 MG

약제 형태:

TABLET

패키지 단위:

DUS, 20 BLISTER @ 10 TABLET

Manufactured by:

GLAXO WELLCOME INDONESIA - Indonesia

승인 날짜:

2019-01-21

제품 특성 요약

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