ZYLORIC

Nazione: Indonesia

Lingua: indonesiano

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

Principio attivo:

ALLOPURINOL

Commercializzato da:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Nome Internazionale):

ALLOPURINOL

Dosaggio:

100 MG

Forma farmaceutica:

TABLET

Confezione:

DUS, 6 BLISTER @ 10 TABLET

Prodotto da:

GLAXO WELLCOME INDONESIA - Indonesia

Data dell'autorizzazione:

2019-01-21

Scheda tecnica

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