Allopurinol tablets

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

allopurinol

Dostępny od:

Arpimed LLC

Kod ATC:

M04AA01

INN (International Nazwa):

allopurinol

Dawkowanie:

100mg

Forma farmaceutyczna:

tablets

Sztuk w opakowaniu:

(30/3x10/) in blister

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2018-08-24

Charakterystyka produktu

SUMMARY PRODUCT CHARACTERISTIC (SPC)
ALLOPURINOL
100 MG AND 300 MG TABLETS
1.1 BRAND NAME – ALLOPURINOL
1.2 INTERNATIONAL NON-PROPERTY NAME - ALLOPURINOL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Allopurinol 100 mg tablet contains:
active ingredient: allopurinol - 100 mg;
_For a full list of excipients, see section 6.1. _
Each Allopurinol 300 mg tablet contains:
active ingredient: allopurinol - 300 mg;
_For a full list of excipients, see section 6.1. _
3. PHARMACEUTICAL FORM
Allopurinol, 100 mg tablets
White or off white biconvex scored tablets with a few small darker
spots.
Allopurinol, 300 mg tablets
White biconvex scored tablets.
_ _
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: 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 phosphoribosyltransferase.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adul