Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
allopurinol
Arpimed LLC
allopurinol
100mg
tablets
Prescription
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 Прочитать полный документ