국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
ALLOPURINOL (UNII: 63CZ7GJN5I) (ALLOPURINOL - UNII:63CZ7GJN5I)
Cardinal Health 107, LLC
ORAL
PRESCRIPTION DRUG
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol is indicated in: Patients who have developed a severe reaction to allopurinol should not be restarted on the drug.
300 mg (orange) scored, round tablets debossed with "2084/V". They are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-7981-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ALLOPURINOL- ALLOPURINOL TABLET CARDINAL HEALTH 107, LLC ---------- ALLOPURINOL TABLETS USP DESCRIPTION Allopurinol, USP has the following structural formula: Allopurinol, USP is known chemically as 1, 5-dihydro-4 _H_-pyrazolo [3, 4- _d_] pyrimidin-4- one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allopurinol and the inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Each scored orange tablet contains 300 mg allopurinol and the inactive ingredients colloidal silicon dioxide, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Soluble in solutions of potassium and sodium hydroxides, very slightly soluble in water and in alcohol; practically insoluble in chloroform and in ether. CLINICAL PHARMACOLOGY Allopurinol acts on purine catabolism, without disrupting the biosynthesis of purines. It reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation. Allopurinol is a structural analogue of the natural purine base, hypoxanthine. It is an inhibitor of xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and of xanthine to uric acid, the end product of purine metabolism in man. Allopurinol is metabolized to the corresponding xanthine analogue, oxipurinol (alloxanthine), which also is an inhibitor of xanthine oxidase. It has been shown that reutilization of both hypoxanthine and xanthine for nucleotide and nucleic acid synthesis is markedly enhanced when their oxidations are inhibited by allopurinol and oxipurinol. This reutilization does not disrupt normal nucleic acid anabolism, however, because feedback inhibition is an integral part of purine biosynthesis. As a result of xanthine oxidase inhibition, the serum concentration of hypoxanthine plus xanthine in patients receiving allopurinol for treatment of hyper 전체 문서 읽기