Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALLOPURINOL (UNII: 63CZ7GJN5I) (ALLOPURINOL - UNII:63CZ7GJN5I)
REMEDYREPACK INC.
ALLOPURINOL
ALLOPURINOL 100 mg
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: - the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). - the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present. the mana
Allopurinol Tablets USP, 100 mg are scored, round, white tablets imprinted “ DAN DAN” and “ 5543” supplied in bottles of 100 (NDC 0591-5543-01) and 1000 (NDC 0591-5543-10). Allopurinol Tablets USP, 300 mg are scored, round, orange tablets imprinted “ DAN DAN” and “ 5544” supplied in bottles of 100 (NDC 0591-5544-01) and 500 (NDC 0591-5544-05). Dispense in a tight, light-resistant container with child-resistant closure. Store at 20 to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 1/2019
New Drug Application
ALLOPURINOL- ALLOPURINOL TABLET REMEDYREPACK INC. ---------- ALLOPURINOL TABLETS USP RX ONLY DESCRIPTION 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. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. The structural formula is represented below: C H N O M.W. 136.11 Allopurinol Tablets USP, 100 mg and 300 mg contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and sodium lauryl sulfate. Allopurinol Tablets USP, 300 mg also contain FD&C Yellow No. 6. 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. 5 4 4 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 hyperuricemia is usually in the range of 0.3 to 0.4 mg/dL compared to a normal level of approximately 0.15 mg/dL. A maximum of 0.9 mg/dL of these oxypurines has been reported when the serum urate was Read the complete document