Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ALLOPURINOL (UNII: 63CZ7GJN5I) (ALLOPURINOL - UNII:63CZ7GJN5I)
Preferred Pharmaceuticals 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 tablets USP 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 tablet USP is indicated in: Patients who have developed a severe reaction to allopurinol tablet USP should not be restarted on the drug.
100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, in bottles of; 30 (NDC 68788-7383-3) and 60 (NDC 68788-7383-6), Bottles of 90 (NDC 68788-7383-9).). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. For more information, go to: www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875. PURINETHOL is a registered trademark of Stason Pharmaceutical, Inc., Irvine, CA Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA. 10 0258 1 687720 Issued October 2020 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
ALLOPURINOL- ALLOPURINOL TABLET PREFERRED PHARMACEUTICALS INC. ---------- PRODUCT INFORMATION ALLOPURINOL TABLETS USP 100 MG AND 300 MG TABLETS Rx Only DESCRIPTION Allopurinol has the following structural formula: Allopurinol 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 white to off white tablet contains 100 mg or 300 mg of allopurinol and the inactive ingredients lactose, crospovidone, magnesium stearate, maize starch, and povidone. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. 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 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 lowered to less than 2 mg/dL by high doses of allopurinol. These values are far below the sa Izlasiet visu dokumentu