Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
allopurinol (UNII: 63CZ7GJN5I) (allopurinol - UNII:63CZ7GJN5I)
Prometheus Laboratories Inc.
allopurinol
allopurinol 100 mg
ORAL
PRESCRIPTION DRUG
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. ZYLOPRIM 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). ZYLOPRIM 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 leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with ZYLOPRIM should be discontinued when the potential for overproduction of uric acid is no longer present. - the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in suc
100-mg (white) scored, flat cylindrical tablets imprinted with “ZYLOPRIM 100” on a raised hexagon, bottles of 100 (NDC 65483-991-10). Store at 15° to 25°C (59° to 77°F) in a dry place. 300-mg (peach) scored, flat, cylindrical tablets imprinted with “ZYLOPRIM 300” on a raised hexagon, bottles of 100 (NDC 65483-993-10) and 500 (NDC 65483-993-50). Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light. PROMETHEUS LABORATORIES INC. Manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27834 for Prometheus Laboratories Inc. San Diego, CA 92121 October 2003 ZY004B03
New Drug Application
ZYLOPRIM- ALLOPURINOL TABLET PROMETHEUS LABORATORIES INC. ---------- PRODUCT INFORMATION ZYLOPRIM (ALLOPURINOL) 100-MG SCORED TABLETS AND 300-MG SCORED TABLETS Rx Only DESCRIPTION ZYLOPRIM (allopurinol) has the following structural formula: ZYLOPRIM 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 lactose, magnesium stearate, potato starch, and povidone. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Lake, lactose, magnesium stearate, and povidone. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. CLINICAL PHARMACOLOGY ZYLOPRIM 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. ZYLOPRIM is a structural analogue of the natural purine base, hypoxanthine. It is an inhiboitor 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. ZYLOPRIM 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 ZYLOPRIM 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 ZYLOPRIM 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 oxypu Baca dokumen lengkapnya