ZYLOPRIM- allopurinol tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

allopurinol (UNII: 63CZ7GJN5I) (allopurinol - UNII:63CZ7GJN5I)

Предлага се от:

Prometheus Laboratories Inc.

INN (Международно Name):

allopurinol

Композиция:

allopurinol 100 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

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

Статус Оторизация:

New Drug Application

Данни за продукта

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