ALLOPURINOL tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

ALLOPURINOL (UNII: 63CZ7GJN5I) (ALLOPURINOL - UNII:63CZ7GJN5I)

Предлага се от:

Proficient Rx LP

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. 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.

Каталог на резюме:

Allopurinol Tablets USP, 100 mg are scored, round, white tablets imprinted DAN DAN and 5543 supplied in bottles of 30, 60, and 90. Allopurinol Tablets USP, 300 mg are scored, round, orange tablets imprinted DAN DAN and 5544 supplied in bottles of 30, 60, and 90. Dispense in a tight, light-resistant container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: March 2009 184001    0309B

Статус Оторизация:

New Drug Application

Данни за продукта

ALLOPURINOL- ALLOPURINOL TABLET
PROFICIENT RX LP
----------
ALLOPURINOL
TABLETS USP
REVISED: MARCH 2009
RX ONLY 184001
DESCRIPTION
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. Its
solubility in water at 37°C is 80
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 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