ALLOPURINOL tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Preferred Pharmaceuticals 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. 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.

Каталог на резюме:

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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ALLOPURINOL- ALLOPURINOL TABLET
PREFERRED PHARMACEUTICALS INC.
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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