ALLOPURINOL tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

NuCare Pharmaceuticals, Inc.

INN (nume internaţional):

ALLOPURINOL

Compoziție:

ALLOPURINOL 100 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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: - 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 allopurinol tablets USP should be discontinued when the potential for overproduction of uric acid is no l

Rezumat produs:

100-mg (white to off white) round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side, bottles of 30 (NDC 66267-665-30), 60 (NDC 66267-665-60) and 90 (NDC 66267-665-90) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No : 457, 458, Village - Matoda, Bavla Road, Ta. - Sanand, Dist. - Ahmedabad - 382210, India. 10 0258 0 665786 Issued January 2016

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ALLOPURINOL- ALLOPURINOL TABLET
NUCARE PHARMACEUTICALS, INC.
----------
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 saturation levels at whi