ALLOPURINOL tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

NuCare Pharmaceuticals, Inc.

INN (International namn):

ALLOPURINOL

Sammansättning:

ALLOPURINOL 300 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side, bottles of 30 (NDC 66267-224-30), 60 (NDC 66267-224-60) and 90 (NDC 66267-224-90). 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

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

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