ALLOPURINOL tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

PD-Rx Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

ALLOPURINOL

Kompozīcija:

ALLOPURINOL 100 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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: - 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 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 i

Produktu pārskats:

100 mg (white) scored, flat-faced beveled edge round tablets debossed with "2083/V". Bottles of 30, 60 and 90. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

ALLOPURINOL- ALLOPURINOL TABLET
PD-RX PHARMACEUTICALS, INC.
----------
ALLOPURINOL 100 MG SCORED 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 scored
white tablet
contains 100 mg allopurinol and the inactive ingredients colloidal
silicon dioxide, lactose
monohydrate, magnesium stearate, microcrystalline cellulose and sodium
starch
glycolate. Each scored orange tablet contains 300 mg allopurinol and
the inactive
ingredients colloidal silicon dioxide, FD&C Yellow No. 6 Lake, lactose
monohydrate,
magnesium stearate, microcrystalline cellulose, and sodium starch
glycolate. Its solubility
in water at 37°C is 80 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