ALLOPURINOL tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

STAT Rx USA LLC

INN (Medzinárodný Name):

ALLOPURINOL

Zloženie:

ALLOPURINOL 100 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 in male patients and 750 mg/day in female patients. T

Prehľad produktov:

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

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

ALLOPURINOL - ALLOPURINOL TABLET
STAT RX USA LLC
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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 to a normal l