ALLOPURINOL- allopurinol tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Bryant Ranch Prepack

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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: Patients who have developed a severe reaction to allopurinol should not be restarted on the drug.

Produktbesonderheiten:

Product: 71335-0599 NDC: 71335-0599-4 90 TABLET in a BOTTLE NDC: 71335-0599-1 30 TABLET in a BOTTLE NDC: 71335-0599-2 60 TABLET in a BOTTLE NDC: 71335-0599-3 100 TABLET in a BOTTLE

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ALLOPURINOL- ALLOPURINOL TABLET
BRYANT RANCH PREPACK
----------
ALLOPURINOL TABLETS USP
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.
Inactive Ingredients: corn starch, croscarmellose sodium, lactose,
magnesium stearate, povidone.
Allopurinol 300 mg also contains FD&C yellow #6 lake. 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 which point
their precipitation would be expected to occur (