ALLOPURINOL tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Major Pharmaceuticals

Designació comuna internacional (DCI):

ALLOPURINOL

Composición:

ALLOPURINOL 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

300 mg (orange) scored, round tablets debossed with "2084/V". They are supplied as follows: Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6572-61 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ALLOPURINOL- ALLOPURINOL TABLET
MAJOR PHARMACEUTICALS
----------
ALLOPURINOL TABLETS USP
RX ONLY
DESCRIPTION
Allopurinol, USP has the following structural formula:
Allopurinol, USP 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. Soluble in
solutions of potassium and sodium hydroxides, very slightly soluble in
water and in
alcohol; practically insoluble in chloroform and in ether.
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