ALLOPURINOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

300 mg (orange) scored, round tablets debossed with "2084/V". They are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-7981-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALLOPURINOL- ALLOPURINOL TABLET
CARDINAL HEALTH 107, LLC
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ALLOPURINOL TABLETS USP
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
hyper