ALLOPURINOL- allopurinol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Corporation dba SKY Packaging

INN (International Name):

ALLOPURINOL

Composition:

ALLOPURINOL 100 mg

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 tablets 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 tablets are 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 tablets 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. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks. Patients who have developed a severe reaction to allopurinol should not be restarted on the drug.

Product summary:

Allopurinol Tablets USP are supplied as follows: 100 mg : White, flat, circular, uncoated tablets with "N020" debossed on one side and score line on the other side. Boxes of 10x10 UD 100, NDC 63739-410-10 300 mg : Orange color, biconvex, circular, uncoated tablets with “N021”debossed on one side and score line on the other side. Boxes of 10x10 UD 100, NDC 63739-796-10 Store at 20° to 25°C (68 to 77°F). See USP Controlled room temperature. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. Manufactured by : Piramal Enterprises Limited, Pithampur, Madhya Pradesh 454775 INDIA Distributed by: McKesson Corporation dba SKY Packaging Memphis, TN 38141 August 2022 21455-1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALLOPURINOL - ALLOPURINOL TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
----------
RX ONLY
DESCRIPTION
Allopurinol has the following structural formula below:
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 alcohol, corn
starch, lactose
monohydrate, magnesium stearate and povidone. Each scored orange
tablet contains
300 mg allopurinol and the inactive ingredients alcohol, corn starch,
lactose
monohydrate, magnesium stearate, pigment blend PB53652 orange and
povidone. It is
very slightly soluble in water and in alcohol; soluble in solutions of
potassium and sodium
hydroxides; 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
hyperuricemia is usually in the range of 0.3 to 0.4 mg/dL compared to
a normal level of
approximat