ALLOPURINOL- allopurinol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

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 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 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. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present. the management

Product summary:

Allopurinol Tablets USP, 100 mg are scored, round, white tablets imprinted DAN DAN and 5543 on the other side. NDC 68071-4131-3 Bottles of 30 NDC 68071-4131-3 Bottles of 60 NDC 68071-4131-9 Bottles of 90 Dispense in a tight, light-resistant container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: February 2015

Authorization status:

New Drug Application

Summary of Product characteristics

ALLOPURINOL- ALLOPURINOL TABLET
NUCARE PHARMACEUTICALS,INC.
----------
ALLOPURINOL
TABLETS USP
REVISED: FEBRUARY 2015
RX ONLY
DESCRIPTION
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. Its solubility in
water at 37°C is 80 mg/dL and is greater
in an alkaline solution. The structural formula is represented below:
C
H
N
O
M.W. 136.11
Allopurinol Tablets USP, 100 mg and 300 mg contain the following
inactive ingredients:
croscarmellose sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch and sodium lauryl sulfate.
Allopurinol Tablets USP, 300 mg also contain FD&C Yellow No. 6.
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.
5
4
4
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