ALLOPURINOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ranbaxy 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 tablets reduce 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 i

Product summary:

100 mg white to off-white colored, round, beveled edged uncoated tablets with "RG10 " embossed on one side and breakline on the other side. The tablets are supplied in the following package sizes: Bottles of 100 tablets    NDC 63304-539-01 Bottles of 1000 tablets  NDC 63304-539-10 300 mg peach colored, round, beveled edged uncoated tablets with "RG11 " embossed on one side and breakline on the other side. The tablets are supplied in the following package sizes: Bottles of 100 tablets    NDC 63304-540-01 Bottles of 500 tablets    NDC 63304-540-05 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonvilla, FL 32257 USA by: Ipca Laboratories Limited 48, Kandivli Ind Estate, Mumbai 400 067, India November 2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALLOPURINOL- ALLOPURINOL TABLET
RANBAXY PHARMACEUTICALS INC.
----------
ALLOPURINOL TABLETS, USP
100 MG AND 300 MG
RX ONLY
DESCRIPTION
Allopurinol has the following structural formula:
C H N O M.W. = 136.11
Allopurinol is known chemically as 1, 5-dihydro-_4H_-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 80.0 mg/dL and is
greater in an alkaline solution. Each scored white to off-white tablet
contains 100 mg allopurinol and
the inactive ingredients lactose monohydrate, corn starch, sodium
starch glycolate, povidone and stearic
acid. Each scored peach tablet contains 300 mg allopurinol and the
inactive ingredients lactose
monohydrate, corn starch, sodium starch glycolate , FD & C yellow no.
6, povidone and stearic acid.
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
tablets for treatment of hyperuricemia is
usually in the range of 0.3 to 0.4 mg/dL compared to a normal level