ALLOPURINOL - allopurinol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals LLC

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: 1.      the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). 2.      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. 3.      the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in m

Product summary:

100-mg (white to off white) scored, flat cylindrical tablets with "I" and "135" on either side of the break line on one side and plain on other side, bottles of 100 (NDC 50742-135-01), 500 (NDC 50742-135-05)and 1000 (NDC 50742-135-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP. 300-mg (peach) scored, flat, cylindrical tablet with "I" and "136" on either side of the break line on one side and plain on other side, bottles of 100 (NDC 50742-136-01), 500 (NDC 50742-136-05)and 1000 (NDC 50742-136-10) . Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light resistant container as defined in the USP. Manufactured for: Ingenus Pharmaceuticals, LLC 4190 Millenia Boulevard Orlando, FL 32839-6408 Customer complaint toll free number: 1-877-748-1970 Manufactured by: Indoco Remedies Ltd. L-32, 33, 34, Verna Industrial Area, Verna Goa. 403 722, India. January 2018 PURINETHOL® (mercaptopurine) is registered Trademark of Teva Biologics and Specialty Products. IMURAN® (azathioprine) is registered Trademark of Prometheus Laboratories Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALLOPURINOL - ALLOPURINOL TABLET
INGENUS PHARMACEUTICALS LLC
---------- ALLOPURINOL TABLETS, USP RX ONLY
DESCRIPTION
Allopurinol has the following structural formula:
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 to
off white tablet contains 100 mg
allopurinol and the inactive ingredients corn starch, lactose
monohydrate, magnesium stearate, povidone
and purified water . Each scored peach tablet contains 300 mg
allopurinol and the inactive ingredients
corn starch, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate,
magnesium stearate, povidone
and purified water. Its solubility in water at 37°C is 80.0 mg/dL and
is greater in an alkaline solution.
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
tablets 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