ALLOPURINOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional 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 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 tablets should not be restarted on the drug.

Product summary:

Allopurinol Tablets, USP are available containing 100 mg or 300 mg of allopurinol, USP. The 100 mg tablets are white, round, scored tablets debossed with M to the left of the score and 31 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-205-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 300 mg tablets are white, round, scored tablets debossed with M to the left of the score and 71 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-206-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from moisture. The brands listed are trademarks of their respective owners. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505   U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12765 R1 7/23

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALLOPURINOL- ALLOPURINOL TABLET
MYLAN INSTITUTIONAL INC.
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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 tablet
contains 100 mg or 300 mg allopurinol, USP and the inactive
ingredients colloidal silicon
dioxide, magnesium stearate, microcrystalline cellulose,
pregelatinized starch (corn),
sodium lauryl sulfate and sodium starch glycolate (potato). Its
solubility in water at 37ºC
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 mg/dL of these oxypurines
has been
reported when the serum urate was lowered to less than 2 mg/dL by high
doses of
allopurinol tablets. These values