ALLOPURINOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

ALLOPURINOL

Composition:

ALLOPURINOL 300 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: Patients who have developed a severe reaction to allopurinol should not be restarted on the drug.

Product summary:

Allopurinol Tablets, USP are available containing either 100 mg or 300 mg of Allopurinol, USP. The 100 mg tablets are white, round, scored compressed 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 0378-0137-01 bottles of 100 tablets NDC 0378-0137-10 bottles of 1000 tablets The 300 mg tablets are white, round, scored compressed 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 0378-0181-01 bottles of 100 tablets NDC 0378-0181-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED DECEMBER 2005 ALLO:R13

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALLOPURINOL- ALLOPURINOL TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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. Its solubility in
water at 37°C is 80.0 mg/dL and is
greater in an alkaline solution.
Each tablet for oral administration contains either 100 mg or 300 mg
of allopurinol, USP and the
following inactive ingredients: colloidal silicon dioxide, magnesium
stearate, microcrystalline
cellulose, pregelatinized starch, sodium lauryl sulfate and sodium
starch glycolate.
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 mg 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 allopuri