allopurinol tablet
INDICATIONS AND USAGE 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.
Mylan Institutional Inc.
ROUND WHITE M 31
M 31 ROUND WHITE
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HOW SUPPLIED:
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
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