allopurinol 300 MG Oral Tablet
1 INDICATIONS AND USAGE Allopurinol tablets are indicated for: • The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) • The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels • The management of adult 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, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol tablets are a xanthine oxidase inhibitor indicated for the management of: • Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) ( 1 ) • Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels ( 1 ) • Adult 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, despite lifestyle changes ( 1 ) Limitations of Use Allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
Mylan Pharmaceuticals Inc.
ROUND WHITE M 71
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
ALLOPURINOL Tablets, USP are available containing 100 mg or 300 mg of
ALLOPURINOL, USP. The 100 mg tablets are white, round, functionally 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 0378-0137-01 bottles of 100 tablets NDC 0378-0137-10 bottles of 1000 tablets The 300 mg tablets are white, round, functionally 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. NDC 0378-0181-01 bottles of 100 tablets NDC 0378-0181-05 bottles of 500 tablets Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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