allopurinol 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 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 is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
sun pharmaceutical industries, inc.
ROUND WHITE MP 71
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16 HOW SUPPLIED/STORAGE AND HANDLING
ALLOPURINOL tablets, USP are supplied as follows:
ALLOPURINOL tablets, 100 mg round, white, scored, debossed MP 71 Bottles of 50 NDC 53489-156-02 Bottles of 100 NDC 53489-156-01 Bottles of 500 NDC 53489-156-05 Bottles of 1000 NDC 53489-156-10
ALLOPURINOL tablets, 300 mg round, orange, scored, debossed MP 80 Bottles of 30 NDC 53489-157-07 Bottles of 50 NDC 53489-157-02 Bottles of 100 NDC 53489-157-01 Bottles of 500 NDC 53489-157-05 Bottles of 1000 NDC 53489-157-10 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) (see USP Controlled Room Temperature). Dispense in tight, light-resistant container.
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