allopurinol tablet
1 INDICATIONS & 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, oxylate 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 are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
Northstar RxLLC
ROUND WHITE N020
N020 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
ALLOPURINOL Tablets are available in multiple tablet strengths with functional scoring and package sizes (bottles with child-resistant caps) as listed in Table 4. TABLE 4:
ALLOPURINOL Tablets Presentations Tablet Strength Tablet Description Package Sizes (NDC) 100 mg white, flat, circular uncoated tablets with “N020” debossed on one side and score line on the other side. Bottles of: • 30 tablets (NDC 16714-041-07) • 100 tablets (NDC 16714-041-10) • 1,000 tablets (NDC 16714-041-12) 300 mg orange color, biconvex, circular, uncoated tablets with “N021” debossed on one side and score line on the other side Bottles of: • 30 tablets (NDC 16714-042-07) • 100 tablets (NDC 16714-042-10) • 500 tablets (NDC 16714-042-11) Storage and Handling Store at 20°C to 25°C (USP Controlled Room Temperature) (68°F to 77°F) in a dry place. Dispense in a tight container as defined in the USP.
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