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, 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 is 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 )
Accord Healthcare Inc.
ROUND WHITE AX
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
ALLOPURINOL tablets, USP are available in multiple tablet strengths with functional scoring and package sizes (bottles) as listed in Table 4. TABLE 4:
ALLOPURINOL Tablets, USP Presentations Tablet Strength Tablet Description Package Sizes (NDC) 100 mg white to off white round, biconvex, uncoated tablet with inscription "AW" on one side and breakline on the other side Bottles of: 30’s count with a child-resistant closure (NDC 16729-134-10) 100’s count with a child-resistant closure (NDC 16729-134-01) 500’s count (NDC 16729-134-16) 1,000’s count (NDC 16729-134-17) 300 mg white to off white round, biconvex with beveled edge, uncoated tablet with inscription "AX" on one side and breakline on the other side Bottles of: 30’s count with a child-resistant closure (NDC 16729-135-10) 100’s count with a child-resistant closure (NDC 16729-135-01) 500’s count (NDC 16729-135-16) 1,000’s count (NDC 16729-135-17) 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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