allopurinol

FDA Drug Profile — Allopurinol

Drug Details

Generic Name
allopurinol
Brand Names
Allopurinol
Application Number
ANDA075798
Sponsor
Cardinal Health 107, LLC
NDC Codes
41
Dosage Forms
TABLET, POWDER
Routes
ORAL
Active Ingredients
ALLOPURINOL

Indications and Usage

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 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 )