Uristat 40 mg tablet: Each film coated tablet contains Febuxostat INN 40 mg.
Uristat 80 mg tablet: Each film coated tablet contains Febuxostat INN 80 mg.
Pharmacology: Febuxostat is FDA approved non-purine, selective inhibitor of xanthine oxidase approved for the chronic management of hyperuricemia in patients with gout. It is not recommended for asymptomatic or secondary hyperuricemia, nor it is indicated for treatment of acute gout. Febuxostat lowers serum uric acid levels by blocking xanthine oxidase - the enzyme responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine (a natural-occurring purine derivative) to xanthine, and then to uric acid.
Uristat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. It is not recommended for the treatment of asymptomatic hyperuricemia.
For the treatment of hyperuricemia in patients with gout, Uristat is recommended at 40 mg or 80 mg once daily.
The recommended starting dose of Uristat is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg per dL after 2 weeks with 40 mg, Uristat 80 mg is recommended.
Uristat can be taken without regard to food or antacid use.
No dose adjustment is necessary when administering Uristat to patients with mild to moderate renal or hepatic impairment.
Febuxostat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.
Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.
Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.
Drugs should be used according to the physician's advice on cardiac & stroke patient.
Liver function should be monitored.
Use in Children: Safety and efficacy in children below the age of 12 years have not been studied.
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Febuxostat is administered to a nursing woman.
The most common side effects of Febuxostat are liver problems, nausea, gout flares, joint pain and rash.
Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.
Store at temperature not exceeding 30 °C in a dry place. Protect from light.
M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.
FC tab 40 mg x 30's. 80 mg x 20's.