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Febuxostat INN

Uristat 80 80 mg 2X10 Tablet
Uristat 40 40 mg 3X10 Tablet


Uristat (Febuxostat) is a xanthine oxidase inhibitor, indicated for the chronic management of hyperuricemia. It achieves its therapeutic effect by decreasing serum uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations Uristat is available as tablets.

Uristat- 40: Each tablet contains febuxostat INN 40 mg. Uristat- 80: Each tablet contains febuxostat INN 80 mg.

Febuxostat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

For treatment of hyperuricemia in patients with gout, febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of febuxostat 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, febuxostat 80 mg is recommended. Febuxostat can be taken without regard to food or antacid use. No dose adjustment is necessary when administering febuxostat in patients with mild to moderate renal & hepatic impairment. Testing for the target serum uric acid level of less than 6 mg per dl may be performed as early as 2 weeks after initiating febuxostat therapy.

Most common adverse reactions: Liver function abnormalities, nausea, arthralgia, rash etc.

1. Gout flare: after initiation of febuxostat, an increase in gout flares is frequently observed. This increase is due to reduction in serum uric acid levels resulting in mobilization of urate from tissue deposits. In order to prevent gout flares when febuxostat is initiated, concurrent prophylactic treatment with an nsaid or colchicine is recommended. 2. Cardiovascular events: in the randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with febuxostat. 3. Liver enzyme: elevations during randomized controlled studies, transaminase elevations greater than 3 times the upper limit of normal.

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. Febuxostat is excreted in the milk of rats. 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.

Febuxostat is an XO inhibitor. Drug interaction studies of febuxostat with drugs that are metabolized by XO (e.g., theophylline, mercaptopurine, azathioprine) have not been conducted. Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity. side

Febuxostat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities. No overdose of was febuxostat reported in clinical studies. Patients should be managed by symptomatic and supportive care should there be an overdose.

Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Uristat- 40: Each box contains 3x10’s tablets in blister strip. Uristat- 80: Each box contains 2x10’s tablets in blister strip.