Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.
Febux-40 Tablet: Each film coated tablet contains Febuxostat INN 40 mg.
Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout.
Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febux is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg/dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be taken without regard to food or antacid use.
Renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment (Clcr 30-89 mL per min). Hepatic impairment: No dose adjustment is necessary in patients with mild or moderate hepatic impairment. Caution should be exercised in patients with severe hepatic impairment.
Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline and also in patients who have hypersensitivity to any ingredient of this preparation.
An increase in gout flares is frequently observed during initiation of anti hyperuricemic agents, including Febux. If gout flare occurs during treatment Febux need not to be discontinued. Prophylactic therapy (i.e. non-steroidal anti-inflammatory drug (NSAID) or colchicines upon initiation of treatment) may be beneficial for up to six months. Monitor for signs and symptoms of MI and stroke. Transaminase elevations have been observed in Febux-treated patients. Monitor liver function tests periodically.
Adverse reactions are liver function abnormalities, nausea, arthralgia and rash. Patients treated with Febuxostat for long term may have a high risk of cardiovascular death.
Inhibition of Xanthine Oxidase by Febuxostat may cause increased plasma concentrations of theophylline, mercaptopurine, azathioprine leading to toxicity.
Use in pregnancy: Pregnancy Category C: Febux should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in nursing mother: It is not known whether this drug is excreted in human milk. Caution should be exercised when Febux is administered to a nursing woman.
Febux-40 Tablet: Each box contains 30's tablets in blister pack.
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