Febuxostat INN
Composition : Each film coated tablet contains Febuxostat INN 40mg.
Indication : It is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of Allopurinol, who are intolerant to Allopurinol, or for whom treatment with Allopurinol is not advisable. It is not recommended for the treatment of asymptomatic hyperuricemia.
Dosage and administration : Recommended Dose: The recommended Febuxostat dosage is 40 mg or 80 mg once daily. The recommended starting dosage of Febuxostat is 40 mg once daily. For patients who do not achive a serum uric acid (sUA) less than 6 mg/dL after two weeks, the recommended Febuxostat dosage is 80 mg once daily. Febuxostat can be taken without regard to food or antacid use. Dose adjustment: For Renal Impairment: No dose adjustment is necessary when administering Febuxostat in patients with mild or moderate renal impairment. The recommended dosage of Febuxostat is limited to 40 mg once daily in patients with severe renal impairment. For Hepatic Impairment: No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Or, as directed by the registered physician.
Use in pregnancy and lactation : Pregnancy : There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to be fetus. Nursing mothers: 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.
Packing: Each box contains 3x10’s tablets in blister pack.
