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Posology: The recommended oral dose of Febuxostat tablets is 40 mg once daily without regard to food. If serum uric acid is >6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat tablets 80 mg once daily may be considered.
Febuxostat tablets work sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Gout flare prophylaxis of at least 6 months is recommended.
Elderly: No dose adjustment is required in the elderly.
Renal impairment: The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min).
No dose adjustment is necessary in patients with mild or moderate renal impairment.
Hepatic impairment: The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Pediatric population: The safety and the efficacy of Febuxostat tablets in children aged below the age of 18 years have not been established. No data are available.
Method of administration: Oral use: Febuxostat tablets should be taken by mouth and can be taken with or without food.
