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Posology: The recommended oral dose of URICTOR is 80 mg once daily without regard to food. If serum uric acid is >6 mg/dL (357 μmol/L) after 2-4 weeks, febuxostat 120 mg once daily may be considered; dosage of 120 mg should be provided by other product instead.
URICTOR works 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 (see Precautions).
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.
Paediatric population: The safety and the efficacy of URICTOR in children aged below the age of 18 years have not been established. No data are available.
Method of administration: Oral use. Swallow tablet in whole. Do not break tablet in half.
URICTOR should be taken by mouth and can be taken with or without food.
