Atenurix Dosage/Direction for Use

For treatment of hyperuricemia in patients with gout, Febuxostat is recommended at 20 mg or 40 mg once daily. Or as prescribed by the physician.
Method of administration: The recommended starting dose of Febuxostat is 20 mg or 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks with 20 mg or 40 mg, higher doses are recommended. Febuxostat can be taken without regard to food or antacid use.
Use in special population: Safety and effectiveness in pediatric patients under 18 years of age have not been established. No dose adjustment is necessary when administering Febuxostat in patients with mild to moderate renal impairment. There are insufficient data in patients with severe renal impairment (CrCl less than 30 mL/min); therefore, caution should be exercised in these patients. No dose adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh Class A or B). No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C); therefore, caution should be exercised in these patients.
Testing for the target serum uric acid level of less than 6 mg/dL may be performed as early as two weeks after initiating Febuxostat therapy.
Gout flares may occur after initiation of Febuxostat due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. If a gout flare occurs during Febuxostat treatment, Febuxostat need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient. Flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of Febuxostat. Prophylactic therapy may be beneficial for up to six months.
Use in Geriatric population: No dose adjustment is necessary in elderly patients. Of the total number of subjects in clinical studies of Febuxostat, 16% were 65 and over, while 4% were 75 and over. Comparing subjects in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out. The C and AUC of Febuxostat following multiple oral doses max 24 of Febuxostat in geriatric subjects (>65 years) were similar to those in younger subjects (18 to 40 years).
Use in patients with Secondary hyperuricemia: No studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients); Febuxostat is not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, Lesch-Nyhan syndrome). The concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.