Urica Special Precautions

Gout Flares: After irritation of Febuxostat (Urica), an increase in gout flares is frequently observed. This increase is due to reduction in serum uric acid levels resulting in mobilization of urate from tissue deposits. Flare prophylaxis with nonsteroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of Febuxostat (Urica). Prophylactic therapy may be beneficial for up to 6 months. Febuxostat (Urica) treatment should not be discontinued when gout flares occur. The gout flare should be managed concurrently, as appropriate for individual patient.
Cardiovascular Events: In randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions and non-fatal strokes) in patients treated with Febuxostat (Urica) than with Allopurinol. A causal relationship with Febuxostat (Urica) has not been established. Signs and symptoms of myocardial infarction and stroke should be monitored.
Liver Enzyme Elevations: In randomized controlled studies, transaminase elevations > 3 times the upper limit of normal were observed (AST: 2%, 2% and ALT: 3%, 2% in Febuxostat (Urica) and Allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted.
Renal Impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment. There are insufficient data in patients with severe renal impairment; therefore, caution should be exercised in these patients.
Hepatic Impairment: No dose adjustment is necessary in patients with mild-moderate hepatic impairment. No studios have been conducted in patients with severe hepatic impairment, thus, caution should be exercised in these patients.
Secondary Hyperuricemia: No studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients) Febuxostat (Urica) is not recommended for use in patients whose rate of urate formation is greatly increased (eg. malignant disease and its treatment, Lesch-Nyhan syndrome). In rare cases, the concentration of xanthine in urine could rise sufficiently to allow deposition in urinary tract.
Use in Children: The safety and efficacy of Febuxostat (Urica) have not been established in patients <18 years.
Use in Elderly: No dose adjustment is necessary in elderly patients. The Cmax and AUC24 of Febuxostat (Urica) following multiple oral doses in geriatric subjects (≥65 years) were similar to those in younger subjects (18-40 years).