Febuxostat Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Gout

Initial dose: 40 mg orally once daily

Maintenance dose: 40 mg or 80 mg orally once daily

Renal Dose Adjustments

CrCl 30 to 89 mL/min: No adjustment recommended

CrCl less than 30 mL/min: Insufficient data; the manufacturer recommends caution when administering this drug to patients with severe renal dysfunction.

Liver Dose Adjustments

Mild or moderate hepatic impairment (Child-Pugh A or B): No adjustment recommended

Severe hepatic impairment (Child-Pugh C): Data not available; the manufacturer recommends caution when administering this drug to patients with severe hepatic dysfunction.

Dose Adjustments

If patients do not achieve a serum uric acid (sUA) level of less than 6 mg/dL after 2 weeks with 40 mg, increasing the dose to 80 mg is recommended.

Precautions

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Febuxostat may be taken without regard to food or antacid use.

After initiation of febuxostat, an increase in gout flares is frequently observed. This increase is due to a reduction in serum uric acid levels resulting in mobilization of urate from tissue deposits. Febuxostat need not be discontinued due to a flare. Flare prophylaxis with a nonsteroidal anti-inflammatory drug (NSAID) or colchicine is recommended for up to six months upon initiation of febuxostat.

Testing for the target serum uric acid level of less than 6 mg/dL may be performed as early as 2 weeks after initiating febuxostat therapy.

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