Generic Name and Formulations:
Febuxostat 40mg, 80mg; tabs.
Takeda Pharmaceuticals USA, Inc.
Indications for ULORIC:
Chronic management of hyperuricemia in patients with gout.
≥18yrs: initially 40mg once daily. Obtain target serum uric acid levels <6mg/dL after 2 weeks of initiating therapy; if not <6mg/dL, may increase to 80mg once daily. Gout flare prophylaxis, with an NSAID or colchicine, upon initiation of therapy and for up to 6 months, is recommended. Severe renal impairment: max 40mg once daily.
<18yrs: not established.
Concomitant azathioprine, mercaptopurine.
Not for treating asymptomatic hyperuricemia. Cardiovascular events: monitor for signs and symptoms of MI and stroke. Measure LFTs at baseline and if liver injury is suspected; interrupt therapy if ALT>3xULN and investigate cause. Do not restart if ALT>3xULN with serum total bilirubin >2xULN without alternative etiologies; for lesser elevations, use with caution. Severe hepatic impairment. Severe renal impairment (see Adult) or ESRD on dialysis. Secondary hyperuricemia (eg, Lesch-Nyhan syndrome, malignant disease, or in organ transplant recipients): not recommended. Discontinue if serious skin reactions are suspected (eg, DRESS, TEN). Pregnancy. Nursing mothers.
See Contraindications. Potentiates xanthine oxidase substrate drugs (eg, theophylline).
Xanthine oxidase inhibitor.
Abnormal LFTs, nausea, arthralgia, rash; gout flares, hepatic failure.
Tabs 40mg—30, 90, 500; 80mg—30, 100, 1000
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