Indications for: ULORIC

Chronic management of hyperuricemia in gout patients who have inadequate response to maximally titrated allopurinol dose, intolerant to allopurinol, or for whom allopurinol therapy is not advisable.

Limitations of Use:

Not for treating asymptomatic hyperuricemia.

Adult Dosage:

≥18yrs: initially 40mg once daily. Obtain target serum uric acid levels <6mg/dL after 2 weeks of initiating therapy; if not <6mg/dL, 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.

Children Dosage:

<18yrs: not established.

ULORIC Contraindications:

Concomitant azathioprine, mercaptopurine.

Boxed Warning:

Cardiovascular death.

ULORIC Warnings/Precautions:

Increased risk of cardiovascular (CV) death; reserve use (see Indications). Monitor for signs/symptoms of CV events. History of CV disease; consider prophylactic low-dose aspirin. 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. Discontinue if serious skin reactions are suspected (eg, SJS, DRESS). Severe hepatic impairment. Severe renal impairment (see Adults) or ESRD on dialysis. Secondary hyperuricemia (eg, Lesch-Nyhan syndrome, malignant disease, or in organ transplant recipients): not recommended. Pregnancy. Nursing mothers.

ULORIC Classification:

Xanthine oxidase inhibitor.

ULORIC Interactions:

See Contraindications. Caution with theophylline.

Adverse Reactions:

Abnormal LFTs, nausea, arthralgia, rash; gout flares, hepatic failure.

How Supplied:

Tabs 40mg—30, 90, 500; 80mg—30, 100, 1000