Rare reports of serious allergic/hypersensitivity reactions, including life-threatening SJS, TEN & acute anaphylactic reaction/shock. Immediately stop treatment if serious allergic/hypersensitivity reactions, including SJS, occur. Monitor for signs & symptoms of allergic/hypersensitivity reactions, MI & stroke. Not recommended in patients w/ ischemic heart disease or CHF; whom the rate of urate formation is greatly increased eg, malignant disease & its treatment, Lesch-Nyhan syndrome; concomitantly treated w/ mercaptopurine/azathioprine; organ transplant recipients. Exacerbation &/or onset of CV disease. Not to be started until an acute attack of gout has completely subsided. Gout flares may occur during treatment initiation; prophylaxis for at least 6 mth w/ an NSAID or colchicine is recommended. Do not discontinue if a gout flare occurs during treatment. LFT is recommended prior to initiation of therapy & periodically thereafter. Patients w/ alteration of thyroid function. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Exercise caution before driving, using machinery or participating in dangerous activities. Severe renal impairment (CrCl <30 mL/min); moderate & severe (Child Pugh Class C) hepatic impairment. Not to be used during pregnancy & breast-feeding. Childn <18 yr.
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