Rare reports of serious allergic/hypersensitivity reactions including SJS, TEN & acute anaphylactic reaction/shock. Closely monitor patients for symptoms of allergic/hypersensitivity reaction; immediately discontinue treatment if serious reactions occur. Not recommended in patients w/ ischaemic heart disease or CHF; in whom rate of urate formation is greatly increased (eg, malignant disease & its treatment, Lesch-Nyhan syndrome); & in organ transplant patients. Do not start treatment until acute attack of gout has completely subsided. Gout flares during initiation of treatment may occur; flare prophylaxis is recommended for at least 6 mth w/ NSAID or colchicine at treatment initiation. Perform LFT prior to initiation of therapy & periodically thereafter based on clinical judgment. Reports of increased TSH values (>5.5 IU/mL) in patients on long-term treatment; caution in patients w/ altered thyroid function. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended w/ concomitant mercaptopurine/azathioprine. May adversely affect ability to drive & use machines. Efficacy & safety have not been fully evaluated in patients w/ severe renal (CrCl <30 mL/min). Safety & efficacy has not been studied in patients w/ moderate & severe (Child Pugh class C) hepatic impairment; & in childn <18 yr. Not to be used during pregnancy & lactation.
Sign Out
