Permanently discontinue treatment in patients who develop concurrent elevation of ALT >3x ULN & total bilirubin >2x ULN in absence of biliary obstruction, or other causes of concurrent elevation. Interrupt treatment for patients who develop hepatotoxicity during treatment (ALT &/or AST >5x ULN or total bilirubin >3x ULN). Discontinue treatment if hepatotoxicity recurs at reduced dose of 500 mg once daily. Closely monitor patients whose underlying medical conditions might be compromised by increased BP, hypokalemia or fluid retention eg, those w/ heart failure, recent MI, CV disease, or ventricular arrhythmia. Control HTN & correct hypokalemia before & during treatment. Monitor patients for HTN, hypokalemia & fluid retention at least once a mth; signs & symptoms of adrenocortical insufficiency particularly those w/drawn from prednisone, have prednisone dose reductions, or experience unusual stress. Measure ALT, AST & bilirubin levels prior initiation of treatment every 2 wk for 1st 3 mth & mthly thereafter. Measure ALT, AST, & bilirubin in patients w/ moderate hepatic impairment prior to start of treatment, every wk for 1st mth, every 2 wk for following 2 mth & mthly thereafter. Avoid concomitant use w/ strong CYP3A4 inducers (phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarb) during treatment. Not to be used in patients w/ baseline severe hepatic impairment (Child-Pugh Class C). May impair reproductive function & fertility in males of reproductive potential. Not to be indicated for use in females. Advise males w/ female partners of reproductive potential to use effective contraception during treatment & for 3 wk after final dose of treatment. Paed. Elderly.
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