Effect on CV morbidity & mortality has not been determined. Risk of hyperuricemia & gout. Increased risk of tendon rupture or injury, which may occur more frequently in patients >60 yr, patients taking corticosteroid or fluoroquinolone drugs, patients w/ renal failure, & patients w/ previous tendon disorders. Immediately discontinue treatment if tendon rupture occurs. Limited experience in patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m
2). Not studied in patients w/ ESRD receiving dialysis &/or severe hepatic impairment (Child-Pugh C). Discontinue in case of pregnancy unless benefits of therapy outweigh potential risks to fetus. Breastfeeding is not recommended during treatment. Safety & effectiveness have not been established in ped patients.
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