Category C—Based on animal data, may cause fetal harm.
There are no clinical data regarding the effect on lactation and nursing
No dosage adjustment necessary
Renal elimination has been reported to account for 58% of clearance, so adjust accordingly. CrCl 30-59: max 80 mg/day; CrCl 15-29: max 40 mg/day; ESRD: avoid use
Hepatic elimination is low. Dose adjustment is not recommended.