Pharmacokinetics of dirithromycin in patients with impaired hepatic function

Dirithromycin is a new macrolide antibiotic. A non-blinded, non-comparative study was performed in patients with mild, (Pugh and Childs Grade A) chronic, stable, impaired hepatic function (CSIHF) to determine the single- and multiple-dose pharmacokinetics and safety in such patients. Eight volunteers had disease affecting primarily the hepatic parenchyma, eight had primarily biliary system diseases and five healthy volunteers served as the control population. CSIHF patients and healthy volunteers all received a single dose of dirithromycin 500 mg po and 2 weeks later a 10-day course of dirithromycin 500 mg po once a day. Blood and urine samples were obtained with single dose administration and on days 1 and 10 of multiple-dose administration