Pharmacokinetics of ibopamine in patients with renal impairment.

The pharmacokinetics of a single oral dose of ibopamine 100 mg were studied in 15 patients with various degrees of chronic renal impairment (CRI) and in 8 subjects with normal renal function and of comparable age, taken as a control group. Plasma total (mainly conjugated) and free epinine and urinary metabolites (total epinine, HVA and DOPAC) were measured. Both total and free epinine were detectable at the earliest sampling time (15 min) in CRI patients and in normal subjects, thus confirming the promptness of ibopamine absorption. Free epinine pharmacokinetic parameters did not show any appreciable differences among the groups with different degrees of renal impairment, and no statistically significant differences were observed between normal subjects and CRI patients. Progressive renal impairment was associated with higher Cmax, longer t1/2 and larger AUC infinity of total epinine, and with reduced urinary elimination of total epinine and metabolites. Statistically significant differences (p less than 0.01) in Cmax/70 kg, t1/2, and AUC infinity/70 kg of total epinine were found between normal subjects and patients with mild renal impairment. No statistically significant differences were observed in 24-h urinary recoveries of both total epinine and metabolites between normal subjects and patients with mild renal impairment. No adverse effects were experienced during the course of the study. As the kinetics of ibopamine's active moiety, free epinine, were not apparently altered by chronic renal failure, adjustment of its dosage should not be necessary in renal diseases.