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Pharmacokinetics of Cefprozil in Healthy Subjects and Patients with Hepatic Impairment

The pharmacokinetics of cefprozil were studied in 12 (9 men, 3 women) subjects with hepatic impairment and in 12 healthy subjects who were matched for age, sex, and weight. Each subject received a single 1000 mg oral dose of cefprozil, which consists of cis and trans isomers in approximately a 90:10 ratio. Serial blood and urine samples were collected and analyzed using validated HPLC/UV methods for the concentration of each isomer. The results of the plasma and urine analyses were subjected to noncompartmental pharmacokinetic analysis. The values for the peak plasma concentrations (Cmax), area under the plasma concentration versus time curve (AUC0–∞), apparent total body clearance (Clt/F), renal clearance (Clr), and percent of drug excreted in urine (% UR) of each isomer were not significantly different in healthy subjects and patients with hepatic impairment. The only parameters that were significantly (P ≤ .05) longer in patients with hepatic impairment were mean residence time in the body (MRT) and half‐life; the MRT for the cis isomer in healthy subjects and subjects with hepatic impairment were 3.33 hr and 3.88 hr, respectively, and for the trans isomer 3.17 hr and 3.68 hr; the half‐life for the cis isomer was 1.62 hr and 2.22 hr, respectively, and for the trans isomer 1.21 hr and 1.54 hr. The pharmacokinetics of the cis and trans isomers of cefprozil were virtually identical in healthy subjects as well as those with hepatic impairment. The results of the study showed that the pharmacokinetics of cefprozil are not significantly affected in patients with hepatic dysfunction, and as a result, the dosage of cefprozil does not require adjustment in patients with hepatic dysfunction.