Pharmacokinetics of imipenem/cilastatin sodium in healthy volunteers and patients with renal insufficiency.

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The pharmacokinetics of imipenem/cilastatin sodium, a new parenteral carbapenem combination antibiotic, were investigated in 4 healthy volunteers and 12 patients with varying degrees of impairment of renal function, after a single or multiple doses (9 doses) of 500mg/500mg of the combination drug administered by a 30-minute drip infusion. Plasma levels of imipenem and cilastatin sodium after a single administration persisted longer in parallel with the degree of impairment of renal function as measured by creatinine clearance (Ccr). Similarly, the urinary recovery of imipenem and cilastatin sodium decreased as the renal function declined. There were significant linear correlations between Ccr and Ke1, β-phase T1/2 and AUC, respectively. In the multiple-dose study, employing 3 patients with moderately impaired renal function, AUCs and urinary recovery of imipenem and cilastatin sodium increased in accordance with the cumulation of dose. Consequently, it is considered that the dose and interval between doses should be determined according to the Ccr in patients with impaired renal function.
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