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Pharmacokinetics of sce 2787 a new cephalosporin for intravenous administration in healthy subjects and patients with renal failure



Pharmacokinetics of sce 2787 a new cephalosporin for intravenous administration in healthy subjects and patients with renal failure



Acta Therapeutica 18(2): 117-132



Plasma and urine concentrations of SCE-2787 were determined after i.v. administration of 1 g in 11 healthy volunteers and 25 patients with varying degrees of impaired renal function. In all cases the plasma creatinine concentrations were known. Glomerular filtration rate was also determined in patients. Like other cephalosporins SCE-2787 is excreted predominantly via the kidney and is therefore eliminated much more slowly in renal failure. The resulting increase in the area under the curve is correlated to both GFR and plasma creatinine levels. Based upon this relationship a dose reduction factor was derived for 6 different degrees of renal function. In patients with no renal function (e.g. patients who need hemodialysis) this factor is about 10. Thus patients receiving the same dose develop approximately a 10-fold greater AUC than subjects with normal renal function. Graded dose recommendations are given tabular form based on this relationship in patients with renal failure, both renal and extrarenal clearance (normally low in healthy subjects) decrease. The lower the GFR, the greater the tubular secretion of SCE-2787 so that the tubular load of the substance increases in renal failure. Since high SCE-2787 levels in the urine are present even in end-stage renal failure, the compound is also suitable for the treatment of urinary tract infections in patients with severely impaired renal function.

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