caa a22 4500 397590709 CHVBK 20180308164937.0 cr unu---uuuuu 161202e199607 xx s 000 0 eng 10.1093/jac/38.1.103 doi (NATIONALLICENCE)oxford-10.1093/jac/38.1.103 Pharmacokinetics of intravenous ciprofloxacin in normal and renally impaired subjects [Elektronische Daten] [A. Shah, J. Lettieri, R. Blum, S. Millikin, D. Sica, A. H. Heller] The pharmacokinetics of intravenous ciprofloxacin and its metabolites were characterized in 42 subjects with various degrees of renal function (group 1, ClCT (mL/min/l·73m2) > 90, n = 10; group 2, ClCT 61-90, n = 11; group 3, ClCT 31-60, n = 11; group 4, ClCT ≤ 30, n = 10). The dosage regimens were—groups 1 and 2: 400 mg iv at 8 hourly intervals; group 3: 400 mg iv at 12 hourly intervals and group 4: 300 mg iv at 12 hourly intervals. Subjects received a single dose on days 1 and 5 and multiple doses on days 2-4. Multiple plasma and urine samples were collected on days 1 and 5 for the analysis of ciprofloxacin and its metabolites (M1, M2 and M3). Plasma concentrations (Cmax, and AUC) of ciprofloxacin and its M1 and M2 metabolites were significantly increased in subjects with reduced (ClCT values (ClCT < 60 mL/min/1·73 m2) compared with normal subjects (ClCT > 90 mL/min/ 1 ·73 m2). A positive correlation was observed between ciprofloxacin clearance (Cl) and ClCT with a slope of 0·29 (r2 = 0·78) and between renal clearance (ClT) and ClCT with a slope of 0·19 (r2 = 0·84). For patients with severe infections a dosage regimen of 400 mg iv 8 hourly is appropriate in patients with ClCT > 60 mL/min/1·73 m2. In patients with ClCT values of 31-60 mL/min/1·73 m2 a dosage regimen of 400 mg 12 hourly provides similar plasma concentrations to those observed for subjects with ClCT 61-90 mL/min/1·73 m2 receiving 400 mg 8 hourly. Based on modeling of the plasma concentrations in subjects with ClCT ≤ 30 ml/min/1·73 m2, a dosage regimen of 400 mg every 24 h will provide plasma concentrations similar to those observed in subjects with ClCT between 61-90 mL/min/1·73 m2 given 400 mg every 8 h. © 1996 by the British Society for Antimicrobial Chemotherapy Original articles nationallicence Shah A. Clinical Pharmacology, Bayer Corp West Haven, CT aut Lettieri J. Clinical Pharmacology, Bayer Corp West Haven, CT aut Blum R. Clinical Pharmacokinetics Laboratory, Millard Fillmore Hospital Buffalo, NY aut Millikin S. Pharmaceutical Product Development Inc., Clinical Research Unit Morrisville, NC aut Sica D. Medical College of Virginia, Virginia Commonwealth University Richmond, VA, USA aut Heller A. H. Clinical Pharmacology, Bayer Corp West Haven, CT aut Journal of Antimicrobial Chemotherapy Oxford University Press 38/1(1996-07), 103-116 0305-7453 38:1<103 1996 38 jac https://doi.org/10.1093/jac/38.1.103 text/html Onlinezugriff via DOI 1 other jats NATIONALLICENCE 856 40 https://doi.org/10.1093/jac/38.1.103 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Shah A. Clinical Pharmacology, Bayer Corp West Haven, CT aut NATIONALLICENCE 700 1- Lettieri J. Clinical Pharmacology, Bayer Corp West Haven, CT aut NATIONALLICENCE 700 1- Blum R. Clinical Pharmacokinetics Laboratory, Millard Fillmore Hospital Buffalo, NY aut NATIONALLICENCE 700 1- Millikin S. Pharmaceutical Product Development Inc., Clinical Research Unit Morrisville, NC aut NATIONALLICENCE 700 1- Sica D. Medical College of Virginia, Virginia Commonwealth University Richmond, VA, USA aut NATIONALLICENCE 700 1- Heller A. H. Clinical Pharmacology, Bayer Corp West Haven, CT aut NATIONALLICENCE 773 0- Journal of Antimicrobial Chemotherapy Oxford University Press 38/1(1996-07), 103-116 0305-7453 38:1<103 1996 38 jac Metadata rights reserved CC BY-NC-4.0 http://creativecommons.org/licenses/by-nc/4.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-oxford