scholarly journals Pharmacokinetics and tolerability of intravenous infusion of the new hydroxyethyl starch 130/0.4 (6%) in 19 subjects with mild to severe renal impairment: terminal half life and peak concentration (Cmax)remain unaffected

Critical Care ◽  
2001 ◽  
Vol 5 (Suppl 1) ◽  
pp. P118 ◽  
Author(s):  
C Jungheinrich ◽  
R Scharpf ◽  
M Wargenau ◽  
F Bepperling
2002 ◽  
Vol 95 (3) ◽  
pp. 544-551 ◽  
Author(s):  
Cornelius Jungheinrich ◽  
Roland Scharpf ◽  
Manfred Wargenau ◽  
Frank Bepperling ◽  
Jean-François Baron

2002 ◽  
Vol 95 (3) ◽  
pp. 544-551 ◽  
Author(s):  
Cornelius Jungheinrich ◽  
Roland Scharpf ◽  
Manfred Wargenau ◽  
Frank Bepperling ◽  
Jean-Fran??ois Baron

2014 ◽  
Vol 58 (11) ◽  
pp. 6471-6476 ◽  
Author(s):  
S. Flanagan ◽  
S. L. Minassian ◽  
D. Morris ◽  
R. Ponnuraj ◽  
T. C. Marbury ◽  
...  

ABSTRACTTwo open-label, single-dose, parallel-group studies were conducted to characterize the pharmacokinetics of the novel antibacterial tedizolid and the safety of tedizolid phosphate, its prodrug, in renally or hepatically impaired subjects. Tedizolid pharmacokinetics in subjects with severe renal impairment without dialysis support was compared with that of matched control subjects with normal renal function. Effects of hemodialysis on tedizolid pharmacokinetics were determined in a separate cohort of subjects undergoing long-term hemodialysis. Effects of hepatic impairment on tedizolid pharmacokinetics were determined in subjects with moderate or severe hepatic impairment and compared with those of matched control subjects with normal hepatic function. Each participant received a single oral (hepatic impairment) or intravenous (renal impairment) dose of tedizolid phosphate at 200 mg; hemodialysis subjects received two doses (separated by 7 days), before and after dialysis, in a crossover fashion. The pharmacokinetics of tedizolid was similar in subjects with severe renal impairment and controls (∼8% lower area under the concentration-time curve [AUC], with a nearly identical peak concentration) and in subjects undergoing hemodialysis before and after tedizolid phosphate administration (∼9% lower AUC, with a 15% higher peak concentration); <10% of the dose was removed during 4 h of hemodialysis. Tedizolid pharmacokinetics was only minimally altered in subjects with moderate or severe hepatic impairment; the AUC was increased approximately 22% and 34%, respectively, compared with that of subjects in the control group. Tedizolid phosphate was generally well tolerated in all participants. These results suggest that tedizolid phosphate dose adjustments are not necessary in patients with any degree of renal or hepatic impairment. (This study has been registered at ClinicalTrials.gov under registration numbers NCT01452828 [renal study] and NCT01431833 [hepatic study].)


DICP ◽  
1991 ◽  
Vol 25 (12) ◽  
pp. 1315-1320 ◽  
Author(s):  
Nancy M. Allen ◽  
Gary D. Dunham ◽  
Jeffrey M. Sailstad ◽  
John W.A. Findlay

Minimal pharmacokinetic data on digoxin immune Fab are currently available, especially in patients with impaired renal function. The serum concentration-time profiles of total digoxin, free digoxin, and digoxin immune Fab in four patients with moderate to severe renal impairment who received digoxin immune Fab are presented. The calculated elimination half-life of digoxin immune Fab was 25–73 hours. The calculated elimination half-life of total digoxin was 24–72 hours. Free digoxin concentrations rebounded to a peak of 1–2.9 ng/mL 44–97 hours after the administration of digoxin immune Fab. The areas under the curve for digoxin immune Fab were 213–1026 μg·h/mL, and total body clearances were 2.3–7.1 mL/min. The total digoxin concentrations peaked at 14–33 times the pre-Fab digoxin concentrations 5–30 hours after digoxin immune Fab administration. In comparing these data with data available from patients with normal renal function, the half-life of digoxin immune Fab and total digoxin was longer, the peak total digoxin concentration occurred later, the ratio of the peak total digoxin concentration to pre-Fab digoxin concentration was larger, and the rebound in free digoxin occurred later in patients with renal impairment. The Fab dose should not be reduced in patients with renal impairment; however, post-Fab monitoring should be extended to compensate for the prolonged half-life of Fab and later rebound of free digoxin.


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