Stass H, Bührmann S, Mitchell A, Kubitza D, Möller J-G, Kribben A, Wenzel R R, Schäfers R F
BAYER HealthCare AG, Research Center, Wuppertal, Germany.
Br J Clin Pharmacol. 2007 Dec;64(6):745-9. doi: 10.1111/j.1365-2125.2007.02902.x. Epub 2007 Jun 6.
We investigated single dose and steady-state pharmacokinetics of moxifloxacin in eight venovenous haemodialysis patients.
Plasma, dialysate and urine pharmacokinetic parameters for moxifloxacin and its main metabolites were calculated after single and multiple (7 days) dosing with 400 mg day(-1).
Moxifloxacin pharmacokinetics after a single dose and at steady state (multidose day 7) were comparable in patients with impaired renal function and healthy subjects (geometric mean/%CV AUC mg l(-1) h single dose 37.0/24.3 in haemodialysis patients vs. 29.8/22.6 in healthy subjects, 95% CI for ratio of haemodialysis patients to healthy subjects 99.34%, 154.60%; steady state 40.4/29.1 haemodialysis patients vs. 33.9/20.1 in healthy subjects, 95% CI for ratio of haemodialysis patients to healthy subjects 90/39%, 156.93%). In haemodialysis patients plasma concentrations of moxifloxacin at steady-state were elevated compared with those after a single 400 mg dose (AUC mg l(-1) h, geometric mean/%CV, 40.4/29.1) compared with 37.0/24.3; 95% CI for ratio of steady-state to single dose 87.29%, 136.52%, as were concentrations of metabolite M1 3.21/34.6 compared with 2.02/45.3, 95% CI for ratio of steady state to single dose 14.21%, 175.07%. Haemodialysis cleared about 9% of the dose as unchanged moxifloxacin.
No dose adjustments are required for venovenous haemodialysis patients on oral moxifloxacin therapy.