Lg. Gisclon et al., ABSENCE OF A PHARMACOKINETIC INTERACTION BETWEEN INTRAVENOUS THEOPHYLLINE AND ORALLY-ADMINISTERED LEVOFLOXACIN, Journal of clinical pharmacology, 37(8), 1997, pp. 744-750
A randomized, placebo-controlled, two-way crossover study in 16 health
y men was performed to determine the effect of orally administered lev
ofloxacin at steady-state conditions, given at 500 mg every 12 hours,
on the pharmacokinetics of theophylline given as a single 4.5-mg/kg in
travenous infusion. Participants were assigned randomly to receive the
ophylline with levofloxacin in one study period and theophylline with
placebo in the other period. Fourteen individuals completed the study.
Mean (+/- SD) values for theophylline pharmacokinetic parameters for
the levofloxacin and placebo treatments, respectively rt ere peak plas
ma concentrations (C-max) of 11.4 (1.8) mu g/mL and 10.7 (1.3) mu g/mL
; areas under the concentration time curve from time 0 extrapolated to
infinity (AUC(0-infinity)) of 124 (32) mu g.hr/mL and 126 (30) mu g.h
r/mL; volumes of distribution at steady state (Vd(ss)) 31.7 (3.5) L an
d 32.0 (3.9) L; clearances (Cl) of 48.6 (11.6) mL/min and 47.4 (10.3)
mL/min; and half-lives (t(1/2)), of 8.1 (1.9) hours and 8.2 (1.8) hour
s. There were no statistically significant differences between treatme
nts for any of these parameters. There It as no pharmacokinetic intera
ction between levofloxacin administered orally at steady-state conditi
ons and intravenously administered theophylline.