Journal of Antimicrobial Chemotherapy, Vol 39, 81-86, Copyright © 1997 by The British Society for Antimicrobial Chemotherapy
J Vincent, R Teng, LC Dogolo, SA Willavize and HL Friedman
Some fluoroquinolone antibiotics interfere with theophylline clearance,
thereby raising concentrations of circulating theophylline and increasing
the potential for toxicity. The effect of steady-state serum concentrations
of the new fluoroquinolone trovafloxacin on the steady- state
pharmacokinetics of theophylline was examined in 12 healthy male
volunteers. For 7 days, the subjects received morning and evening
theophylline doses adjusted to achieve steady-state plasma concentrations
of 8-15 mg/L, the lower end of the therapeutic range. From day 8 to day 15,
six volunteers received, in addition to theophylline, 200 mg of
trovafloxacin in the morning and placebo in the evening (group A) and six
received placebo twice daily (group B). Serial plasma samples obtained over
12 h and 60 h after the morning theophylline dose on days 7 and 14,
respectively, were analysed for theophylline by HPLC with UV detection.
There were no significant differences in mean Cmax or AUC(0-12) between the
two groups on day 7 or on day 14, nor were there significant within-group
differences on the two days. On day 14, mean Cmax, AUC(0-12) and T(1/2)
(measured on day 14 only) in group A were 10.15 mg/L, 107.32 mg x h/L and
9.0 h, respectively. In group B, the values were 10.81 mg/L, 113.73 mg x
h/L and 8.3 h, respectively. The study drugs were well tolerated, and no
clinically significant changes in vital signs or laboratory test values
were noted. We conclude that steady-state concentrations of trovafloxacin
have no clinically significant effect on the steady-state concentrations of
theophylline within the therapeutic range in healthy subjects.
ORIGINAL ARTICLES
Effect of trovafloxacin, a new fluoroquinolone antibiotic, on the steady-state pharmacokinetics of theophylline in healthy volunteers
Central Research Division, Pfizer Inc., Groton, CT 06340, USA.
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