Pharmacokinetics and safety of lomefloxacin following multiple doses.
This was a randomized, double-blind, placebo-controlled study comparing the safety and tolerance of 400 mg lomefloxacin, given orally twice daily, to that of placebo administered to eight and four subjects, respectively, for 2 wk. This dose, interval, and duration of dosing were chosen to be identical to the highest anticipated clinical dose for the longest anticipated clinical duration. Subject assessments included ophthalmological examinations performed prior to the study, at midstudy, and after the dosing. No clinically significant differences from baseline were observed for any test result. Analysis of trough plasma concentrations, CMIN, showed that steady state was achieved on Day 4 (Fig. 2). At steady-state, mean plasma concentrations of lomefloxacin ranged from a maximum of 4.86 micrograms/ml to a minimum of 1.47 micrograms/ml. Mean time to maximum plasma concentration on Day 14 was 1.23 hr in the morning and 3.81 hr in the evening. Plasma half-life was approximately 8 hr. Lomefloxacin was well tolerated at 400 mg administered twice daily for 2 wk; plasma concentrations were maintained at a level that is above the MIC of most clinically significant isolates.
Hunt
T L
TL
Pharmaco Dynamics Research, Inc., Austin, TX 78704.
Adams
M A
MA
D042462:4-Quinolones; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D024841:Fluoroquinolones; D006207:Half-Life; D006801:Humans; D008297:Male; D015363:Quinolones; D011897:Random Allocation; D012307:Risk Factors
D042462:4-Quinolones; D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D015363:Quinolones; C053091:lomefloxacin