Document Type
Article
Original Publication Date
1992
Journal/Book/Conference Title
Antimicrobial Agents and Chemotherapy
Volume
36
Issue
2
First Page
308
Last Page
312
DOI of Original Publication
10.1128/AAC.36.2.308
Date of Submission
November 2015
Abstract
The safety and pharmacokinetics of ofloxacin in 48 healthy male volunteers were studied in a two-center, randomized, double-blind, placebo-controlled study. Ofloxacin (200 or 400 mg) or placebo was administered as 1-h infusions every 12 h for 7 days. Plasma ofloxacin concentrations were measured by high-performance liquid chromatography. Mean harmonic half-lives ranged from 4.28 to 4.98 h in the 200-mg dosing group and from 5.06 to 6.67 h in the 400-mg dosing group. Intragroup comparisons of trough plasma concentration-versus-time data from study days 2 through 7 revealed that steady state was achieved by day 2 of both multiple-dose regimens. Intergroup comparisons of mean harmonic half-lives, the areas under the concentration-time curve from 0 to 12 and 0 to 60 h, clearance, and apparent volume of distribution (area method) revealed that the pharmacokinetics of ofloxacin are dose independent. Both ofloxacin dosage regimens appeared to be reasonably well tolerated. The two dosage regimens of ofloxacin, 200 or 400 mg every 12 h, appear to be safe and provide serum drug concentrations in excess of the MICs for most susceptible pathogens over the entire dosing interval.
Rights
Copyright © 1992, American Society for Microbiology
Is Part Of
VCU Pharmacotherapy and Outcomes Science Publications
Comments
Originally published at http://dx.doi.org/10.1128/AAC.36.2.308. At time of publishing, Gary R. Matzke was at University of Minnesota.