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

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.

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

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