Safety of multiple doses of ofloxacin in healthy volunteers
Stein, G.E.; Flor, S.C.; Beals, B.S.
Drugs under Experimental and Clinical Research 17(10-11): 525-529
1991
ISSN/ISBN: 0378-6501 PMID: 1841044 Document Number: 387772
A safety profile of ofloxacin, a new fluoroquinolone antibiotic, was assessed in twelve healthy male volunteers. Ofloxacin was dosed at 400 mg twice daily over a 10-day course of treatment. This evaluation included chemistry and haematologic profiles, neurologic evaluations, ophthalmologic examinations, audiometric testing, and electrocardiogram before, during and the end of the study. In addition, plasma samples were analysed for ofloxacin prior to each morning dose and a complete plasma concentration profile was performed on day 6. Gastrointestinal complaints such as nausea, diarrhoea and upset were the most frequent side effects reported. The only other adverse event that occurred in more than one volunteer was headache. None of the subjects in this study developed a serious side effect and no physical or psychological changes were observed. Laboratory values remained in their normal ranges with the exception of one volunteer who developed a 3-fold rise in one liver function test at the end of the study. The subject was asymptomatic and this aberration resolved without sequelae. In summary, a 10-day course of ofloxacin was found to be safe and have a low potential for toxicity. The side effects observed in this study were mild and similar to those observed with other fluoroquinolones.