title: Toxicologic evaluation of ofloxacin.
abstract: Results of studies conducted to characterize local, systemic, reproductive, and mutagenic effects indicate that ofloxacin is well tolerated within reasonable multiples of the intended clinical dose. Quinolone-associated arthropathic effects characterized by blister, erosion, and increased synovial fluid occurred in rats and dogs and appeared to be both age- and dose-related. Maternal toxicity and embryotoxicity were noted, but there was no teratogenicity in rats or rabbits. There was no impairment of fertility, and no adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of offspring occurred. Target-organ studies revealed no evidence of ocular toxicity in rats, nephrotoxicity in rabbits, or antigenicity or ototoxicity in guinea pigs. Overall, the toxicologic evaluation of ofloxacin has shown this compound to be a drug with a low toxicologic potential.
authors.affiliation: Department of Toxicology, R.W., Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869.
authors.forename: G J
authors.initials: GJ
authors.lastname: Davis
authors.forename: B E
authors.initials: BE
authors.lastname: McKenzie
mesh_terms: D000014:Abnormalities, Drug-Induced; D000208:Acute Disease; D000818:Animals; D002908:Chronic Disease; D004285:Dogs; D015242:Ofloxacin / Q000633:toxicity*; D051381:Rats
chemical_list: D015242:Ofloxacin