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Toxicologic evaluation of ofloxacin
1Department of Toxicology, R.W., Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869.
The American Journal of Medicine
|December 29, 1989
Summary
Ofloxacin demonstrates good tolerability at clinical doses. While some age- and dose-related joint issues were observed in animal studies, overall toxicologic potential is low, with no significant reproductive or developmental concerns.
Area of Science:
- Pharmacology and Toxicology
- Drug Safety Evaluation
Background:
- Ofloxacin is a fluoroquinolone antibiotic.
- Comprehensive toxicologic assessments are crucial for drug safety.
Purpose of the Study:
- To evaluate the local, systemic, reproductive, and mutagenic effects of ofloxacin.
- To characterize potential adverse effects across various organ systems and life stages.
Main Methods:
- Animal studies in rats, dogs, rabbits, and guinea pigs.
- Assessment of local, systemic, reproductive, and target-organ toxicity.
Main Results:
- Ofloxacin was well tolerated within clinical dose multiples.
- Age- and dose-dependent arthropathic effects observed in rats and dogs.
- No teratogenicity, impaired fertility, or adverse effects on neonatal development noted.
- No ocular, nephrotoxic, antigenic, or ototoxic effects identified in target organs.
Conclusions:
- Ofloxacin exhibits a low toxicologic potential.
- The drug is generally safe for intended clinical use, with specific considerations for age and dose regarding joint health.