As with other anti-infectives, prolonged use may result in overgrowth of non
susceptible organisms, including fungi. If super infection occurs discontinue
use and institute alternative therapy. Whenever clinical judgment dictates,
the patient should be examined with the aid of magnification, such as slit lamp
biomicroscopy and, where appropriate, fluorescein staining. Ofloxacin should
be discontinued at the first appearance of a skin rash or any other sign of
The systemic administration of quinolones, including ofloxacin, has led to
lesions or erosions of the cartilage in weight-bearing joints and other signs
of arthropathy in immature animals of various species. Ofloxacin, administered
systemically at 10 mg/kg/day in young dogs (equivalent to 110 times the maximum
recommended daily adult ophthalmic dose) has been associated with these
types of effects.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies to determine the carcinogenic potential of ofloxacin have
not been conducted.
Ofloxacin was not mutagenic in the Ames test, in vitro and in vivo
cytogenic assay, sister chromatid exchange assay (Chinese hamster and human
cell lines), unscheduled DMA synthesis (UDS) assay using human fibroblasts,
the dominant lethal assay, or mouse micronucleus assay. Ofloxacin was positive
in the UDS test using rat hepatocyte, and in the mouse lymphoma assay.
In fertility studies in rats, ofloxacin did not affect male or female fertility
or morphological or reproductive performance at oral dosing up to 360 mg/kg/day
(equivalent to 4000 times the maximum recommended daily ophthalmic dose).
Pregnancy Category C: Ofloxacin has been shown to have an embryocidal
effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent
to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day
(equivalent to 1800 times the maximum recommended daily ophthalmic dose).
These dosages resulted in decreased fetal body weight and increased fetal
mortality in rats and rabbits, respectively. Minor fetal skeletal variations
were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been
shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day
when administered to pregnant rats and rabbits, respectively.
Additional studies in rats with doses up to 360 mg/kg/day during late gestation
showed no adverse effect on late fetal development, labor, delivery, lactation,
neonatal viability, or growth of the newborn. There are, however, no adequate
and well-controlled studies in pregnant women. Ofloxacin ophthalmic solution
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
In nursing women a single 200 mg oral dose resulted in concentrations of ofloxacin
in milk which were similar to those found in plasma. It is not known whether
ofloxacin is excreted in human milk following topical ophthalmic administration.
Because of the potential for serious adverse reactions from ofloxacin in nursing
infants, a decision should be made whether to discontinue nursing or to discontinue
the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in infants below the age of one year have not been
established. Quinolones, including ofloxacin, have been shown to cause arthropathy
in immature animals after oral administration; however, topical ocular administration
of ofloxacin to immature animals has not shown any arthropathy. There is no
evidence that the ophthalmic dosage form of ofloxacin has any effect on weight
No overall differences in safety or effectiveness have been observed between
elderly and younger patients.