Included as part of the PRECAUTIONS section.
Otic Use Only
CETRAXAL (ciprofloxacin otic solution) is for otic use only. It should not be used for
injection, for inhalation or for opical ophthalmic use.
CETRAXAL (ciprofloxacin otic solution) should be discontinued at the first appearance of a
skin rash or any other ign of hypersensitivity.
Growth of Resistant Organisms with Prolonged Use
As with other anti-infectives, use of CETRAXAL (ciprofloxacin otic solution) may result in
overgrowth of onsusceptible organisms, including yeast and fungi. If
super-infection occurs, discontinue use and institute alternative therapy.
Lack of Clinical Response
If the infection is not improved after one week of therapy,
cultures may help guide further treatment.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term carcinogenicity studies in mice and rats have been
completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250
mg/kg (rats) were administered for up to 2 years, there was no evidence that
ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No
long-term studies of CETRAXAL (ciprofloxacin otic solution) have been performed to evaluate carcinogenic
Eight in vitro mutagenicity tests have been conducted
with ciprofloxacin, and the test results are listed below:
- Salmonella/Microsome Test (Negative)
- Escherichia coli DNA Repair Assay (Negative)
- Mouse Lymphoma Cell Forward Mutation Assay (Positive)
- Chinese Hamster V79 Cell HGPRT Test (Negative)
- Syrian Hamster Embryo Cell Transformation Assay (Negative)
- Saccharomyces cerevisiae Point Mutation Assay (Negative)
- Saccharomyces cerevisiae Mitotic Crossover and Gene
Conversion Assay (Negative)
- Rat Hepatocyte DNA Repair Assay (Positive).
Two of the 8 in vitro tests were positive, but
results of the following 3 in vivo test systems gave negative results:
- Rat Hepatocyte DNA Repair Assay
- Micronucleus Test (Mice)
- Dominant Lethal Test (Mice).
Fertility studies performed in rats at oral doses of
ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment. This
would be over 100 times the maximum recommended clinical dose of ototopical
ciprofloxacin based upon body surface area, assuming total absorption of
ciprofloxacin from the ear of a patient treated with CETRAXAL (ciprofloxacin otic solution) twice per day.
Use In Specific Populations
Pregnancy Category C.
Reproduction studies have been performed in rats and mice
using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg
and have revealed no evidence of harm to the fetus as a result of
ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced
gastrointestinal disturbances resulting in maternal weight loss and an increased
incidence of abortion, but no teratogenicity was observed at either dose. After
intravenous administration of doses up to 20 mg/kg, no maternal toxicity was
produced in the rabbit, and no embryotoxicity or teratogenicity was observed.
Animal reproduction studies have not been conducted with
CETRAXAL (ciprofloxacin otic solution) . No adequate and well-controlled studies have been performed in
pregnant women. Caution should be exercised when CETRAXAL (ciprofloxacin otic solution) is used by a pregnant
Ciprofloxacin is excreted in human milk with systemic use.
It is not known whether ciprofloxacin is excreted in human milk following otic
use. Because of the potential for serious adverse reactions 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.
The safety and effectiveness of CETRAXAL (ciprofloxacin otic solution) in infants below one year of age have
not been established. The efficacy of CETRAXAL (ciprofloxacin otic solution) in treating otitis externa in
pediatric patients one year or older has been demonstrated in controlled clinical
trials (seeÂ Â Clinical Studies).
There is no evidence that the otic administration of
quinolones has any effect on weight bearing joints, even though systemic
administration of some quinolones has been shown to cause arthropathy in
No overall differences in safety and effectiveness have been
observed between elderly and younger patients.