WARNINGS AND PRECAUTIONS
Otic Use Only
CETRAXAL is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use.
CETRAXAL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
Growth of Resistant Organisms with Prolonged Use
As with other anti-infectives, use of CETRAXAL may result in overgrowth of nonsusceptible 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.
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. No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when CETRAXAL is used by a pregnant woman.
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 in infants below one year of age have not been established. The efficacy of CETRAXAL in treating otitis externa in pediatric patients one year or older has been demonstrated in controlled clinical trials (see Section 14 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 immature animals.
No overall differences in safety and effectiveness have been observed between elderly and younger patients.