Ciprofloxacin otic Pregnancy and Breastfeeding Warnings

Ciprofloxacin otic is also known as: Cetraxal

Ciprofloxacin otic Pregnancy Warnings

Ciprofloxacin otic has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal embryotoxicity or teratogenicity, although maternal toxicity in some animal studies resulted in increased incidence of abortion. There are no controlled data in human pregnancy. Systemic ciprofloxacin has been shown to distribute into amniotic fluid. Concentrations reported were 57% (at 2 to 4 hours post dose) to 1000% (at 10 to 12 hours post dose) of that found in maternal serum. Cartilage damage and arthropathies associated with ciprofloxacin have been reported in immature animals of various species, giving rise to concern over its possible toxic effects on human fetal bone formation. Ciprofloxacin otic is only recommended for use during pregnancy when benefit outweighs risk.

Ciprofloxacin otic Breastfeeding Warnings

There are no data on the excretion of ciprofloxacin otic into human milk. Concentrations of orally administered ciprofloxacin found in breast milk have ranged from 85% (at 24 hours post dose) to 214% (at 4 hours post dose) of maternal serum concentration. In one case report, an infant developed perforated pseudomembranous colitis following ingestion of ciprofloxacin via the mother's milk. In addition, quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. However, limited data indicate that systemic absorption after otic administration is extremely low. Plasma levels of ciprofloxacin and hydrocortisone are expected to be below the level of quantitation after administration of 3 drops of suspension into the ear. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue the drug or to discontinue nursing, taking into account the importance of the drug to the mother.

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