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Ciprofloxacin ophthalmic Pregnancy and Breastfeeding Warnings

Ciprofloxacin ophthalmic is also known as: Ciloxan

Ciprofloxacin ophthalmic Pregnancy Warnings

Ciprofloxacin ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies 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. Limited data indicate that systemic absorption after ophthalmic administration is extremely low (between 2.5 and 5 ng/mL). Ciprofloxacin ophthalmic should only be given during pregnancy when benefit outweighs risk.

Ciprofloxacin ophthalmic Breastfeeding Warnings

There are no data on the excretion of ciprofloxacin ophthalmic into breast milk. Oral ciprofloxacin is excreted in milk. 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. Limited data indicate that systemic absorption after ophthalmic administration is extremely low (between 2.5 and 5 ng/mL). The manufacturer recommends that caution be used when administering ciprofloxacin ophthalmic to nursing women.

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