Ciprofloxacin ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Ciloxan

Medically reviewed by Drugs.com. Last updated on Apr 30, 2024.

Ciprofloxacin ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; according to some experts, it is preferable to avoid use during pregnancy (as a precaution).

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity. In rabbits, gastrointestinal toxicity was observed with oral doses and resulted in maternal weight loss and increased incidence of abortion (but no teratogenicity); no maternal toxicity (and no embryotoxicity or teratogenicity) observed with IV doses. There are no controlled data in human pregnancy.

Systemic ciprofloxacin distributes into amniotic fluid. Levels reported were 57% (at 2 to 4 hours postdose) to 1000% (at 10 to 12 hours postdose) of that found in maternal serum. Cartilage damage and arthropathy have been reported in immature animals of various species giving rise to concern over 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).

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Ciprofloxacin ophthalmic Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Maternal use of an ophthalmic drop containing this drug poses negligible risk for a nursing infant.
-Placing pressure over the tear duct by the corner of the eye for at least 1 minute then removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches the breast milk after using eye drops.

Oral ciprofloxacin is excreted in human breast milk. Limited data indicate that systemic absorption after ophthalmic administration is extremely low (between 2.5 and 5 ng/mL).

Traditionally, systemic fluoroquinolones have not been used in infants due to concern over toxic effects on their developing joints; however, some studies suggest risk is low. Absorption of the small amounts of fluoroquinolones in milk may be blocked by the calcium in milk; data insufficient to prove or disprove.

See references

Further information

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