Ofloxacin ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Ocuflox

Medically reviewed by Drugs.com. Last updated on Apr 8, 2024.

Ofloxacin ophthalmic Pregnancy Warnings

AU, UK: Use is not recommended.
US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Animal studies have failed to reveal evidence of teratogenicity after oral doses up to 810 mg/kg/day (about 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (about 1800 times the maximum recommended daily ophthalmic dose) in pregnant rats and rabbits, respectively. Increased fetal mortality and decreased fetal weight observed with doses of 810 mg/kg/day in rats and 160 mg/kg/day in rabbits; minor fetal skeletal defects observed in rats administered 810 mg/kg/day. There are no controlled data in human pregnancy.

Cartilage damage and arthropathy reported in immature animals with systemic quinolones have given rise to concern over effects on bone formation in the developing fetus; some experts recommend not using this drug in pregnant women.

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.

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Ofloxacin ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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.

Systemically administered ofloxacin is excreted into breast milk at levels similar to those in plasma.

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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