Animal studies have failed to reveal evidence of teratogenicity at oral doses up to 50 mg/kg/day or when dosed IV at 25 mg/kg/day (about 250 to 2250 and 120 to 1000 times the systemic exposure of the maximum recommended human ophthalmic dose, respectively). Oral doses of 810 mg/kg/day in rats showed decreased fetal body weight and increased mortality. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

See references

Caution is recommended; benefit should outweigh risk.

Excreted into human milk: Yes

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

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