This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities, use is contraindicated.

US FDA pregnancy category:
-IV injection and oral solution: C
-Tablets: Not assigned.

Risk summary: Published data from case reports, case control studies, and observational studies on use of this drug during pregnancy have not identified any drug-related risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes.

Animal studies have failed to reveal evidence of teratogenicity but have revealed evidence of fetotoxicity and maternal toxicity. This drug was not teratogenic in rats treated during organogenesis with oral doses up to 810 mg/kg/day (9.4 times the maximum recommended human dose [MRHD] based on doses normalized for total body surface area [BSA]); decreased fetal body weight and increased fetal mortality were observed at 810 mg/kg/day, but not at the next lower dose of 90 mg/kg/day (1.2 times the MRHD based on doses normalized for total BSA), while maternal toxicity was limited to lower weight gain at both doses. No teratogenicity was seen in rabbits treated during organogenesis with oral doses up to 50 mg/kg/day (1.1 times the MRHD based on doses normalized for total BSA); maternal toxicity at that dose consisted of lower weight gain and decreased food intake compared to controls and abortion in 4 of 16 dams. There are no controlled data in human pregnancy.

Of 549 cases reported by the European Network of Teratology Information Services involving exposure to other fluoroquinolones, congenital malformations were reported in 4.8%; however, this was not higher than the background rate.

This drug has been recommended by the US CDC as an alternative agent for postexposure prophylaxis and treatment of anthrax in pregnant women. The Working Group on Civilian Biodefense has recommended this drug as an alternative for plague. The risk of drug use during pregnancy is outweighed by the high fatality rates from these infections.

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. Because safer alternatives are generally available, some experts consider fluoroquinolones contraindicated during pregnancy, especially during the first trimester.

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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

LactMed: Use is considered acceptable with monitoring of the infant for possible effects on the gastrointestinal flora (e.g., diarrhea or candidiasis [thrush, diaper rash]); avoiding breastfeeding between 4 to 6 hours after maternal dosing should decrease the infant's exposure to this drug in breast milk.
-According to some experts: Use is considered acceptable; may cause diarrhea in infant
-According to some authorities: Use is contraindicated.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-This drug is the L-isomer (S-enantiomer) of ofloxacin, which is excreted into human milk.
-No data available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown.
-Due to the potential risk of serious side effects in the nursing infant, lactating women may consider pumping and discarding breast milk during therapy and for 2 days after the last dose; alternatively, lactating women should be advised not to breastfeed during therapy and for 2 days after the last dose.

According to some experts, amounts of this drug in breast milk appear to be low and would not be expected to cause any harmful effects in nursing infants.

Cartilage erosion and arthropathy have been observed in immature animals giving rise to concern over toxic effects in the developing joints of nursing infants; 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.

Postpartum (time not specified), 10 lactating women received ofloxacin (the racemic mixture) 400 mg orally every 12 hours for 3 doses. At 2 hours after the third dose, milk ofloxacin levels were highest and averaged 2.4 mg/L. Milk levels then declined and averaged 1.9 mg/L at 4 hours, 1.25 mg/L at 6 hours, 0.64 mg/L at 9 hours, 0.29 mg/L at 12 hours, and 0.05 mg/L at 24 hours after the dose. Based on peak milk levels in this study, an exclusively breastfed infant would receive up to 0.36 mg/kg daily (estimated) with this maternal dose regimen.

A woman received levofloxacin 500 mg once a day (IV for 9 days, then orally for 17 days); 26 breast milk samples were collected, starting on day 10 of therapy and continuing for 6 days after therapy was stopped. Using a pharmacokinetic model, a peak milk level of 8.2 mg/L at 5 hours after dosing was predicted. Milk levels declined with a half-life of 7 hours (estimated); at 65 hours after the dose, traces of this drug were still detectable in breast milk. According to author calculation, a fully breastfed infant of a mother taking 500 mg/day would receive 1.25 mg/day in breast milk, which is much lower than the dose used to treat children.

This drug has been recommended by the US CDC as an alternative agent for postexposure prophylaxis and treatment of anthrax in lactating women. The Working Group on Civilian Biodefense has recommended this drug as an alternative for plague.

See references