Summary of Use during Lactation

No information is available on the clinical use of gemifloxacin during breastfeeding; however, amounts in breastmilk appear to be low. Fluoroquinolones have traditionally not been used in infants because of concern about adverse effects on the infants' developing joints. However, recent studies indicate little risk.[1,2] The calcium in milk might prevent absorption of the small amounts of fluoroquinolones in milk,[3] but insufficient data exist to prove or disprove this assertion. Use of gemifloxacin is acceptable in nursing mothers. However, it is preferable to use an alternate drug for which safety information is available.

Drug Levels

Maternal Levels. A nursing mother took one tablet of gemifloxacin 320 mg orally. A single breastmilk sample obtained 3 hours after the dose contained approximately 0.9 mg/L.[4]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Ciprofloxacin, Levofloxacin

References

1.

Gürpinar AN, Balkan E, Kiliç N, et al. The effects of a fluoroquinolone on the growth and development of infants. J Int Med Res. 1997;25:302–6. [PubMed: 9364293]

2.

van den Oever HL, Versteegh FG, Thewessen EA, et al. Ciprofloxacin in preterm neonates: Case report and review of the literature. Eur J Pediatr. 1998;157:843–5. [PubMed: 9809826]

3.

Fleiss PM. The effect of maternal medications on breast-feeding infants. J Hum Lact 1992;8:7. Letter. PMID: 1558663. [PubMed: 1558663]

4.

Sagirli O, Demirci S, Onal A. A very simple high-performance liquid chromatographic method with fluorescence detection for the determination of gemifloxacin in human breast milk. Luminescence. 2015;30:1326–9. [PubMed: 25808579]

Substance Name

Gemifloxacin

CAS Registry Number

175463-14-6

Drug Class

Breast Feeding

Lactation

Fluoroquinolones

Quinolones