Ofloxacin

Drug Levels and Effects:




Summary of Use during Lactation:


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] Thecalciumin milk might prevent absorption of the small amounts of fluoroquinolones in milk.[3] Insufficient data exist to prove or disprove this assertion. Developmental problems have been reported in two infants exposed to ofloxacin in breastmilk, their mothers were also exposed to several drugs during pregnancy and during breastfeeding, so the problems cannot necessarily be attributed to ofloxacin. Short-term use of ofloxacin is acceptable in nursing mothers. Avoiding breastfeeding for 4 to 6 hours after a dose should decrease the exposure of the infant to ofloxacin in breastmilk.

Maternal use of an ear drop or eye drop that contains ofloxacin presents negligible risk for the nursing infant. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.


Drug Levels:


Maternal Levels

Ten lactating women (time postpartum not stated) were given ofloxacin 400 mg orally every 12 hours for 3 doses. Milk ofloxacin was measured after the third dose. The highest levels averaging 2.41 mg/L occurred 2 hours after the dose. Average milk levels then fell as follows: 1.91 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.[4] Using the peak milk level data from this study, an exclusively breastfed infant would receive an estimated maximum of 0.36 mg/kg daily with this maternal dosage regimen.

Infant Levels

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


Effects in Breastfed Infants:


Ofloxacin was used as part of multidrug regimens to treat two pregnant women with multidrug-resistant tuberculosis, one throughout pregnancy and postpartum and the other postpartum only. The infants were breastfed (extent and duration not stated). At age 4.6 and 5.1 years, the children were developing normally except for a mild speech delay in one and hyperactivity in the other.[5]


Possible Effects on Lactation:


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


Alternate Drugs to Consider:


Ciprofloxacin,Levofloxacin,Norfloxacin


References:


1. Gurpinar AN, Balkan E, Kilic N et al. The effects of a fluoroquinolone on the growth and development of infants. J Int Med Res. 1997;25:302-6. PMID: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. PMID:9809826
3. Fleiss PM. The effect of maternal medications on breast-feeding infants. J Hum Lact. 1992;8:7. Letter. PMID:1558663
4. Giamarellou H, Kolokythas E, Petrikkos G et al. Pharmacokinetics of three newer quinolones in pregnant and lactating women. Am J Med. 1989;87(suppl 5A):49S-51S. PMID:2589384
5. Drobac PC, del Castillo H, Sweetland A J et al. Treatment of multidrug-resistant tuberculosis during pregnancy: long-term follow-up of 6 children with intrauterine exposure to second-line agents. Clin Infect Dis. 2005;40:1689-92. PMID:15889370



Substance Identification:




Substance Name:

Ofloxacin

CAS Registry Number:

82419-36-1

Drug Class:


  • Antiinfective Agents

  • Antibacterial Agents

  • Quinolones

  • Fluoroquinolones


  • Administrative Information:




    LactMed Record Number:


    204


    Last Revision Date:


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