Last update: May 11, 2019

Πεφλοξασίνη

Low Risk for breastfeeding


Moderately safe. Probably compatible.
Mild risk possible. Follow up recommended.
Read the Comment.

Fluoroquinolone antibacterial with actions and uses similar to those of ciprofloxacin.
Oral or intravenous administration twice daily.

It is excreted in small amount into breast milk (Giamarellou 1989).

Structurally similar Quinolone-related medication has been used in neonates and infants without known side effects (Newby 2017, Dutta 2006, Belet 2004, Drossou 2004, van den Oever 1998, Gürpinar 1997). There are excreted tiny amounts into breast milk and absorption through the child’s gut may be interfered by calcium in the milk (Fleiss 1992, Neuvonen 1991).

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives with a safer pharmacokinetic profile for breastfeeding may be preferable, especially in the neonatal period and in case of prematurity.

Should it be prescribed to a nursing mother Norfloxacine, Ofloxacine and Ciprofloxacine are to be chosen since they have shown a lowest excretion into the milk (Butler 2014).

The possible negativity of cultures in febrile infants whose mothers take antibiotics should be taken into account.

Unreasonably prolonged or repetitive use of antibiotics is harmful to health.
Due to the publication of reports of serious or potentially serious side effects in patients treated with fluoroquinolones, several health authorities propose restricting their indiscriminate outpatient use and reserving them for certain serious diseases (EMA 2018, FDA 2016).

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

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Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 333 daltons
Protein Binding 20 - 30 %
VD 1 - 2,6 l/Kg
pKa 6, -
Tmax 1,2 - 2,2 hours
T1/2 6,2 - 13,8 hours
M/P ratio 1 -
Theoretical Dose 0,13 - 0,53 mg/Kg/d
Relative Dose 1,98 - 7,97 %

References

  1. EMA. Resumen de la audiencia pública de la EMA sobre antibióticos quinolonas y fluoroquinolonas. 2018 Full text (link to original source) Full text (in our servers)
  2. EMA-PRAC. Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use. Pharmacovigilance Risk Assessment Committee. 2018 Full text (link to original source) Full text (in our servers)
  3. Newby BD, Timberlake KE, Lepp LM, Mihic T, Dersch-Mills DA. Levofloxacin Use in the Neonate: A Case Series. J Pediatr Pharmacol Ther. 2017 Abstract
  4. FDA. FDA updates warnings for fluoroquinolone antibiotics. News Release. 2016 Full text (link to original source) Full text (in our servers)
  5. FDA. La FDA actualiza las advertencias para los antibióticos conocidos como fluoroquinolonas. Comunicado de Prensa. 2016 Full text (link to original source)
  6. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  7. Dutta S, Chowdhary G, Kumar P, Mukhopadhay K, Narang A. Ciprofloxacin administration to very low birth weight babies has no effect on linear growth in infancy. J Trop Pediatr. 2006 Abstract
  8. Drossou-Agakidou V, Roilides E, Papakyriakidou-Koliouska P, Agakidis C, Nikolaides N, Sarafidis K, Kremenopoulos G. Use of ciprofloxacin in neonatal sepsis: lack of adverse effects up to one year. Pediatr Infect Dis J. 2004 Abstract
  9. Belet N, Haciömeroğlu P, Küçüködük S. Ciprofloxacin treatment in newborns with multi-drug-resistant nosocomial Pseudomonas infections. Biol Neonate. 2004 Abstract
  10. van den Oever HL, Versteegh FG, Thewessen EA, van den Anker JN, Mouton JW, Neijens HJ. Ciprofloxacin in preterm neonates: case report and review of the literature. Eur J Pediatr. 1998 Abstract
  11. Gürpinar AN, Balkan E, Kiliç N, Kiriştioğlu I, Doğruyol H. The effects of a fluoroquinolone on the growth and development of infants. J Int Med Res. 1997 Abstract
  12. Bressolle F, Gonçalves F, Gouby A, Galtier M. Pefloxacin clinical pharmacokinetics. Clin Pharmacokinet. 1994 Abstract
  13. Fleiss PM. The effect of maternal medications on breastfeeding infants. J Hum Lact. 1992 Abstract
  14. Neuvonen PJ, Kivistö KT, Lehto P. Interference of dairy products with the absorption of ciprofloxacin. Clin Pharmacol Ther. 1991 Abstract
  15. Giamarellou H, Kolokythas E, Petrikkos G, Gazis J, Aravantinos D, Sfikakis P. Pharmacokinetics of three newer quinolones in pregnant and lactating women. Am J Med. 1989 Abstract

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