Last update: May 11, 2019

Ofloxacin

Very Low Risk for breastfeeding


Safe. Compatible.
Not risky for breastfeeding or infant.

Fluoroquinolone with bactericidal effect by inhibition of bacterial DNA synthesis.
Oral or intravenous administration twice a day.

Both ofloxacin and its isomer, levofloxacin, are excreted in tiny amounts into breast milk (Cahill 2005, Zhang 1997, Giamarellou 1989).
No problems attributable to ofloxacin have been observed in infants whose mothers took it (Drobac 2005).

Structurally similar Quinolone-related medication has been used in neonates and infants without known side effects (Newby 2017, Dutta 2006, Belet 2004, Drossou 2004, Chin 2001, van den Oever 1998, Gürpinar 1997). It is excreted in tiny amounts into breast milk and absorption through the child’s gut may be interfered by calcium in the milk (Fleiss 1992, Neuvonen 1991).

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,

Various medical societies and expert consensus consider the use of this medication safe during breastfeeding (Briggs 2017, Hale 2017 p721, Nahum 2006).
American Academy of Pediatrics: medication usually compatible with breastfeeding (AAP 2001).

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, Arbex 2010).

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OPHTHALMIC USE:
The small dose and poor plasma uptake of most topical ophthalmologic preparations make it very unlikely that significant amounts will pass into breast milk.


See below the information of this related product:

Alternatives

We do not have alternatives for Ofloxacin since it is relatively safe.

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.

Groups

Ofloxacin belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Ofloxacin in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 98 %
Molecular weight 361 daltons
Protein Binding 32 %
VD 1,4 l/Kg
pKa 6,2 -
Tmax 0,5 - 2 hours
T1/2 5 - 7 hours
M/P ratio 1- 1,7 -
Theoretical Dose 0,0075 - 0,36 mg/Kg/d
Relative Dose 0,05 - 2,7 %

References

  1. 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)
  2. 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)
  3. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  4. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. 11th edition (acces on line) 2017
  5. 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
  6. FDA. La FDA actualiza las advertencias para los antibióticos conocidos como fluoroquinolonas. Comunicado de Prensa. 2016 Full text (link to original source)
  7. FDA. FDA updates warnings for fluoroquinolone antibiotics. News Release. 2016 Full text (link to original source) Full text (in our servers)
  8. 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
  9. Arbex MA, Varella Mde C, Siqueira HR, Mello FA. Antituberculosis drugs: drug interactions, adverse effects, and use in special situations. Part 2: second line drugs. J Bras Pneumol. 2010 Abstract Full text (link to original source) Full text (in our servers)
  10. Nahum GG, Uhl K, Kennedy DL. Antibiotic use in pregnancy and lactation: what is and is not known about teratogenic and toxic risks. Obstet Gynecol. 2006 Abstract
  11. 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
  12. Drobac PC, del Castillo H, Sweetland A, Anca G, Joseph JK, Furin J, Shin S. 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 Jun 1;40(11):1689-92. Epub 2005 Apr 18. Abstract Full text (link to original source) Full text (in our servers)
  13. Cahill JB Jr, Bailey EM, Chien S, Johnson GM. Levofloxacin secretion in breast milk: a case report. Pharmacotherapy. 2005 Abstract
  14. Belet N, Haciömeroğlu P, Küçüködük S. Ciprofloxacin treatment in newborns with multi-drug-resistant nosocomial Pseudomonas infections. Biol Neonate. 2004 Abstract
  15. 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
  16. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  17. Chin KG, McPherson CE 3rd, Hoffman M, Kuchta A, Mactal-Haaf C. Use of anti-infective agents during lactation: Part 2--Aminoglycosides, macrolides, quinolones, sulfonamides, trimethoprim, tetracyclines, chloramphenicol, clindamycin, and metronidazole. J Hum Lact. 2001 Feb;17(1):54-65. Abstract
  18. 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
  19. 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
  20. Zhang Y, Zhang Q, Xu Z. [Tissue and body fluid distribution of antibacterial agents in pregnant and lactating women]. Zhonghua Fu Chan Ke Za Zhi. 1997 Abstract
  21. Fleiss PM. The effect of maternal medications on breastfeeding infants. J Hum Lact. 1992 Abstract
  22. Neuvonen PJ, Kivistö KT, Lehto P. Interference of dairy products with the absorption of ciprofloxacin. Clin Pharmacol Ther. 1991 Abstract
  23. 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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