Last update: May 11, 2019

Norfloxacin

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 every 12 hours.

It is excreted in breast milk in a negligible or negligible amount: one mother took 200 mg (1/4 of the usual daily dose) and the detection in milk was less than 0.05 mg / L (Takase 1981 cited in AEMPS 2018, Merck 2013 , Dan 1993 and Wise 1984).

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). 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).

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, Arbex 2010).

----------------------
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, so ophthalmic use would be compatible with breastfeeding.

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.

Other names

Norfloxacin is also known as


Norfloxacin in other languages or writings:

Groups

Norfloxacin belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Norfloxacin in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 30 - 40 %
Molecular weight 319 daltons
Protein Binding 15 %
Tmax 1 - 2 hours
T1/2 3 - 4 hours
Theoretical Dose < 0,0075 mg/Kg/d
Relative Dose < 0,22 %

References

  1. AEMPS-Stada. Norfloxacino Ficha técnica 2018 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. 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)
  4. 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
  5. FDA. La FDA actualiza las advertencias para los antibióticos conocidos como fluoroquinolonas. Comunicado de Prensa. 2016 Full text (link to original source)
  6. FDA. FDA updates warnings for fluoroquinolone antibiotics. News Release. 2016 Full text (link to original source) Full text (in our servers)
  7. 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
  8. Merck. Norfloxacin. Drug Summary. 2013 Full text (in our servers)
  9. 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
  10. Belet N, Haciömeroğlu P, Küçüködük S. Ciprofloxacin treatment in newborns with multi-drug-resistant nosocomial Pseudomonas infections. Biol Neonate. 2004 Abstract
  11. 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
  12. 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
  13. 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
  14. 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
  15. Dan M, Weidekamm E, Sagiv R, Portmann R, Zakut H. Penetration of fleroxacin into breast milk and pharmacokinetics in lactating women. Antimicrob Agents Chemother. 1993 Abstract Full text (link to original source) Full text (in our servers)
  16. Fleiss PM. The effect of maternal medications on breastfeeding infants. J Hum Lact. 1992 Abstract
  17. Neuvonen PJ, Kivistö KT, Lehto P. Interference of dairy products with the absorption of ciprofloxacin. Clin Pharmacol Ther. 1991 Abstract
  18. Wise R. Norfloxacin--a review of pharmacology and tissue penetration. J Antimicrob Chemother. 1984 Abstract
  19. Takase Z, Shirafuji H, Uchida M. Basic and clinical studies on AM-715 in the field of obstetrics and gynecology. Chemotherapy (Tokyo). 1981;29 (Suppl 4):697-704. Chemotherapy (Tokyo). 1981

Total visits

55,064

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write to us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Confederación Nacional de Pediatría (CONAPEME) from Mexico

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM