Last update Nov. 20, 2020

Garenoxacin Mesylate

Limited compatibility

Unsafe. Moderate/severe adverse effects. Compatible under certain circumstances. Follow-up recommended. Use safer alternative or discontinue breastfeeding from 5 to 7 T ½ . Read Commentary.

Fluoroquinolone antibacterial with actions and uses similar to those of ciprofloxacin.
Oral administration once daily.

It is excreted in small amount into breast milk (Amsden 2004).

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 possibility of transient gastroenteritis due to alteration of the intestinal flora in infants whose mothers take antibiotics should be taken into account (Briggs 2017, Ito 1993).

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).

The manufacturer has withdrawn it from the market due to its potentially serious side effects (EMA 2007).

Alternatives

  • Ciprofloxacin (Safe substance and/or breastfeeding is the best option.)
  • Norfloxacin (Safe substance and/or breastfeeding is the best option.)
  • Ofloxacin (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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Other names

Garenoxacin Mesylate in other languages or writings:

Group

Garenoxacin Mesylate belongs to this group or family:

Tradenames

Main tradenames from several countries containing Garenoxacin Mesylate in its composition:

Pharmacokinetics

Variable Value Unit
Protein Binding 75 %
pKa 6.05 -
Tmax 1.1 - 2.5 hours
T½ 13.3 - 17.8 hours
M/P ratio 0.35 - 0.44 -
Theoretical Dose 0.45 mg/Kg/d
Relative Dose 5.1 %

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. 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. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  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. EMA. Questions and answers on the withdrawal of the marketing application for Garenoxacin mesylate. 2007 Full text (link to original source) 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. 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
  11. Belet N, Haciömeroğlu P, Küçüködük S. Ciprofloxacin treatment in newborns with multi-drug-resistant nosocomial Pseudomonas infections. Biol Neonate. 2004 Abstract
  12. Amsden GW, Nicolau DP, Whitaker AM, Maglio D, Bello A, Russo R, Barros A Jr, Gajjar DA. Characterization of the penetration of garenoxacin into the breast milk of lactating women. J Clin Pharmacol. 2004 Abstract
  13. Gajjar DA, Bello A, Ge Z, Christopher L, Grasela DM. Multiple-dose safety and pharmacokinetics of oral garenoxacin in healthy subjects. Antimicrob Agents Chemother. 2003 Abstract
  14. 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
  15. 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
  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

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