Last update Jan. 19, 2021

Ethyl Loflazepate

Low Risk

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

Derived from long-acting benzodiazepines with properties similar to diazepam. Indicated in the short-term treatment of anxiety disorders.
Oral administration once or twice a day.

It is excreted in human milk in a small amount, but it could be clinically significant: RD 6 -12% (Nishimura 2021).
No problems have been observed in infants whose mothers have taken it (Nishimura 2021).

It has very few bibliographical references and is marketed in few countries.

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives are preferable.

It is advisable to choose short-acting benzodiazepines and use the minimum effective dose (Rowe 2013), especially during the neonatal period and in cases of prematurity because they can accumulate in the infant during chronic use (Sachs 2013).

It is advisable to monitor drowsiness and the adequate feeding of the infant.
It is not recommended to share a bed with the baby if this medication is being taken due to an increased risk of suffocation or sudden infant death (UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006).

Alternatives

  • Brotizolam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Lorazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Midazolam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Oxazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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.

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

Ethyl Loflazepate in other languages or writings:

Group

Ethyl Loflazepate belongs to this group or family:

Tradenames

Main tradenames from several countries containing Ethyl Loflazepate in its composition:

Pharmacokinetics

Variable Value Unit
Molecular weight 361 daltons
pKa 9.51 -
Tmax 1.5 - 3 hours
77 (51 - 103) hours
M/P ratio 0.1 -
Theoretical Dose 0.001 - 0.002 mg/Kg/d
Relative Dose 6 - 12 %

References

  1. Nishimura A, Furugen A, Umazume T, Kitamura S, Soma M, Noshiro K, Takekuma Y, Sugawara M, Iseki K, Kobayashi M. Benzodiazepine Concentrations in the Breast milk and Plasma of Nursing Mothers: Estimation of Relative Infant Dose. Breastfeed Med. 2021 Jan 15. Abstract
  2. (ABM): Blair PS, Ball HL, McKenna JJ, Feldman-Winter L, Marinelli KA, Bartick MC; Academy of Breastfeeding Medicine.. Bedsharing and Breastfeeding: The Academy of Breastfeeding Medicine Protocol #6, Revision 2019. Breastfeed Med. 2020 Jan;15(1):5-16. Abstract Full text (link to original source) Full text (in our servers)
  3. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  4. UNICEF. Ball H, Blair PS. (For UNICEF UK). Caring for your baby at night. Health professional´s guide. 2017 Full text (link to original source) Full text (in our servers)
  5. UNICEF UK. Statement on co-sleeping following publication of new NICE postnatal guidance. Infosheet. 2014 Full text (link to original source) Full text (in our servers)
  6. Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. Abstract Full text (link to original source) Full text (in our servers)
  7. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  8. UNICEF UK Baby Friendly Initiative statement on Bed-sharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case-control studies. None 2013 Full text (link to original source) Full text (in our servers)
  9. L.Landa Rivera, M.Díaz-Gómez, A.Gómez Papi, J.M.Paricio Talayero, C.Pallás Alonso, M.T.Hernández Aguilar, J.Aguayo Maldonado, J.M.Arena Ansotegui, S.Ares Segura, A.Jiménez Moya, J.J.Lasarte Velillas, J.Martín Calama, M.D.Romero Escós. El colecho favorece la práctica de la lactancia materna y no aumenta el riesgo de muerte súbita del lactante. Dormir con los padres. Rev Pediatr Aten Primaria. 14:53-60 2012 Full text (link to original source) Full text (in our servers)
  10. ABM - The Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #6: Guideline on Co-Sleeping and Breastfeeding. Breastfeeding Medicine 2008 Abstract Full text (link to original source) Full text (in our servers)
  11. ABM - Comité de protocolos de la Academia médica de lactancia materna (Academy of Breastfeeding Medicine). Protocolo Clínico de la ABM #6: Lineamientos sobre la práctica de dormir al bebé junto con la madre y la lactancia materna Revisión, marzo de 2008. Breastfeeding Medicine 2008 Full text (link to original source) Full text (in our servers)
  12. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  13. Cautreels W, Jeanniot JP. Quantitative analysis of CM 6912 (ethyl loflazepate) and its metabolites in plasma and urine by chemical ionization gas chromatography mass spectrometry. Application to pharmacokinetic studies in man. Biomed Mass Spectrom. 1980 Abstract

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