Last update: May 4, 2019

Dipotassium Clorazepate

Low Risk for breastfeeding


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

Long-acting benzodiazepine.

Most of the clorazepate is metabolized to N-desmethyldiazepam (nordiazepam) which is the active metabolite of diazepam.

It is excreted in breast milk in clinically insignificant amounts (Rey 1979).

Sedation has been observed in infants whose mothers were taking diazepam (Wesson 1985).

Due to the lack of publications on this subject, until more information is known about this drug in relation to breastfeeding, safer known alternatives are preferred, especially in the neonatal period and in case of prematurity (McElhatton 1994).

The occasional use and low doses of benzodiazepines are compatible with breastfeeding (Kelly 2012, Rubin 2004, Iqbal 2002, Hägg 2000, McElhatton 1994, Lee 1993, Kanto 1982).

It is advisable to choose a short-acting benzodiazepine and minimal effective dose as possible (Rowe 2013), mostly in neonatal period.

Follow-up for sedation and feeding ability of the infant.

It is not recommended to share a bed (co-sleeping, bed-sharing) with the baby if this drug is being taken, due to increased risk of asphyxia or sudden infant death (UNICEF UK 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF UK 2006).

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.

Group

Dipotassium Clorazepate belongs to this group or family:

Tradenames

Main tradenames from several countries containing Dipotassium Clorazepate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 97 %
Molecular weight 409 daltons
Protein Binding 98 %
Tmax 1 hours
T1/2 40 - 60 hours
Theoretical Dose 0,001 - 0,002 mg/Kg/d
Relative Dose 0,2 - 2,4 %
Ped.Relat.Dose 0,2 %

References

  1. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  2. 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)
  3. 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)
  4. 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)
  5. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  6. 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. 2013 Full text (link to original source) Full text (in our servers)
  7. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012 Sep;161(3):448-51. Abstract
  8. 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)
  9. Normon. Clorazepato Ficha técnica. 2011 Full text (in our servers)
  10. Abbott. Clorazepate. Drug Summary. 2009 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. 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)
  13. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  14. Rubin ET, Lee A, Ito S. When breastfeeding mothers need CNS-acting drugs. Can J Clin Pharmacol. 2004 Fall;11(2):e257-66. Epub 2004 Dec 8. Abstract
  15. Iqbal MM, Sobhan T, Ryals T. Effects of commonly used benzodiazepines on the fetus, the neonate, and the nursing infant. Psychiatr Serv. 2002 Jan;53(1):39-49. Review. Abstract Full text (in our servers)
  16. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  17. McElhatton PR. The effects of benzodiazepine use during pregnancy and lactation. Reprod Toxicol. 1994 Nov-Dec;8(6):461-75. Review. Abstract
  18. Lee JJ, Rubin AP. Breast feeding and anaesthesia. Anaesthesia. 1993 Jul;48(7):616-25. Review. Abstract Full text (link to original source) Full text (in our servers)
  19. Wesson DR, Camber S, Harkey M, Smith DE. Diazepam and desmethyldiazepam in breast milk. J Psychoactive Drugs. 1985 Jan-Mar;17(1):55-6. No abstract available. Abstract
  20. Kanto JH. Use of benzodiazepines during pregnancy, labour and lactation, with particular reference to pharmacokinetic considerations. Drugs. 1982 May;23(5):354-80. Review. Abstract
  21. Rey E, Giraux P, d'Athis P, Turquais JM, Chavinie J, Olive G. Pharmacokinetics of the placental transfer and distribution of clorazepate and its metabolite nordiazepam in the feto-placental unit and in the neonate. Eur J Clin Pharmacol. 1979 Apr 17;15(3):181-5. Abstract

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