Last update: May 21, 2017

Clemastine Fumarate

Low Risk for breastfeeding


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

1st generation antihistamine, ethanolamine, with moderate sedative and marked antimuscarinic effects. The latter could decrease prolactin production, which is important for milk production especially in the first few weeks.

Their pharmacokinetic data (high volume of distribution and high percentage of plasma protein binding) explain the negligible excretion observed in milk (Kok 1982).

However, there is a published case of a 10-week-old infant who showed signs of lethargy, irritability and rejection of feeding, although the mother took phenytoin and carbamazepine in addition to clemastine. No levels of clemastine were detected in the girl's plasma, who recovered well and continued to breastfeed (Kok 1982).

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives may be preferable, especially during the neonatal period and in case of prematurity. Lethargy and adequate feeding of the infant should be monitored.

Co-sleeping with the baby is not recommended if this drug is being taken (UNICEF 2013, Landa 2012, ABM 2008, UNICEF 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.

Other names

Clemastine Fumarate is also known as


Clemastine Fumarate in other languages or writings:

Group

Clemastine Fumarate belongs to this group or family:

Tradenames

Main tradenames from several countries containing Clemastine Fumarate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 460 daltons
Protein Binding 95 %
VD 11,4 l/Kg
Tmax 5 hours
T1/2 10 - 12 hours
M/P ratio 0,25 - 0,5 -
Theoretical Dose 0,0015 mg/Kg/d
Relative Dose 1,1 - 3,4 %

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. 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)
  5. 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)
  6. 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)
  7. 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)
  8. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  9. Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000 Nov;16(4):319-31. Review. Erratum in: J Hum Lact 2001 Feb;17(1):90. Abstract
  10. Ghaeli P, Kaufman MB. Oral antihistamines/decongestants and breastfeeding. J Hum Lact. 1993 Abstract
  11. Kok TH, Taitz LS, Bennett MJ, Holt DW. Drowsiness due to clemastine transmitted in breast milk. Lancet. 1982 Abstract

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