Is Clemastine Fumarate compatible with breastfeeding? Do we have alternatives for Clemastine Fumarate?

Clemastine Fumarate

May 21, 2017 (Low Risk)

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

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

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

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Synonyms

  • Clemastine
  • Meclastine Fumarate
  • Mecloprodine Fumarate

Writings

  • Κλεμαστίνη Όξινη Φουμαρική (Greek)
  • Клемастина Фумарат (Cyrillic)
  • クレマスチンフマル酸塩 (Japanese)
  • C21H26ClNO,C4H4O4 (Molecular formula)

Drug trade names

References

  1. 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)
  2. 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)
  3. 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)
  4. ABM - The Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #6: Guideline on Co-Sleeping and Breastfeeding. Breastfeeding Medicine 2008Abstract Full text (link to original source) Full text (in our servers)
  5. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  6. Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000Abstract
  7. Ghaeli P, Kaufman MB. Oral antihistamines/decongestants and breastfeeding. J Hum Lact. 1993Abstract
  8. Kok TH, Taitz LS, Bennett MJ, Holt DW. Drowsiness due to clemastine transmitted in breast milk. Lancet. 1982Abstract