Last update July 15, 2017

Dimetindene Maleate (systemic use)

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

First generation antihistamine drug which is derived from ethylene diamine with important sedative and antimuscarinic effects.

At latest update no published data on excretion into breast milk was found.
Inhibition of breastfeeding in the first weeks after birth due to an antiprolactin effect may appear.
For both the mother and the infant it would be safer taking antihistamines with proven safety and without sedative effect, especially in case of premature babies and infants under 1 month of age.

Otherwise when used during lactation, take the lowest effective dose but avoiding a prolonged use. Follow-up the baby for drowsiness and feeding issues.
It is not recommended to share a bed with your baby if you are taking this medicine.

The topical use as a gel or cream is compatible with breastfeeding. Do not apply on the chest. See Dimethindene Maleate (topical).


See below the information of this related product:

Alternatives

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

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Dimetindene Maleate (systemic use) in other languages or writings:

Group

Dimetindene Maleate (systemic use) belongs to this group or family:

Tradenames

Main tradenames from several countries containing Dimetindene Maleate (systemic use) in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 70 %
Molecular weight 409 daltons
Protein Binding 90 %
Tmax 2 hours
T½ 6 hours

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. 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)
  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. None 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. Radler S, Blaschke G. Transdermal absorption of dimethindene in man. Arch Pharm (Weinheim). 1995 Abstract
  10. Arnera V, Wermeille M, Wellman M, Llull JB, Althaus MA, Balant LP. Pharmacokinetics of dimetindene after intravenous and oral administration to healthy volunteers. Arzneimittelforschung. 1990 Abstract

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