Last update Oct. 29, 2024

Dimetindene Maleate (systemic use)

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

1st generation antihistamine, alkylamine derivative, with sedative and antimuscarinic effect. It is used orally for the symptomatic treatment of pruritus, urticaria, rhinitis, cough. In cream or gel form it is used topically in pruritus.

At the date of last update we did not find published data on its excretion in breast milk. 

It has an antiprolactin effect that could inhibit lactation in the first weeks after delivery.

Although its occasional and moderate use during lactation is probably safe, until further published data on this drug in relation to lactation are available, safer known alternatives are preferable.

Monitor drowsiness and adequate feeding of the infant.

Due to its sedative effect, bed-sharing with the infant is not recommended if this drug is being taken. (UNICEF 2018, 2017, 2017, 2014, 2014, 2013 and 2006, Landa 2012, ABM 2008)

Topical use as a dermatological preparation is safe during lactation. The low cutaneous absorption (Radler 1995) and the high fixation to plasma proteins make unlikely the passage of a significant amount into breast milk. Do not apply on the breast.


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

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:

List of 6 tradenames

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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