Last update Jan. 25, 2022

Doxepin (Topic Cream)

Low Risk

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

A tricyclic antidepressant dibenzoxepine with actions and uses similar to amitriptyline with major antihistaminic, antimuscarinic and sedative properties. Due to its potent H1 and H2 antihistamine action, it is used in the treatment of moderate to severe pruritus of atopic dermatitis and other pruritic conditions (Valeant 2013). Topical application 3 to 4 times a day no more than 8 days in a row.

Since the last update we have not found published data on its excretion in breastmilk via application to the skin.

After cutaneous administration, plasma concentrations can range from undetectable to 47 micrograms (mcg)/Litre. The therapeutic levels for treating a depressive state orally are from 30 to 150 mcg/L.(Valeant 2013)

Sedation may occur when applied to more than 10% of the body surface (Valeant 2013). With other types of dermatological preparation (oil/water nanoemulsions), much lower plasma levels of 0.29 mcg/L are reached (Sandig 2013), where there would be no possibility of systemic effects.

Sedation has occurred in infants (under two months) whose mothers were taking doxepin orally. (Frey 1999, Matheson 1985)

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.

If used during breastfeeding, do not apply on the breast in order to prevent the infant from ingesting it; do not apply over large areas (maximum 10% of body surface) or for prolonged periods (maximum 8 days) to minimize systemic absorption.


See below the information of this related product:

  • Doxepin Hydrochloride (Very unsafe. Contraindicated. Use of an alternative or cessation of breastfeeding. Read the Comment.)

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.

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

Doxepin (Topic Cream) in other languages or writings:

Group

Doxepin (Topic Cream) belongs to this group or family:

Tradenames

Main tradenames from several countries containing Doxepin (Topic Cream) in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. baja - poor (dermat.) %
Molecular weight 316 daltons
Protein Binding 76 - 80 %
VD 179 l/Kg
pKa 9.76 -
15 - 31 hours
M/P ratio 1.7 -

References

  1. Sandig AG, Campmany AC, Campos FF, Villena MJ, Naveros BC. Transdermal delivery of imipramine and doxepin from newly oil-in-water nanoemulsions for an analgesic and anti-allodynic activity: development, characterization and in vivo evaluation. Colloids Surf B Biointerfaces. 2013 Mar 1;103:558-65. Abstract
  2. Valeant. Doxepin (Zonalon). Drug Summary. 2013 Full text (in our servers)
  3. Frey OR, Scheidt P, von Brenndorff AI. Adverse effects in a newborn infant breast-fed by a mother treated with doxepin. Ann Pharmacother. 1999 Jun;33(6):690-3. Abstract
  4. Matheson I, Pande H, Alertsen AR. Respiratory depression caused by N-desmethyldoxepin in breast milk. Lancet. 1985 Nov 16;2(8464):1124. No abstract available. Abstract

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