Last update: May 16, 2019

Doxepin (Topic Cream)

Low Risk for breastfeeding


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:

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
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Other names

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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 -
T1/2 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)

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