Doxepin topical Pregnancy and Breastfeeding Warnings
Brand names: Prudoxin, Zonalon
Medically reviewed by Drugs.com. Last updated on Aug 21, 2023.
Doxepin topical Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
US FDA pregnancy category: B
Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Doxepin topical Breastfeeding Warnings
Not recommended; according to some manufacturers, benefit to mother should outweigh risk to the infant.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Maternal use is unlikely to cause a problem for the nursing infant as long as it is applied away from the breasts so that the infant cannot ingest the drug directly.
See also
References for pregnancy information
- (2001) "Product Information. Zonalon (doxepin topical)." Bioglan Pharmaceutical Inc
- MHRA. Medicines and Health Regulatory Agency (2013) MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate
References for breastfeeding information
- (2001) "Product Information. Zonalon (doxepin topical)." Bioglan Pharmaceutical Inc
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- MHRA. Medicines and Health Regulatory Agency (2013) MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
