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Doxepin topical Pregnancy and Breastfeeding Warnings

Doxepin topical is also known as: Prudoxin, Zonalon

Medically reviewed on August 31, 2017

Doxepin topical Pregnancy Warnings

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.

Use is recommended only if clearly needed and the benefit outweighs the risk.

US FDA pregnancy category: B

See references

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 references

References for pregnancy information

  1. "Product Information. Zonalon (doxepin topical)." Bioglan Pharmaceutical Inc, Malvern, PA.
  2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."

References for breastfeeding information

  1. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  2. "Product Information. Zonalon (doxepin topical)." Bioglan Pharmaceutical Inc, Malvern, PA.
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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