Maprotiline Pregnancy and Breastfeeding Warnings
Maprotiline is also known as: Ludiomil
Medically reviewed by Drugs.com. Last updated on Aug 28, 2020.
Maprotiline Pregnancy Warnings
Animal studies have failed to reveal evidence of impaired fertility or fetal harm. There are no controlled data in human pregnancy.
To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by going to https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants.
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.
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: B
Comment: A pregnancy registry is available.
Maprotiline Breastfeeding Warnings
After a single dose of 100 mg orally, peak milk levels of 110 mcg/L occurred at approximately 8 hours. Patients at steady state had milk levels corresponding to blood levels.
Caution is recommended.
Excreted into human milk: Yes
Comment: Use of preferred antidepressants should be considered, especially when breastfeeding newborn or premature infants.
References for pregnancy information
- "Product Information. Ludiomil (maprotiline)." Ciba-Geigy Pharmaceuticals, East Hanover, NJ.
References for breastfeeding information
- 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 -]):
- "Product Information. Ludiomil (maprotiline)." Ciba-Geigy Pharmaceuticals, East Hanover, NJ.
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.