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Trimipramine Pregnancy and Breastfeeding Warnings

Trimipramine is also known as: Surmontil

Medically reviewed on August 18, 2016.

Trimipramine Pregnancy Warnings

Animal models have revealed evidence of embryotoxicity and an increased incidence of major anomalies. There are no controlled data in human pregnancy.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-Some experts recommend: This drug should not be used during the first and third trimesters of pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments:
-Withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers had taken this drug during the last trimester of pregnancy.
-A pregnancy exposure registry is available.

See references

Trimipramine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.
-Some experts recommend: Use is contraindicated.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies other tricyclic antidepressants as drugs whose effects on the nursing infant are unknown but may be of concern.
-Alternative agents (e.g., nortriptyline, paroxetine, sertraline) may be preferred when breastfeeding newborn or preterm infants, or when large doses are necessary.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Surmontil (trimipramine)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. 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 -]):
  3. "Product Information. Surmontil (trimipramine)" Wyeth-Ayerst Laboratories, Philadelphia, PA.
  4. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

Further information

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

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