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Amitriptyline / perphenazine Pregnancy and Breastfeeding Warnings

Brand names: Duo-Vil, Etrafon, Etrafon Forte, Triavil

Medically reviewed by Last updated on May 27, 2024.

Amitriptyline / perphenazine Pregnancy Warnings

Animal studies have failed to reveal evidence of fetotoxicity. 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:

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

-A pregnancy exposure registry is available.
-Neonates exposed to this drug late in the third trimester may require respiratory support, tube feeding, and/or prolonged hospitalization.
-Exposed neonates should be monitored after delivery for direct toxic effects of this drug, drug discontinuation syndrome, and serotonin syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo/hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).

See references

Amitriptyline / perphenazine Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes (amitriptyline, perphenazine)

-The effects of the combination drug in the nursing infant are unknown.
-Amitriptyline and perphenazine are considered drugs for which the effect on nursing infant are unknown but may be of concern by the American Academy of Pediatrics.

See references

References for pregnancy information

  1. "Product Information. Etrafon 2-10 (amitriptyline-perphenazine)." Schering Corporation

References for breastfeeding information

  1. "Product Information. Etrafon 2-10 (amitriptyline-perphenazine)." Schering Corporation
  2. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network.
  3. Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health

Further information

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