Protriptyline Pregnancy and Breastfeeding Warnings

Brand names: Vivactil

Medically reviewed by Drugs.com. Last updated on Jun 5, 2023.

Protriptyline Pregnancy Warnings

Animal studies have failed to reveal evidence of adverse effects on reproduction. There are no adequate and well-controlled studies in pregnant women.

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 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

Comments:
-Use in women of childbearing potential should be used if benefit outweighs hazards to the mother and fetus.
-A pregnancy exposure registry is available.

See references

Protriptyline Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-The effects on 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

Further information

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

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