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Nortriptyline Pregnancy and Breastfeeding Warnings

Nortriptyline is also known as: Aventyl Hydrochloride, Pamelor

Nortriptyline Pregnancy Warnings

Animal studies have shown reproductive toxicity. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. 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. AU TGA pregnancy category: C US FDA pregnancy category: Not Assigned Comments: -Neonatal withdrawal symptoms (irritability, hypertonism, tremors, irregular breathing, weak suckling) and anticholinergic symptoms (urine retention, constipation) may occur after chronic use and administration near term. -Since the kinetics of this drug change during pregnancy, serum levels should be monitored and the dose should be adjusted if needed.

See references

Nortriptyline Breastfeeding Warnings

Benefit should outweigh risk. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Pamelor (nortriptyline)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Pamelor (nortriptyline)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

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