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Propantheline Pregnancy and Breastfeeding Warnings

Propantheline is also known as: Pro-Banthine

Medically reviewed by Drugs.com. Last updated on Feb 5, 2019.

Propantheline Pregnancy Warnings

Animal studies using this drug have not been reported. Animal studies using parasympatholytic agents have revealed a potential malformation association. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

See references

Propantheline Breastfeeding Warnings

This drug should not be used unless there are no safer alternatives.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant are unknown.
-Some experts state that breastfed infants of patients taking this drug for prolonged periods should be monitored for signs/symptoms of decreased lactation (e.g., decreased weight gain, hunger).
-Use may suppress lactation or milk letdown, especially when used for long-term treatment.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Propantheline Bromide (propantheline)." Roxane Laboratories Inc, Columbus, OH.

References for breastfeeding information

  1. "Product Information. Propantheline Bromide (propantheline)." Roxane Laboratories Inc, Columbus, OH.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. National Library of Medicine (US) "Drugs and Lactation Database (LactMed) Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK501922/" (2006):
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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