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Atropine / difenoxin Pregnancy and Breastfeeding Warnings

Atropine / difenoxin is also known as: Motofen

Atropine / difenoxin Pregnancy Warnings

Animal studies at doses 31 and 61 times the human dose showed no teratogenicity, however at 20 times the maximum human dose there was an increase in delivery time and a significant increase in stillbirths; neonatal survival was reduced with most deaths occurring within 4 days of delivery. There are no controlled data in human pregnancy.

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 not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

See references

Atropine / difenoxin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

See references

References for pregnancy information

  1. "Product Information. Motofen (atropine-difenoxin)." Sebela Pharmaceuticals (2006):

References for breastfeeding information

  1. "Product Information. Motofen (atropine-difenoxin)." Sebela Pharmaceuticals (2006):

Further information

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