Skip to main content

Atropine / difenoxin Pregnancy and Breastfeeding Warnings

Brand names: Motofen

Atropine / difenoxin Pregnancy Warnings

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

US FDA pregnancy category: C

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.

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

See also

References for pregnancy information

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

References for breastfeeding information

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

Further information

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

Medical Disclaimer