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.
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 also
References for pregnancy information
- (2006) "Product Information. Motofen (atropine-difenoxin)." Sebela Pharmaceuticals
References for breastfeeding information
- (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.