This drug should not be used during pregnancy prior to 37 completed weeks of gestation.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned


Comment:
-Limited data in human pregnancy did not show clear adverse developmental outcomes
-Any dose of this drug that produces sustained increased uterine tone could put the embryo or fetus at risk.
-When this drug was removed for fetal distress, normal rhythm returned with no neonatal sequelae; remove this drug for persistent tachysystole with or without fetal heart rate changes and follow established management protocols.

Animal data with this product are not available. Prostaglandin E2 has been shown to be embryotoxic in rats and rabbits. There are no controlled data in human pregnancy. A human 3-year pediatric follow-up study did not show deleterious physical or psychomotor effects in 51 infants born after maternal treatment with this drug.

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.

See references

-Exogenous drug has not been measured in human milk, but this drug is a normal component of breastmilk in small amounts and may be protective in the infant gastrointestinal tract.
-This drug given orally may suppress lactation in the first few days postpartum; this suppression does not appear to occur one month postpartum.
-It is unknown if vaginal or endocervical administration may suppress lactation postpartum, but it should probably not be used if breastfeeding is desired.

This drug is not indicated for use during lactation.

Excreted into human milk: Unknown

See references