Fentanyl-Piramal Use In Pregnancy & Lactation

Pregnancy: There are no adequate data from the use of FENTANYL in pregnant women. Fentanyl can cross the placenta in early pregnancy. Studies in animals have shown some reproductive toxicity (see Pharmacology: Toxicology: Non-Clinical Information under Actions). The potential risk for humans is unknown.
Administration (intramuscular (IM) or IV) during childbirth (including cesarean section) is not recommended because fentanyl crosses the placenta and may suppress spontaneous respiration in the newborn period. If FENTANYL is administered, assisted ventilation equipment must be immediately available for the mother and infant if required. An opioid antagonist for the child must always be available.
Breast-feeding: Fentanyl is excreted into human milk. Therefore, breast-feeding or use of expressed breast milk is not recommended for 24 hours following the administration of this drug. The risk/benefit of breast-feeding following FENTANYL administration should be considered.
Fertility: There are no clinical data on the effects of fentanyl on male or female fertility. In animal studies, some tests on rats showed reduced female fertility at maternal toxic doses (see Pharmacology: Toxicology: Non-Clinical Information under Actions).