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Formoterol / glycopyrrolate Pregnancy and Breastfeeding Warnings

Formoterol / glycopyrrolate is also known as: Bevespi Aerosphere

Formoterol / glycopyrrolate Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: C Comments: -Physicians should be contacted if pregnancy occurs while taking this drug. -This drug should be used during labor only if the potential benefit justifies the potential risk.

Glycopyrrolate: There was no evidence of teratogenic effects in rats and rabbits at doses higher than the maximum recommended human daily inhalation dose (MRHDID). Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier. Formoterol fumarate: This drug has been shown to be teratogenic, embryocidal, to increase pup loss at birth and during lactation, and to decrease pup weights in rats and teratogenic in rabbits. Umbilical hernia, prolonged pregnancy and fetal brachygnathia, and subcapsular cysts on the liver were observed in rats and rabbits at doses higher than MRHDID. 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

Formoterol / glycopyrrolate 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: Unknown (formoterol-glycopyrrolate) Excreted into animal milk: Yes (formoterol); Unknown (glycopyrrolate) Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Bevespi Aerosphere (formoterol-glycopyrrolate)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. "Product Information. Bevespi Aerosphere (formoterol-glycopyrrolate)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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