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Olodaterol / tiotropium Pregnancy and Breastfeeding Warnings

Olodaterol / tiotropium is also known as: Stiolto Respimat

Olodaterol / tiotropium Pregnancy Warnings

Animal reproduction studies were conducted with the individual components of this drug, tiotropium bromide and olodaterol. There are no adequate and well-controlled human studies that have investigated the effects of this drug on preterm labor or labor at term, and in pregnant women. Tiotropium: In rats, tiotropium caused fetal resorption, litter loss, decreases in the number of live pups at birth and the mean pup weights, and a delay in pup sexual maturation at approximately 40 times the RHDID (recommended human daily inhalation doses). In rabbits, tiotropium caused an increase in post-implantation loss at approximately 430 times the RHDID. Such effects were not observed at approximately 5 and 95 times the RHDID in rats and rabbits respectively. Olodaterol: Placental transfer of olodaterol was observed in pregnant rats. Olodaterol has been shown to be teratogenic in New Zealand rabbits at approximately 7130 times the RHDID. Olodaterol exhibited the following fetal toxicities: enlarged or small heart atria or ventricles, eye abnormalities, and split or distorted sternum. No significant effects occurred at approximately 1353 times the RHDID. 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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: C Comment: The use of this drug during labor should be restricted to patients in whom the benefits clearly outweigh the risks due to a potential interference of beta-agonist with uterine contractility.

See references

Olodaterol / tiotropium Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Stiolto Respimat (olodaterol-tiotropium)." Boehringer Ingelheim, Ridgefield, CT.

References for breastfeeding information

  1. "Product Information. Stiolto Respimat (olodaterol-tiotropium)." Boehringer Ingelheim, Ridgefield, CT.

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