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Olodaterol Pregnancy and Breastfeeding Warnings

Olodaterol is also known as: Striverdi Respimat

Olodaterol Pregnancy Warnings

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at maximum recommended human daily inhalation dose (MRHDID). No clinical data on exposed pregnancies are available. Clinical data on fertility are not available for this drug, and nonclinical studies performed with this drug showed no adverse effect on fertility. This drug and/or its metabolites crossed the placenta in rats. Enlarged or small heart atria or ventricles, eye abnormalities, and split or distorted sternum have been shown in rats at inhalation doses approximately 7,130 times the MRDHID: The inhibitory effect of beta-adrenergic agonists on uterine contraction should be taken into account. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 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.

UK: Use should be avoided. AU, US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C

See references

Olodaterol Breastfeeding Warnings

AU, UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

Clinical data from nursing women exposed to olodaterol are not available. No adverse effects on development or reproductive performance were seen in breast-fed pups at maternal inhalational doses up to 3,665 microgram/kg/day.

See references

References for pregnancy information

  1. "Product Information. Striverdi Respimat (olodaterol)." Boehringer Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Striverdi Respimat (olodaterol)." Boehringer Ingelheim, Ridgefield, CT.

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