<p>There are no adequate and well-controlled studies with this inhaler or with two of its individual components, Glycopyrrolate or Formoterol Fumarate, in pregnant women to inform a drug-associated risk. There are no available data on the effects of this inhaler on the breastfed child or on milk production. Budesonide, like other ICS, is present in human milk. There are no available data on the presence of Glycopyrrolate or Formoterol Fumarate in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother&#39;s clinical need for this inhaler and any potential adverse effects on the breastfed child from this inhaler or from the underlying maternal condition.</p>