The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Comments:
-Absorption of this drug after inhalation is negligible, so fetal drug exposure is not expected.
-Experience over several decades (based on published literature, cohort studies, case control studies, and case series) have not identified increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
-Animal studies at up to 10,000 times the maximum recommended human daily inhalation dose did not show evidence of structural alterations.

Animal studies of oral and inhalation of this drug did not cause fetal structural alterations at doses up to 10,000 times the maximum recommended human daily inhalation dose (MRHDID). There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Concentrations in plasma after inhaled doses are low, so levels in human milk are expected to be low also.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references