Animal studies do not indicate teratogenicity at inhaled doses approximately 1353 and 2731 times the maximum recommended human daily inhalation dose (MRHDID) administered during organogenesis. At doses about 7130 times the MRHDID teratogenicity was seen: enlarged or small atria or ventricles, eye abnormalities, and split or distorted sternum. Placental transfer was seen in animals. 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 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 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.

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-There is no adequate data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Animal studies did not show teratogenicity when inhalation doses up to 2731 times the maximum recommended human daily inhalation dose (MRHDID) were given during organogenesis.
-Beta agonists may interfere with uterine contractility; use this drug during labor only if the benefit clearly outweighs the risk.

See references

The manufacturer makes no recommendation regarding use during lactation.

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

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.
-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