Pregnancy: In animal studies, some effects on the foetus, typical for a beta-2 agonist, occurred at exposure levels substantially higher than those that occur with therapeutic use. Extensive experience with other beta-2 agonists has provided no evidence that such effects are relevant for women receiving clinical doses.
There are no adequate and well-controlled studies of salmeterol in pregnant women. The effect of salmeterol on human pregnancy is unknown.
As with any medicine, use during pregnancy should be considered only if the expected benefit to the mother is greater than any possible risk to the foetus.
Lactation: Plasma levels of salmeterol after inhaled therapeutic doses are negligible and therefore levels in milk should be correspondingly low. Nevertheless, as there is limited experience of the use of salmeterol in nursing mothers, its use in such circumstances should only be considered if the expected benefit to the mother is greater than any possible risk to the infant.
Studies in lactating animals support the view that salmeterol is likely to be secreted in only very small amounts into breast milk.