There are no data on human fertility. Animal studies indicate no effects of fluticasone propionate or salmeterol xinafoate on male or female fertility.
There are limited data in pregnant women. Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.
Results from a retrospective epidemiological study did not find an increased risk of major congenital malformations (MCMs) following exposure to fluticasone propionate when compared to other inhaled corticosteroids, during the first trimester of pregnancy (see Pharmacology: Pharmacodynamics under Actions).
Reproductive toxicity studies in animals, either with single drug or in combination, revealed the foetal effects expected at excessive systemic exposure levels of a potent beta2-adrenoreceptor agonist and glucocorticosteroid. Extensive clinical experience with drugs in these classes has revealed no evidence that the effects are relevant at therapeutic doses.
Salmeterol and fluticasone propionate concentrations in plasma after inhaled therapeutic doses are very low and therefore concentrations in human breast milk are likely to be correspondingly low. This is supported by studies in lactating animals, in which low drug concentrations were measured in milk. There are no data available for human breast milk.
Administration during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.