Salflumix Easyhaler Use In Pregnancy & Lactation

Pregnancy: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicates no malformative or feto/neonatal toxicity related to salmeterol and fluticasone propionate. Animal studies have shown reproductive toxicity after administration of β₂ adrenoreceptor agonists and glucocorticosteroids (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Administration of Salflumix Easyhaler to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.
Breastfeeding: It is unknown whether salmeterol and fluticasone propionate/metabolites are excreted in human milk.
Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted into the milk of lactating rats.
A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Salflumix Easyhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: There are no data in humans. However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility.