Adeflo MDI Use In Pregnancy & Lactation

Use in Pregnancy: A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of salmeterol and fluticasone propionate. Animal studies have shown reproductive toxicity after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids.
Administration of Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
The lowest effective dose of Fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.
Use in Lactation: 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 breast-feeding or to discontinue Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.