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Fluticasone / salmeterol Pregnancy and Breastfeeding Warnings

Fluticasone / salmeterol is also known as: Advair Diskus, Advair HFA

Fluticasone / salmeterol Pregnancy Warnings

Corticosteroids and beta2-agonists have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. In mouse reproduction assays, fluticasone propionate by the subcutaneous route at a dose approximately 3/5 the maximum recommended human daily inhalation dose (MRHDID) combined with oral salmeterol at a dose approximately 410 times the MRHDID produced cleft palate, fetal death, increased implantation loss, and delayed ossification. These observations are characteristic of glucocorticoids. No developmental toxicity was observed at combination doses of fluticasone propionate subcutaneously up to approximately 1/6 the MRHDID and doses of salmeterol up to approximately 55 times the MRHDID. In rats, combining fluticasone propionate subcutaneously at a dose equivalent to the MRHDID and a dose of salmeterol at approximately 810 times the MRHDID produced decreased fetal weight, umbilical hernia, delayed ossification, and changes in the occipital bone. These effects were not seen when combining fluticasone propionate subcutaneously at a dose less than the MRHDID and an oral dose of salmeterol at approximately 80 times the MRHDID. There are no controlled data in human pregnancy. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Patients should contact their physician if pregnancy occurs while taking this drug. If needed, the lowest effective dose of this drug should be used.

Fluticasone / salmeterol Breastfeeding Warnings

UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Caution is recommended. AU: The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Unknown (fluticasone-salmeterol) Excreted into animal milk: Yes (fluticasone-salmeterol) Comments: The effects in the nursing infant are unknown.

Salmeterol: Plasma levels of salmeterol, after inhaled therapeutic doses, are very low. In rats, salmeterol xinafoate is excreted in the milk. Fluticasone: Subcutaneous administration to lactating rats of tritiated fluticasone propionate resulted in measurable radioactivity in the milk. There are no controlled data on the use of this drug by nursing mothers.

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