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Fluticasone / vilanterol Pregnancy and Breastfeeding Warnings

Fluticasone / vilanterol is also known as: Breo Ellipta

Fluticasone / vilanterol Pregnancy Warnings

FDA pregnancy category: C Potential benefit should outweigh the potential risk.

No teratogenicity interactions between fluticasone and vilanterol were seen in animals at the maximum recommended human daily inhalation dose (MRHDID) alone or in combination. Vilanterol caused decreased or absent ossification in cervical vertebral centrum and metacarpals in animals at approximately 1,000 times the MRHDID. Hypoadrenalism occurred in infants born to mothers using corticosteroids during pregnancy. There are no controlled data in human pregnancy. 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.

Fluticasone / vilanterol Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown (fluticasone and vilanterol) Excreted into animal milk: Unknown (fluticasone and vilanterol) The effects in the nursing infant are unknown.

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