In rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose approximately times the MRHDID for adults (on a mg/m² basis at a maternal subcutaneous dose of 4 mcg/kg/day). However, no teratogenic effects were reported at fluticasone propionate doses up to approximately 20 times the MRHDID for adults (on a mg/m² basis at a maternal oral dose up to 300 mcg/kg/day). No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration [see CLINICAL PHARMACOLOGY ].
The PROPEL sinus implants are intended for use after sinus surgery to maintain patency and to locally deliver steroid to the sinus mucosa: PROPEL for use in the ethmoid sinus, PROPEL Mini for use in the ethmoid sinus and frontal sinus opening, and PROPEL Contour for use in the frontal and maxillary sinus ostia. The implants are intended for use in patients ≥18 years of age. Contraindications include patients with intolerance to mometasone furoate (MF) or a hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implants in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For complete prescribing information see IFU at . Rx only.