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 ].
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Withdraw systemic corticosteroid therapy gradually and monitor for objective signs of adrenal insufficiency (., fatigue, lassitude, weakness, nausea, vomiting, hypotension) during withdrawal of systemic therapy. 18 23 35 Also carefully monitor lung function (FEV 1 or morning PEF), adjunctive β 2 -adrenergic agonist use, and asthma symptoms. 23 35 Patients who have been maintained on ≥20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during the later part of the transfer. 18 35