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 ].
Although patients receiving systemic corticosteroid therapy are more susceptible to secondary infection than patients not receiving corticosteroids, administration via the inhaled route minimizes this risk. Corticosteroid therapy can mask the symptoms of infection and should not be used in cases of bacterial, fungal, or viral infections that are not adequately controlled by anti-infective agents, except in life-threatening circumstances. Fluticasone; salmeterol should be avoided in patients with tuberculosis infections of the respiratory tract if possible. The incidence or course of acute bacterial or viral infection is probably minimally affected by inhaled corticosteroids in immunocompetent individuals; however, close monitoring of patients with immunosuppression is recommended if treatment with an inhaled corticosteroid is necessary.
Fluticasone propionate is a highly selective agonist at the glucocorticoid receptor with negligible activity at androgen , estrogen , or mineralocorticoid receptors , thereby producing anti-inflammatory and vasoconstriction effects. It has been shown to have a wide range of inhibitory effects on multiple cell types (. mast cell , eosinophil , neutrophil , macrophages , and lymphocytes ) and mediators (. histamine , eicosanoids , leukotrienes , and cytokines ) involved in inflammation . Fluticasone propionate is stated to exert a topical effect on the lungs without significant systemic effects at usual doses, due to its low systemic bioavailability .