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 ].
Single dose intranasal administration of 220 micrograms of Nasacort Allergy or Triamcinolone Nasal Spray in normal adult subjects and in adult patients with allergic rhinitis demonstrated minimal absorption of triamcinolone acetonide. The mean peak plasma concentration was approximately ng/mL (range to 1 ng/mL) and occurred at hours post dose. The mean plasma drug concentration was less than ng/mL at 12 hours and below the assay detection limit at 24 hours. The average terminal half life was hours. Dose proportionality was demonstrated in normal subjects and in patients following a single intranasal dose of 110 micrograms or 220 micrograms Nasacort Allergy or Triamcinolone Nasal Spray. Following multiple doses in paediatric patients, plasma drug concentrations, AUC, C max and T max were similar to those values observed in adult patients.