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 ].
Initial dose based on previous asthma drug therapy and disease severity; 100 mcg via oral inhalation once daily is the usual recommended starting dose for patients not on an inhaled corticosteroid. After 2 weeks of therapy, if asthma symptoms are uncontrolled, increase dose to 200 mcg via oral inhalation once daily. Max: 200 mcg once daily. Administer at the same time each day. The maximum beneficial effect may not be achieved for up to 2 weeks or longer after starting treatment. Titrate to the lowest effective dose once asthma stability is achieved.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of AirDuo™ RespiClick® and its Authorized Generic, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: