Propionate results

Results shown are from a 12-week, multicenter, randomized, double-blind, parallel-group study of 349 patients aged 12 years and older, with asthma (mean baseline forced expiratory volume in 1 second [FEV 1 ] 66% to 69% predicted) previously treated with medium doses of inhaled corticosteroids. Patients were randomized to treatment with ADVAIR DISKUS 250/50, fluticasone propionate 250 mcg, salmeterol 50 mcg, or placebo, each given twice daily through the DISKUS device. Patients were withdrawn from the study because of worsening asthma if they met any of the following criteria: a clinical exacerbation requiring emergency treatment, hospitalization, or use of asthma medication not allowed by the study protocol; a decrease in FEV 1 of more than 20% from the predose FEV 1 at the randomization visit; more than a 20% decrease from the mean morning baseline PEF (peak expiratory flow) on more than 3 of 7 days immediately preceding a visit; 12 or more albuterol puffs per day on more than 2 of 7 days immediately preceding a visit; or more than 2 nights with awakenings caused by asthma symptoms that required albuterol during the 7 days immediately preceding a clinic visit.

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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.

Propionate results

propionate results

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.

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