Propionate

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression and/or manifestations of Cushing's syndrome in some patients. Clobetasol propionate has been shown to suppress the HPA axis at doses as low as 2 g/day. Conditions which increase systemic absorption include application of high-potency corticosteroids, use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (., skin abrasion), use in pediatric patients, use in patients with hepatic disease, and the use of an occlusive dressing. Clobetasol propionate preparations should not be used with occlusive dressings. Patients receiving large doses of a potent topical corticosteroid like clobetasol should be evaluated periodically for evidence of HPA axis suppression and manifestations of Cushing's syndrome. If these effects are noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation. Infrequently, signs and symptoms of withdrawal may occur, requiring supplemental systemic corticosteroids. It is recommended that the administration of clobetasol creams, ointments, gels, or topical solutions be limited to no more than 14 days duration, in order to limit the risk of systemic effects. Clobetasol propionate emollient creams may be administered for up to 4 weeks duration if applied to no more than 5—10% of body surface area. The total weekly dose limit of 50 g or 50 mL of a % preparation should not be exceeded for any clobetasol preparation.

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.

Propionate

propionate

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