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FDA Labeling Changes
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CLOBEX® (clobetasol propionate) Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older (see PRECAUTIONS). Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week.
Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression.
Patients should be instructed to use CLOBEX® (clobetasol propionate) Spray, 0.05% for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS).
Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations (see PRECAUTIONS: Pediatric Use).
There is currently no drug history available for this drug.
CLOBEX® (clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7).
The following is the chemical structure:
Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of CLOBEX® (clobetasol propionate) Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a vehicle base composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.