Clobetasol Propionate Spray
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
1.1 Indication
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. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week. Do not use more than 26 sprays per application or 52 sprays per day. Treatment should be limited to 4 consecutive weeks. Patients should be instructed to use Clobetasol Propionate Spray, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2)]. 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.
1.2 Limitations of UseClobetasol Propionate Spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol Propionate Spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol Propionate Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
History
There is currently no drug history available for this drug.
Other Information
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
Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.
Sources
Clobetasol Propionate Spray Manufacturers
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Actavis Pharma, Inc.
![Clobetasol Propionate Spray [Actavis Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clobetasol Propionate Spray | Actavis Pharma, Inc.
Clobetasol Propionate Spray, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use. Clobetasol Propionate Spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely.
The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use more than 26 sprays per application or 52 sprays per day.
Clobetasol Propionate Spray, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 4 weeks. Therapy should be discontinued when control has been achieved. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with Clobetasol Propionate Spray, 0.05%. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. 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. Use in pediatric patients younger than 18 years is not recommended because of the potential for HPA axis suppression [see Use in Specific Populations (8.4)].
Unless directed by physician, Clobetasol Propionate Spray, 0.05% should not be used with occlusive dressings.
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