"The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a "...
CLOBEX® (clobetasol propionate) Lotion, 0.05% is a super-high potent corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older (see PRECAUTIONS). Treatment should be limited to 2 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl.oz.) per week.
For the treatment of moderate to severe plaque psoriasis, localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment with CLOBEX® (clobetasol propionate) Lotion, 0.05% may be treated for up to 2 additional weeks. Any additional benefits of extending treatment should be weighed against the risk of HPA axis suppression before prescribing for more than 2 weeks.
Patients should be instructed to use CLOBEX® (clobetasol propionate) Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS).
Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression (see PRECAUTIONS: Pediatric Use).
DOSAGE AND ADMINISTRATION
CLOBEX® Lotion, 0.05% should be applied to the affected skin areas twice daily and rubbed in gently and completely. (See INDICATIONS AND USAGE.)
CLOBEX® Lotion, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to:
- 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses,
- and up to 2 additional weeks in very localized lesions of moderate to severe plaque psoriasis (no more than 10% body surface area) that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® (clobetasol propionate) Lotion 0.05%.
The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Use in pediatric patients younger than 18 years is not recommended because of numerically high rates of HPA axis suppression (See PRECAUTIONS: Pediatric Use).
Unless directed by physician, CLOBEX® Lotion, 0.05% should not be used with occlusive dressings.
CLOBEX® Lotion, 0.05% is supplied in the following sizes:
2 fl. oz./59 mL NDC 0299-3848-02 high density polyethylene
4 fl. oz./118 mL NDC 0299-3848-04 high density polyethylene bottles.
Store at controlled room temperature 68° to 77°F (20°-25°C). Protect from freezing.
Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA. Revised: August, 2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/30/2012
Additional Clobex Lotion Information
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