"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
CLOBEX® 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 CLOBEX® Spray, 0.05% for the minimum amount of time necessary to achieve the desired results [see DOSAGE AND ADMINISTRATION]. 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.
Limitations of Use
CLOBEX® Spray, 0.05% should not be used on the face, axillae, or groin. CLOBEX® Spray, 0.05% should not be used if there is atrophy at the treatment site. CLOBEX® Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
DOSAGE AND ADMINISTRATION
CLOBEX® Spray, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.
CLOBEX® 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.
CLOBEX® 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 CLOBEX® 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].
Unless directed by physician, CLOBEX® Spray, 0.05% should not be used with occlusive dressings.
Dosage Forms And Strengths
Spray, 0.05% w/w
Storage And Handling
CLOBEX® Spray, 0.05% is supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes:
2 fl oz/59 mL NDC 0299-3849-02
4.25 fl oz/125 mL NDC 0299-3849-04
Keep tightly closed. Store under controlled room temperature conditions 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not freeze, refrigerate or store above 30°C. Spray is flammable; avoid heat, flame or smoking when using this product.
Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA. Manufactured by: CPL, Mississauga, Ontario, Canada L5N 6L6. Revised: 08/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/14/2012
Additional Clobex Spray Information
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