Clobex

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Uses

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).

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History

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Other Information

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.

Sources

Clobex Manufacturers

Physicians Total Care, Inc.

Clobex | Physicians Total Care, Inc.

CLOBEX® (clobetasol propionate) Spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely. Do not exceed 30 sprays per application or 60 sprays per day. (See INDICATIONS AND USAGE).

CLOBEX® (clobetasol propionate) Spray, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to 4 weeks. 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® (clobetasol propionate) Spray, 0.05%.

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.

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 the potential for HPA axis suppression. (See PRECAUTIONS: Pediatric Use).

Unless directed by physician,CLOBEX® (clobetasol propionate) Spray, 0.05% should not be used with occlusive dressings.

No Recall
Physicians Total Care, Inc.

Clobex | Physicians Total Care, Inc.

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.

No Recall
Galderma Laboratories, L.p.

Clobex | Galderma Laboratories, L.p.

CLOBEX Shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.

CLOBEX Shampoo, 0.05%, should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.

Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying CLOBEX Shampoo, 0.05%.

Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.

Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after 4 weeks of treatment with CLOBEX Shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.

CLOBEX Shampoo, 0.05%, should not be used with occlusive dressings (shower cap or bathing cap) unless directed by a physician.

No Recall
Galderma Laboratories, L.p.

Clobex | Galderma Laboratories, L.p.

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 (8.4)].

Unless directed by physician, CLOBEX® Spray, 0.05% should not be used with occlusive dressings.

No Recall
Galderma Laboratories, L.p.

Clobex | Galderma Laboratories, L.p.

CLOBEX Lotion, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.

CLOBEX Lotion, 0.05% should be applied to the affected skin areas twice daily and rubbed in gently and completely.

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.

CLOBEX Lotion, 0.05% contains a 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 localized lesions (less than 10% body surface area) of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX Lotion, 0.05%.

Unless directed by physician, CLOBEX Lotion, 0.05% should not be used with occlusive dressings.

No Recall