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Temovate E (Clobetasol Propionate Topical (Emollient)) - Indications and Dosage

 



INDICATIONS AND USAGE

TEMOVATE E Emollient is a super-high potency cortico-steroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

In the treatment of moderate to severe plaque-type psoriasis, TEMOVATE E Emollient applied to 5% to 10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Treatment beyond 4 consecutive weeks is not recommended. Patients should be instructed to use TEMOVATE E Emollient for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS and INDICATIONS AND USAGE). Use in pediatric patients under 16 years of age has not been studied.

DOSAGE AND ADMINISTRATION

Apply a thin layer of TEMOVATE E Emollient to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

TEMOVATE E Emollient is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

In moderate to severe plaque-type psoriasis, TEMOVATE E Emollient applied to 5% to 10% of body surface area can be used up to 4 weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age has not been studied.

TEMOVATE E Emollient should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with TEMOVATE E Emollient, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

TEMOVATE E Emollient, 0.05% is supplied in:

15-g tubes (NDC 0173-0454-01),

30-g tubes (NDC 0173-0454-02), and

60-g tubes (NDC 0173-0454-03).

Store between 15° and 30°C (59° and 86°F). TEMOVATE E Emollient should not be refrigerated.

GlaxoSmithKline Consumer Healthcare LP,

Pittsburgh, PA 15230

©2002, GlaxoSmithKline. All rights reserved.

August 2002/RL-1086

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