TEMOVATE (clobetasol propionate emollient cream)
Emollient, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY -

NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE

Temovate E^® (clobetasol propionate emollient cream) Emollient, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:

Clobetasol propionate has the molecular formula C₂₅H₃₂ClFO₅ and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

Temovate E^® Emollient contains: clobetasol propionate 0.5 mg/g in an emollient base of cetostearyl alcohol, isopropyl myristate, propylene glycol, cetomacrogol 1000, dimethicone 360, citric acid, sodium citrate, purified water, and imidurea as a preservative.

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂.

Temovate E^® Emollient is a super-high potency corticosteroid 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 per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.

In the treatment of moderate to severe plaque-type psoriasis, Temovate E^® Emollient applied to 5-10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g per 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.

Temovate E^® (clobetasol propionate emollient cream) Emollient, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

In controlled trials with clobetasol propionate formulations, the following adverse reactions have been reported: burning/stinging, pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia. The incidence of local adverse reactions reported in the trials with Temovate E^® Emollient was less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated patients.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of other topical clobetasol propionate formulations.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as Temovate E^® Emollient. These reactions are uled in an approximately decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

Topically applied Temovate E^® Emollient can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

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 for 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.

Temovate E^® (clobetasol propionate emollient cream) Emollient, 0.05% is supplied in 60 g tubes (NDC) 0462-0301-60)

Store between 15° and 30°C (59° and 86°F).

Temovate E^® Emollient should not be refrigerated.

PharmaDerm^®
a division of ALTANA Inc
Duluth, GA 30096 USA
www.pharmaderm.com

I8301
R3/06
#154