FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
Clobetasol propionate cream (emollient) 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 466.98. It is a white to cream-colored crystalline powder insoluble in water.
Each gram of clobetasol propionate cream (emollient) contains: clobetasol propionate 0.5 mg 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.
Clobetasol propionate cream (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, clobetasol propionate cream (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 clobetasol propionate cream (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.
Clobetasol propionate cream (emollient) 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 clobetasol propionate cream (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 clobetasol propionate cream (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 clobetasol propionate cream (emollient) can be absorbed in sufficient amounts to produce systemic effects.
Apply a thin layer of clobetasol propionate cream (emollient) to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).
Clobetasol propionate cream (emollient) is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used. Use in children under 12 years of age is not recommended.
In moderate to severe plaque-type psoriasis, Clobetasol Propionate Cream (Emollient) applied to 5 - 10% of body surface area can be used for up to 4 weeks. The total dose 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. 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.
Clobetasol propionate cream (emollient) should not be used with occlusive dressings.
Clobetasol Propionate Cream USP, 0.05% (Emollient) is supplied as follows:
|NDC 0168-0301-15||15 g|
|NDC 0168-0301-30||30 g|
|NDC 0168-0301-60||60 g|
Store between 15° and 30°C (59° and 86°F).
Clobetasol Propionate Cream (Emollient) should not be refrigerated.
E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747