Clobetasol Propionate Lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older.

Treatment should be limited to 2 consecutive weeks.

For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz) per week.

Patients should be instructed to use Clobetasol Propionate Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results.

Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression.

Clobetasol Propionate Lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site.

Clobetasol Propionate Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

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.

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

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested. Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for clinical glucocorticosteroid insufficiency after withdrawal of treatment. This may occur during treatment or upon withdrawal of the topical corticosteroid.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression.

Local adverse reactions may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria, skin atrophy and telangiectasia. Some local adverse reactions may be irreversible. Clobetasol propionate is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Clobetasol Propionate Lotion, 0.05% should be discontinued until the infection has been adequately controlled.

There are no adequate and well-controlled studies in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Lotion, 0.05% is administered to a nursing woman.

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• Use in patients under 18 years of age. GoToSource

• Rosacea or perioral dermatitis. GoToSource

Adrenal suppression (adrenal glands do not make enough of the hormone cortisol). GoToSource

Cushing’s syndrome (body makes too much of the hormone cortisol). GoToSource

Osteoporosis (loss of bone density). GoToSource

Telangiectasia (spider veins), steroid-induced acne, delayed wound healing, allergic contact dermatitis, trichostasis spinulosa (disorder of hair follicle) and striae (stretch marks). GoToSource

Atrophy, erythema (redness of skin or mucous membranes), purpura (red or purple spots on skin), rosacea-like facial eruptions, perioral dermatitis (facial rash), folliculitis (inflammation of hair follicles), tinea incognito (fungal skin infection), skin tolerability reactions (stinging, burning), increased intraocular pressure and cataract formation. GoToSource

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