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USP Monographs: Clobetasol Propionate Ointment
Short-term relief of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, including plaque psoriasis and dermatoses of the scalp. Generally most effective in acute or chronic dermatoses e. Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects. Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.
Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient. Cream, ointment, gel, lotion, shampoo, and foam 0. Not to be used in the treatment of rosacea 1 6 18 80 87 89 or perioral dermatitis.
Consider location of the lesion and the condition being treated when choosing a dosage form. Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.
Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing e. Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness. For dermatologic use only; avoid contact with eyes. Do not apply to the face or intertriginous areas e. Cream, ointment, gel, or solution containing clobetasol propionate not intended for ophthalmic, oral, or intravaginal use.
The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating. Apply cream, ointment, gel, lotion, or foam sparingly in a thin film and rub gently into affected area. Apply shampoo onto dry scalp; leave for 15 minutes before washing and rinsing; avoid contact with lips.
After a favorable response is achieved, frequency of application may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible. Manufacturers state that the cream, gel, ointment, or solution should not be used with occlusive dressings.
Soak or wash the affected area to remove scales; apply a thin film of the corticosteroid preparation; rub gently into the lesion; and apply another thin film. If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape. Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.
Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of clobetasol proprionate are essential at each dressing change. Occlusive dressing usually is left in place for 12—24 hours and therapy is repeated as needed. The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.
In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion. Available as clobetasol propionate; dosage expressed in terms of the salt. Intermittent maintenance therapy, such as administration of the drug once 12 or twice weekly 20 21 for up to 6 months, has resulted in prolonged periods of remission from corticosteroid-responsive dermatoses in some patients.
Administer the least amount of topical preparations that provides effective therapy. Apply cream, ointment, gel, foam, or solution sparingly to affected area twice daily, preferably in the morning and evening.
Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis. Apply cream, ointment, gel, lotion, foam, or solution sparingly to affected area twice daily, preferably in the morning and evening.
Apply shampoo to scalp once daily. Maximum 50 g of 0. Maximum 50 mL 50 g of 0. In patients with plaque psoriasis, maximum 50 g of 0. In patients with psoriasis of the scalp, maximum 4 consecutive weeks of therapy with shampoo. No dosage adjustments with cream, ointment, gel, or solution. Known hypersensitivity to clobetasol propionate, other corticosteroids, or any ingredient in the formulation. Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.
Clobetasol propionate is a potent topical corticosteroid and can be absorbed in sufficient amounts to produce systemic effects, including HPA-axis suppression. Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis. Perform periodic HPA-axis evaluation by appropriate testing e. HPA-axis function recovery generally is prompt and complete following drug discontinuance. Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.
Infants and children may be more susceptible to adverse systemic effects. Possible adverse local reactions e. Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue; a these effects are most likely to occur even with short-term use in intertriginous e.
If irritation occurs during treatment, discontinue drug and institute appropriate therapy. If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.
When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation. Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection including vaccinia and varicella and herpes simplex of the eye or adjacent skin ; a however, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.
Certain topical clobetasol propionate preparations cream, gel, ointment, solution should not be used with occlusive dressings. Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly. Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy. Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.
Not known whether topical clobetasol is distributed into milk. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin ACTH stimulation. Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.
Striae have been reported in children treated inappropriately with topical corticosteroids. Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic effect; chronic topical corticosteroid therapy may interfere with growth and development. Burning, stinging, irritation, itching, skin atrophy, dry skin, cracking or fissuring of the skin, erythema, folliculitis, numbness of fingers, tenderness in the elbow, telangiectasia.
Clobetasol propionate solution or shampoo: Potential pharmacologic interaction with other corticosteroid-containing preparations a. Topically applied clobetasol propionate can be absorbed through normal intact skin. Percutaneous penetration of clobetasol propionate varies among individuals 5 33 34 35 41 42 61 66 67 69 70 and can be altered by using different vehicles.
Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver. Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in bile. Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part from steroid receptor binding. Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.
Anti-inflammatory effects may occur through induction of phospholipase A 2 inhibitory proteins lipocortins ; decreased arachidonic acid release from membrane phospholipids.
Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed. Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.
Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician. Importance of patients informing clinician that they are receiving topical clobetasol propionate therapy, if surgery is contemplated.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of informing patients of other important precautionary information. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Temovate clobetasol propionate cream 0. Pittsburgh, PA; Aug. The Pharmaceutical Press; Effect on adrenal function of topically applied clobetasol propionate Dermovate.
Vitiligo treated with topical clobetasol propionate. The use of a new topical steroid in general practice. Clinical use of topical corticosteroids. Naysmith A, Hancock BW. Transient acantholytic dermatosis in South Africa. Intermittent treatment of psoriasis with clobetasol propionate. Acta Derm Venereol Stockh. The effect on plasma corticosteroid levels of the short term topical application of clobetasol propionate.
A double-blind trial of 0. Gould PW, Wilson L. Psoriasis treated with clobetasol propionate and photochemotherapy. A study of the comparative efficacy of diflucortolone valerate 0. Plasma cortisol values after topical application of diflucortolone valerate 0. The use of topical steroids in psoriasis. Clobetasol propionate versus fluocinonide creams in psoriasis and eczema.