FOR EXTERNAL USE ONLY. Avoid contact with the eyes.
Because of the potency of clobetasol proprionate and its potential for causing adverse systemic effects during topical therapy, the usual dosage should NOT be exceeded and occlusive dressings (including bandages) should NOT be applied to areas of clobetasol proprionate application (see Dosage & Administration).
Endocrine System Effects: Clobetasol proprionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g/day.
Systemic absorption of topical corticosteroids may cause manifestations of hypercortisolism (Cushing's syndrome) and reversible HPA axis suppression, leading to glucocorticosteroid insufficiency. If either of the previously mentioned are observed, withdraw the drug gradually by reducing the frequency of application, or by substituting a less potent corticosteroid. Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency.
Because of the potential systemic absorption, patients should be periodically evaluated for HPA axis suppression. Factors that predispose a patient using topical corticosteroid to HPA axis suppression include potency and formulation of topical steroid, application over large surface areas, duration of exposure, use under occlusion, increased hydration of the stratum corneum, use on thin skin areas (e.g., face), use on broken skin or other conditions with an altered skin barrier, and use in patients with liver failure. If HPA axis suppression occurs, the drug should either be gradually withdrawn, the frequency of application reduced, or replaced with a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes can also result from systemic absorption of topical corticosteroids. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids.
Local Effects: Local adverse reactions may more likely occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruption, hypopigmentation, hypertrichosis, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Clobetasol proprionate is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis (see Contraindications).
Hypersensitivity: Clobetasol should be used with caution in patients with a history of local hypersensitivity to other corticosteroids or any excipients of the product. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed with patch testing. Although hypersensitivity reactions are rare with topical steroids, clobetasol proprionate should be discontinued and appropriate therapy instituted.
Concomitant Skin Infections: In cases of bacterial infections of the skin, appropriate antifungal or antibacterial agents should be used as primary therapy. If it is considered necessary, the topical corticosteroid may be used as an adjunct to control inflammation, erythema and itching. Is a favorable response does not occur promptly, use of clobetasol proprionate should be discontinued until the infection has been adequately controlled.
Use in Psoriasis: Topical steroids may be hazardous in psoriasis due to rebound relapses, development of tolerance, risk of generalized pustular psoriasis and development of local or systemic toxicity due to impairment of the skin's barrier function. Careful patient supervision is important in these patients.
Renal and Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Use in Children: Children (<12 years old): Care should be taken when using clobetasol proprionate to ensure the amount applied is the minimum that provides therapeutic benefit. Use of clobetasol proprionate is not recommended for children below 12 years old (see Contraindications).
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to adrenocorticotropic hormone stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Use in Elderly: Elderly (≥65 years old): Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.