viral infection
Clobetasol (Temovate) Contraindications and Precautions
Clobetasol is contraindicated in any patient with a history of severe hypersensitivity to other corticosteroids or any ingredients in the preparation. Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to clobetasol should not receive any form of clobetasol. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression and/or manifestations of Cushing’s syndrome in some patients. Clobetasol propionate has been shown to suppress the HPA axis at doses as low as 2 g/day. Conditions which increase systemic absorption include application of high-potency corticosteroids, use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of an occlusive dressing. Clobetasol propionate preparations should not be used with occlusive dressings. Patients receiving large doses of a potent topical corticosteroid like clobetasol should be evaluated periodically for evidence of HPA axis suppression and manifestations of Cushing’s syndrome. If these effects are noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids. It is recommended that the administration of clobetasol creams, ointments, gels or topical solutions be limited to no more than 14 days duration, in order to limit the risk of systemic effects. Clobetasol propionate emollient creams may be administered for up to 4 weeks duration if applied to no more than 5 - 10% of body surface area. The total weekly dose limit of 50 g or 50 ml of a 0.05% preparation should not be exceeded for any clobetasol preparation. Clobetasol preparations should not be used with occlusive dressings.
Topical corticosteroids should be used with caution in patients with diabetes mellitus. Exacerbation of diabetes may occur with systemic absorption of the topical corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.
Children and infants may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, and therefore are more susceptible to developing systemic toxicity, especially with very-high-potency products. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Chronic corticosteroid therapy in children may also interfere with growth and development. Topical clobetasol preparations are generally not recommended for use in children and infants under 12 years of age, except where the benefits of treatment would outweigh the potential risks of therapy. Limited data on adverse reactions and efficacy exist.
Clobetasol is classified as FDA pregnancy risk category C. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in laboratory animals. Clobetasol has been shown to be a significant teratogen in both mice and rabbits when administered via subcutaneous injection. Effects included cleft palate and skeletal abnormalities. Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. There are no adequate and well-controlled studies of teratogenic effects from topical application of clobetasol in pregnant women. Clobetasol has greater potency, and thus greater teratogenic potential, than other topical corticosteroids. If clobetasol must be used during pregnancy, the potential risks should be discussed with the patient. Topical corticosteroids, including clobetasol, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women.
It is not known whether topical administration of clobetasol could result in sufficient systemic absorption to produce detectable quantities in breast milk. Increased blood pressure has been reported in an infant whose mother applied a topical corticosteroid ointment directly to the nipples. When used in low doses, systemically administered corticosteroids (e.g., prednisone) are distributed into breast milk in quantities not likely to have a deleterious effect on the infant. Regardless, a decision should be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of the drug to the mother. Most authorities recommend caution when prescribing topical corticosteroids to lactating women.
The normal inflammatory response to local infections can be masked by clobetasol. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (e.g., herpes infection, measles, varicella), should be initiated or continued only if the appropriate anti-infective treatment is instituted. If the infection does not respond to the antimicrobial therapy, the concurrent use of the topical corticosteroid should be discontinued until the infection is controlled. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers. Use clobetasol preparations with caution in patients with markedly impaired circulation or peripheral vascular disease; skin ulceration has been reported in these patients following topical corticosteroid use.
As with other potent fluorinated topical corticosteroids, clobetasol should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis. Clobetasol may aggravate these conditions. Clobetasol preparations should not be applied to the face, groin, or axillae. Care should be taken to avoid use around the eyes; ophthalmic administration is contraindicated. Visual impairment, ocular hypertension and worsened cataracts have been reported with ocular exposure to other high potency topical corticosteroids. Preexisting glaucoma may be aggravated if clobetasol is used in the periorbital area.
Topical corticosteroids should be used for brief periods, or under close medical supervision in patients with evidence of pre-existing skin atrophy. Elderly patients may be more likely to have preexisting skin atrophy secondary to aging. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients. Topical clobetasol clinical trials included insufficient numbers of elderly patients to do a separate analysis of efficacy and safety in this population. Based on available data, no dosage adjustments are required for elderly patients receiving topical clobetasol. Use of lower potency topical corticosteroids also may be necessary in some patients.
[ Last revised: 1/12/2004 11:58:00 AM ]
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