Topical therapy of corticosteroid responsive acute and chronic skin eruptions, where an anti-inflammatory, anti-allergenic and antipruritic activity is required in the topical management of these conditions.

Corticosteroid enemas are used as adjunctive therapy in the management of certain inflammatory diseases involving the rectum, or sigmoid and left colon.

Untreated tubercular, bacterial and fungal infections involving the skin, and in certain viral diseases such as herpes simplex, chickenpox, and vaccinia; hypersensitivity to any of the components of the product. Individual products may contain nonmedicinal ingredients causing hypersensitivity in some patients, e.g., the manufacturer of prednicarbate warns the product is contraindicated in individuals sensitive to wool/lanolin since the emollient cream contains wool alcohols ointment and wool wax alcohols.

If used under an occlusive dressing, particularly over extensive areas, or on the face, scalp, axilla(e), scrotum or when applied to the genitourinary tract or when administered rectally, sufficient absorption may take place to give rise to adrenal suppression and other systemic effects. Fluorinated corticosteroids in particular should be used with caution on the face.

Topical corticosteroids (particularly the potent ones) should be used with caution on lesions close to the eye because systemic absorption may cause increased intraocular pressure, glaucoma or cataracts.

Tolerance to the vasoconstrictive effects of topical corticosteroids may occur with repeated administration

Although hypersensitivity reactions have been rare with topically applied steroid products, the drug should be discontinued and appropriate therapy initiated if there are signs of reaction.

Prolonged use of topical corticosteroid products may produce atrophy of the skin and of subcutaneous tissues particularly on flexor surfaces and on the face. If this is noted, discontinue the use of the product.

In cases of infections of the skin, appropriate anti-infective agents should be used in primary therapy. In selected cases, the topical corticosteroid product may be used as an adjunct to control inflammation, erythema, and itching.

Topical corticosteroids should be used with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation. They should also be used with caution in patients receiving other immunosuppressants.

If a symptomatic response is not noted within a few days to a week, the local applications of corticosteroid should be discontinued and the patient re-evaluated. During the use of topical corticosteroids secondary infections may occur.

Under certain circumstances such as prolonged use, application over a large area of the body, use of an occlusive dressing, administration by retention enema, use in children or infants or use of a potent agent, adverse systemic corticosteroid effects may occur. If long-term therapy is anticipated, measures such as interrupting treatment periodically or treating one body area at a time may help to minimize the risk of adverse systemic effects. When long-term rectal use is discontinued, it must be tapered gradually.

Patients should be advised to inform current and subsequent physicians of the prior use of corticosteroids.

Occlusive dressings should not be applied if there is an elevation of body temperature.

The use of topical corticosteroids is generally considered to be compatible with pregnancy.

The use of topical corticosteroids is generally considered to be compatible with lactation.

Pediatric patients have a higher skin surface to body weight ratio than do adults and may absorb a higher percentage of topically applied corticosteroids. This may translate into a greater susceptibility to topical corticosteroid-induced HPA axis suppression and to exogenous corticosteroid effects. Caregivers should be reminded that diapers or plastic pants could constitute occlusive dressings when topical coritcosteroids are applied in the diaper area.

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 ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelle, headaches and bilateral papilledema.

The following local adverse reactions have been reported with the use of topical corticosteroids: dryness, itching, burning, local irritation, striae, skin atrophy, atrophy of subcutaneous tissues, telangiectasia, hypertrichosis, change in pigmentation and secondary infection. It should be noted that infection can be masked by the anti-inflammatory action of topical corticosteroids. If applied to the face, acne rosacea or perioral dermatitis can occur. When occlusive dressings are used, pustules, miliaria, folliculitis and pyoderma may occur. Contact sensitivity to a particular dressing material or adhesive may occur occasionally.

In rare instances, treatment of psoriasis with systemic or very potent topical corticosteroids (or their withdrawal) is thought to have provoked the pustular form of the disease.

Adrenal suppression has also been reported following topical corticosteroid therapy. Conditions that may increase systemic adsorption include use of the more potent steroids, use over a prolonged period of time, use over a large surface area and use with an occlusive dressing.