Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for gluococorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. In addition, use of VANOS Cream for longer than 2 weeks may also suppress the immune system (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility).

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression. This may be done by using cosyntropin (ACTH1–24) stimulation testing. Patients should not be treated with VANOS Cream for more than 2 weeks at a time and only small areas should be treated at any time due to the increased risk of HPA-axis suppression.

If HPA-axis suppression is 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 upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Application of VANOS Cream, 0.1% twice daily for 14 days in 18 adult patients with plaque-type psoriasis (10–50% BSA, mean 19.6% BSA) and 31 adult patients (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2–10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 patients with psoriasis (with 12% and 25% BSA) and 1 patient with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH1–24) (See CLINICAL PHARMACOLOGY ).

Controlled clinical efficacy studies of VANOS Cream in pediatric patients younger than 17 years of age have not been conducted; (See PRECAUTIONS: Pediatric Use).

HPA-axis suppression has not been evaluated in psoriasis patients who are less than 18 years of age.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS: Pediatric Use).

If irritation develops, VANOS Cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of VANOS Cream should be discontinued until the infection has been adequately controlled.

VANOS Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.