impoyz

Important safety information

Clobetasol propionate has been shown to suppress the HPA axis at the dose tested. (5.1) • Cushing’s syndrome, hyperglycemia, and glucosuria can also result from systemic absorption of topical corticosteroids. (5.1) • Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. (5.1) • Children may be more susceptible to systemic toxicity from use of topical corticosteroids. (5.1, 8.4) • Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings, prolonged use, or use of higher potency corticosteroids, including clobetasol propionate. These reactions include: irritation, dryness, acneiform eruptions, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. (5.1, 6.2) 5.1 Effects on the Endocrine System Clobetasol Propionate Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential for systemic absorption, use of topical corticosteroids, including Clobetasol Propionate Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of Clobetasol Propionate Cream on the HPA axis, subjects with plaque psoriasis applied Clobetasol Propionate Cream twice daily to at least 20% of involved Body Surface Area (BSA) for 15 days. Abnormal ACTH stimulation tests suggestive of HPA axis suppression were seen in 3 of 24 (12.5%) subjects on Clobetasol Propionate Cream [see Clinical Pharmacology (12.2)]. In another trial to evaluate the effects of Clobetasol Propionate Cream on the HPA axis, subjects with moderate to severe plaque psoriasis applied Clobetasol Propionate Cream twice daily to at least 25% of involved BSA for 28 consecutive days. Abnormal ACTH stimulation test suggestive of HPA axis suppression was seen in 8 of 26 (30.8%) of subjects on Clobetasol Propionate Cream. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids. Minimize the unwanted risks from endocrine effects by mitigating risk factors favoring increased systemic bioavailability and by using the product as recommended [see Dosage and Administration (2)]. Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)]. 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including Clobetasol Propionate Cream. Some local adverse reactions may be irreversible. 5.3 Concomitant Skin Infections Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of Clobetasol Propionate Cream until the infection has been adequately treated. 5.4 Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.