Betamethasone Dipropionate

5 WARNINGS AND PRECAUTIONS Effects on endocrine system: Betamethasone dipropionate lotion (augmented) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) Ophthalmic Adverse Reactions: Betamethasone dipropinate lotion (augmented) may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.2 ) 5.1 Effects on Endocrine System Betamethasone dipropionate lotion (augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose 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 betamethasone dipropionate lotion (augmented) on the HPA axis, betamethasone dipropionate lotion (augmented) was applied once daily at 7 mL per day for 21 days to diseased scalp and body skin in subjects with scalp psoriasis, betamethasone dipropionate lotion (augmented) was shown to lower plasma cortisol levels below normal limits in 2 out of 11 subjects. HPA axis suppression in these subjects was transient and returned to normal within a week. In one of these subjects, plasma cortisol levels returned to normal while treatment continued. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [ see Use in Specific Populations (8.4) ]. 5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids, including betamethasone dipropionate lotion (augmented), may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate lotion (augmented) [ see Adverse Reactions (6.2) ]. Avoid contact of betamethasone dipropionate lotion (augmented) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.3 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, topical corticosteroids should be discontinued and appropriate therapy instituted.

6 ADVERSE REACTIONS Most common adverse reactions (<1%) are: erythema, folliculitis, pruritus, and vesiculation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials, adverse reactions associated with the use of betamethasone dipropionate lotion (augmented) reported at a frequency of less than 1% included erythema, folliculitis, pruritus, and vesiculation. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, striae, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria. Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported. Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.