FDA label ef1d3b69-0745-dbca-e053-2995a90a1ef9

5. WARNINGS AND PRECAUTIONS 5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Systemic effects of topical corticosteroids may include reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortisone Butyrate. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Lotion due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations ( 8.4 ) ]. Patients applying a topical corticosteroid to a large surface area or to areas under occlusion should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST). Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Lotion as recommended [see Dosage and Administration (2) ]. If HPA axis suppression is noted, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids [see Adverse Reactions (6)]. 5.2 Concomitant Skin Infection s If skin infections are present or develop, an appropriate antifungal, antibacterial or antiviral agent shouldbe used. If a favorable response does not occur promptly, use of Hydrocortisone Butyrate Lotion should be discontinued until the infection has been adequately controlled [see Adverse Reactions (6)]. 5.3 Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing. Discontinue Hydrocortisone Butyrate Lotion if the diagnosis is established [see Adverse Reactions (6)]. Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluations for HPA axis suppression if Hydrocortisone Butyrate Lotion is applied to large surface areas or used under occlusion. If HPA axis suppression is noted, reduce the application frequency, discontinue use, or switch to a lower potency corticosteroid. (5.1, 8.4) Systemic effects of topical corticosteroids may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. (5.1, 8.4) Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface-to-body-mass ratios. (5.1, 8.4) Initiate appropriate therapy if concomitant skin infections develop. (5.2)

6. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: HPA axis suppression. This has been observed in pediatric subjects using Hydrocortisone Butyrate Lotion [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 ) ] Concomitant skin infections [see Warnings and Precautions ( 5.2 ) ] Allergic contact dermatitis [see Warnings and Precautions ( 5.3 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The safety data derived from Hydrocortisone Butyrate Lotion clinical trials reflect exposure to Hydrocortisone Butyrate Lotion twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age and adult subjects 18 years of age and older with mild to moderate atopic dermatitis. Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Hydrocortisone Butyrate Lotion. Although the rates of application site reactions in the vehicle group were greater than those in the Hydrocortisone Butyrate group in both studies, these rates are included in the tables (Table 1 and Table 2) because skin irritation is a known adverse reaction of topical corticosteroids. 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. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions included: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria and telangiectasia. The most common adverse reactions (> 1%) are application site reactions. To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1- 856-697-1441 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. tables 1 and 2