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warnings and cautions
5 WARNINGS AND PRECAUTIONS Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluations for HPA axis suppression if Locoid® 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 ) Discontinue use if irritation develops. ( 5.3 ) 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 Locoid® Lotion. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Locoid® 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 (ACTH 1-24 ) stimulation testing (CST). If HPA axis suppression is noted, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted.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. 5.2 Concomitant Skin Infections If skin infections are present or develop, an appropriate antifungal, antibacterial or antiviral agent should be used. If a favorable response does not occur promptly, use of Locoid® Lotion should be discontinued until the infection has been adequately controlled. 5.3 Skin Irritation Locoid® Lotion may cause local skin adverse reactions [see Adverse Reactions ( 6 ) ]. If irritation develops, Locoid® Lotion should be discontinued and appropriate therapy instituted. 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.
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 Locoid Lotion [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 ) ] Concomitant skin infections [see Warnings and Precautions ( 5.2 ) ] Skin irritation [see Warnings and Precautions ( 5.3 ) ] The most common adverse reactions (>1%) are HPA axis suppression and application site reactions ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Triax Pharmaceuticals, LLC at 800-978-5060 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience The safety data derived from Locoid® Lotion clinical trials reflect exposure to Locoid® 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 and older with mild to moderate atopic dermatitis. 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. Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Locoid® Lotion. Although the rates of application site reactions in the vehicle group were greater than those in the Locoid® 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. TABLE 1. Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis Locoid Lotion (n=139) n (%) Vehicle (n=145) n (%) Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation 2 (1) 20 (14) Infantile acne 1 (1) 0 (0) Skin depigmentation 1 (1) 0 (0) TABLE 2. Frequency of adverse reactions in adult subjects with mild to moderate atopic dermatitis Locoid Lotion (n=151) n (%) Vehicle (n=150) n (%) Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus 5 (3) 7 (5) 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.