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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 Lipocream 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. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) Systemic effects of topical corticosteroids may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body-mass ratios. ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) Initiate appropriate therapy if concomitant skin infections develop. ( Error! Hyperlink reference not valid. ) 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 Lipocream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Locoid Lipocream due to their larger skin-surface-to-body-mass ratios [see Error! Hyperlink reference not valid. ] . 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). Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Locoid Lipocream as recommended [see Error! Hyperlink reference not valid. ] . If HPA-axis suppression is noted, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted.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 Error! Hyperlink reference not valid. ] . 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 Lipocream should be discontinued until the infection has been adequately controlled [see Error! Hyperlink reference not valid. ] . 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 Locoid Lipocream if the diagnosis is established [see Error! Hyperlink reference not valid. ] .
warnings and cautions
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 Lipocream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Locoid Lipocream due to their larger skin-surface-to-body-mass ratios [see Error! Hyperlink reference not valid. ] . 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). Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Locoid Lipocream as recommended [see Error! Hyperlink reference not valid. ] . 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 Error! Hyperlink reference not valid. ] .
warnings and cautions
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 Lipocream should be discontinued until the infection has been adequately controlled [see Error! Hyperlink reference not valid. ] .
warnings and cautions
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 Locoid Lipocream if the diagnosis is established [see Error! Hyperlink reference not valid. ] .
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 Lipocream [see Error! Hyperlink reference not valid. ) and Error! Hyperlink reference not valid. ] Concomitant skin infections [see Error! Hyperlink reference not valid. ] Allergic contact dermatitis [see Error! Hyperlink reference not valid. ] The most common adverse reactions (≥1%) are application site reactions. ( Error! Hyperlink reference not valid. ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 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. The safety data derived from Locoid Lipocream clinical trials reflect exposure to Locoid Lipocream twice daily for up to 4 weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis. Adverse reactions shown in the table below include those for which there is some basis to believe there is a causal relationship to Locoid Lipocream. Table 1. Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis Locoid Lipocream (n=131) Vehicle (n=133) Application site reactions, including application site folliculitis, irritation, dermatitis, erythema 1.5% 1.5% Acne 0.8% 0.0% Telangiectasia 0.0% 0.8% 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 but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
adverse reactions
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. The safety data derived from Locoid Lipocream clinical trials reflect exposure to Locoid Lipocream twice daily for up to 4 weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis. Adverse reactions shown in the table below include those for which there is some basis to believe there is a causal relationship to Locoid Lipocream. Table 1. Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis Locoid Lipocream (n=131) Vehicle (n=133) Application site reactions, including application site folliculitis, irritation, dermatitis, erythema 1.5% 1.5% Acne 0.8% 0.0% Telangiectasia 0.0% 0.8%
adverse reactions
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 but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.