HYDROCORTISONE BUTYRATE

Hydrocortisone butyrate lotion, 0.1% contains hydrocortisone butyrate, a non- fluorinated hydrocortisone ester, for topical use. The chemical name of hydrocortisone butyrate is 11 β ,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate. It has the following structural formula: Hydrocortisone butyrate USP is a white crystalline powder with a molecular weight of 432.56, and a molecular formula of C 25 H 36 O 6 . It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of hydrocortisone butyrate lotion, 0.1% contains 1 mg of hydrocortisone butyrate USP in a white to off white lotion base consisting of butylated hydroxytoluene, butylparaben, ceteth-20, cetostearyl alcohol, citric acid monohydrate, light mineral oil, propylparaben, purified water, sodium citrate, and white petrolatum. Image-01

Hydrocortisone butyrate lotion, 0.1% is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Hydrocortisone butyrate lotion, 0.1% is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )

Apply a thin layer to the affected skin areas two times daily, and rub in gently. Do not apply hydrocortisone butyrate lotion, 0.1% in the diaper area unless directed by a physician. Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of hydrocortisone butyrate lotion, 0.1% has not been established beyond 4 weeks of use [see WARNINGS AND PRECAUTIONS (5.1) ] . Do not use hydrocortisone butyrate lotion, 0.1% with occlusive dressings unless directed by a physician. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings. Hydrocortisone butyrate lotion, 0.1% is not for oral, ophthalmic, or intravaginal use. Apply a thin layer to the affected skin two times daily. ( 2 ) Rub in gently. ( 2 ) Discontinue hydrocortisone butyrate lotion, 0.1% when control is achieved. ( 2 ) Reassess diagnosis if no improvement is seen within 2 weeks. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. Safety and efficacy of hydrocortisone butyrate lotion, 0.1% has not been established beyond 4 weeks of use. ( 2 ) Avoid use under occlusion or in the diaper area. ( 2 ) Hydrocortisone butyrate lotion, 0.1% is not for oral, ophthalmic, or intravaginal use. ( 2 )

None. None. ( 4 )

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) ] The most common adverse reactions (>1%) are application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 and/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, 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 lotion 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 Hydrocortisone Butyrate 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 Hydrocortisone Butyrate Lotion ( n=151) n (%) Vehicle ( n=150) n (%) Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus 5 (3) 7 (5) 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.