LOCOID LIPOCREAM

No studies were conducted to determine the pharmacokinetics of Hydrocortisone Butyrate Lotion. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin, occlusive dressings, or widespread application may increase percutaneous absorption. ...

In a multicenter, randomized, vehicle-controlled trial of 284 pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis, Hydrocortisone Butyrate Lotion or vehicle was applied twice daily for up to 4 weeks. Treatment success was assessed at day 29 (after 28 days of treatment) and was defined as the proportion of subjects who achieved both “clear” or “almost clear” and at least a 2-grade improvement from baseline on a 5-point Physician’s Global Assessment (PGA) scale. The trial results are shown in Table 3 . TABLE 3. Efficacy results at Day 29 in Pediatric Subjects 3...

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• HPA axis suppression [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]
• Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5. 2)]
• Skin infections [see Warnings and Precautions (5.3)]
• Allergic contact dermatitis [see Warnings and Precautions (5.4)] The most common adverse reactions (> 1%) are application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIO...

None. None. ( 4 )

• Endocrine System Adverse Reactions: o 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) o Systemic effects of topical cortico...