Hydrocortisone Butyrate

Endocrine System Adverse Reactions: 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 Cream (lipid), 0.1% 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 ) Ophthalmic Adverse Reactions: Topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 ) Skin Infections: Initiate appropriate therapy if concomitant skin infections develop. ( 5.3 )

Endocrine System Adverse Reactions Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, can cause systemic adverse reactions including HPA-axis suppression with the potential for clinical glucocorticosteroid insufficiency. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Consider patients for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24) stimulation testing (CST). If HPA-axis suppression is noted, reduce the frequency of application or withdraw Hydrocortisone Butyrate Cream (lipid), 0.1%, or substitute a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. Studies conducted in pediatric subjects demonstrated reversible HPA-axis suppression after use of Hydrocortisone Butyrate Cream (lipid), 0.1%. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Cream (lipid), 0.1% due to their larger skin-surface-to-body-mass ratios [ see Use in Specific Populations ( 8.4 ) , Clinical Pharmacology ( 12.2 ) ]. Cushing’s Syndrome, Hyperglycemia, and Glucosuria Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. Additional Considerations for Endocrine Adverse Reactions Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Cream (lipid), 0.1% as recommended [ see Dosage and Administration ( 2 ) ].

Ophthalmic Adverse Reactions Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products [ see Adverse Reactions ( 6.2 ) ]. Avoid contact of Hydrocortisone Butyrate Cream (lipid), 0.1% with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

Skin Infections Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, may delay healing or worsen concomitant skin infections. If skin infections are present or develop, use an appropriate antifungal, antibacterial or antiviral agent. If a favorable response does not occur promptly, discontinue use of Hydrocortisone Butyrate Cream (lipid), 0.1% until the infection has been adequately controlled.

Allergic Contact Dermatitis Use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%, can cause 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 Cream (lipid), 0.1% if the diagnosis is established.