Hydrocortisone Butyrate
Generic Name: hydrocortisone butyrate
Brand Names:
Hydrocortisone Butyrate
11 DESCRIPTION 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 .
Overview
11 DESCRIPTION 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 .
Uses
1 INDICATIONS AND USAGE 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 )
Dosage
2 DOSAGE AND ADMINISTRATION 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.
Side Effects
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 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.
Warnings
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 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 ) 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. 4 CONTRAINDICATIONS None. None. ( 4 )
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Hydrocortisone butyrate lotion, 0.1%, is white to off white in color and supplied in bottles of 2 fl. oz. (NDC 68180-951-01) and 4 fl. oz. (NDC 68180-951-02). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.
Frequently Asked Questions
What is Hydrocortisone Butyrate used for?▼
1 INDICATIONS AND USAGE 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 )
What are the side effects of Hydrocortisone Butyrate?▼
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 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.
What are the important warnings for Hydrocortisone Butyrate?▼
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 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 ) 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. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.