Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Mayne Pharma Inc.
TOPICAL
PRESCRIPTION DRUG
Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. None. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Hydrocortisone Butyrate Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Note: The animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (MTHD) for hydrocortisone butyrate lotion (25 g lotion). Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses
Hydrocortisone Butyrate Lotion, 0.1%, is white to off white in color and supplied in bottles of 2 fl. oz. (NDC 51862-159-02) and 4 fl. oz. (NDC 51862-159-04). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.
Abbreviated New Drug Application
HYDROCORTISONE BUTYRATE- HYDROCORTISONE BUTYRATE LOTION MAYNE PHARMA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HYDROCORTISONE BUTYRATE LOTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROCORTISONE BUTYRATE LOTION. HYDROCORTISONE BUTYRATE LOTION 0.1%, FOR TOPICAL USE. INITIAL U.S. APPROVAL: 1982 INDICATIONS AND USAGE Hydrocortisone Butyrate Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. (1) DOSAGE AND ADMINISTRATION Apply a thin layer to the affected skin two times daily. (2) Rub in gently. (2) Discontinue Hydrocortisone Butyrate 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 has not been established beyond 4 weeks of use. (2) Avoid use under occlusion or in the diaper area. (2) Hydrocortisone Butyrate Lotion is not for oral, ophthalmic, or intravaginal use. (2) DOSAGE FORMS AND STRENGTHS Lotion, 0.1% (1 mg/g), supplied in bottles of 2 fl. oz. and 4 fl. oz. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluation 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 s Belgenin tamamını okuyun