Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Preferred Pharmaceuticals, Inc.
TOPICAL
PRESCRIPTION DRUG
None. 8.1 Pregnancy 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/m 2 /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 of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation d
Hydrocortisone Butyrate Lotion, 0.1%, is white to off white in color and supplied in bottles of 4 fl. oz. (NDC 68788-7719-01). 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 LOTION PREFERRED PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HYDROCORTISONE BUTYRATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROCORTISONE BUTYRATE. HYDROCORTISONE BUTYRATE LOTION, 0.1%, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1982 INDICATIONS AND USAGE 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 AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS Lotion, 0.1% (1 mg/g), supplied in bottles of 4 fl. oz. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS The most common adverse reactions (> 1%) are application site reactions. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TELIGENT PHARMA, INC. AT 1- 856-697-1441 AND/OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6) SEE 17 FOR PATIENT COUNSELING INFORMATION. (6) REVISED: 7/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1. INDICATION AND USAGE 2. DOSAGE AND ADMINISTRATION 3. DOSAGE FORMS AND STRENGTHS Apply a thin layer to the affected skin two times daily. (2) Rub in gently. (2) Discontinue Hydrocortisone Butyrate Lotion when control is achieved. (2) Reassess diagnosis if no improvement is seen within 2 weeks. Before prescribing for more than 2 weeks, and 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 ButyrateLotion 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) Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency. Consider periodic evaluations for HPA axi Prečítajte si celý dokument