Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
Glenmark Pharmaceuticals Inc., USA
BETAMETHASONE DIPROPIONATE
BETAMETHASONE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Risk Summary There are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate cream (augmented) to women who are breastfeeding. It is possible that topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for betamethasone dipropionate cream (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate cream (augmented) or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate cream (augmented) directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations ( Error! Hyperlink reference not valid. )] .
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
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM GLENMARK PHARMACEUTICALS INC., USA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BETAMETHASONE DIPROPIONATE CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BETAMETHASONE DIPROPIONATE CREAM. BETAMETHASONE DIPROPIONATE CREAM (AUGMENTED), FOR TOPICAL USE INITIAL U.S. APPROVAL: 1983 INDICATIONS AND USAGE Betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. (1) DOSAGE AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • ADVERSE REACTIONS • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK PHARMACEUTICALS INC., USA AT 1 (888) 721-7115 OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 8/2020 FULL PRESCRIBING INFORMATION: CONTENTS* Apply a thin film to the affected skin areas once or twice daily. (2) Discontinue therapy when control is achieved. (2) Use no more than 50 g per week. (2) Do not use with occlusive dressings unless directed by a physician. (2) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2) Not for oral, ophthalmic, or intravaginal use. (2) Cream, 0.05% (3) Hypersensitivity to any component of this medicine. (4) Effects on endocrine system: Betamethasone dipropionate cream (augmented) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. ( Olvassa el a teljes dokumentumot