Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
REMEDYREPACK INC.
TOPICAL
PRESCRIPTION DRUG
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 or older. Betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Risk Summary There are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area
Betamethasone dipropionate cream USP (augmented), 0.05% is a white cream supplied in NDC: 70518-3701-00 PACKAGING: 1 in 1 CARTON, 50 g in 1 TUBE TYPE 0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BETAMETHASONE DIPROPIONATE CREAM (AUGMENTED) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BETAMETHASONE DIPROPIONATE CREAM (AUGMENTED). BETAMETHASONE DIPROPIONATE CREAM, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1983 RECENT MAJOR CHANGES Warnings and Precautions Ophthalmic Adverse Reactions ( 5.2) 05/2019 INDICATIONS AND USAGE Betamethasone dipropionate cream (augmented), 0.05% 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 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) DOSAGE FORMS AND STRENGTHS Cream, 0.05% ( 3) CONTRAINDICATIONS Hypersensitivity to any component of this medicine. ( 4) WARNINGS AND PRECAUTIONS 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. ( 5.1, 8.4) Ophthalmic Adverse Reactions: Betamethasone dipropionate cream (augmented) may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.2) ADVERSE REACTIO Прочитайте повний документ