Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
NuCare Pharmaceuticals,Inc.
TOPICAL
PRESCRIPTION DRUG
Betamethasone dipropionate cream, 0.05% (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, 0.5% (augmented)is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Betamethasone dipropionate cream, 0.5% (augmented)should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous
Betamethasone dipropionate cream, 0.05% (augmented) is a white to off-white cream supplied in 15 g (NDC 68071-1657-5) Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM NUCARE PHARMACEUTICALS,INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BETAMETHASONE DIPROPIONATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BETAMETHASONE DIPROPIONATE. BETAMETHASONE DIPROPIONATE CREAM, 0.05% (AUGMENTED*), FOR TOPICAL USE INITIAL U.S. APPROVAL: 1983 INDICATIONS AND USAGE Betamethasone dipropionate cream, 0.05% (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 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, 0.5% (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) ADVERSE REACTIONS The most common adverse reaction reported in 0.4% of adult patients is stinging. ( 6.1) The most common adverse reactions reported in 10% of pediatric patients are signs of skin atrophy, telangiectasia, bruising, shininess. ( 6.1, 8.4) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc Baca dokumen lengkapnya