Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
Proficient Rx LP
BETAMETHASONE DIPROPIONATE
BETAMETHASONE 0.5 mg in 1 g
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 63187-433-15) 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 PROFICIENT RX LP ---------- 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 • • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • ADVERSE REACTIONS • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK GENERICS 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. REVISED: 2/2015 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 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, 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 Aqra d-dokument sħiħ