Country: United States
Language: English
Source: NLM (National Library of Medicine)
Betamethasone Dipropionate (UNII: 826Y60901U) (Betamethasone - UNII:9842X06Q6M)
Proficient Rx LP
TOPICAL
PRESCRIPTION DRUG
Betamethasone Dipropionate Cream USP (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 or older. Betamethasone Dipropionate Cream USP (Augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. There are no adequate and well-controlled studies in pregnant women. Betamethasone Dipropionate Cream USP (Augmented), 0.05% 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 corticosteroid production
Betamethasone Dipropionate Cream USP (Augmented), 0.05% is available as follows: 15 g tube (NDC 71205-275-15) Store at 20-25°C (68-77°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 CREAM USP (AUGMENTED), 0.05% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BETAMETHASONE DIPROPIONATE CREAM USP (AUGMENTED), 0.05%. BETAMETHASONE DIPROPIONATE CREAM USP (AUGMENTED), 0.05% FOR TOPICAL USE INITIAL U.S. APPROVAL: 1983 INDICATIONS AND USAGE Betamethasone Dipropionate Cream USP (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.0 (1) DOSAGE AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • ADVERSE REACTIONS • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO AT 1-866-634-9120 OR FDA AT 1- 800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 4/2022 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 USP (Augmented), 0.05% 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 Read the complete document