BETAMETHASONE DIPROPIONATE cream

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Disponível em:

NuCare Pharmaceuticals,Inc.

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
NUCARE PHARMACEUTICALS,INC.
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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