BETAMETHASONE DIPROPIONATE cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals,Inc.

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Betamethasone Dipropionate Cream USP (Augmented), 0.05% is available as follows: 15 g tube (NDC 68071-4814-5) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

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 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
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 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. (5.1, 8.4)
Visual disturbances: Betamethasone Dipropionate Cream USP (Augmented),
0.05% may increase the
risk of cataracts and glaucoma. If visual symptoms occur, consider
referral to an ophthalmologist for
evaluation. (5.2)
ADVERSE REACTIONS
The most common adverse reaction repo