BETAMETHASONE DIPROPIONATE cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Betamethasone Dipropionate (UNII: 826Y60901U) (Betamethasone - UNII:9842X06Q6M)

זמין מ:

Proficient Rx LP

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

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].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
PROFICIENT RX LP
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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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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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