BETAMETHASONE DIPROPIONATE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

RPK Pharmaceuticals, Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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. Risk Summary There are no available data on Betamethasone Dipropionate Cream USP (Augmented), 0.05% use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that Betamethasone Dipropionate Cream USP (Augmented), 0.05% may increase the risk of having a low birthweight infant and to use Betamethasone Dipropio

Produktbesonderheiten:

Product: 53002-8280 NDC: 53002-8280-1 15 g in a TUBE

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
RPK 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. (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 AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2023
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 u