BETAMETHASONE DIPROPIONATE ointment, augmented

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Preferred Pharmaceuticals Inc.

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Betamethasone dipropionate ointment (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 ointment (augmented) 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 ointment (augmented) 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 ointment (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate ointment (augmented) on the

Resumo do produto:

Betamethasone Dipropionate Cream USP 0. 05% is supplied in: 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 OINTMENT,
AUGMENTED
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE
DIPROPIONATE OINTMENT (AUGMENTED) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR BETAMETHASONE DIPROPIONATE OINTMENT (AUGMENTED).
BETAMETHASONE DIPROPIONATE OINTMENT (AUGMENTED) 0.05% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1983
RECENT MAJOR CHANGES
Warnings and Precautions
Ophthalmic Adverse Reactions (5.2) 05/2019
INDICATIONS AND USAGE
Betamethasone dipropionate ointment (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
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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
Most common adverse reactions (less than 1%) are: erythema,
folliculitis, pruritus, and vesiculation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACTAVIS AT
1-800-432-8534 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2022
Apply a thin film to the affected skin areas once or twice daily. (2)
Discontinue therapy when control is achieved. (2)
Limit therapy to no more than 2 consecutive weeks. (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)
Ointment, 0.05% (3)
Hypersensitivity to any component of this medicine. (4)
Effects on endocrine system: Betamethasone dipropionate ointment
(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 corti