BETAMETHASONE DIPROPIONATE cream, augmented

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Taro Pharmaceuticals U.S.A., Inc.

INN (Nome Internazionale):

Betamethasone Dipropionate

Composizione:

Betamethasone 0.5 mg in 1 g

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Betamethasone dipropionate cream USP (augmented), 0.05% is a white cream supplied in 15 g (NDC 51672-1310-1), 30 g (NDC 51672-1310-2) and 50 g (NDC 51672-1310-3) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM,
AUGMENTED
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE
DIPROPIONATE CREAM (AUGMENTED) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR BETAMETHASONE DIPROPIONATE CREAM (AUGMENTED).
BETAMETHASONE DIPROPIONATE CREAM, 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 cream (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
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
(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)
Ophthalmic Adverse Reactions: Betamethasone dipropionate cream
(augmented) may increase the
risk of cataracts and glaucoma. If visual symptoms occur, consider
referral to an ophthalmologist for
evaluation. (5.2)
ADVERSE REA