BETAMETHASONE DIPROPIONATE cream

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Glenmark Pharmaceuticals Inc., USA

INN (nume internaţional):

BETAMETHASONE DIPROPIONATE

Compoziție:

BETAMETHASONE 0.5 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Risk Summary There are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate cream (augmented) to women who are breastfeeding. It is possible that topical administration of large amounts of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for betamethasone dipropionate cream (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate cream (augmented) or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate cream (augmented) directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations ( Error! Hyperlink reference not valid. )] .

Rezumat produs:

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE
DIPROPIONATE CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BETAMETHASONE DIPROPIONATE CREAM.
BETAMETHASONE DIPROPIONATE CREAM (AUGMENTED), FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
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 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 GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2020
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
(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. (