BETAMETHASONE DIPROPIONATE cream, augmented

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

BETAMETHASONE DIPROPIONATE

Composition:

BETAMETHASONE 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone Dipropionate Cream USP, 0.05% (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 USP, 0.05% (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 USP, 0.05% (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 USP, 0.05% (Augmented)may increase the risk of having a low birthweight infant and to use Betamethasone Dipropio

Product summary:

Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is supplied as follows: NDC 0168-0265-15, 15 gram tube NDC 0168-0265-50, 50 gram tube Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM,
AUGMENTED
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE.
BETAMETHASONE DIPROPIONATE
CREAM, 0.05% (AUGMENTED) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BETAMETHASONE
DIPROPIONATE CREAM, 0.05% (AUGMENTED).
BETAMETHASONE DIPROPIONATE CREAM, 0.05 % (AUGMENTED)
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1983
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Betamethasone Dipropionate Cream, 0.05% (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 FOUGERA PHARMACEUTICALS
INC. AT 1-800-645-9833 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2020
Warnings and Precautions Ophthalmic Adverse Reactions (5.2) 05/2019
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, 0.05%
(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
occlus