CLOBETASOL PROPIONATE (EMOLLIENT)- clobetasol propionate cream

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

clobetasol propionate (UNII: 779619577M) (clobetasol - UNII:ADN79D536H)

Disponível em:

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

DCI (Denominação Comum Internacional):

clobetasol propionate

Composição:

clobetasol propionate 0.5 mg in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Clobetasol propionate cream, 0.05% (emollient) is a super-high potency corticosteroid indicated for: Clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week. Clobetasol propionate cream, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended. Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. The total dosage should not exceed 50 grams per week. Avoid use if skin atrophy is present at the treatment site. None Pregnancy Category C. There are no adequate and well-controlled

Resumo do produto:

How Supplied Clobetasol Propionate Cream USP, 0.05% (emollient), is a white to off-white cream, supplied as follows: NDC 0168-0301-15 15 g tube NDC 0168-0301-30 30 g tube NDC 0168-0301-60 60 g tube Storage and Handling Store between 15°C and 30°C (59°F and 86°F) Clobetasol Propionate Cream USP, 0.05% (emollient) should not be refrigerated.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CLOBETASOL PROPIONATE (EMOLLIENT)- CLOBETASOL PROPIONATE CREAM
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
CLOBETASOL
PROPIONATE CREAM, 0.05% (EMOLLIENT) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT)
CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT), FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Clobetasol propionate cream, 0.05% (emollient) is a corticosteroid
indicated for:
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Limitations of Use
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Cream: 0.05% (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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The relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in
patients 12 years of age or older. (1.1)
The treatment of moderate to severe plaque-type psoriasis in patients
16 years of age and older.
(1.2)
Clobetasol propionate cream, 0.05% (emollient) should not be used in
the treatment of rosacea or
perioral dermatitis, and should not be used on the face, groin, or
axillae. (1.3)
The total dosage should not exceed 50 grams per week.(1.3)
Avoid use if skin atrophy is present at the treatment site.(1.3)
Apply a thin layer of Clobetasol propionate cream, 0.05% (emollient)
to the affected skin areas twice
daily and rub in gently and completely. (2)
Treatment should be limited to 2 consecutive weeks, and amounts
greater than 50 grams per week
should not be used. (2)
In moderate to severe plaque-type psoriasis, Clobetasol propionate
cream, 0.05% (emollient) applied
to 5% to 10% of body surface area can be used for up to 4 weeks. The
total dosage should not
exceed 50 grams per week. When dosing for more than 2 weeks, any
additional benefit of extending
treatment should be weighed against the risk of HPA suppression. (2)
Clobetasol propionate is a highly potent topical corticosteroid that
ha