CLOBETASOL PROPIONATE- clobetasol propionate cream

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Tersedia dari:

NuCare Pharmaceuticals,Inc.

Rute administrasi :

TOPICAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Clobetasol propionate cream (emollient) USP, 0.05% is a super-high potency corticosteroid indicated for: Clobetasol propionate cream (emollient) USP, 0.05% 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 (emollient) USP, 0.05% 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 (emollient) USP, 0.05% 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

Ringkasan produk:

How Supplied Clobetasol Propionate Cream (Emollient) USP, 0.05% is a white to off-white cream.NDC 68071-4221-6 Box of 60g Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Clobetasol Propionate Cream (Emollient) USP, 0.05% should not be refrigerated.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL PROPIONATE CREAM
(EMOLLIENT) USP, 0.05% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLOBETASOL
PROPIONATE CREAM (EMOLLIENT) USP, 0.05%
CLOBETASOL PROPIONATE CREAM (EMOLLIENT) USP, 0.05% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Clobetasol propionate cream (emollient) USP, 0.05% is a corticosteroid
indicated for:
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)
Limitations of Use
Clobetasol propionate cream (emollient) USP, 0.05% should not be used
in the treatment of rosacea or perioral 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)
DOSAGE AND ADMINISTRATION
Apply a thin layer of clobetasol propionate cream (emollient) USP,
0.05% 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 (emollient) USP, 0.05% 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)
DOSAGE FORMS AND STRENGTHS
Cream: 0.05% ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
Clobetasol propionate is a highly potent topical corticosteroid that
has been shown to suppress the HPA axis doses as
low as 2 grams per day.