CLOBETASOL PROPIONATE (EMOLLIENT)- clobetasol propionate cream

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Teligent Pharma, Inc.

Manustamisviis:

TOPICAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Clobetasol propionate cream USP, 0.05% (emollient) is a super-high potency corticosteroid indicated for: Clobetasol propionate cream USP, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-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 USP, 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 USP, 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 Cate

Toote kokkuvõte:

How Supplied Clobetasol Propionate Cream USP, 0.05% (emollient), is a white to off-white cream, supplied as follows: NDC 52565-094-15   15 g tube NDC 52565-094-30   30 g tube NDC 52565-094-45   45 g tube NDC 52565-094-60   60 g tube Storage and Handling Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].                      Clobetasol Propionate Cream USP, 0.05% (emollient) should not be refrigerated.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

CLOBETASOL PROPIONATE (EMOLLIENT) - CLOBETASOL PROPIONATE CREAM
TELIGENT PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL PROPIONATE CREAM
(EMOLLIENT) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CLOBETASOL PROPIONATE
CREAM (EMOLLIENT).
CLOBETASOL PROPIONATE CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Clobetasol propionate cream USP, 0.05% (emollient) 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 USP, 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)
DOSAGE AND ADMINISTRATION
Apply a thin layer of Clobetasol propionate cream USP, 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 USP, 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)
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.(5.1)
Cushing's syndrome, hyperglycemia, and glucosuria ca