CLOBETASOL PROPIONATE emulsion

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Akorn

INN (Tarptautinis Pavadinimas):

CLOBETASOL PROPIONATE

Sudėtis:

CLOBETASOL PROPIONATE 0.5 mg in 1 g

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Clobetasol propionate emollient cream, 0.05% is a super-high potency corticosteroid indicated for: Clobetasol propionate emollient cream, 0.05% 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 emollient cream 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 emollient cream, 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 well-controlled st

Produkto santrauka:

Clobetasol Propionate Emollient Cream, 0.05% is supplied in 15-g tubes (NDC 50383-270-15), 30-g tubes (NDC 50383-270-30), and 60-g tubes (NDC 50383-270-60). Store between 15° and 30° C (59° and 86° F). Clobetasol propionate emollient cream, 0.05% should not be refrigerated .

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE EMULSION
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL
PROPIONATE EMOLLIENT CREAM, 0.05% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR CLOBETASOL PROPIONATE EMOLLIENT CREAM, 0.05%.
CLOBETASOL PROPIONATE EMOLLIENT CREAM, 0.05%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Clobetasol propionate emollient cream, 0.05% is a corticosteroid
indicated for: (1)
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Cream: 0.05% (3) (3)
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reaction is burning/stinging (incidence 5%);
common adverse reactions
(incidence < 2%) are pruritis, irritation, erythema, folliculitis,
cracking and fissuring of the skin, numbness
of the fingers, tenderness in the elbow, skin atrophy, and
telangiectasia. (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HI-TECH PHARMACAL CO.,
INC. AT 1-800-
262-9010 OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
REVISED: 3/2022
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 emollient cream, 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. (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 emollient cream, 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, c