CLOBETASOL PROPIONATE EMOLLIENT FORMULATION- clobetasol propionate aerosol, foam

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Padagis Israel Pharmaceuticals Ltd

ИНН (Международная Имя):

CLOBETASOL PROPIONATE

состав:

CLOBETASOL PROPIONATE 0.5 mg in 1 g

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Clobetasol Propionate Foam, 0.05% (Emulsion) is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. None. Risk Summary There are no available data on Clobetasol Propionate Foam, 0.05% (Emulsion) use in pregnant women to inform of a drug associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birth weight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use Clobetasol Propionate Foam, 0.05% (Emulsion) on the smallest area of skin and for the shortest duration possible (see Data ). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure with human exposure was compu

Обзор продуктов:

Clobetasol Propionate Foam, 0.05% (Emulsion) contains 0.5 mg of clobetasol propionate, USP per gram. The white emulsion aerosol foam is available as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION . Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Keep out of reach of children.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CLOBETASOL PROPIONATE EMOLLIENT FORMULATION- CLOBETASOL
PROPIONATE AEROSOL, FOAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL
PROPIONATE FOAM, (EMULSION) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
CLOBETASOL PROPIONATE FOAM (EMULSION).
CLOBETASOL PROPIONATE FOAM (EMOLLIENT FORMULATION) 0.05%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
RECENT MAJOR CHANGES
Warnings and Precautions, _Ophthalmic Adverse Reactions_ (5.3) 05/2018
INDICATIONS AND USAGE
•
DOSAGE AND ADMINISTRATION
Clobetasol Propionate Foam, 0.05% (Emulsion) is not for oral,
ophthalmic, or intravaginal use. (2)
•
•
DOSAGE FORMS AND STRENGTHS
Foam, 0.05%. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING. (6)
REVISED: 08/2018 (6)
Clobetasol Propionate Foam, 0.05% (Emulsion) is a corticosteroid
indicated for the treatment of
inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses in patients 12
years and older. (1.1)
Apply Clobetasol Propionate Foam, 0.05% (Emulsion) to the affected
area(s) twice daily, morning and
evening, for up to 2 consecutive weeks. The maximum weekly dose should
not exceed 50 g. (2)
Avoid use on face, axilla, and groin, or if skin atrophy is present at
the treatment site. (2)
Clobetasol Propionate Foam, 0.05% (Emulsion) has been shown to
suppress the HPA axis. Systemic
absorption of Clobetasol Propionate Foam, 0.05% (Emulsion) may produce
reversible HPA axis
suppression, Cushing’s syndrome, hyperglycemia, and unmask latent
diabetes. (5.1)
Because of the potential for systemic absorption, use of topical
corticosteroids may require that
patients be periodically evaluated for HPA axis suppression. (5.1)
Modify use s