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% is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. None. Risk Summary There are no available data on Clobetasol Propionate Foam, 0.05% 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% 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.

Обзор продуктов:

Clobetasol Propionate Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white 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- 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 SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLOBETASOL
PROPIONATE FOAM.
CLOBETASOL PROPIONATE FOAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
RECENT MAJOR CHANGES
Warnings and Precautions, _Ophthalmic Adverse Reactions_ (5.2) 04/2018
INDICATIONS AND USAGE
Clobetasol Propionate Foam, 0.05% is a corticosteroid indicated for
treatment of moderate to severe
plaque psoriasis of the scalp and mild to moderate plaque psoriasis of
non-scalp regions of the body
excluding the face and intertriginous areas in patients 12 years and
older. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
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DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥ 4%) are application site burning
and other application site reactions.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
Apply a thin layer to the affected skin areas twice daily. (2)
Limit treatment to 2 consecutive weeks. (2)
Do not use more than 50 grams per week or more than 21 capfuls per
week. (2)
Discontinue therapy when control is achieved. (2)
Do not use with occlusive dressings unless directed by physician. (2)
Avoid use on the face, groin, or axillae, or if skin atrophy is
present at the treatment site. (2)
Foam, 0.05% (3)
None (4)
Clobetasol Propionate Foam, 0.05% can cause reversible HPA axis
suppression with the potential for
glucocorticosteroid insufficiency during and after withdrawal of
treatment. Risk factors include the use
of high-potency topical corticosteroid, use over a large surface area
or to areas under occlusion