ADAPALENE AND BENZOYL PEROXIDE gel

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Доступна с:

Bryant Ranch Prepack

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. None There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m 2 /day) the maximum recommended human dose (MRHD) of 2 grams of adapalene and benzoyl peroxide gel, 0.1%/2.5%. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate,

Обзор продуктов:

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows:    45 gram pump NDC 63629-8607-1 Storage and handling -Store at 25°C; excursions permitted to 15° – 30°C (59° – 86°F). -Protect from light. -Keep out of reach of children. -Keep away from heat. -Keep tube tightly closed.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE GEL
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE AND
BENZOYL PEROXIDE GEL, 0.1%/2.5% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5%.
ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a combination of
adapalene, a retinoid, and benzoyl
peroxide, and is indicated for the topical treatment of acne vulgaris
in patients 9 years of age and older.
(1)
DOSAGE AND ADMINISTRATION
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is not for oral,
ophthalmic, or intravaginal use. (2)
Apply a thin film of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% to
affected areas of the face and/or
trunk once daily after washing. Use a pea-sized amount for each area
of the face (e.g., forehead, chin,
each cheek). Avoid the eyes, lips and mucous membranes. (2)
DOSAGE FORMS AND STRENGTHS
Each gram of Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% contains 1
mg (0.1%) adapalene and 25
mg (2.5%) benzoyl peroxide. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Ultraviolet Light and Environmental Exposure: Avoid exposure to
sunlight and sunlamps. Wear sunscreen
when sun exposure cannot be avoided. (5.1) (5)
Erythema, scaling, dryness, stinging/burning, irritant and allergic
contact dermatitis may occur with use of
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% and may necessitate
discontinuation. (5.2) (5)
ADVERSE REACTIONS
Most commonly reported adverse events (≥1%) in patients treated with
Adapalene and Benzoyl Peroxide
Gel, 0.1%/2.5% were dry skin, contact dermatitis, application site
burning, application site irritation and
skin irritation.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at
1-866-634-9120 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch
SEE 17 FOR PATIENT COUNSELING INFORMATION.
R