ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5% 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:

GABAR HEALTH SCIENCES CORP

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 Pregnancy Category C. 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/m2/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, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.6 to 6.0 mg adapalene/kg/day [25 to 59 times (mg/m2) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of adapalene and benzoyl peroxide gel 0.1% / 2.5%. Because many drugs are excreted in human milk, caution should be exercised when adapalene and benzoyl peroxide gel 0.1% / 2.5% is administered to a nursing woman. Safety and effectiveness of adapalene and benzoyl peroxide gel 0.1% / 2.5% in pediatric patients under the age of 9 have not been established. Clinical studies of adapalene and benzoyl peroxide gel 0.1% / 2.5% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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 82429-313-45 Storage and handling • Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. • 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 GEL, 0.1%/2.5%- ADAPALENE AND BENZOYL
PEROXIDE GEL, 0.1%/2.5% GEL
GABAR HEALTH SCIENCES CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE AND
BENZOYL PEROXIDE GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ADAPALENE AND BENZOYL PEROXIDE GEL.
ADAPALENE AND BENZOYL PEROXIDE GEL, 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) 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)
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. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GABAR HEALTH SCIENCES
CORP, AT 1-470-
737-9424 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIEN