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:

TEVA PHARMACEUTICALS USA, INC

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Adapalene and Benzoyl Peroxide gel is indicated for the topical treatment of acne vulgaris. None. Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl Peroxide gel. Animal reproduction studies have not been conducted with the combination gel. Furthermore, such studies are not always predictive of human response; therefore, Adapalene and Benzoyl Peroxide gel 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 8 times (mg/m2 /day) the maximum recommended human dose (MRHD) of 2 grams of Adapalene and Benzoyl Peroxide gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 41 and 81 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats; and umbilical h

Обзор продуктов:

Adapalene and Benzoyl Peroxide gel 0.3%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows: 45 gram pump NDC 0093-6303-45 Storage and handling • Store at controlled room temperature 20–25°C (68–77°F) with excursions permitted to 15°–30°C (59°–86°F) [see USP controlled room temperature]. • Protect from light. • Keep out of reach of children. • Keep away from heat.

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE GEL
TEVA PHARMACEUTICALS USA, INC
----------
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, 0.3%/2.5% IS FOR TOPICAL USE.
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
Adapalene and Benzoyl Peroxide gel is a combination of adapalene, a
retinoid, and benzoyl peroxide, and
is indicated for the topical treatment of acne vulgaris. (1)
DOSAGE AND ADMINISTRATION
Adapalene and Benzoyl Peroxide gel is not for oral, ophthalmic, or
intravaginal use. (2)
Apply a thin layer of Adapalene and Benzoyl Peroxide gel 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
Gel, 0.3%/2.5% in 45-g pump (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 and may necessitate
discontinuation. (5.2)
ADVERSE REACTIONS
Most commonly reported adverse reactions (≥1%) in patients treated
with Adapalene and Benzoyl
Peroxide gel were skin irritation, eczema, atopic dermatitis, and skin
burning sensation. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA PHARMACEUTICALS
USA, INC. AT 1-
888-838-2872 OR FDA AT
1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARN