ADAPALENE AND BENZOYL PEROXIDE gel

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Teva Pharmaceuticals, Inc.

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and benzoyl peroxide topical gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide topical gel. Risk Summary Available pharmacovigilance data with adapalene and benzoyl peroxide topical gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with the combination gel. Adapalene gel, 0.3% Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant r

Povzetek izdelek:

Adapalene and benzoyl peroxide topical 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 0480-3154-45 Keep this and all medication out of the reach of children.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE GEL
TEVA PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE AND
BENZOYL PEROXIDE TOPICAL GEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL.
ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
Adapalene and benzoyl peroxide topical gel 0.3%/2.5%, is a combination
of adapalene, a retinoid, and
benzoyl peroxide and is indicated for the topical treatment of acne
vulgaris in adults and pediatric patients
12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
For topical use only
Adapalene and benzoyl peroxide topical gel is not for oral, ophthalmic
or intravaginal use. (2)
Apply a thin layer of adapalene and benzoyl peroxide topical gel to
affected areas of the face and/or
trunk once daily after washing. (2)
Use a pea-sized amount for each area of the face (e.g., forehead,
chin, each cheek). (2)
Avoid the eyes, lips, and mucous membranes. (2)
DOSAGE FORMS AND STRENGTHS
Topical Gel, 0.3%/2.5%. (3)
CONTRAINDICATIONS
Adapalene and benzoyl peroxide topical gel is contraindicated in
patients with a history of hypersensitivity
reactions to benzoyl peroxide or any components of the formulation in
adapalene and benzoyl peroxide
topical gel. (4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity_: Severe hypersensitivity reactions, including
anaphylaxis and angioedema, have been
reported with the use of benzoyl peroxide products. (5.1)
_Photosensitivity_: Avoid exposure to sunlight and sunlamps. Wear
broad spectrum sunscreen and
protective clothing when sun exposure cannot be avoided. (5.2)
_Skin Irritation_: Erythema, scaling, dryness, stinging/burning,
irritant and allergic contact dermatitis may
occur with use of adapalene and benzoyl peroxide topical gel and may
necessitate discontinuation.
(5.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%) are skin
i