ADAPALENE AND BENZOYL PEROXIDE gel

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Mayne Pharma Inc.

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Adapalene and Benzoyl Peroxide 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 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 gel. Risk Summary Available pharmacovigilance data with Adapalene and Benzoyl Peroxide 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 rats and rabbits during or

Product samenvatting:

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 68308-662-45

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE GEL
MAYNE PHARMA INC.
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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 TOPICAL GEL 0.3%/2.5%
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 in adults and
pediatric patients 12 years of age and
older. (1)
DOSAGE AND ADMINISTRATION
For topical use only
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. (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 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
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 gel and may
necessitate discontinuation. (5.3)
ADVERSE REACTIONS
Most commonly reported adverse reactions (≥1%) in patients treated
with Adapalene and Benzoyl
Peroxide gel were skin irritation, ecze