ADAPALENE AND BENZOYL PEROXIDE gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Viona Pharmaceuticals Inc

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

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:

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ADAPALENE AND BENZOYL PEROXIDE - ADAPALENE AND BENZOYL PEROXIDE GEL
VIONA 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, 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
irritation, ec