ADAPALENE AND BENZOYL PEROXIDE- adapalene and benzoyl peroxide gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Actavis Pharma, Inc.

INN (International Name):

ADAPALENE

Sammensetning:

ADAPALENE 1 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 Teratogenic Effects: 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 or benzoyl peroxide. 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 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. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of greater than or equal to 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findin

Produkt oppsummering:

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 tube       NDC 0472-0310-45 45 gram pump     NDC 0472-0310-38 STORAGE AND HANDLING Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and keep away from heat. Keep tube tightly closed.   Keep out of reach of children.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE GEL
ACTAVIS 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 GEL 0.1% / 2.5%, 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 is not for oral, ophthalmic, or
intravaginal use. (2) Apply a thin film 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
Each gram of adapalene and benzoyl peroxide gel contains 1 mg (0.1%)
adapalene, USP and 25 mg (2.5%) benzoyl
peroxide, USP. (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 events (greater than or equal to 1%) in
patients treated with adapalene and benzoyl
peroxide gel were dry skin, contact dermatitis, application site
burning, application site irritation and skin irritation. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACTAVIS AT
1-800-432-8534 OR FDA AT 1-800-FDA-1088
OR _WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/