Country: United States
Language: English
Source: NLM (National Library of Medicine)
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)
Actavis Pharma, Inc.
ADAPALENE
ADAPALENE 1 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE GEL ACTAVIS PHARMA, 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 0.1% / 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/ Read the complete document