Adapalene and benzoyl peroxide is the generic equivalent of the brand-name drug ADAPALENE and BENZOYL PEROXIDE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Adapalene and benzoyl peroxide through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE 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. 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.
Mechanism of Action
12.1 Mechanism of Action Adapalene Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown. Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Adapalene Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown. Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects. 12.2 Pharmacodynamics Pharmacodynamics of adapalene and benzoyl peroxide gel is unknown. 12.3 Pharmacokinetics A pharmacokinetic s…
Contraindications & Precautions
4 CONTRAINDICATIONS None None.
Adverse Reactions
6 ADVERSE REACTIONS Most commonly reported adverse events (≥1%) in patients treated with adapalene and benzoyl peroxide gel 0.1%/2.5% were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying condition…
Drug Interactions
7 DRUG INTERACTIONS Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted with adapalene and benzoyl peroxide gel 0.1%/2.5%.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For topical use only; adapalene and benzoyl peroxide gel 0.1%/2.5% is not for oral, ophthalmic, or intravaginal use. 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. Adapalene and benzoyl peroxide gel 0.1%/2.5% is not for oral, ophthalmic, or intravaginal use. ( 2 ) A…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION [See FDA Approved Patient Labeling (Patient Information) ] Information for Patients Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply adapalene and benzoyl peroxide gel as a thin layer, avoiding the eyes, lips and mucous membranes. Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation. Adapalene and benzoyl peroxide gel may cause irritation such as erythema, scaling, dryness, stinging or burning. Advi…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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