Generic equivalent of ADAPALENE
2 SKUs available · Available to order · NABP accredited · DSCSA compliant
Adapalene is the generic equivalent of the brand-name drug ADAPALENE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Adapalene through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Adapalene Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )
12.1 Mechanism of Action 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.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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. 12.2 Pharmacodynamics Clinical pharmacodynamic studies have not been conducted for Adapalene Gel, 0.3%. 12.3 Pharmacokinetics Systemic exposure of adapalene following topical application of Adapalene Gel, 0.3% was evaluated in a clinical…
4 CONTRAINDICATIONS Adapalene Gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3% [see WARNINGS AND PRECAUTIONS (5.1) ] . Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3%. ( 4 )
6 ADVERSE REACTIONS The most frequently reported (≥ 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging. ( 6.1 ) 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 Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the…
2 DOSAGE AND ADMINISTRATION Wash affected areas gently with a non-medicated soap. Apply a thin film of Adapalene Gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Adapalene Gel, 0.3%. Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin…
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Information for Patients Patients using Adapalene Gel, 0.3% should receive the following information and instructions: Apply a thin film of Adapalene Gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be a…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| ADAPALENE TOPICAL GEL, 0.003 45 G | 2-Day |
| ADAPALINE GEL 0.3% 45G | 2-Day |
Premier Pharma stocks 2 Adapalene SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Adapalene is the generic equivalent of ADAPALENE. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Adapalene in 3 mg/g and GEL.
Adapalene carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
12.1 Mechanism of Action 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.
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