EPIDUO FORTE

EPIDUO FORTE (adapalene and benzoyl peroxide) topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula: Adapalene: Molecular formula: C 28 H 28 O 3 Molecular weight: 412.5 Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula: Benzoyl Peroxide: Molecular formula: C 14 H 10 O 4 Molecular weight: 242.23 EPIDUO FORTE gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. 20089-0415-chem-struct-01 20089-0415-chem-struct-02

EPIDUO FORTE is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. EPIDUO FORTE, 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 )

For topical use only. EPIDUO FORTE is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of EPIDUO FORTE 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). Wash hands after application as EPIDUO FORTE may bleach hair or colored fabrics. Avoid the eyes, lips and mucous membranes. For topical use only EPIDUO FORTE is not for oral, ophthalmic or intravaginal use. ( 2 ) Apply a thin layer of EPIDUO FORTE 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 )

EPIDUO FORTE is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPIDUO FORTE. EPIDUO FORTE is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPIDUO FORTE. ( 4 )

The most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [ see Warnings and Precautions ( 5.1 ) ] Skin Irritation/Contact Dermatitis [ see Warnings and Precautions ( 5.3 ) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During the randomized, double-blind, vehicle- and active-controlled clinical trial, 217 subjects were exposed to EPIDUO FORTE. A total of 197 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Adverse reactions reported within 12 weeks of treatment in at least 1% of subjects treated with EPIDUO FORTE and for which the rate with EPIDUO FORTE exceeded the rate for the vehicle are presented in Table 1: Table 1. Adverse Reactions Occurring in ≥ 1% of Subjects with Acne Vulgaris in a 12-week Clinical Trial EPIDUO FORTE (N=217) Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=217) Vehicle (N=69) Skin irritation 4% <1% 0% Eczema 1% 0% 0% Dermatitis atopic 1% 0% 0% Skin burning sensation 1% 0% 0% Local tolerability evaluations presented in Table 2, were conducted at each trial visit in the clinical trial by assessment of erythema, scaling, dryness, and stinging/burning, which peaked at Week 1 of therapy and decreased thereafter. Table 2. Incidence of Local Cutaneous Irritation in 12-week Clinical Trial in Subjects with Acne Vulgaris Maximum Severity During Treatment End of Treatment Severity (Final Score) Moderate Severe Moderate Severe EPIDUO FORTE (N=213) Erythema 20% 1% 4% <1% Scaling 17% 1% 1% <1% Dryness 15% 2% 3% <1% Stinging/Burning 19% 6% 1% 1% Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=212) Erythema 15% 1% 2% <1% Scaling 12% <1% 2% 0% Dryness 13% 1% 2% 0% Stinging/Burning 14% 9% 3% 0% Vehicle (N=68) Erythema 6% 1% 1% 0% Scaling 6% 0% 1% 0% Dryness 4% 1% 1% 0% Stinging/Burning 3% 1% 0% 0% 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of EPIDUO FORTE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders : sunburn, blister (including vesicles and bullae), pruritus, hyperpigmentation and hypopigmentation..