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Adapalene And Benzoyl Peroxide

FDA Drug Information • Also known as: Adapalene And Benzoyl Peroxide, Epiduo, Epiduo Forte

Brand Names
Adapalene And Benzoyl Peroxide, Epiduo, Epiduo Forte
Drug Class
Retinoid [EPC]
Route
TOPICAL
Dosage Form
GEL
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION 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 Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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.

What Is Adapalene And Benzoyl Peroxide Used For?

1 INDICATIONS AND USAGE Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

  • For topical use only. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is not for oral, ophthalmic, or intravaginal use.
  • Apply a thin layer of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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 Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% may bleach hair or colored fabrics.
  • Avoid the eyes, lips and mucous membranes.
  • For topical use only
  • Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is not for oral, ophthalmic, or intravaginal use. ( 2 )
  • Apply a thin layer of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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 )

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 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 adapalene and benzoyl peroxide topical gel, 0.3%/2.5%. 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 adapalene and benzoyl peroxide topical gel, 0.3%/2.5% and for which the rate with adapalene and benzoyl peroxide topical gel, 0.3%/2.5% 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 Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (N=217) Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=217) Vehicle Gel (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 Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% (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 Gel (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 adapalene and benzoyl peroxide topical gel, 0.3%/2.5%. 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.

    • Contraindications

    4 CONTRAINDICATIONS Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%.

  • Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. ( 4 )

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary Available pharmacovigilance data with Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with the combination gel. Adapalene gel, 0.3% Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data) . Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown. Based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Hence, maternal use is not expected to result in fetal exposure of the drug. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD of 2 grams of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (41 and 81 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft...

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as a 45 gram pump NDC: 72162-1432-2: 45 g in a BOTTLE, PUMP 16.2 Storage and handling Store at controlled room temperature 20° – 25°C (68° – 77°F) with excursions permitted to 15° – 30°C (59° – 86°F) [see USP controlled room temperature]. Keep away from heat. Protect from light. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.