Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING EPIDUO (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 0299-5908-45 45 gram pump NDC 0299-5908-25 Storage and handling - Store at 25ºC; excursions permitted to 15º - 30ºC (59º - 86ºF). - Protect from light. - Keep out of reach of children. - Keep away from heat. - Keep tube tightly closed.; PACKAGE LABEL 45 g PUMP Rx Only NDC 0299-5908-25 Epiduo® (adapalene and benzoyl peroxide) Gel 0.1% / 2.5% PUMP FOR TOPICAL USE ONLY NET WT. 45g GALDERMA For topical use only. Not for ophthalmic, oral or intravaginal use. Usual dosage: Apply a thin film once a day to affected areas. See package insert for complete prescribing information. Each gram contains: Active: adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous gel consisting of: Inactive: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° and 86°F (15° and 30°C). See carton closure for lot number and expiration date. Marketed by: GALDERMA LABORATORIES, L.P. 14501 North Freeway, Fort Worth, TX 76177 USA Made in Canada. All trademarks are the property of their respective owners. www.epiduo.com P51741-3 45-gram-pump-carton; PACKAGE LABEL - 45 g TUBE 45g-tube-carton-image; Epiduo ® (adapalene and benzoyl peroxide) Gel 0.1% / 2.5% FOR TOPICAL USE ONLY NET WT. 45 g NDC 0299-5908-45 Rx only GALDERMA For topical use only. Not for ophthalmic, oral or intravaginal use. Usual dosage: Apply a thin film once a day to affected areas. See package insert for complete prescribing information. Each gram contains Active: adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous gel consisting of Inactive: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° and 86°F (15° and 30°C). See carton closure for lot number and expiration date. Marketed by: GALDERMA LABORATORIES, L.P. 14501 North Freeway, Fort Worth, TX 76177 USA www.epiduo.com P51359-3 Manufactured by: G Production Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada. Galderma is a registered trademark.
- 16 HOW SUPPLIED/STORAGE AND HANDLING EPIDUO (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 0299-5908-45 45 gram pump NDC 0299-5908-25 Storage and handling - Store at 25ºC; excursions permitted to 15º - 30ºC (59º - 86ºF). - Protect from light. - Keep out of reach of children. - Keep away from heat. - Keep tube tightly closed.
- PACKAGE LABEL 45 g PUMP Rx Only NDC 0299-5908-25 Epiduo® (adapalene and benzoyl peroxide) Gel 0.1% / 2.5% PUMP FOR TOPICAL USE ONLY NET WT. 45g GALDERMA For topical use only. Not for ophthalmic, oral or intravaginal use. Usual dosage: Apply a thin film once a day to affected areas. See package insert for complete prescribing information. Each gram contains: Active: adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous gel consisting of: Inactive: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° and 86°F (15° and 30°C). See carton closure for lot number and expiration date. Marketed by: GALDERMA LABORATORIES, L.P. 14501 North Freeway, Fort Worth, TX 76177 USA Made in Canada. All trademarks are the property of their respective owners. www.epiduo.com P51741-3 45-gram-pump-carton
- PACKAGE LABEL - 45 g TUBE 45g-tube-carton-image
- Epiduo ® (adapalene and benzoyl peroxide) Gel 0.1% / 2.5% FOR TOPICAL USE ONLY NET WT. 45 g NDC 0299-5908-45 Rx only GALDERMA For topical use only. Not for ophthalmic, oral or intravaginal use. Usual dosage: Apply a thin film once a day to affected areas. See package insert for complete prescribing information. Each gram contains Active: adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous gel consisting of Inactive: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate. Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° and 86°F (15° and 30°C). See carton closure for lot number and expiration date. Marketed by: GALDERMA LABORATORIES, L.P. 14501 North Freeway, Fort Worth, TX 76177 USA www.epiduo.com P51359-3 Manufactured by: G Production Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada. Galderma is a registered trademark.
Overview
EPIDUO (adapalene and benzoyl peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Active: 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 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. adapalene structure bp structure
Indications & Usage
EPIDUO gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. EPIDUO gel 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 & Administration
For topical use only; EPIDUO gel is not for oral, ophthalmic, or intravaginal use. Apply a thin film of EPIDUO 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. EPIDUO gel is not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply a thin film of EPIDUO 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 )
Warnings & 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 EPIDUO gel and may necessitate discontinuation. ( 5.2 ) 5.1 Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during the use of EPIDUO gel. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of sunscreen products and protective apparel, (e.g., hat) are recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, may be irritating to patients under treatment with EPIDUO gel. 5.2 Local Cutaneous Reactions Erythema, scaling, dryness, and stinging/burning may be experienced with use of EPIDUO gel. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Irritant and allergic contact dermatitis may occur. Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of EPIDUO gel, or discontinue use. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with EPIDUO gel. Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
Contraindications
None None. ( 4 )
Adverse Reactions
Most commonly reported adverse events (≥1%) in patients treated with EPIDUO gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. ( 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 Studies Experience 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 clinical trials, 1401 subjects were exposed to EPIDUO gel. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months. Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with EPIDUO gel and those reported in subjects treated with the vehicle gel are presented in Table 1: Table 1. Drug Related Adverse Events Reported in Clinical Trials by at Least 1% of Patients Treated For 12 Weeks System Organ Class/Preferred Term EPIDUO Gel N=564 Vehicle Gel N=489 Subjects with AE(s) 14% 4% Dry skin 7% 2% Contact dermatitis 3% <1% Application site burning 2% <1% Application site irritation 1% <1% Skin irritation 1% 0% Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging. Table 2. Incidence of Local Cutaneous Irritation in Controlled Clinical Trials (N = 553) Treatment Emergent Signs and Symptoms Maximum Severity During Treatment End of Treatment Severity (12 weeks) Mild Moderate Severe Mild Moderate Severe Erythema 27% 13% 1% 8% 2% 1% Scaling 35% 11% 1% 9% 1% <1% Dryness 41% 13% 1% 10% 2% <1% Stinging/burning 41% 15% 3% 7% 2% 1% Analysis over the 12-week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter. During a pediatric clinical trial, 285 children with acne vulgaris, 9 to 11 years of age were treated with EPIDUO gel or with the vehicle gel once daily for 12 weeks. Overall, the safety profile of EPIDUO gel in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed adverse events. Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of EPIDUO gel: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. 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.
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 EPIDUO gel.
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