Epiduo

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Epiduo

Classes

Topical Peroxide and Retinoid Combinations for Acne

Administration

For storage information, see specific product information within the How Supplied section.

Topical Administration

For topical use only. Not for oral, ophthalmic, or intravaginal use.
Wash hands after use as product may bleach hair or colored fabrics.

Other Topical Formulations

Gel
Instruct patients to cleanse the area(s) to be treated with a mild or soapless cleanser, and then pat dry.
Apply a thin layer to the affected area(s) of the face and/or trunk. Do not use more than the recommended amount and do not apply more often than once daily as skin irritation may occur.
When applying to the face, use a pea-sized amount to each area of the face (e.g., forehead, chin, each cheek). Avoid eyes, lips, and mucous membranes.
Wash hands after applying the gel.
 
Gel Pad
Instruct patients to cleanse the area(s) to be treated with a mild or soapless cleanser, and then pat dry.
Remove the gel pad from foil and unfold before using.
Apply gel pad to the affected area(s) of the face and/or trunk. Do not use more than the recommended amount and do not apply more often than once daily as skin irritation may occur.
Use pad for area of the face (e.g., forehead, chin, each cheek). Avoid eyes, lips, and mucous membranes.
Wash hands after applying the gel.

Adverse Reactions
Severe

xerosis / Delayed / 1.0-2.0
erythema / Early / 1.0-1.0

Moderate

contact dermatitis / Delayed / 3.0-3.0
atopic dermatitis / Delayed / 1.0-1.0
conjunctivitis / Delayed / Incidence not known

Mild

skin irritation / Early / 1.0-4.0
rash / Early / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
blepharedema / Early / Incidence not known
photosensitivity / Delayed / Incidence not known
pruritus / Rapid / Incidence not known
skin hyperpigmentation / Delayed / Incidence not known
skin discoloration / Delayed / Incidence not known

Common Brand Names

Epiduo

Dea Class

Rx

Description

Topical combination acne product
Adapalene is a topical retinoid-like drug and benzoyl peroxide has drying actions, sebostatic effects, and causes mild skin desquamation
First topical retinoid and benzoyl peroxide fixed-dose combination product

Dosage And Indications
For the treatment of acne vulgaris. Topical dosage (adapalene 0.1%; benzoyl peroxide 2.5% gel) Adults

Apply to the affected areas of the face and/or trunk once daily after cleansing. Apply a pea-sized amount to each area of the face (e.g., forehead, chin, each cheek).

Children and Adolescents 9 years and older

Apply to the affected areas of the face and/or trunk once daily after cleansing. Apply a pea-sized amount to each area of the face (e.g., forehead, chin, each cheek).

Topical dosage (adapalene 0.3%; benzoyl peroxide 2.5% gel) Adults

Apply to the affected areas of the face and/or trunk once daily after cleansing. Apply a pea-sized amount to each area of the face (e.g., forehead, chin, each cheek).

Children and Adolescents 12 years and older

Apply to the affected areas of the face and/or trunk once daily after cleansing. Apply a pea-sized amount to each area of the face (e.g., forehead, chin, each cheek).

Topical dosage (adapalene 0.1%; benzoyl peroxide 2.5% gel pad) Adults

Apply to the affected areas of the face and/or trunk once daily after cleansing. Use gel pad for area of the face (e.g., forehead, chin, each cheek).

Children and Adolescents 9 years and older

Apply to the affected areas of the face and/or trunk once daily after cleansing. Use gel pad for area of the face (e.g., forehead, chin, each cheek).

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

Aminolevulinic Acid: (Moderate) Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution.
Clindamycin; Tretinoin: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided.
Dapsone: (Minor) Coadministration of topical benzoyl peroxide-containing products with topical sulfone products, such as dapsone, may cause skin and facial hair to temporarily change color to a yellow/orange color.
Fluocinolone; Hydroquinone; Tretinoin: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided. (Minor) Keratolytic agents or products that contain keratolytic agents, such as benzoyl peroxide, can potentiate the skin irritation caused by hydroquinone and hydroquinone-containing products. Also, concurrent use of topical hydroquinone and topical peroxide (e.g., benzoyl peroxide) on the same area of skin can result in transient dark staining of the skin due to oxidation of hydroquinone. Removal of staining can be accomplished by discontinuing concurrent use and by normal soap cleansing. Concurrent application of such agents should generally be avoided.
Halobetasol; Tazarotene: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Hydroquinone: (Minor) Keratolytic agents or products that contain keratolytic agents, such as benzoyl peroxide, can potentiate the skin irritation caused by hydroquinone and hydroquinone-containing products. Also, concurrent use of topical hydroquinone and topical peroxide (e.g., benzoyl peroxide) on the same area of skin can result in transient dark staining of the skin due to oxidation of hydroquinone. Removal of staining can be accomplished by discontinuing concurrent use and by normal soap cleansing. Concurrent application of such agents should generally be avoided.
Isotretinoin: (Moderate) Benzoyl peroxide will cause additive irritant and drying effects with concomitant oral isotretinoin use. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
Methoxsalen: (Moderate) Use methoxsalen and adapalene together with caution; the risk of severe burns or phototoxicity may be additive. If concurrent use is necessary, closely monitor patients for signs or symptoms of skin toxicity.
Photosensitizing agents (topical): (Moderate) Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution.
Porfimer: (Major) Avoid coadministration of porfimer with adapalene due to the risk of increased photosensitivity. Porfimer is a light-activated drug used in photodynamic therapy; all patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like adapalene may increase the risk of a photosensitivity reaction. (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
Salicylic Acid: (Moderate) Concomitant use of other potentially irritating topical products with adapalene should be done cautiously because of additive local irritation. Particular caution should be exercised in using adapalene in combination with preparations containing salicylic acid. If these preparations have been used, it is advisable not to start therapy with adapalene until the effects of such preparations in the skin have subsided. (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
Sodium Thiosulfate; Salicylic Acid: (Moderate) Concomitant use of other potentially irritating topical products with adapalene should be done cautiously because of additive local irritation. Particular caution should be exercised in using adapalene in combination with preparations containing salicylic acid. If these preparations have been used, it is advisable not to start therapy with adapalene until the effects of such preparations in the skin have subsided. (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
Tazarotene: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Topical Local Anesthetics: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
Tretinoin, ATRA: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided.
Tretinoin; Benzoyl Peroxide: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided.
Trifarotene: (Moderate) Avoid concurrent use of trifarotene with other topical products that may dry or irritate the skin, such as benzoyl peroxide.
Verteporfin: (Moderate) Use caution if coadministration of verteporfin with adapalene is necessary due to the risk of increased photosensitivity. Verteporfin is a light-activated drug used in photodynamic therapy; all patients treated with verteporfin will be photosensitive. Concomitant use of other photosensitizing agents like adapalene may increase the risk of a photosensitivity reaction. (Moderate) Use caution if coadministration of verteporfin with benzoyl peroxide is necessary due to the risk of increased photosensitivity. Verteporfin is a light-activated drug used in photodynamic therapy; all patients treated with verteporfin will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.

How Supplied

Adapalene, Benzoyl Peroxide Topical Swab: 0.1-2.5%
Adapalene, Benzoyl Peroxide/Epiduo Topical Gel: 0.1-2.5%, 0.3-2.5%

Maximum Dosage
Adults

1 application per day topically.

Geriatric

1 application per day topically.

Adolescents

1 application per day topically.

Children

12 years: 1 application per day topically.
9 to 11 years: 1 application per day topically for adapalene 0.1%; benzoyl peroxide 2.5%; safety and efficacy have not been established for adapalene 0.3%; benzoyl peroxide 2.5%.
younger than 9 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

•adapalene: Adapalene modulates cell differentiation and keratinization. Adapalene also possesses potent antiinflammatory and comedolytic properties.
•benzoyl peroxide: Benzoyl peroxide exhibits antimicrobial effects against Propionibacterium acnes, which is the predominant organism in sebaceous follicles and comedones. Benzoyl peroxide also demonstrates keratolytic activity, which produces drying and desquamative actions and contributes to its efficacy in comedone treatment.

Pharmacokinetics

Adapalene; benzoyl peroxide is administered topically.
Adapalene: The distribution and metabolism of absorbed adapalene is unknown. Excretion appears to be primarily by the biliary route.
Benzoyl peroxide: After absorption, benzoic acid is excreted in the urine.

Topical Route

Adapalene: Following topical application, absorption through human skin is low. During clinical trials, trace amounts (< 0.25 ng/mL) of the parent compound have been found in the plasma of patients with acne after chronic use.
Benzoyl peroxide: Following topical application, benzoyl peroxide is absorbed through the epidermis. In the skin, benzoyl peroxide is metabolized to benzoic acid. Approximately 5% of the benzoic acid is systemically absorbed.

Pregnancy And Lactation
Pregnancy

Available data regarding the use of adapalene; benzoyl peroxide during pregnancy are insufficient to establish a drug-associated risk of major birth defects, miscarriages, or other adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with the combination product. For the adapalene component, no teratogenic effects were observed in rats treated with oral doses of 0.15 to 5 mg adapalene/kg/day, up to 8- to 25-times the maximum recommended human (MRHD) dose of 2 grams. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of at least 25 mg adapalene/kg/day (i.e., 41- to 123-times and 81- to 246-times MRHD, respectively). These findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats; and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal teratogenic studies in rats and rabbits at doses of up to 6 mg/kg/day, 9.7- to 59-times MRHD, exhibited no fetotoxicity, minimal increases in supernumerary ribs in both species, and delayed ossification in rabbits. For benzoyl peroxide, systemic exposure is unknown and benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance) which is eliminated in the urine; therefore, maternal use is not expected to result in fetal drug exposure. 

There are no data on the presence of benzoyl peroxide, adapalene topical gel, or their metabolites in human milk, the effects on a breast-fed infant, or the effects on milk production. For benzoyl peroxide, systemic exposure is unknown and benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance) which is eliminated in the urine; therefore, any amount of benzoyl peroxide excreted into human milk by a nursing mother would be rapidly metabolized by tissue and stomach esterases. Adapalene is poorly absorbed through human intact skin and the amount of drug excreted into the breast milk is expected to be minimal. However, it is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorptions to produce detectable quantities. To minimize potential exposure to a breast-fed infant, use adapalene; benzoyl peroxide on the smallest area of skin and for the shortest duration possible while breast-feeding. Instruct patients not to apply to the area near the nipples, and be careful to avoid direct contact between the infant and the treated area. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.