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  • CLASSES

    Topical Retinoids for use for Acne

    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
     

    COMMON BRAND NAMES

    Epiduo

    HOW SUPPLIED

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

    DOSAGE & INDICATIONS

    For the treatment of acne vulgaris.
    Topical dosage (adapalene 0.1%; benzoyl peroxide 2.5%)
    Adults, Adolescents and Children >= 9 years

    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%)
    Adults, Adolescents and Children >= 12 years

    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).

    MAXIMUM DOSAGE

    Adults

    1 application/day topically.

    Geriatric

    1 application/day topically.

    Adolescents

    1 application/day topically.

    Children

    >= 9 years: 1 application/day topically.
    < 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.

    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.

    ADMINISTRATION

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

    Topical Administration

    Administer topically after washing. Instruct patient to wash face with a non-medicated soap, then apply a thin layer to the affected area. 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.

    STORAGE

    Epiduo:
    - Avoid exposure to heat
    - Protect from light
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Accidental exposure, eczema, skin abrasion, sunburn

    Apply adapalene; benzoyl peroxide only to affected areas. Accidental exposure to unaffected skin may cause irritation. Avoid contact with the eyes, lips, angles of the nose and other mucous membranes. Do not apply to skin that is cut or is affected with seborrheic dermatitis, eczema, a skin abrasion, or sunburn.

    Pregnancy

    Adapalene; benzoyl peroxide is classified as a pregnancy category C drug. There are no adequate and well controlled studies in pregnant women. According to the manufacturer, adapalene; benzoyl peroxide should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

    Breast-feeding

    According to the manufacturer, adapalene; benzoyl peroxide should be used cautiously in breast-feeding women. It is not known whether adapalene; benzoyl peroxide is excreted in breast milk. Adapalene is poorly absorbed through human intact skin and approximately only 5% of topically applied benzoyl peroxide is systemically absorbed. The amount of drug excreted into the breast milk is expected to be minimal , and therefore risk to the nursing infant is low. Do not 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. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Sunlight (UV) exposure

    Sunlight (UV) exposure may potentiate the effects of adapalene; benzoyl peroxide. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using topical adapalene; benzoyl peroxide. If sun exposure cannot be avoided during topical adapalene; benzoyl peroxide therapy, sunscreen products and physical sun blocks (protective clothing, hats) are recommended for protection of treated areas. Weather extremes, such as wind or cold, also may be irritating to patients receiving adapalene; benzoyl peroxide.

    ADVERSE REACTIONS

    Severe

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

    Moderate

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

    Mild

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

    DRUG INTERACTIONS

    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, such as benzoyl peroxide; clindamycin, 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.
    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.
    Mequinol; 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. (Moderate) Mequinol; tretinoin (Solage) solution contains a high concentration of ethanol which may be very drying to the skin. The concomitant use of other medications or skin-care items with drying effects can be additive or cause irritation, including astringents, benzoyl peroxide, salicylic acid, medicated soaps/shampoos, or hair waxes.
    Photosensitizing agents: (Moderate) Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution.
    Porfimer: (Moderate) Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution.
    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.
    Verteporfin: (Moderate) Concomitant use of adapalene and photosensitizing agents may cause additive phototoxicity; use together with caution.

    PREGNANCY AND LACTATION

    Pregnancy

    Adapalene; benzoyl peroxide is classified as a pregnancy category C drug. There are no adequate and well controlled studies in pregnant women. According to the manufacturer, adapalene; benzoyl peroxide should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

    According to the manufacturer, adapalene; benzoyl peroxide should be used cautiously in breast-feeding women. It is not known whether adapalene; benzoyl peroxide is excreted in breast milk. Adapalene is poorly absorbed through human intact skin and approximately only 5% of topically applied benzoyl peroxide is systemically absorbed. The amount of drug excreted into the breast milk is expected to be minimal , and therefore risk to the nursing infant is low. Do not 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. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    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.