Version May 2024
Acne vulgaris (adapalene 0.1% or 0.3%/benzoyl peroxide 2.5%):
Topical: Apply to affected areas of skin once daily. Consider starting with the lowest possible concentration to minimize skin irritation and increase potency as tolerated. For moderate to severe acne, may be used as part of an appropriate combination regimen (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in manufacturer's labeling; however, systemic absorption is not extensive making the need for a dose adjustment unlikely.
There are no dosage adjustments provided in manufacturer's labeling; however, systemic absorption is not extensive making the need for a dose adjustment unlikely.
Refer to adult dosing.
(For additional information see "Adapalene and benzoyl peroxide: Pediatric drug information")
Note: Application of more than recommended amount or more frequent administration does not result in quicker onset of action and is associated with more irritant effects.
Acne vulgaris:
Epiduo (adapalene 0.1%/benzoyl peroxide 2.5%): Children ≥7 years and Adolescents; limited data in children <9 years: Topical: Apply a thin film once daily to affected areas of cleansed and dried skin (Ref).
Epiduo Forte (adapalene 0.3%/benzoyl peroxide 2.5%): Children ≥12 years and Adolescents: Topical: Apply a thin film once daily to affected areas of cleansed and dried skin.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive making the need for a dose adjustment unlikely.
There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive making the need for a dose adjustment unlikely.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults. Also see individual agents.
>10%: Local: Local desquamation (mild: 9% to 35%; moderate 1% to 17%; severe: ≤1%), local discomfort (stinging; mild: ≤41%; moderate: ≤19%; severe: ≤6%), local dryness of skin (mild: 10% to 41%; moderate: 2% to 15%; severe: ≤2%), localized burning (mild: ≤41%; moderate: ≤19%; severe: ≤6%), localized erythema (mild: 8% to 27%; moderate: 2% to 20%; severe: ≤1%)
1% to 10%:
Dermatologic: Atopic dermatitis (1%), contact dermatitis (3%), eczema (1%), skin irritation (≤4%), xeroderma (7%)
Local: Application-site burning (1% to 2%), application-site irritation (1%)
Postmarketing:
Dermatologic: Hyperpigmentation, hypopigmentation, pruritus, skin blister (including bulla and skin vesicle), skin discoloration, skin pain, skin rash, sunburn
Hypersensitivity: Facial swelling
Ophthalmic: Conjunctivitis, eyelid edema
Respiratory: Pharyngeal edema
Hypersensitivity to adapalene, benzoyl peroxide, or any component of the formulation.
Canadian labeling (additional contraindications not in US labeling): Application to areas of skin affected by eczema or seborrheic dermatitis; pregnancy or planning to become pregnant.
Concerns related to adverse effects:
• Bleaching effects: May bleach hair or colored fabric.
• Hypersensitivity reactions: Hypersensitivity, including anaphylaxis, angioedema, and urticaria, have been reported with benzoyl peroxide medications. Discontinue use immediately and initiate appropriate therapy if severe hypersensitivity occurs.
• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily broad-spectrum sunscreen use and other protective measures (eg, hat) are recommended if sun exposure cannot be avoided.
• Skin irritation: Certain cutaneous signs and symptoms (eg, erythema, dryness, scaling, burning/stinging) may occur during treatment; these are most likely to occur during the first 4 weeks and usually lessen with continued use. Irritant and allergic contact dermatitis may occur. Use of moisturizer, decreased use, or discontinuation may be recommended.
Concurrent drug therapy issues:
• Sulfone products: Concomitant use of benzoyl peroxide with sulfone products (eg, dapsone, sulfacetamide) may cause temporary discoloration (yellow/orange) of facial hair and skin. Application of products at separate times during the day or washing off benzoyl peroxide prior to application of other products may avoid skin discoloration (Dubina 2009).
Other warnings/precautions:
• Appropriate use: For external use only; avoid contact with abraded skin, mucous membranes, and eyes. Do not apply to cuts, abrasions, eczematous or sunburned skin. Avoid use of waxing as a depilatory method on treated skin. 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).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Epiduo: Adapalene 0.1% and benzoyl peroxide 2.5% (45 g) [contains edetate (edta) disodium, polysorbate 80, propylene glycol]
Epiduo Forte: Adapalene 0.3% and benzoyl peroxide 2.5% (45 g, 60 g) [contains edetate (edta) disodium, polysorbate 80, propylene glycol]
Generic: Adapalene 0.1% and benzoyl peroxide 2.5% (45 g); Adapalene 0.3% and benzoyl peroxide 2.5% (45 g)
Pad, External:
Generic: Adapalene 0.1% and benzoyl peroxide 2.5% (1 ea, 14 ea)
Yes
Gel (Adapalene-Benzoyl Peroxide External)
0.1-2.5% (per gram): $2.67 - $9.89
0.3-2.5% (per gram): $13.26 - $15.44
Gel (Epiduo External)
0.1-2.5% (per gram): $10.99
Gel (Epiduo Forte External)
0.3-2.5% (per gram): $18.79
Pads (Adapalene-Benzoyl Peroxide External)
0.1-2.5% (per each): $94.29 - $115.54
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Tactupump: Adapalene 0.1% and benzoyl peroxide 2.5% (5 g, 15 g, 30 g, 45 g, 60 g, 70 g, 90 g) [contains edetate (edta) disodium, polysorbate 80, propylene glycol]
Tactupump Forte: Adapalene 0.3% and benzoyl peroxide 2.5% (15 g, 70 g) [contains edetate (edta) disodium, polysorbate 80, propylene glycol]
Generic: Adapalene 0.1% and benzoyl peroxide 2.5% (60 g, 70 g); Adapalene 0.3% and benzoyl peroxide 2.5% (70 g)
Topical: Apply a pea-sized amount for each area of the face and/or trunk (eg, forehead, chin, each cheek). Skin should be clean and dry before applying. For external use only; avoid applying to eyes, lips, and mucous membranes. Do not apply to cuts, abrasions, eczematous or sunburned skin. Wash hands after application.
Topical: Gel: Apply a pea-sized amount for each affected area of the face (eg, forehead, chin, each cheek). May also be applied to affected areas of the trunk. Skin should be clean and dry before applying. For external use only; avoid applying to eyes, lips, and mucous membranes; not for oral, ophthalmic, or intravaginal use.
Acne vulgaris: Topical treatment of acne vulgaris in patients ≥9 years of age (Epiduo, Tactupump [Canadian product]) or ≥12 years of age (Epiduo Forte, Tactupump Forte [Canadian product]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Dapsone (Topical): Benzoyl Peroxide may enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the use of these agents in combination may cause skin and facial hair to temporarily turn a tan or yellow/orange color. Risk C: Monitor therapy
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Refer to individual monographs.
It is not known if adapalene or benzoyl peroxide are present in breast milk following topical administration.
The manufacturer recommends that caution be exercised when administering to breastfeeding women. Also refer to individual monographs.
Benzoyl peroxide releases free-radical oxygen which oxidizes bacterial proteins in the sebaceous follicles decreasing the number of anaerobic bacteria and decreasing irritating-type free fatty acids.
Adapalene is a retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris.
Absorption: Via the skin
Metabolism: Benzoyl peroxide: Converted to benzoic acid in skin
Excretion: Adapalene: Primarily through bile; Benzoyl peroxide: Urine
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