Adapalene, Benzoyl Peroxide

Pharmacologic Category

Acne Products; Retinoic Acid Derivative; Topical Skin Product; Topical Skin Product, Acne

Dosing: Adult

Acne vulgaris: Adapalene 0.1%/benzoyl peroxide 2.5% or Adapalene 0.3%/benzoyl peroxide 2.5%: Topical: Apply to affected areas of skin once daily.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive making the need for a dose adjustment unlikely.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive making the need for a dose adjustment unlikely.

Dosing: Pediatric

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 (Eichenfield 2013)

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

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive making the need for a dose adjustment unlikely.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive making the need for a dose adjustment unlikely.

Use: Labeled Indications

Acne vulgaris:

US labeling: Topical treatment of acne vulgaris in patients 9 years and older (Epiduo) or 12 years and older (Epiduo Forte).

Canadian labeling: Topical treatment of mild and moderate acne vulgaris, characterized by comedones, inflammatory papules/pustules in patients 9 years and older (Tactupump) or treatment of moderate and severe acne vulgaris characterized by comedones, inflammatory papules/pustules with or without occasional nodules in patients 12 years and older (Tactupump Forte).

Clinical Practice Guidelines

Acne:

American Academy of Dermatology, "Guidelines of Care for the Management of Acne Vulgaris," May 2016

Administration: 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.

Administration: Pediatric

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.

Storage/Stability

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and heat.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat pimples (acne).

Frequently reported side effects of this drug

• Burning

• Dryness

• Redness

• Scaling

• Stinging

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Severe skin irritation

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Contraindications

There are no contraindications listed in the US labeling.

Canadian labeling: Hypersensitivity to adapalene, benzoyl peroxide, or any component of the formulation; application to areas of skin affected by eczema or seborrheic dermatitis; pregnancy or planning to become pregnant.

Warnings/Precautions

Concerns related to adverse effects:

• Bleaching effects: May bleach hair or colored fabric.

• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily 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:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• 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).

Pregnancy Risk Factor

C

Pregnancy Considerations

Refer to individual monographs.

Breast-Feeding Considerations

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.

Briggs' Drugs in Pregnancy & Lactation

• Adapalene

Adverse Reactions

Also see individual agents.

>10%:

Dermatologic: Local dryness (mild 10% to 41%; moderate 2% to 15%), stinging sensation of the skin (mild 7% to 41%; moderate 1% to 19%), localized erythema (mild 8% to 27%; moderate 2% to 20%)

Local: Local desquamation (mild 9% to 35%; moderate 1% to 17%)

1% to 10%:

Dermatologic: Xeroderma (14%), skin irritation (≤4%), contact dermatitis (3%), burning sensation of skin (≤2%), atopic dermatitis (1%), eczema (1%)

Local: Application site irritation (1%)

<1%, postmarketing, and/or case reports: Conjunctivitis, constriction of the pharynx, eyelid edema, facial swelling, pruritus, skin blister, skin discoloration, skin pain, skin rash, sunburn

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

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

Isotretinoin (Topical): Benzoyl Peroxide may diminish the therapeutic effect of Isotretinoin (Topical). Risk D: Consider therapy modification

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

Dosage Forms: US

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 disodium, polysorbate 80, propylene glycol]

Epiduo Forte: Adapalene 0.3% and benzoyl peroxide 2.5% (45 g, 60 g) [contains edetate disodium, polysorbate 80, propylene glycol]

Generic: Adapalene 0.1% and benzoyl peroxide 2.5% (45 g)

Dosage Forms: Canada

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 disodium, polysorbate 80, propylene glycol]

Tactupump Forte: Adapalene 0.3% and benzoyl peroxide 2.5% (15 g, 70 g) [contains edetate disodium, polysorbate 80, propylene glycol]

Generic: Adapalene 0.1% and benzoyl peroxide 2.5% (60 g, 70 g)

Anatomic Therapeutic Chemical (ATC) Classification

• D10AD53

Generic Available (US)

Yes

Pricing: US

Gel (Adapalene-Benzoyl Peroxide External)

0.1-2.5% (per gram): $2.67 - $9.89

Gel (Epiduo External)

0.1-2.5% (per gram): $10.99

Gel (Epiduo Forte External)

0.3-2.5% (per gram): $14.78

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.

Mechanism of Action

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.

Pharmacodynamics/Kinetics

Absorption: Via the skin

Metabolism: Benzoyl peroxide: Converted to benzoic acid in skin

Excretion: Adapalene: Primarily through bile; Benzoyl peroxide: Urine

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Related Information

• Adapalene
• Benzoyl Peroxide

Index Terms

Adapalene/Benzoyl Peroxide; Benzoyl Peroxide and Adapalene; Epiduo Forte

References

Dubina MI, Fleischer AB Jr. Interaction of topical sulfacetamide and topical dapsone with benzoyl peroxide. Arch Dermatol. 2009;145(9):1027-1029. doi:10.1001/archdermatol.2009.186.[PubMed 19770443]

Eichenfield LF, Krakowski AC, Piggott C, et al. Evidence-based recommendations for the diagnosis and treatment of pediatric acne. Pediatrics. 2013;(131 Suppl 3):S163-186.[PubMed 23637225]

Epiduo (adapalene and benzoyl peroxide) [prescribing information]. Fort Worth, TX: Galderma; January 2013.

Epiduo Forte (adapalene and benzoyl peroxide) [prescribing information]. Fort Worth, TX: Galderma; July 2015.

Tactupump (adapalene and benzoyl peroxide) [product monograph]. Thornhill, Ontario, Canada: Galderma Canada Inc; May 2019.

Brand Names: International

Acnegel (BD); Acniact (EG); Effezel (MX); Epidual (BD); Epiduo (AE, AR, AT, AU, BB, BE, BR, CH, CL, CO, CR, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GR, GT, HK, HN, IE, IL, IN, IS, IT, JP, KR, KW, LB, LU, MY, NI, NO, NZ, PA, PH, PL, PT, QA, RO, SA, SE, SG, SV, TH, VN); Epiduo Forte (PH); Fona Plus (BD); Palenzo (EG)

Last Updated 2/28/20