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Adapalene and Benzoyl Peroxide

Medically reviewed by Drugs.com. Last updated on Aug 29, 2020.

Pronunciation

(a DAP a leen & BEN zoe il peer OKS ide)

Index Terms

  • Adapalene/Benzoyl Peroxide
  • Benzoyl Peroxide and Adapalene
  • Epiduo Forte

Dosage Forms

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)

Brand Names: U.S.

  • Epiduo
  • Epiduo Forte

Pharmacologic Category

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

Pharmacology

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

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).

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.

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.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

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

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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.

Storage

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

Drug Interactions

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). 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. Monitor therapy

Isotretinoin (Topical): Benzoyl Peroxide may diminish the therapeutic effect of Isotretinoin (Topical). Management: Avoid combined use of benzoyl peroxide and topical isotretinoin. If concomitant use cannot be avoided, consider separating application times and monitoring for signs and symptoms of clinical failure of isotretinoin. Consider therapy modification

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

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

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:

• 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.

Patient Education

What is this drug used for?

• It is used to treat pimples (acne).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning

• Dryness

• Redness

• Scaling

• Stinging

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.