Adapalene/​Benzoyl Peroxide

DEA Class; Rx

Common Brand Names; Epiduo, Epiduo Forte

  • Acne Agents, Topical Combos

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

Indicated for the treatment of acne vulgaris.

Hypersensitivity to adapalene, benzoyl peroxide or any of its components

  • Stinging/ burning (3-41%)
  • Dryness (1-41%)
  • Scaling (1-35%)
  • Erythema (1-27%)
  • Contact dermatitis (3%)
  • Application site burning (2%)
  • Application site irritation (1%)
  • Skin irritation (1%)

Avoid eyes, lips, and mucous membranes

For external use only

Do not apply to abrasions, cuts, eczematous or sunburned skin

Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps, and cleansers, exfoliants)

Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, reported with use of benzoyl peroxide products; if a serious hypersensitivity reaction occurs, discontinue treatment immediately and initiate appropriate therapy

Avoid exposure to sunlight, including sunlamps, during use; patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution; use of broad-spectrum sunscreen products and protective apparel (eg, hat) are recommended when exposure cannot be avoided; weather extremes, such as wind or cold, may be irritating to patients under treatment

Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution

Use of sunscreen products and protective apparel, (eg, hat) are recommended when exposure cannot be avoided

Weather extremes, such as wind or cold, may be irritating to patients under treatment

Erythema, scaling, dryness, and stinging/burning may be experienced with use; these are most likely to occur during first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of medication

Irritant and allergic contact dermatitis may occur; depending upon severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce frequency of application, or discontinue use

The product should not be applied to cuts, abrasions, eczematous or sunburned skin

As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with this gel

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)

Available pharmacovigilance data in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; animal reproduction studies have not been conducted with the combination gel

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.

Adapalene/benzoyl peroxide

topical gel

  • 0.1%/2.5%
  • 0.3%/2.5%

pad

  • 0.1%/2.5%

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