Classes
DEA Class; Rx
Common Brand Names; Epiduo, Epiduo Forte
- Acne Agents, Topical Combos
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
Indications
Indicated for the treatment of acne vulgaris.
Contraindications
Hypersensitivity to adapalene, benzoyl peroxide or any of its components
Adverse Effects
- 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%)
Warnings
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)
Pregnancy and Lactation
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
Maximum Dosage
1 application per day topically.
1 application per day topically.
1 application per day topically.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Adapalene/benzoyl peroxide
topical gel
- 0.1%/2.5%
- 0.3%/2.5%
pad
- 0.1%/2.5%