Adapalene and benzoyl peroxide

U.S. BRAND NAMES — Epiduo™

PHARMACOLOGIC CATEGORY
Acne Products
Topical Skin Product
Topical Skin Product, Acne

DOSING: ADULTS — Acne vulgaris: Topical: Apply once daily to affected areas after skin has been cleaned and dried

DOSING: PEDIATRIC — Children ≥ 12 years: Refer to adult dosing.

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, topical:
Epiduo™ : Adapalene 0.1% and benzoyl peroxide 2.5% (45 g)

DOSAGE FORMS: CONCISE
Gel, topical:
Epiduo™ : Adapalene 0.1% and benzoyl peroxide 2.5% (45 g)

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — Apply a pea-sized amount for each area of the face (eg, forehead, chin, each cheek). Skin should be clean and dry before applying. For external use only; avoid applying to eyes and mucous membranes.

USE — Topical treatment of acne vulgaris

ADVERSE REACTIONS SIGNIFICANT
>10%: Dermatologic: Dry skin (<1% to 14%)

1% to 10%: Dermatologic: Scaling (<1% to 9%), erythema (1% to 8%), burning (1% to 7%), stinging (1% to 7%), contact dermatitis (3%), skin irritation (1%)

CONTRAINDICATIONS — There are no contraindications listed in the manufacturer's labeling.

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Bleaching effects: May bleach hair or colored fabric. Photosensitivity: Use is associated with increased suspectibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures are recommended. 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. Use of moisturizer, decreased use, or discontinuation may be recommended.

Concurrent drug therapy issues: Topical acne product: Use concomitant topical acne therapy with caution; cumulative irritancy may occur.

Special populations: Pediatrics: Safety and efficacy have not been established in children <12 years of age.

Other warnings/precautions: Appropriate use: For external use only; avoid contact with abraded skin, mucous membranes, and eyes.

DRUG INTERACTIONS
Vitamin A: May enhance the adverse/toxic effect of Retinoid-like Compounds. Risk D: Consider therapy modification

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — There are no well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.

LACTATION — Excretion in breast milk unknown/use caution

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