Dosing and uses of Epiduo, Epiduo Forte (adapalene/benzoyl peroxide)
Adult dosage forms and strengths
adapalene/benzoyl peroxide
topical geL
- 0.1%/2.5%
- 0.3%/2.5%
Acne Vulgaris
Apply thin film to affected areas of the face and/or trunk qPM after washing
Pediatric dosage forms and strengths
adapalene/benzoyl peroxide
topical geL
- 0.1%/2.5%
- 0.3%/2.5%
Acne Vulgaris
<9 years: Safety and efficacy not established
≥9 years: Apply thin film to affected facial areas and/or trunk qPM after washing
Epiduo, Epiduo Forte (adapalene/benzoyl peroxide) adverse (side) effects
>10%
Stinging/ burning (3-41%)
Dryness (1-41%)
Scaling (1-35%)
Erythema (1-27%)
1-10%
Contact dermatitis (3%)
Application site burning (2%)
Application site irritation (1%)
Skin irritation (1%)
Postmarketing Reports
Allergic contact dermatitis
Blister
Conjunctivitis
Eczema
Eyelid edema
Local skin pain
Pruritus
Rash
Swelling
Skin discoloration
Sunburn
Throat tightness
Warnings
Contraindications
Hypersensitivity to adapalene, benzoyl peroxide or any of its components
Cautions
Avoid eyes, lips, and mucous membranes
For external use only
Minimize UV light exposure; use sunscreen and protective clothing
Extreme weather (eg, wind, cold) may cause skin irritation
Adverse reaction risk higher during first month of treatment; generally subsides with use
Do not apply to abrasions, cuts, eczematous or sunburned skin
Skin irritation: Apply moisturizer, reduce application frequency, or discontinue
Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps and cleansers, exfoliants)
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk, exercise caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Epiduo, Epiduo Forte (adapalene/benzoyl peroxide)
Mechanism of action
Adapalene: Binds to specific retinoic acid nuclear receptors and modulates cellular differentiation, keratinization and inflammatory processes; exact mechanism of action for treatment of acne is unknown
Benzoyl peroxide: Elicits action by releasing active oxygen; effective in vitro against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones; also elicits a keratolytic and desquamative effect which may also contribute to its efficacy
Pharmacokinetics
Absorption: Benzoyl peroxide absorbed by the skin where it is converted to benzoic acid
Excretion: adapalene (bile), benzoyl peroxide (urine)
Administration
Instructions
For topical use only; not for ophthalmic, oral, or intravaginal use
Avoid mucous membranes, eyes, and lips
Apply pea-sized amount for each facial area (eg, chin, forehead, cheek)
