Dosing & Uses
Dosing Forms & Strengths
adapalene/benzoyl peroxide
topical gel
- 0.1%/2.5%
- 0.3%/2.5%
pad
- 0.1%/2.5%
Acne Vulgaris
Apply thin film to affected areas of the face and/or trunk qPM after washing
Dosage Forms & Strengths
adapalene/benzoyl peroxide
topical gel
- 0.1%/2.5%
- 0.3%/2.5%
pad
- 0.1%/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
Adverse 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
Hyperpigmentation and hypopigmentation
Warnings
Contraindications
Hypersensitivity to adapalene, benzoyl peroxide or any of its components
Cautions
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 & Lactation
Pregnancy
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
Adapalene gel, 0.3%
- Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; in animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations
Benzoyl peroxide gel, 2.5%
- The systemic exposure of benzoyl peroxide is unknown; based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine; hence, maternal use is not expected to result in fetal exposure of the drug
Lactation
Adapalene gel, 0.3%
- There are no data on presence of adapalene topical gel or its metabolite in human milk, effects on breastfed infant, or effects on milk production; in animal studies, adapalene is present in rat milk with oral administration of the drug
- When a drug is present in animal milk, it is likely that the drug will be present in human milk; it is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk
Benzoyl peroxide gel, 2.5%
- The systemic exposure of benzoyl peroxide is unknown; based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine; any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be rapidly metabolized by tissue and stomach esterases; there are no data on presence of benzoyl peroxide in human milk, its effects on breastfed infant or on milk production
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on breastfed child from the medication or from the underlying maternal condition.
- To minimize potential exposure to the breastfed infant via breastmilk, use the medication on the smallest area of skin and for shortest duration possible while breastfeeding; advise breastfeeding women not to apply the drug directly to the nipple and areola to avoid direct infant exposure
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
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)
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.