Benzoyl peroxide (Epsolay)

1. Health Canada Product Monograph — Benzoyl peroxide

• Epsolay is used to treat inflammatory lesions (papules and pustules) of rosacea in adults.
• Epsolay has not been studied for acne or other skin conditions, so its Health Canada authorization applies specifically to inflammatory rosacea lesions.
• Clinical studies supporting Epsolay's approval enrolled adults with moderate to severe inflammatory rosacea lesions, reflecting the population in which its benefit has been demonstrated.

• Benzoyl peroxide is converted in the skin to benzoic acid, a naturally occurring substance that is cleared in the urine, so maternal use of Epsolay is not expected to expose the fetus to meaningful amounts of drug.
• No animal reproductive studies have been conducted with Epsolay or benzoyl peroxide, so it should be used in pregnancy only if clearly needed.

• Any benzoyl peroxide absorbed into breast milk would be expected to be broken down by tissue and stomach enzymes, so breastfeeding is not expected to expose the infant to the drug.
• The benefits of breastfeeding should still be weighed against the mother's clinical need for treatment and any possible effects on the nursing infant.

• No overall differences in safety or effectiveness were seen between patients 65 years and older and younger patients, and no dose adjustment is needed for older adults.

• Epsolay has not been studied in children, and Health Canada has not authorized its use in patients under 18 years of age.

• The recommended dose is a pea-sized amount applied once daily as a thin layer to each area of the face (forehead, chin, nose, and each cheek) on clean, dry skin.
• Before first use, prime the pump until the first drop of cream is released.
• Avoid the eyes, lips, and mouth, and avoid applying to cuts, abrasions, eczema-affected, or sunburned skin.
• Wash hands thoroughly after each application.
• Any unused Epsolay should be discarded 60 days after it is first opened.
• If a dose is missed, resume the normal daily application at the next scheduled time; do not apply extra cream to make up for the missed dose.
• No dose adjustment is required for elderly patients, and Epsolay is not authorized for pediatric use.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Acute overdose from topical use is unlikely.
• Applying more product than directed does not improve results and may cause marked skin redness, peeling, or discomfort.
• If accidentally swallowed, the patient should be monitored and given appropriate supportive care as needed.

• Application-site pain may occur.
• Application-site redness (erythema) may occur.
• Application-site itching (pruritus) may occur.
• Application-site swelling (edema) may occur.
• Skin dryness may occur.
• Skin scaling or peeling may occur.
• A stinging or burning sensation may occur with application.
• Application-site irritation or mild dermatitis may occur.
• Application-site rash has been reported.
• Application-site discharge has been reported uncommonly.
• Reactivation of oral cold sores (herpes) has been reported uncommonly.
• Flushing of the skin may occur.
• A temporary flare of rosacea symptoms has been reported in rare cases.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Hypersensitivity reactions, including anaphylaxis, angioedema, and hives (urticaria), have been reported with benzoyl peroxide products.
• Severe skin irritation or contact dermatitis that does not improve with a moisturizer may require discontinuing Epsolay.
• Marked redness, peeling, or discomfort can occur if Epsolay is applied more often or more heavily than recommended.
• Seek urgent medical attention for facial or mouth swelling, difficulty breathing, or a widespread rash after using this medication.

• Use with caution regarding sun exposure, since benzoyl peroxide can increase sensitivity to sunlight; minimize sun and tanning-bed exposure and use sun protection when exposure cannot be avoided.
• Discontinue Epsolay at the first sign of sunburn.
• Use with caution on skin that is broken, abraded, eczematous, or sunburned, since irritation is more likely in these areas.
• Epsolay is for topical use only and should not be used orally, in the eyes, or intravaginally; rinse thoroughly with water if it gets in or near the eyes.
• Epsolay may bleach hair or colored fabric, so contact with clothing, towels, and bedding should be minimized.
• The tumor-promoting potential of benzoyl peroxide seen in some animal studies has unknown significance in humans, since no carcinogenicity studies have been conducted with Epsolay itself.
• Epsolay has not been evaluated for use on body areas beyond the face or in patients with other concurrent inflammatory or infectious skin conditions.
• The benzoyl peroxide in Epsolay is encapsulated in a microcapsule shell designed to release the drug gradually into the skin, which is intended to reduce irritation compared with conventional benzoyl peroxide formulations, though local irritation can still occur.

• Contraindicated in patients with a history of hypersensitivity to benzoyl peroxide or to any ingredient in the formulation.

• No formal drug-drug interaction studies have been conducted with Epsolay.
• Concomitant use of abrasive cleansers, strong drying agents, or other irritant skin products may produce additive skin irritation when combined with Epsolay.
• Combining Epsolay with other topical acne or rosacea treatments, such as retinoids or other peroxide-containing products, may increase the risk of additive irritation.
• Because systemic absorption of benzoyl peroxide from Epsolay is minimal, clinically significant interactions with oral or other systemic medications are not expected.

• Not applicable; Epsolay is applied to the skin rather than taken by mouth.

• Epsolay should be applied once daily, at approximately the same time each day, to maintain consistent treatment coverage.
• There is no need to time application around meals, since Epsolay is applied topically to the face rather than swallowed.
• Many patients find it convenient to apply Epsolay as part of a morning or evening skincare routine, before makeup or sunscreen.

• Store between 15°C and 25°C, away from heat, and do not freeze.
• Discard any unused Epsolay 60 days after first opening it.
• Keep out of the sight and reach of children.

• Epsolay is a once-daily topical cream for the inflammatory bumps and pimples of rosacea, and while local skin irritation and sun sensitivity are common, patients should apply only a thin layer to clean skin, use sun protection, and watch for signs of a true allergic reaction.