Adapalene (Differin)

1. Health Canada Product Monograph — Adapalene

• Adapalene is used to treat acne vulgaris in patients 12 years of age and older.

Contraindicated in pregnancy. Confirm pregnancy status and discuss alternative therapy with the prescriber before dispensing.

• Adapalene is contraindicated during pregnancy because oral retinoids have been linked to birth defects, and increased systemic absorption of topical adapalene may occur under certain conditions such as damaged skin or excessive use.

• It is not known whether adapalene passes into human breast milk; caution should be used when applying adapalene while breastfeeding, and application to the chest should be avoided to prevent contact exposure of the infant.

• Safety and effectiveness of adapalene in patients over 65 years of age have not been established, so no specific dosing recommendations exist for this age group.

• Adapalene is approved for acne in patients 12 years of age and older; safety and effectiveness in children under 12 have not been established.

• Apply a thin film of adapalene cream, gel, or lotion once daily to the affected areas of the face, chest, or back, before bedtime and after washing.
• Ensure the skin is dry before application, and avoid the eyes, lips, angles of the nose, and mucous membranes.
• If irritation occurs, application can be reduced to every other day or temporarily stopped until symptoms subside, then resumed once daily as tolerated.
• Clinical improvement is usually seen after four to eight weeks of regular use, with continued improvement over time.
• If a dose is missed, resume the usual once-daily application the following evening; do not apply extra to make up for a missed application.

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

• Adapalene is intended for topical use only; applying more than the recommended amount does not speed up or improve results and may cause marked skin redness, peeling, or discomfort.
• Accidental oral ingestion of adapalene may produce the same effects as excess intake of vitamin A, including a risk of birth defects if it occurs during pregnancy.
• If oral ingestion occurs, pregnancy testing is recommended for women of childbearing age.

• Skin dryness is common with adapalene, especially in the first few weeks.
• Redness (erythema) of the skin may occur.
• Skin peeling or scaling may occur.
• A burning or stinging sensation may occur, particularly right after application.
• Itching (pruritus) may occur.
• Sunburn or increased sun sensitivity may occur.
• Skin irritation and general skin discomfort may occur.
• Irritant dermatitis (a stronger, localized skin inflammation) may occur.
• Atopic dermatitis or eczema may occur or worsen with use.
• Generalized skin swelling (edema) may occur.
• Acne may appear to flare temporarily when treatment is first started.
• Hives (urticaria) may occur.
• Seborrhea (oily skin) may occur.
• Cold sores (herpes simplex) may reactivate.
• A vesicular (blistering) rash may occur.
• Small pale patches of skin (pityriasis alba) may occur.
• General pain, including at the application site, may occur.
• Facial swelling unrelated to an allergic reaction may occur.
• Eye pain may occur if the product accidentally contacts the eyes.
• Inflammation of the eye and eyelid (keratoconjunctivitis) may occur with accidental eye contact.
• These effects are usually mild to moderate, occur mainly in the first two to four weeks of treatment, and tend to improve as the skin adjusts.

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

• Severe local irritation with marked redness, peeling, or discomfort can occur, particularly if adapalene is applied more often or in larger amounts than recommended.
• Allergic contact dermatitis has been reported.
• Rare cases of angioedema and anaphylactic (severe allergic) reactions have been reported.
• Eyelid swelling, redness, itching, or irritation may occur if the product contacts the eye area.
• Skin burns, including second-degree burns in rare cases, have been reported at the application site.
• Changes in skin pigmentation, including lightening or darkening of treated skin, have been reported.
• If adapalene is accidentally swallowed, it may cause effects similar to excess vitamin A intake, including a risk of birth defects if ingested during pregnancy.
• Seek medical attention for severe skin reactions, signs of an allergic reaction such as facial swelling or difficulty breathing, or accidental ingestion of the product.

• Use with caution together with other potentially irritating topical products, such as abrasive soaps, strong cleansers, or products with high alcohol, astringent, spice, or lime content.
• Use with caution when combining with other topical acne treatments containing sulfur, resorcinol, or salicylic acid, as these may increase irritation; allow their effects to subside before starting adapalene.
• Avoid excessive exposure to sunlight and sunlamps while using adapalene, and use sun protection and protective clothing when sun exposure cannot be avoided.
• Avoid waxing as a hair-removal method on skin being treated with adapalene, since it can worsen irritation.
• Weather extremes such as wind or cold may increase skin irritation during treatment.
• Do not apply adapalene to cuts, abrasions, eczematous skin, or sunburned skin.
• Use non-comedogenic, water-based cosmetics only, and remove make-up thoroughly before applying adapalene.

• Contraindicated in patients with known hypersensitivity to adapalene or to any ingredient in the formulation.
• Contraindicated in patients with eczema or seborrheic dermatitis.
• Contraindicated in pregnancy.
• Contraindicated in women who are planning a pregnancy.

• No clinically significant interactions with systemic medications are expected, since absorption of adapalene through the skin is low.
• Concomitant use of abrasive cleansers, strong drying agents, or other irritant skin products may produce additive skin irritation when combined with adapalene.
• Other topical anti-acne treatments, such as erythromycin solution, clindamycin phosphate solution, or benzoyl peroxide, may be used in the morning if adapalene is applied at night, without a known interaction.

• No food interactions have been established with topical adapalene.

• Apply adapalene once daily in the evening, before bedtime, after washing and drying the skin.

• Store adapalene cream, gel, and lotion at room temperature between 15°C and 30°C.
• Keep the product from freezing, keep the container tightly closed, and keep out of the reach of children.

• Adapalene is a topical retinoid used once daily at night to treat acne; visible improvement usually takes four to eight weeks, so continue using it as directed even if results are not immediate.
• Mild dryness, redness, peeling, or stinging are common early on and usually improve with continued use; a moisturizer can help, or application can be reduced to every other day if needed.
• Avoid excessive sun exposure and use sun protection, since treated skin is more sensitive to sunburn.
• Do not use adapalene during pregnancy or if planning a pregnancy, due to the risk of birth defects.
• Avoid applying adapalene to cuts, sunburned skin, or areas already irritated by other acne products.