Adagel Plus0.1% + 2.5%

Adapalene and benzoyl peroxide combination gel is indicated for the topical treatment of acne vulgaris.

Contains adapalene (a synthetic retinoid) and benzoyl peroxide as active ingredients in a topical gel base. Marketed in more than one strength - commonly 0.1% adapalene/2.5% benzoyl peroxide, and 0.3% adapalene/2.5% benzoyl peroxide - with the higher-strength formulation generally approved for an older minimum age; confirm the exact strength and approved age range on the specific product's own label.

This is a combination topical gel that pairs a retinoid (adapalene) with an antibacterial and comedolytic agent (benzoyl peroxide) in a single product, addressing multiple aspects of acne development - excess skin cell shedding, clogged pores, inflammation, and acne-causing bacteria - through complementary mechanisms. Combining the two in one formulation improves convenience compared to using each ingredient separately. As with other retinoid-containing products, it commonly causes some skin dryness, redness, and peeling, particularly during the first few weeks of use, and it increases the skin's sensitivity to sunlight, making sun protection an important part of using it safely.

Therapeutic Class: Topical Acne Treatment (Retinoid + Antibacterial/Comedolytic Combination)

Systemic absorption of both components from topical use is generally low; a pharmacokinetic study in adults using 2 grams/day over a large treated area found quantifiable adapalene blood levels in only a minority of subjects, at very low concentrations, consistent with predominantly local action. Benzoyl peroxide is largely converted to benzoic acid within the skin and is not expected to accumulate systemically with normal use.

• Wash the affected area with a mild, non-medicated soap and pat dry before application
• Apply a thin layer once daily, using a pea-sized amount for each area of the face
• Avoid the eyes, lips, and mucous membranes
• For topical use only - not for oral, ophthalmic, or intravaginal use
• Wash hands after application, since this product may bleach hair or coloured fabrics (given the benzoyl peroxide component)
• Avoid washing the area too frequently or scrubbing the skin too hard
• Use appropriate sun protection (broad-spectrum sunscreen and protective clothing) during treatment

No formal drug-drug interaction studies have been conducted with this combination gel; however, the following should be considered:

• Other topical acne products (particularly peeling, desquamating, or abrasive agents): use with caution given a possible cumulative skin irritancy effect; avoid combining without medical guidance.
• Other topical retinoids or exfoliating products: combining may increase dryness and irritation; generally avoided.
• Sulfur, resorcinol, or salicylic acid-containing products: may add to skin irritation if used at the same time.

Common side effects

• Skin irritation, dryness, and scaling
• Redness (erythema)
• Stinging or burning sensation
• Sunburn

Less common effects

• Eczema or atopic dermatitis-type reaction
• Skin discoloration
• Contact dermatitis (irritant or allergic)

Serious effects (seek urgent medical attention)

• Severe hypersensitivity reactions, including anaphylaxis and angioedema: have been reported with benzoyl peroxide-containing products; hives, difficulty breathing, feeling light-headed, or swelling of the face, lips, tongue, or throat require immediate emergency care and permanent discontinuation.
• Severe local reactions: eyelid swelling, significant blistering, or facial swelling.

Pregnancy

No teratogenic effects were observed in animal studies with oral adapalene at doses well above the maximum recommended human topical dose; systemic absorption from normal topical use is low. Discuss use during pregnancy with your doctor, given general caution around retinoid-class products.

Breastfeeding

Given low systemic absorption from topical use, this combination is generally considered acceptable during breastfeeding when used as directed; avoid applying to the breast/chest area before nursing, and discuss any specific concerns with your doctor.

• Photosensitivity: minimize or avoid exposure to natural or artificial UV light, including sunlamps and tanning beds; use sunscreen and protective clothing when sun exposure cannot be avoided.
• Skin irritation: erythema, scaling, dryness, and stinging/burning are common, particularly during the first few weeks, and may necessitate a temporarily reduced application frequency or, if severe, discontinuation.
• Excessive application does not improve results and increases the risk of irritation; use only a thin layer as directed.
• Avoid use around mucous membranes, cuts, abrasions, sunburned skin, or eczema.
• This product may bleach hair or coloured fabric, given the benzoyl peroxide component; wash hands after application.
• Visible improvement can take up to 12 weeks; acne may appear to worsen initially before improving - continue as directed unless irritation is severe.

Excessive topical application does not improve effectiveness and increases the risk of skin irritation, redness, and peeling. If accidentally ingested, contact a doctor or pharmacist for advice, particularly for a child. Discontinue use and seek medical attention if a severe local or allergic reaction occurs.

Store at controlled room temperature (generally 15-30°C), protected from light and heat; do not freeze. Keep out of reach of children.

• Children under 9 years (0.1%/2.5% strength) or under 12 years (0.3%/2.5% strength): Safety and efficacy have not been established; not recommended in these younger age groups.
• Adolescents within the approved age range: Established for use at the same dosing as adults.
• Patients with sensitive or eczema-prone skin: May experience more pronounced irritation; consider a lower-strength formulation or less frequent application under medical guidance.

Treatment is generally continued for at least 12 weeks to assess full effectiveness, since visible improvement in acne can take this long to become apparent; longer-term use is common for ongoing acne management, as directed by a doctor or dermatologist, with periodic reassessment.

Drug Class: Naphthoic acid derivative retinoid (adapalene) combined with a topical antibacterial/keratolytic agent (benzoyl peroxide)

Adapalene works by normalizing the growth and shedding of skin cells within hair follicles, reducing the formation of microcomedones (the earliest, microscopic acne lesions) and helping existing clogged pores resolve; it also has some direct anti-inflammatory activity. Benzoyl peroxide releases oxygen within the pore, creating an environment hostile to Cutibacterium acnes (the bacteria implicated in acne), and also has a mild peeling (keratolytic) effect that helps unclog pores. Together, these complementary actions target several of the processes that drive acne formation.

The 0.1%/2.5% strength is approved for patients 9 years and older; the 0.3%/2.5% strength is approved for patients 12 years and older. Safety and effectiveness have not been established below these respective minimum ages.