Adapalene and benzoyl peroxide topical

Name: Adapalene and benzoyl peroxide topical

What is adapalene and benzoyl peroxide topical?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Adapalene is similar to vitamin A. It helps the skin renew itself.

Adapalene and benzoyl peroxide topical (for the skin) is a combination medicine used to treat acne in adults and children who are at least 9 years old.

Adapalene and benzoyl peroxide topical may also be used for purposes not listed in this medication guide.

What happens if I overdose?

An overdose of adapalene and benzoyl peroxide topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Adapalene and benzoyl peroxide dosing information

Usual Adult Dose for Acne:

Usual dose: Apply a thin layer to the affected area once a day

Comments:
-The affected area should be thoroughly washed and dried before application.
-A pea-sized amount should be used for each area of the face (e.g., forehead, chin, each cheek).

Use: Topical treatment of acne vulgaris

Usual Pediatric Dose for Acne:

Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel
9 years and older:
-Usual dose: Apply a thin layer to the affected area once a day

Comments:
-The affected area should be thoroughly washed and dried before application.
-A pea-sized amount should be used for each area of the face (e.g., forehead, chin, each cheek).

Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel
12 years and older:
-Usual dose: Apply a thin layer to the affected area once a day

Comments:
-The affected area should be thoroughly washed and dried before application.
-A pea-sized amount should be used for each area of the face (e.g., forehead, chin, each cheek).

Use: Topical treatment of acne vulgaris

For Healthcare Professionals

Applies to adapalene / benzoyl peroxide topical: topical gel

General

The most commonly reported side effects include irritative contact dermatitis, burning sensation, and dry skin.[Ref]

Dermatologic

Common (1% to 10%): Irritative contact dermatitis, dry skin/dryness, skin irritation, erythema, skin exfoliation/scaling
Uncommon (0.1% to 1%): Sunburn, pruritus, atopic dermatitis, eczema
Frequency not reported: Skin pain/stinging pain
Postmarketing reports: Allergic contract dermatitis, blisters/vesicles, skin discoloration, rash[Ref]

Local

Common (1% to 10%): Application site burning, application site irritation[Ref]

Nervous system

Common (1% to 10%): Burning sensation/skin burning sensation[Ref]

Ocular

Postmarketing reports: Eyelid edema, conjunctivitis[Ref]

Respiratory

Postmarketing reports: Throat tightness[Ref]

Other

Postmarketing reports: Swelling face[Ref]

Some side effects of adapalene / benzoyl peroxide topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Acne

Usual dose: Apply a thin layer to the affected area once a day

Comments:
-The affected area should be thoroughly washed and dried before application.
-A pea-sized amount should be used for each area of the face (e.g., forehead, chin, each cheek).

Use: Topical treatment of acne vulgaris

Usual Pediatric Dose for Acne

Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel
9 years and older:
-Usual dose: Apply a thin layer to the affected area once a day

Comments:
-The affected area should be thoroughly washed and dried before application.
-A pea-sized amount should be used for each area of the face (e.g., forehead, chin, each cheek).

Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel
12 years and older:
-Usual dose: Apply a thin layer to the affected area once a day

Comments:
-The affected area should be thoroughly washed and dried before application.
-A pea-sized amount should be used for each area of the face (e.g., forehead, chin, each cheek).

Use: Topical treatment of acne vulgaris

Other Comments

Administration advice:
-This drug is for topical use only, and should be used with caution around mucous membranes and disrupted skin (e.g., abrasions, cuts, eczema, sunburns).

Storage requirements:
-Protect from light and heat; do not freeze.

General:
-Excessive application may increase the risk of skin irritation without improving efficacy.
-Oral, ophthalmic, or intravaginal use should be avoided.

Monitoring:
-Excessive skin irritation
-Sunburns/increased photosensitivity

Patient advice:
-Patients should be counseled on using appropriate sun protection while on therapy.
-Patients should be instructed to wash the affected area with a mild, non-medicated soap and pat the area dry before application. Patients should be told to avoid washing the area too frequently or scrubbing the skin too hard.
-Patients should be warned that benefits may not be seen for up to 12 weeks; initially, acne may look worse, but patients should not discontinue use during this time.
-Patients should be told to avoid contact with extremes in weather, other topical drugs, agents with strong drying effects, preparations with high alcohol concentrations, abrasive soaps, astringents, spices, and/or lime or lime peels to decrease the risk of skin irritation.

Adapalene / benzoyl peroxide topical Pregnancy Warnings

Animal studies have not been reported. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: C Comment: -Patients who become pregnant during treatment should consider discontinuation of this drug.

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