Adapalene and Benzoyl Peroxide

• It is used to treat pimples (acne).

• Tell all of your health care providers that you take adapalene and benzoyl peroxide. This includes your doctors, nurses, pharmacists, and dentists.
• Certain acne products that contain benzoyl peroxide or salicylic acid can rarely cause very bad and sometimes life-threatening allergic reactions or very bad irritation. Before first use, you may need to follow certain steps to make sure you do not have an allergic reaction. Use this medicine as you were told by the doctor or read the package label. Talk with the doctor.
• Use care when putting on. It may bleach hair or colored fabric.
• Skin may look worse before it looks better.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Some weather conditions may irritate the skin. Talk with the doctor.
• Do not wax the affected skin. This may irritate the skin.
• Use of other skin products while using adapalene and benzoyl peroxide may cause more irritation.
• Talk with your doctor before you use other drugs or products on your skin.
• It may take several weeks to see the full effects.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• People using adapalene and benzoyl peroxide may get skin reactions where this medicine is used. These reactions may include burning, dryness, redness, scaling, or stinging. Most of the time, these reactions will go away within 4 weeks after starting adapalene and benzoyl peroxide. If these reactions last for longer than 4 weeks or get worse, talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about adapalene and benzoyl peroxide, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about adapalene and benzoyl peroxide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using adapalene and benzoyl peroxide.

Review Date: October 4, 2017

Acne vulgaris:

US labeling: Topical treatment of acne vulgaris in patients 9 years and older (Epiduo) or 12 years and older (Epiduo Forte).

Canadian labeling: Topical treatment of mild and moderate acne vulgaris, characterized by comedones, inflammatory papules/pustules in patients 9 years and older (Tactupump) or treatment of moderate and severe acne vulgaris characterized by comedones, inflammatory papules/pustules with or without occasional nodules in patients 12 years and older (Tactupump Plus).

Acne vulgaris:

Adapalene 0.1%/benzoyl peroxide 2.5%: Children ≥9 years and Adolescents: Topical: Refer to adult dosing.

Adapalene 0.3%/benzoyl peroxide 2.5%: Children ≥12 years and Adolescents: Topical: Refer to adult dosing.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy

Dapsone (Topical): Benzoyl Peroxide may enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the use of these agents in combination may cause skin and facial hair to temporarily turn a tan or yellow/orange color. Monitor therapy

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Animal reproduction studies have not been conducted with this combination. The Canadian labeling does not recommend use in pregnant women and advises contraceptive counseling to women of reproductive potential prior to initiating therapy. Refer to individual monographs.