Adapalene and benzoyl peroxide

What is Adapalene and benzoyl peroxide?

• Adapalene and benzoyl peroxide (Epiduo) is a combination of adapalene, a retinoid, and benzoyl peroxide, and is used for the topical treatment of acne vulgaris.

File:Adapalene structure.svg

Adapalene structure

File:Benzoyl-peroxide.svg

Benzoyl-peroxide

What are the uses of this medicine?

• Adapalene and benzoyl peroxide (Epiduo) is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age and older.
• Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

How does this medicine work?

Adapalene:

• Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein.
• Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes.
• However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

Benzoyl peroxide:

• Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage:

• Apply a thin film of adapalene and benzoyl peroxide gel 0.1% / 2.5% to affected areas of the face and/or trunk once daily after washing.
• Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek).

Administration:

• Adapalene and benzoyl peroxide gel 0.1% / 2.5% is for skin use only. Do not use adapalene and benzoyl peroxide gel 0.1% / 2.5% in or on your mouth, eyes, or vagina.
• Apply adapalene and benzoyl peroxide gel 0.1% / 2.5% 1 time a day.
• Do not use more adapalene and benzoyl peroxide gel 0.1% / 2.5% than you need to cover the treatment area.
• Using too much adapalene and benzoyl peroxide gel 0.1% / 2.5% or using it more than 1 time a day may increase your chance of skin irritation.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As adapalene and benzoyl peroxide gel 0.1% / 2.5% contains 1 mg (0.1%) adapalene and 25 mg (2.5%) benzoyl peroxide.

This medicine is available in fallowing brand namesː

• Epiduo

What side effects can this medication cause?

The most common side effects of this medicine include:

• dry skin
• contact dermatitis
• application site burning
• application site irritation
• skin irritation

Adapalene and benzoyl peroxide gel 0.1% / 2.5% may cause serious side effects including:

• Local skin reactions

What special precautions should I follow?

• Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of adapalene and benzoyl peroxide gel 0.1% / 2.5% and may necessitate discontinuation.
• Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no well-controlled trials in pregnant women treated with adapalene and benzoyl peroxide gel 0.1% / 2.5%.

Can this medicine be used in children?

• It is not known if adapalene and benzoyl peroxide gel 0.1% / 2.5% is safe and effective in children younger than 9 years old.

What are the active and inactive ingredients in this medicine?

• Active ingredient: adapalene and benzoyl peroxide
• Inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate.

Who manufactures and distributes this medicine?

Manufactured by:

• TOLMAR Inc., Fort Collins, CO 80526 for
• Sandoz Inc., Princeton NJ

What should I know about storage and disposal of this medication?

• Store adapalene and benzoyl peroxide gel 0.1% / 2.5% at room temperature, 68° – 77° F (20° – 25° C)
• Keep adapalene and benzoyl peroxide gel 0.1% / 2.5% inside container and out of light and away from heat.

• Dailymed label info on Adapalene and benzoyl peroxide
• FDA Adapalene and benzoyl peroxide