Pronunciation:

a-DAP-a-leen, BEN-zoe-il per-OX-ide

Brand Names:

• Epiduo
• Epiduo Forte

Dosage Forms:

• Gel/Jelly
• Pad

Classifications:

Therapeutic—

Antiacne

Chemical—

Retinoid

Uses of This Medicine:

Adapalene and benzoyl peroxide combination is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean (tiny openings on the skin).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Epiduo® in children younger than 9 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Epiduo® Forte in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of adapalene and benzoyl peroxide combination in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eczema (skin disorder) or
• Sunburn—Should not be used in patients with these conditions.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Before applying this medicine, wash the affected area of your skin with water and a mild soap. Rinse well and pat dry.
• Apply a small amount of the medicine to each affected area of the skin (eg, forehead, chin, cheeks, chest, shoulders, back), and gently rub it in.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (gel):
  • For acne:
    • Epiduo®:
      • Adults and children 9 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day.
      • Children younger than 9 years of age—Use and dose must be determined by your doctor.
    • Epiduo® Forte:
      • Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine may make your skin more sensitive to sunlight, wind, and cold weather. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. You may need to wear protective clothing, such as a hat.

Skin reactions such as dryness, redness, scaling, burning, or stinging can occur when you use this medicine. Use a moisturizer as needed to lessen these skin problems.

Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include rough skin cleansers, hair removal products, soaps or cosmetics that cause dryness, or products that contain alcohol, astringents, spices, or lime.

Do not use "waxing" as a hair removal method on skin areas treated with this medicine.

Allow this medicine to dry completely before getting dressed. This medicine may cause bleaching of clothes or hair. I

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Dryness and peeling of the skin

flushing or redness of the skin

unusually warm skin

Less common

Blistering, burning, crusting, or flaking of the skin

burning, itching, redness, skin rash, swelling, or soreness at the application site

scaling, severe redness, or swelling of the skin

Incidence not known

Skin pain

sunburn

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Burning, dry, or itching eyes

change in the color of the treated skin

discharge or excessive tearing

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

skin rash, encrusted, scaly, and oozing

swelling of the face

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.