In the U.S.—

In Canada—

• Antiacne agent (topical)

Adapalene (a-DAP-a-leen) is used to treat acne. It works partly by keeping skin pores clear.

Adapalene is available only with your doctor's prescription, in the following dosage form:

Topical
• Gel (U.S. and Canada)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to adapalene. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Adapalene has not been studied in pregnant women. It is not recommended for use during pregnancy. Adapalene in large doses has been shown to cause some bone problems in the fetuses of some animals. Before using this medicine, make sure your doctor knows if you are pregnant or if you are trying to become pregnant.

Breast-feeding—It is not known if adapalene passes into breast milk.

Children—Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of adapalene in children up to 12 years of age with use in other age groups. In teenagers, adapalene is not expected to cause different side effects or problems than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of adapalene in the elderly with use in other age groups. Older adults are not likely to develop acne.

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 doctor and pharmacist if you are using any other topical prescription or nonprescription (over-the-counter [OTC]) medicine that is to be applied to the same area of the skin.

• Eczema or
• Seborrheic dermatitis—Use of this medicine may cause or increase the irritation associated with eczema or seborrheic dermatitis

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 irritation of the skin.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

Do not use this medicine in or around the eyes, lips, or inside of the nose. Spread the medicine away from these areas when applying. If the medicine accidently gets on these areas, wash with water at once.

Apply the medicine to clean, dry areas of the skin affected by acne. Rub in gently and well. Wash your hands afterwards to remove any medicine that may remain on them.

To help clear up your acne completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a short time. If you stop using this medicine too soon, your acne may return or get worse.

Dosing—

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

• For topical dosage form (gel):
  • For acne:
    • Adults and teenagers—Apply a small amount as a thin film once a day, at least one hour before bedtime. Apply the medicine to dry, clean areas affected by acne. Rub in gently and well.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

During the first 3 weeks you are using adapalene, your acne may seem to get worse before it gets better. Full improvement should be seen within 12 weeks, especially if you use the medicine every day. You should not stop using adapalene if your acne seems worse at first, unless irritation or other symptoms become severe. Check with your doctor if your acne does not improve within 8 to 12 weeks.

Do not apply any topical product to the same area where you are using adapalene, unless otherwise directed by your doctor. If applied to the same area treated with adapalene, the following products may cause mild to severe irritation of the skin:

• Hair products that irritate the skin, such as permanents or hair removal products
• Skin products for acne (such as clindamycin or erythromycin) or other skin products containing a peeling agent (such as benzoyl peroxide, resorcinol, salicylic acid, or sulfur)
• Skin products that cause one to be more sensitive to the sun, such as those containing spices or lime
• Skin products that are too drying or that contain a large amount of alcohol, such as astringents, cosmetics, shaving creams, or after-shave lotions
• Skin products that are abrasive, such as some soaps or skin cleansers

Your doctor may ask you to use other topical products, such as benzoyl peroxide, clindamycin, or erythromycin, during your treatment with adapalene. Applying the products at different times of the day will lessen the chance of causing skin irritation.

If your skin becomes too dry or red at any time, discuss with your doctor whether you should continue using adapalene. Applying creams, lotions, or moisturizers as needed helps lessen these skin problems.

During treatment with this medicine, avoid getting too much sun on treated areas and do not use sunlamps. Since your skin may be more prone to sunburn or skin irritation, use sunscreen or sunblocking lotions regularly with a sun protection factor (SPF) of 15 or more. Wear protective clothing against sun, wind, and cold weather.

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 as soon as possible if any of the following side effects occur:

• More common--especially during the first month of use
  • Burning sensation or stinging of skin;  dryness and peeling of skin;  itching of skin;  redness of skin 
  
  

Other 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. However, check with your doctor if the following side effect continues or is bothersome:

• Rare--more common during the first month of use
  • Worsening of acne 
  
  

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