Adapalene

WHY is this medicine prescribed?

Adapalene is used to treat acne in adults and children 12 years of and older. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the skin.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Prescription adapalene comes as a gel, a solution (liquid), lotion, a cream, and a pledget (individual medicated swab for one time use) to apply to the skin. Nonprescription (over the counter) adapalene comes as a gel to apply to the skin. Adapalene is usually applied once a day at bedtime. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply adapalene exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor or stated on the package. Applying more adapalene or applying adaplene more often than recommended will not speed up or improve results, but it may irritate your skin.

Adapalene controls acne but does not cure it. Your acne may get worse during the first few weeks of treatment, and it may take 8 to 12 weeks or longer before you feel the full benefit of adapalene. During the first weeks of your treatment, adapalene may bring previously unseen pimples to the skin surface. Continue to use adapalene even if your acne worsens or you do not see much improvement at first.

Do not apply adapalene to skin that is sunburned, broken, or covered with eczema (a skin disease). If you have any of these conditions, do not apply adapalene until your skin has healed.

Be careful not to get adapalene in your eyes, nose, mouth, or vagina. If you do get adapalene in your eyes, your eyes may become red, irritated, or swollen.

Your skin may become dry or irritated during the first 2–4 weeks of your treatment. If your skin stings, burns, or becomes irritated at any time during your treatment, talk to your doctor. Your doctor may tell you to use a moisturizer to help with dryness or tell you to apply Adapalene less often.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

To use the cream, gel, lotion, solution, or pledgets, follow these steps:

1. Gently wash the affected skin with a mild soap or soapless cleanser and pat dry with a soft towel. Do not use harsh or abrasive cleansers, and do not scrub your skin vigorously. Ask your doctor or pharmacist to recommend a gentle cleanser.
2. If you are using the gel or cream, use your fingers to spread a thin film of medication over the affected area. If you are using a pledget, remove it from the foil pouch and gently wipe the affected area. If you are using the solution, apply a thin layer to the affected area using a clean cotton swab or other applicator. Adapalene lotion comes in a pump that dispenses measured amounts of the medication. If you are using the lotion, press down on the top of the pump 3–4 times so that the medication comes out onto your palm and apply a thin film of the medication over the affected area. Adapalene should be applied to the entire affected area, not only to a single pimple or spot.
3. You may feel a slight warmth or stinging in the place where you applied adapalene. This feeling is normal and should go away by itself in a short time.
4. If you used a pledget, discard it after use. Do not save it to use again.

What SPECIAL PRECAUTIONS should I follow?

Before taking adapalene,

• tell your doctor and pharmacist if you are allergic to adapalene, any other medications, or any ingredient in adapalene topical products. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had eczema or any other skin condition.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using adapalene, call your doctor. If you are breastfeeding while using adapalene, apply the smallest amount to the skin and do not apply it directly to the nipple and areola (the colored area around each nipple).

• plan to avoid unnecessary or prolonged exposure to real and artificial sunlight (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen, especially if you sunburn easily. Adapalene may make your skin sensitive to sunlight or ultraviolet light.

• you should know that weather extremes, such as wind and cold, may be particularly irritating.

• tell your doctor about all skin products that you use, including soaps, cleansers, moisturizers, and cosmetics. Many skin care products can irritate your skin, if you use them with adapalene, especially those that are harsh, dry out the skin, or contain alcohol, spices, or lime rind. If you have been using these products, your doctor may want you to wait before you begin using adapalene. Ask your doctor to recommend products that will not irritate your skin.

• do not use hot wax to remove unwanted hair from the area you are treating with adapalene during your treatment with this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Adapalene may cause side effects. The following symptoms are likely to affect your skin during the first 2-4 weeks of treatment. Tell your doctor if any of these symptoms are severe or do not go away:

• redness
• scaling
• dryness
• burning or stinging
• pain at the application site

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives, itching, shortness of breath or difficulty breathing
• swelling of the eyes, face, lips, tongue, or throat

Adapalene may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

If someone swallows adapalene, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.