Adapalene Topical

A brief sensation of warmth or stinging may occur immediately after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2-4 weeks of using the medication. These effects usually decrease with continued use. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Your doctor may want you to decrease how often you use adapalene, change the strength, or have you stop using it.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: very red/irritated skin, an intense burning sensation, eye redness and watering (conjunctivitis), eyelid swelling, skin discoloration.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Do not share this medication with others.Cosmetics may be used, but clean skin thoroughly before applying the medication.Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.

If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until morning, wait until your next dose is scheduled.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Different forms of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Gel preparations are flammable. Do not expose to heat or fire sources. Do not smoke during use. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Reviewed on 4/16/2014 References

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 adapalene, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to adapalene 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.

Pediatric

Studies of adapalene 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.

Geriatric

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 adapalene. Make sure you tell your doctor if you have any other medical problems, especially:

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

Apply the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not apply extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include skin redness, scaling, or irritation.

Avoid exposure to sunlight or tanning beds. Adapalene can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using other skin medications that contain sulfur, resorcinol, or salicylic acid (common in topical acne medications or skin cleansers).

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: products containing alpha hydroxy acids, products containing glycolic acid, hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotions), medicated or abrasive soaps and cleansers, soaps and cosmetics with a strong drying effect.