Azelaic Acid Topical

WHY is this medicine prescribed?

Azelaic acid gel and foam is used to clear the bumps, lesions, and swelling caused by rosacea (a skin disease that causes redness, flushing, and pimples on the face). Azelaic acid cream is used to treat the pimples and swelling caused by acne. Azelaic acid is in a class of medications called dicarboxylic acids. It works to treat rosacea by decreasing the swelling and redness of the skin. It works to treat acne by killing the bacteria that infect pores and by decreasing production of keratin, a natural substance that can lead to the development of acne.

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?

Azelaic acid comes as a gel, foam, and a cream to apply to the skin. It is usually applied twice a day, in the morning and the evening. To help you remember to use azelaic acid, use it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use azelaic acid exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Be careful not to get azelaic acid in your eyes or mouth. If you do get azelaic acid in your eyes, wash with plenty of water and call your doctor if your eyes are irritated.

Azelaic acid foam is flammable. Stay away from open fire, flames, and do not smoke while you are applying azelaic acid foam, and for a short time afterwards.

To use the gel, foam, or cream, follow these steps:

1. Wash the affected skin with water and a mild soap or soapless cleansing lotion and pat dry with a soft towel. Ask your doctor to recommend a cleanser, and avoid alcoholic cleansers, tinctures, abrasives, astringents, and peeling agents, especially if you have rosacea.
2. Shake the azelaic acid foam well before use.
3. Apply a thin layer of gel, or cream to the affected skin. Gently and thoroughly massage it into the skin. Apply a thin layer of foam to the entire face including cheeks, chin, forehead, and nose.
4. Do not cover the affected area with any bandages, dressings, or wrappings.
5. You may apply make-up to your face after the medication is dry.
6. Wash your hands with soap and water after you finish handling the medication.

What SPECIAL PRECAUTIONS should I follow?

Before using azelaic acid,

• tell your doctor and pharmacist if you are allergic to azelaic acid or any other medications.

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

• tell your doctor if you have or have ever had asthma, or cold sores that keep coming back.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using azelaic acid, call your doctor.

• you should know that azelaic acid may cause changes in your skin color, especially if you have a dark complexion. Tell your doctor if you notice any changes in your skin color.

What SPECIAL DIETARY instructions should I follow?

If you have rosacea, you should avoid foods and drinks that cause you to flush or blush. These may include alcoholic drinks, spicy foods, and hot drinks such as coffee and tea.

If you have acne, continue your normal diet unless your doctor tells you otherwise.

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?

Azelaic acid may cause side effects. The following symptoms are likely to affect the skin you are treating with azelaic acid gel, foam, or cream. Tell your doctor if any of these symptoms are severe or do not go away:

• itching
• burning
• stinging
• tingling
• tenderness
• dryness

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

• swelling of the face, throat, tongue, lips, and eyes
• difficulty swallowing or breathing
• hoarseness
• rash
• hives

Azelaic acid may cause other side effects. Call your doctor if you have any unusual problems while using 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). Do not freeze. Dispose of the gel pump and the foam 8 weeks after opening the container.

Azelaic acid foam is flammable, keep it away from flames and extreme heat. Do not puncture or incinerate the azelaic acid foam container.

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 OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take 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.