Azelex

Azelaic acid is a prescription medication used to treat acne and rosacea.

Azelaic acid belongs to a group of drugs called carboxylic acids. These work by killing the bacteria that infect pores and by decreasing the production of keratin. Too much keratin can cause rosacea.

This medication comes in cream and gel forms and is usually applied to the skin two times a day.

Common side effects of azelaic acid include itching, burning, stinging, and tingling of the skin.

Azelaic acid cream is a prescription medication used to treat mild-to-moderate acne. Azelaic acid gel is approved to treat mild-to-moderate rosacea.

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

• Allergan, Inc.

Serious side effects have been reported with azelaic acid. See the “Azelaic acid Precautions” section.

Common side effects of azelaic acid include the following:

• itching
• burning
• stinging
• tingling

This is not a complete list of azelaic acid side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No azelaic acid drug interactions have been identified by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with the use of azelaic acid including the following:

• Skin irritation. Though this is likely to occur early on, if skin irritation is excessive or persistent, it is necessary to contact you provider right away if you have some or all of the following symptoms of skin irritation
  • rash
  • itching
  • burning
  • stinging
• Hypopigmentation. Skin discoloration may occur with the use of azelaic acid.

Do not use azelaic acid if you are allergic to azelaic acid or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of azelaic acid, there are no specific foods that you must exclude from your diet when using this medication.

Before using azelaic acid, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to azelaic acid or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Azelaic acid falls into category B. There are no well-done studies that have been done in humans with azelaic acid. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if azelaic acid crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using azelaic acid.

Use azelaic acid exactly as prescribed.

Azelaic acid comes in gel and cream forms and is usually applied to the skin two times every day, in the morning and in the evening.

Before applying azelaic acid, wash the affected skin with water and mild soap or cleanser and pat dry with a soft towel. Apply a thin layer of cream or gel to the affected skin. Gently massage it into the skin. Do not get azelaic acid in your eyes or mouth. If you get azelaic acid in your eyes, wash thoroughly with water and call your doctor if your eyes are irritated.

Do not cover the affected skin with bandages, dressings, or wraps. You may apply non-irritating cosmetics after the cream or gel is dry.

Wash your hands after handling azelaic acid.

If you miss a dose, apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and apply your next dose at the regular time. Do not apply two doses of azelaic acid at the same time.

Use azelaic acid exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The azelaic acid dose your doctor recommends will be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose of Azelex (azelaic acid cream) for the treatment of acne is a thin layer of cream applied two times daily.

The recommended dose of Finacea (azelaic acid gel) for the treatment of rosacea is a thin layer of gel applied two times daily.

If you use too much azelaic acid, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store azelaic acid at room temperature between 15-30°C (59-86°F).
• Keep this and all medicines out of the reach of children.