Name: Azelex

Pregnancy & Lactation

Pregnancy Category: B

Lactation: enters breast milk; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Patient Handout

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Azelex Food Interactions

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.

Azelex Usage

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.

Azelex Dosage

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.

Other Requirements

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What do I need to tell my doctor BEFORE I take Azelex?

  • If you have an allergy to azelaic acid or any other part of Azelex (azelaic acid cream).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What should i avoid while using azelaic acid topical (azelex, finacea, finacea plus, finevin)?

Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If this does happen, rinse with water. Do not use on sunburned, windburned, dry, chapped, irritated, or broken skin. Wait until these conditions have healed before using this medication.

Avoid using other medications on the areas you treat with azelaic acid topical unless your doctor tells you to.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime.

Your doctor may recommend avoiding spicy foods, hot foods or drinks, alcoholic beverages and other foods or beverages that may cause flushing or redness of the skin during treatment with azelaic acid topical.

Do not cover the area after applying azelaic acid. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

  • Acne (Pimples)