Azelaic Acid

Name: Azelaic Acid

Azelaic Acid Precautions

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.

Azelaic Acid 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.

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.

Uses of Azelaic acid

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.

Side Effects of Azelaic acid

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.

Azelaic acid 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.

Azelaic acid and Pregnancy

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.

Azelaic acid 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.

Azelaic acid 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.

Actions

  • Exact mechanism of action for treatment of acne vulgaris not fully elucidated; however, effect appears to result partially from antibacterial activity.1 2 3 4 5 6 7 9 10 11 12 13 14 15 17 19 20

  • Inhibits growth of susceptible organisms (principally Propionibacterium acnes)1 2 4 5 7 10 11 13 14 16 17 19 20 on skin by inhibiting protein synthesis.1 2 7 10 11 19 20

  • Usually bacteriostatic; may be bactericidal in high concentrations against P. acnes and Staphylococcus epidermidis2 5 7 19

  • May inhibit follicular keratinization,20 which may prevent development or maintenance of comedones.1 2 12 14 19

  • Exhibits antiproliferative effects against hyperactive and abnormal melanocytes but does not exhibit an appreciable depigmenting effect on normally pigmented skin.9

  • Exact mechanism of action for treatment of rosacea is unknown.22

Pronunciation

(a zeh LAY ik AS id)

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Usual Pediatric Dose for Acne

20% cream:
Greater than or equal to 12 years: Apply to affected area twice a day, morning and evening. The skin should be gently washed, rinsed with warm water, and patted dry before application.

Other Comments

The skin should be washed and dried before application. A thin film should be applied and massaged gently but thoroughly into the skin. The hands should be washed following application. Improvement is typically seen within 4 weeks.

Azelaic Acid Identification

Substance Name

Azelaic Acid

CAS Registry Number

123-99-9

Drug Class

Antineoplastic Agents

Dermatologic Agents

Administrative Information

LactMed Record Number

541

Last Revision Date

20160204

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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