Description

Azelex

What is azelaic acid topical?

Azelaic acid is a naturally occurring acid. It helps the skin to renew itself more quickly and therefore reduces pimple and blackhead formation. It also helps to kill the bacteria that cause acne and rosacea.

Azelaic acid topical (for the skin) is used to treat acne and rosacea.

Azelaic acid topical may also be used for purposes not listed in this medication guide.

Azelex

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use this medication if you are allergic to azelaic acid or propylene glycol.

Azelaic acid topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether azelaic acid topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use azelaic acid topical?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Clean the affected area with a mild soap or a soap-free cleansing lotion and pat dry with a soft towel. Apply the medication as directed.

Azelaic acid topical is usually applied twice daily, in the morning and at bedtime. Follow your doctor’s instructions.

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

It may take up 4 weeks or longer before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 12 weeks of treatment.

If you have excessive burning, dryness, or irritation, ask your doctor about using azelaic acid once daily.

Store at room temperature away from moisture and heat.

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What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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 should I avoid while using azelaic acid topical?

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.

Azelaic acid topical side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using azelaic acid topical and call your doctor at once if you have:

• severe burning, stinging, or warmth;
• severe itching or tingling;
• severe redness, dryness, peeling, or other irritation; or
• changes in skin color.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Azelaic acid topical side effects (more detail)

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Azelaic acid topical dosing information

Usual Adult Dose for Acne:

20% Cream Formulations: Apply a thin layer to the affected area(s) 2 times a day

Comments:
-The affected area(s) should be gently washed and patted dry before application.
-This drug should be gently but thoroughly massaged into the affected area(s) in the morning and evening.
-The duration of therapy is based upon the patient and the severity of the acne.
-Improvement in patients with inflammatory lesions usually occurs within 4 weeks.

Use: Topical treatment of mild-to-moderate inflammatory acne vulgaris

Usual Adult Dose for Acne Rosacea:

15% Gel/Foam Formulations: Apply a thin layer to the affected area(s) 2 times a day

Comments:
-The affected area(s) should be gently washed and dried before application with a very mild soap or soapless cleansing lotion.
-This drug should be gently but thoroughly massaged into the affected areas in the morning and evening.
-Patients may apply cosmetics once the treatment has dried.
-Patients should be reassessed if improvement is not observed after completing 12 weeks of treatment.
-For patients using foam formulations, the smallest amount of foam should be used to adequately cover the affected area(s) with a thin layer.

Use: Topical treatment of the inflammatory papules and pustules of mild to moderate rosacea

Usual Pediatric Dose for Acne:

12 years and older:
20% Cream Formulations: Apply a thin layer to the affected area(s) 2 times a day

Comments:
-The affected area(s) should be gently washed and patted dry before application.
-This drug should be gently but thoroughly massaged into the affected area(s) in the morning and evening.
-Improvement in patients with inflammatory lesions usually occurs within 4 weeks.

Use: Topical treatment of mild-to-moderate inflammatory acne vulgaris

Detailed Azelaic acid topical dosage information

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