Azelex

Azelaic acid topical cream is used for treatment of acne. This medicine acts by killing the bacteria to prevent acne formation and it keeps the skin pores clear.

Azelaic acid topical foam and gel forms are used for treatment of rosacea.

This medication may also use in treating chloasma.

This product is available in gel/jelly, foam, and cream.

Tell to your doctor if you are allergic to Azelaic acid or to any other medications.

You should also inform your healthcare providers if you are allergic to foods, dyes, or animals.

Studies have shown that the use of Azelaic acid topical cream has not demonstrated problems in children 12 years and older. Safety and effectiveness in children younger than 12 years have not been established.

Studies have shown that the use of Azelaic acid topical foam or gel has not demonstrated problems in children and elderlies.

Pregnancy category B - No risks have been found in humans.

There are no adequate studies whether Azelaic acid can pass through breast milk or if it could cause harmful effects to the infant.

Discuss with your doctor if you are breastfeeding a baby.

Tell your doctor if you are taking any other medication as drug interaction may occur when two or more drugs are being taken at the same time.

Use this medicine exactly as prescribed by your doctor. Excessive use of medication is not recommended. This medication is not for long-term use as doing so may cause skin irritation. You should continue using this medication for the full time of treatment.

This medicine is for external use only. Avoid contact in your eyes, nose, mouth, vagina, or even in open wounds. If this medicine accidently gets in these areas, rinse these areas thoroughly and check with your doctor immediately.

Do not use alcoholic cleansers, tinctures and astringents, or abrasives and peeling agents with the foam or gel to prevent extra skin irritation.

Directions to use:

• Clean the affected area by washing it with mild soap and water. Pat it dry after cleansing.
• Shake the foam can well before using.
• Apply a small amount of the medicine to each affected area of the skin and massage it gently into the skin until it disappears.
• Do not cover the treated area with a bandage unless directed to do so by your doctor.
• Wash your hands after applying the medication. You may apply cosmetics after the foam or gel has dried.

Recommended dosage of Azelaic acid topical cream for acne:

• Adults and teenagers (12 years or older) — Apply a thin layer to the affected area(s) twice a day, in the morning and evening.
• Children younger than 12 years — Use and dose must be determined by your doctor.

Recommended dosage of Azelaic acid topical foam or gel for mild to moderate rosacea:

• Adults — Apply a thin layer to the affected area(s) twice a day, in the morning and evening.
• Children — Use and dose must be determined by your doctor.

If you miss a dose of this medicine, use it as soon as possible. However, if it is near for your next dose, skip the missed dose and start again to your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store the medication in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of reach of children. Do not keep expired medications. Do not throw the canister onto a fire even if it is empty.

Your doctor will be checking you regularly to monitor the effectiveness of the medication. Blood tests may be ordered for undesirable effects.

Check with your doctor if

• If your acne does not improve within 4 weeks, or if it becomes worse.
• If your rosacea does not improve within 12 weeks, or if it becomes worse.
• If your skin color is lighter in the treated areas, especially if you have dark skin. Hypopigmentation may occur while you are using this medicine.
• If you have a skin rash, burning, dryness, redness, peeling, stinging, swelling, or irritation on the skin.

If any of the following side effects occur, check with your doctor as soon as possible.

• Burning, stinging, or tingling of the skin
• Dryness, itching, peeling, or redness of the skin
• Fast heartbeat
• Fever
• Hives, itching, or skin rash
• Hoarseness
• Irritation
• Joint pain, stiffness, or swelling
• Redness of the skin
• Swelling of the eyelids, face, lips, hands, or feet
• Tightness in the chest
• Troubled breathing or swallowing

Less serious side effects:

• Change in skin color at treated areas

Not all side effects are listed above.

If you notice any other effects, check with your healthcare professional.