GENERIC NAME: AZELAIC ACID CREAM - TOPICAL (ay-ze-LAY-ik AS-id)
BRAND NAME(S): Azelex
USES: This medication is used to treat mild to moderate acne. It works by reducing the amount of acne-causing bacteria on the skin and by helping to keep your pores open and unblocked, thus decreasing the number of acne pimples. Azelaic acid belongs to a class of drugs known as dicarboxylic acids.
HOW TO USE: Before using this medication, clean the affected area and pat dry. Apply this medication to the skin usually twice daily, in the morning and evening, or as directed by your doctor. Apply a thin layer and massage gently into the affected areas. Wash your hands after use.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.Avoid contact in or near the eyes or inside the nose and mouth. If this medication gets into any of these areas, wash immediately with plenty of water and call your doctor if irritation persists. Do not place a bandage or cover over the cream unless your doctor tells you to do so.Do not use large amounts of this medication or apply it more often than directed. Your condition will not improve any faster, and the risk of side effects may increase. Use this medication for the full course of treatment as directed by your doctor. It usually takes about 1 month to see an improvement, but the full effects of treatment may take longer.Tell your doctor if your condition does not improve after 1 month or if it worsens.
SIDE EFFECTS: Temporary stinging, burning, itching, or tingling of the skin may occur, usually at the beginning of treatment. These effects usually lessen as your body adjusts to this medication. However, if minor irritation continues, your doctor may instruct you to only use this product once daily. If any of these effects persist or worsen, stop using this medication and tell your doctor or pharmacist promptly.Tell your doctor immediately if any of these unlikely side effects occur: worsening of cold sores or fever blisters (oral herpes), unusual or unwanted hair growth.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rarely, some people may experience lightening of skin color (hypopigmentation) after using this medication. This side effect may be more noticeable in people with dark skin color. Consult your doctor for more details and report any skin color changes.Tell your doctor immediately if any of these rare but serious side effects occur: worsening of asthma symptoms (such as shortness of breath, wheezing).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, repeated episodes of cold sores or fever blisters (oral herpes).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication may pass into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.
OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
MISSED DOSE: If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C). Do not freeze. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.