IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.
AZELAIC ACID CREAM - TOPICAL
(ay-zeh-LAY-ick)
COMMON BRAND NAME(S): Azelex
USES: This medication is used for the treatment of mild to moderate acne. Azelaic acid belongs to a class of drugs known as dicarboxylic acids. It works by stopping the growth of bacteria on the skin and by reducing the amount of a natural skin substance (keratin) that can cause acne.
HOW TO USE: This medication is applied to the skin twice daily, or as directed by your doctor. To apply, clean the affected area with a mild soap or soap-free cleanser and pat dry. Apply a thin layer on the skin and massage in gently. Wash hands well after use.
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.
Avoid contact in or near the eyes or inside the nose and mouth. If it gets in your eyes wash out immediately with plenty of water and call your doctor if irritation persists. Do not apply any type of dressing or covering over the cream unless told to do so by your doctor.
Do not use large amounts or apply this more often than directed. Your condition will not clear faster, but the chance for side effects may be increased. Use for the full course of treatment as directed by your doctor. Improvement is usually seen within 4 weeks, but the full effects of this medication may take longer.
Inform your doctor if your condition persists or worsens after 4 weeks.
SIDE EFFECTS: Stinging, burning, itching, tingling, redness or drying of the skin may occur, usually at the beginning of treatment.
These side effects may be controlled by using this medication once daily instead of twice daily. Consult your doctor for more details.
If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
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.
Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in skin color (hypopigmentation), worsening of cold sores or fever blisters (oral herpes).
Dark-skinned individuals may notice a lightening in skin color. Consult your doctor or pharmacist for advice and report these changes if they occur.
Tell your doctor immediately if any of these rare but very serious side effects occur: worsening of asthma symptoms (shortness of breath, wheezing, increased use of quick-relief inhalers).
A very serious allergic reaction to this drug is unlikely but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, 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.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; to propylene glycol or benzoic acid; or if you have any other allergies.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, repeat 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 passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
Avoid use of skin care products that can cause further irritation (e.g., cleansers that contain alcohol, tinctures, astringents, abrasives and peeling agents). Consult your doctor or pharmacist for details.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.
NOTES: Do not share this medication with others.
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 July 2008 Copyright(c) 2008 First DataBank, Inc.