Generic Name: azelaic acid (Topical route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiacne Antibacterial
Azelaic acid is used to treat mild to moderate acne. It works in part by stopping the growth of skin bacteria that can help cause acne. Azelaic acid also helps to lessen acne by keeping skin pores (tiny openings on the skin's surface) clear.
It may also be used to treat other conditions as determined by your doctor.
Azelaic acid is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, azelaic acid is used in certain patients with the following medical condition:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of azelaic acid in children with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of azelaic acid in the elderly with use in other age groups.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
This section provides information on the proper use of a number of products that contain azelaic acid. It may not be specific to Azelex. Please read with care.
When applying the cream, use only a small amount of medicine and apply a thin film to clean, dry skin that is affected by acne. It is important to rub it in gently but well.
After applying azelaic acid cream, wash your hands well to remove any medicine that may remain on them.
Keep this medicine away from the eyes, other mucous membranes, such as the mouth, lips, and inside of the nose, and sensitive areas of the neck. If the medicine accidently gets on these areas, wash with water at once.
To help clear up your acne completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a short time. If you stop using this medicine too soon, your acne may return or get worse.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
If your acne does not improve within 4 weeks, or if it becomes worse, check with your health care professional. However, it may take longer than 4 weeks before you notice full improvement in your acne even if you use the medicine every day.
If this medicine causes too much redness, peeling, or dryness of your skin, check with your doctor. It may be necessary for you to reduce the number of times a day that you use the medicine or to stop using the medicine for a short time until your skin is less irritated.
If your doctor has ordered another medicine to be applied to the skin along with this medicine, it is best to apply them at different times. This may help keep your skin from becoming too irritated. Also, if the medicines are used at or near the same time, they may not work properly.
You may continue to use cosmetics (make-up) while you are using this medicine for acne. However, it is best to use only water-base cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your acne worse. If you have any questions about this, check with your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:Rare
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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