Description
Azelaic acid topical cream is used to treat mildly to moderately inflamed acne. The topical foam and gel are used to treat mild to moderate rosacea. For acne, it works by killing the bacteria that cause acne and by keeping the skin pores clean.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Cream
- Foam
- Gel/Jelly
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of azelaic acid topical cream in children 12 years of age and older. Safety and efficacy in children younger than 12 years of age have not been established.
Appropriate studies on the relationship of age to the effects of azelaic acid topical foam or gel have not been performed in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of azelaic acid topical in the elderly.
Breastfeeding
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.
Drug Interactions
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.
Other Interactions
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Asthma—Use with caution. May make this condition worse.
Proper Use
It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated.
This medicine is for use only on the skin. Do not get it in your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off with water and check with your doctor right away, especially if you have red, sore eyes.
To help clear up your acne or rosacea completely, it is very important that you keep using this medicine for the full treatment time. Do not miss any doses.
Avoid using alcoholic cleansers, tinctures and astringents, or abrasives and peeling agents with the foam or gel to prevent extra skin irritation.
Avoid eating spicy foods, thermally hot foods and drinks (eg, hot coffee, tea), and alcoholic beverages while you are using the gel.
The foam is flammable. Avoid fire, flame, and smoking when you apply the medicine and right after it is applied.
To use the cream, foam, or gel:
- Wash your hands with soap and water before and after using this medicine.
- Before applying, wash the affected area of your skin with water and a mild soap or a cleansing lotion that does not contain soap. Rinse well and pat dry.
- Shake the foam can well before using.
- Apply a small amount of the medicine to each affected area and gently rub it in.
- You may apply cosmetics after the foam or gel has dried.
- Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
Dosing
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.
- For topical dosage form (cream):
- For acne:
- Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) two times a day, in the morning and evening.
- Children younger than 12 years—Use and dose must be determined by your doctor.
- For acne:
- For topical dosage forms (foam, gel):
- For mild to moderate rosacea:
- Adults—Apply a thin layer to the affected area(s) two times a day, in the morning and evening.
- Children—Use and dose must be determined by your doctor.
- For mild to moderate rosacea:
Missed Dose
If you miss a dose of this medicine, apply 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.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not store the foam can at temperatures above 49 degrees C (120 degrees F). Do not poke holes in the can or throw it into a fire, even if the can is empty. Throw away any unused medicine 8 weeks after using it for the first time.
Precautions
It is very important that your doctor check your progress at regular visits for any unwanted effects that may be caused by this medicine.
If your acne does not improve within 4 weeks, or if it becomes worse, check with your doctor.
If your rosacea does not improve within 12 weeks, or if it becomes worse, check with your doctor.
Hypopigmentation may occur while you are using this medicine. Check with your doctor right away if your skin color is lighter in the treated areas, especially if you have dark skin.
This medicine may cause allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have itching skin, trouble breathing, or large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs after using this medicine.
This medicine may cause skin reactions. Check with your doctor right away if you have a skin rash, burning, dryness, redness, peeling, stinging, swelling, or irritation on the skin.
Side Effects
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 immediately if any of the following side effects occur:
More common
- Burning, stinging, or tingling of the skin
- dryness, itching, peeling, or redness of the skin
Less common
- Blistering, burning, crusting, dryness, or flaking of the skin
- scaling, severe redness, soreness, or swelling of the skin
Incidence not known
- Blurred vision
- eye pain, redness, or swelling
- fast heartbeat
- fever
- hives, itching, or skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- tearing
- tightness in the chest
- trouble breathing or swallowing
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:
Rare
- Change in skin color at treated areas
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.
DRG-20062084
