Avage® (tazarotene) Cream, 0.1% – Consumer Medicine Information
|Condition:||Wrinkles (Facial Wrinkles)|
|Ingredients:||tazarotene, benzyl alcohol, carbomer homopolymer type B; carbomer 1342; edetate disodium; medium chain triglycerides; mineral oil; purified water; sodium thiosulfate; sorbitan monooleate and sodium hydroxide to adjust pH|
Use only on the face.
Read this leaflet carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug. This leaflet does not take the place of talks with your doctor. If you have any questions, or are not sure about something, ask your doctor or pharmacist.
What is the most important information I should know about AVAGE® Cream?
- AVAGE® Cream can cause birth defects in unborn children of women who are pregnant when they use the product. If you are a woman who can become pregnant, you must not be pregnant when you start using AVAGE® Cream, and you must avoid pregnancy while you use it. See the sections “Who should not use AVAGE® Cream?” “How should I use AVAGE® Cream?” and “What should I avoid while using AVAGE® Cream?” for more information.
- Avoid sunlight and other medicines that may increase your sensitivity to sunlight (See “Who should not use AVAGE® Cream?” and “What should I avoid while using AVAGE® Cream?”)
- AVAGE® Cream does not remove wrinkles or repair sun-damaged skin. (See “What is AVAGE® Cream?” for more details.)
What is Avage® Cream?
- AVAGE® Cream is a prescription medicine that may reduce fine facial wrinkles and certain types of dark and light spots on your face.
- AVAGE® is for patients who are using a total skin care program and avoiding sunlight. AVAGE® Cream does not remove wrinkles, repair sun-damaged skin, reverse skin aging from the sun (photoaging), or bring back more youthful or younger skin. AVAGE® does not work for everyone who uses it. It may work better for some patients than for others.
- The active ingredient in AVAGE® Cream is tazarotene.
Who should not use Avage® Cream?
Do not use AVAGE® Cream if
- you are pregnant, plan to become pregnant, or may become pregnant. AVAGE® Cream may harm your unborn child. Women who can become pregnant must have proof they are not pregnant from a reliable pregnancy test, done within 2 weeks before starting AVAGE® Cream. Talk with your doctor about effective birth control if you are a woman who is able to become pregnant.
- you have sunburn or eczema. If you have sunburn, wait until full recovery before using AVAGE® Cream. AVAGE® Cream may cause severe irritation if used on eczema. Wait until your doctor tells you your eczema has cleared up before starting AVAGE® treatment.
- you are allergic to the ingredients in AVAGE® Cream. The active ingredient is tazarotene. See the end of this information for a list of inactive ingredients.
Tell your doctor before using AVAGE® if
- you are breast feeding. We do not know if AVAGE® Cream can pass through your milk and harm the baby.
- you are sensitive to sunlight. AVAGE® may not be right for you or you may need extra protection from sunlight.
- you take certain other medicines, vitamins, and supplements that increase your sensitivity to sunlight. These include Vitamin A and medicines that are called thiazides, tertracyclines, fluoroquinolones, phenothiazines, and sulfonamides. Therefore, tell your doctor if you take any prescription or non-prescription medicines, vitamins, or supplements. This will help your doctor decide if you can take AVAGE® Cream.
- you take any other prescription or non-prescription medicines, supplements or vitamins. Some of them may make you more sensitive to sunlight.
How should I use Avage ® Cream?
- If you are able to become pregnant, take a reliable pregnancy test within 2 weeks before beginning to use AVAGE® Cream to be sure you are not pregnant. If you have menstrual periods, start taking AVAGE® Cream during a normal menstrual period. These actions help assure you are not pregnant when you begin use.
- If you get pregnant while using AVAGE® Cream, stop use and contact your doctor right away.
- Use AVAGE® Cream only under the guidance of your doctor as part of a total skin care program in which you avoid sunlight. This program should include avoiding sunlight as much as possible, using clothing to protect you from sunlight, using sunscreens with an SPF of 15 or higher, and using face creams that add moisture to your skin.
- Follow these directions:
- Use AVAGE® Cream once a day in the evening.
- In the evening, gently wash your face with mild soap. Pat your skin dry and wait 20-30 minutes before applying AVAGE® Cream.
- Be sure your skin is dry before you use AVAGE® Cream.
- Apply only a pea-sized amount (about ¼ inch or 5 mm wide) to your face at one time. This should be enough to cover the wrinkled or discolored areas lightly. You can include your eyelids, if desired.
- Wash your hands after applying the medicine. If the cream gets on areas you do not need to treat, wash it off.
- In the morning, apply a moisturizing sunscreen of SPF 15 or greater.
What should I avoid while using Avage® Cream?
- Do not become pregnant while using AVAGE® Cream. See the section “How should I use AVAGE® Cream?” for more information. Use effective birth control while using AVAGE® Cream, and be sure you are not pregnant before you start using AVAGE® Cream.
- If you become pregnant while using AVAGE® Cream, stop use and contact your doctor right away.
- AVAGE® Cream makes you more sensitive to sunlight. It works only in patients who follow a sun avoidance program. Therefore, avoid sunlight as much as possible. Use cover-up clothing and sunscreens of at least SPF 15 during the day when using AVAGE® Cream. Also, do not use sunlamps, unless your doctor tells you to.
- If you are sensitive to sunlight or in the sun a lot on your job, be especially careful to protect your skin. Use sunscreens and protective clothing. Stay out of the sun as much as possible.
- Avoid cosmetics, medicines and supplements that may make you more sensitive to sunlight, including Vitamin A.
What are the possible side effects of Avage® Cream?
AVAGE® can cause increased skin irritation and increased chance of sunburn.
While you use AVAGE® Cream, strong wind or cold may irritate your skin more than usual.
The most common side effects of AVAGE® (tazarotene) Cream 0.1% are peeling, redness, burning, dryness, and irritated and itching skin.
These are not all the side effects possible with AVAGE® Cream. For more information, ask your doctor or pharmacist.
Tell your doctor if side effects become problems. Your doctor may adjust your dose of AVAGE® Cream. However, the effectiveness of AVAGE® Cream when used less often than once a day has not been proven.
What are the ingredients of Avage® Cream?
The active ingredient is tazarotene. The inactive ingredients are benzyl alcohol; carbomer homopolymer type B; carbomer 1342; edetate disodium; medium chain triglycerides; mineral oil; purified water; sodium hydroxide; sodium thiosulfate; and sorbitan monooleate.
General advice about prescription medicines
This medicine is for your use only. Never give it to other people. It may harm them even if their skin problem appears to be the same as yours. Medicines are sometimes prescribed for conditions not mentioned in patient information leaflets. Do not use AVAGE® Cream for a condition for which it was not prescribed. Do not use AVAGE® Cream after the expiration date on the bottom seal of the tube.
Where can I get more information about AVAGE® Cream?
You can contact Allergan by calling 1.800.433.8871. You can ask your doctor or pharmacist for the information about AVAGE® Cream that is written for health professionals.