Generic Name: tretinoin (Topical route)
Patients with acute promyelocytic leukemia (APL) can have severe adverse reactions to tretinoin including retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal and multi-organ failure. High-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. Patients can also develop rapidly evolving leukocytosis during therapy which can lead to an increased risk of life-threatening complications. There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. Pregnancy testing is necessary prior to initiation of treatment in women of childbearing potential and the patient must be instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Dermatological Agent
Chemical Class: Retinoid
Tretinoin is used to treat acne. It works partly by keeping skin pores clear.
One of the tretinoin creams is used to treat fine wrinkles, dark spots, or rough skin on the face caused by damaging rays of the sun. It works by lightening the skin, replacing older skin with newer skin, and by slowing down the way the body removes skin cells that may have been harmed by the sun. Tretinoin works best when used within a skin care program that includes protecting the treated skin from the sun. However, it does not completely or permanently erase these skin problems or greatly improve more obvious changes in the skin, such as deep wrinkles caused by sun or the natural aging process.
Tretinoin may also be used to treat other skin diseases as determined by your doctor.
Tretinoin 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, tretinoin is used in certain patients with the following medical conditions:
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 on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups. Children are unlikely to have skin problems due to the sun. In older children treated for acne, tretinoin is not expected to cause different side effects or problems than it does 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 tretinoin in patients 50 years of age and older with use in other age groups.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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.
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:
This section provides information on the proper use of a number of products that contain tretinoin. It may not be specific to Refissa. Please read with care.
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 irritation of the skin.
Do not apply this medicine to windburned or sunburned skin or on open wounds.
Do not use this medicine in or around the eyes or lips, or inside of the nose. Spread the medicine away from these areas when applying. If the medicine accidentally gets on these areas, wash with water at once.
This medicine usually comes with patient directions. Read them carefully before using the medicine.
Before applying tretinoin, wash the skin with a mild soap or cleanser and warm water by using the tips of your fingers. Then gently pat dry. Do not scrub your face with a sponge or washcloth. Wait 20 to 30 minutes before applying this medicine to make sure the skin is completely dry. Applying tretinoin to wet skin can irritate the skin.
To use the cream or gel form of this medicine:
To use the solution form of this medicine:
After applying the medicine, wash your hands to remove any medicine that might remain on them.
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, 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.
The gel product is flammable and should be kept away from fire or excessive heat.
During the first 3 weeks you are using tretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. It may take longer than 12 weeks before you notice full improvement of your acne, even if you use the medicine every day. Check with your health care professional at any time skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.
You should avoid washing the skin treated with tretinoin for at least 1 hour after applying it.
Avoid using any topical medicine on the same area within 1 hour before or after using tretinoin. Otherwise, tretinoin may not work properly or skin irritation might occur.
Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as tretinoin:
Using these products along with tretinoin may cause mild to severe irritation of the skin. Although skin irritation can occur, some doctors sometimes allow benzoyl peroxide to be used with tretinoin to treat acne. Usually tretinoin is applied at night so that it does not cause a problem with any other topical products that you might use during the day. Check with your doctor before using topical medicines with tretinoin.
During the first 6 months of use, avoid overexposing the treated areas to sunlight, wind, or cold weather. The skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks. However, you should not stop using this medicine unless the skin irritation becomes too severe. Do not use a sunlamp .
To help tretinoin work properly, regularly use sunscreen or sunblocking lotions with a sun protection factor (SPF) of at least 15. Also, wear protective clothing and hats, and apply creams, lotions, or moisturizers often.
Check with your doctor at any time your skin becomes too dry and irritated. Your health care professional can help you choose the right skin products for you to reduce skin dryness and irritation and may include the following:
In some animal studies, tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if tretinoin causes skin tumors to develop faster in humans.
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:More common
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
The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.
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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