GENERIC NAME: TRETINOIN - ORAL (TRET-i-noyn)
BRAND NAME(S): Vesanoid
WARNING: Tretinoin may cause serious (sometimes fatal) side effects. Therefore, it must be used only under close medical supervision. Some patients may develop a life-threatening syndrome, usually during the first month of treatment with this medication. Tell your doctor immediately if you experience any of the following symptoms: fever, trouble breathing, unusual tiredness, weight gain, swelling of the arms/legs/ankles/feet, dizziness, or fainting. You may be given other medications (e.g., corticosteroids such as dexamethasone) to treat these side effects. Your doctor will also monitor your white blood cell count.
This medication can cause severe birth defects if used during pregnancy. Therefore, this medication is not recommended for use during pregnancy. Also, it is important to prevent pregnancy while taking this drug. Pregnancy tests should be done one week before you start treatment with tretinoin. When possible, do not start tretinoin treatment until you have a negative pregnancy test result. As soon as treatment begins, you must immediately start using two effective forms of birth control together (or completely avoid sexual intercourse). However, do not use "mini-pills" (progesterone birth control pills that do not contain estrogen) because they may not work as well while you are taking tretinoin. You must also have monthly pregnancy testing and birth control counseling from your doctor while taking this medication. Continue using birth control as directed until one month after tretinoin use has been stopped.
USES: Tretinoin is used with other medications (e.g., chemotherapy) to treat a certain type of cancer of the white blood cells (APL-acute promyelocytic leukemia). APL is a disease of too many white blood cells that do not mature or function properly. This medication is used to lessen the signs and severity of this disease (induce remission). Further treatment after remission will be determined by your doctor. Tretinoin works by promoting the growth of normal, mature cells in the bone marrow and blood. This medication helps to reverse symptoms of APL such as infections, tiredness, and bleeding. Tretinoin belongs to a class of drugs known as retinoids, which is related to vitamin A.
HOW TO USE: Take this medication by mouth, usually twice a day or as directed by your doctor. It may be taken with food.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. The dosage is based on your medical condition, body size, and response to therapy. Follow your doctor's directions for how long to take this medication.Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased.Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.
SIDE EFFECTS: See also Warning section.Headache, dizziness, fever, weakness, tiredness, dry mouth, dry skin, other skin changes, thinning hair, nausea, vomiting, itching, bone pain, mouth sores, increased sweating, and earache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Headache may occur several hours after taking a dose. Mild pain medications (e.g., acetaminophen) usually help relieve these headaches, which tend to go away as your body gets used to tretinoin. Talk with your doctor about which pain relievers are right for you.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.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: stomach/abdominal pain, yellowing eyes/skin, dark urine, hearing problems (e.g., hearing loss), change in the amount of urine, mental/mood changes, fast/slow/irregular heartbeat.Seek immediate medical attention if any of these rare but very serious side effects occur: severe headache, persistent nausea/vomiting, vision changes, chest pain, jaw/left arm pain, trouble breathing, weakness on one side of the body, slurred speech, confusion, pain/redness/swelling of arms/legs.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 (especially of the face/tongue/throat), 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.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A or related drugs; or if you have any other allergies. This product may contain inactive ingredients (such as soybean, paraben preservatives), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high cholesterol/triglycerides (blood fats).This drug may cause dizziness, severe headaches, or vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.Children may be more sensitive to the effects of this drug, especially if they are also taking tetracycline medication. Tell your doctor immediately if your child experiences severe headache, nausea/vomiting, or vision problems.Do not donate blood while you are taking this medication and for at least 1 month after you stop taking it. This will prevent the possibility of your blood being given to a pregnant woman.This medication is not recommended for use during pregnancy due to the risk of birth defects and harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Use two effective forms of birth control together to prevent pregnancy. Talk to your doctor about reliable birth control options. (See also Warning section.)It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. 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.This drug should not be used with the following medication because very serious interactions may occur: vitamin A.If you are currently using the medication listed above, tell your doctor or pharmacist before starting tretinoin.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that prevent bleeding (anti-fibrinolytic drugs such as aminocaproic acid, aprotinin, tranexamic acid), hydroxyurea, ketoconazole, "mini-pill" (progesterone birth control pills that do not contain estrogen), tetracyclines, sulfisoxazole containing drugs.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 a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., complete blood counts, liver function, blood cholesterol and triglyceride levels, pregnancy tests) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take 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) away from light and moisture. Do not store in the bathroom. 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 December 2013. Copyright(c) 2013 First Databank, Inc.
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