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Generic Name: Bosentan (boe SEN tan)
Brand Name: Tracleer
- Liver problems have happened. Call your doctor right away if you get signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- You will be watched closely by your doctor.
- If you have liver disease, talk with your doctor.
- This medicine may cause birth defects if you take it while you are pregnant.
- Do not take Tracleer (bosentan) if you are pregnant. A pregnancy test will be done to show that you are NOT pregnant before starting this medicine.
- A pregnancy test will be done every month during care and for 1 month after care ends.
- Use 2 kinds of birth control that you can trust during care and for 1 month after care ends.
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Tracleer.
- If you get pregnant while taking this medicine or within 1 month after your last dose, call your doctor right away.
- You may only get Tracleer through a special program. Talk with your doctor.
Uses of Tracleer:
- It is used to treat high blood pressure in the lungs.
What do I need to tell my doctor BEFORE I take Tracleer?
- If you have an allergy to bosentan or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have liver disease or raised liver enzymes.
- If you are taking any of these drugs: Cyclosporine or glyburide.
- If you are breast-feeding. Do not breast-feed while you take Tracleer.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Tracleer with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Tracleer?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how Tracleer affects you.
- Do not stop taking this medicine all of a sudden without calling your doctor. Signs of high pressure in the lungs like shortness of breath, dizziness, or weakness may get worse. Talk with your doctor.
- Talk with your doctor before you drink alcohol.
- A very bad and sometimes deadly reaction has happened with Tracleer. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
- This medicine may affect being able to father a child. It is not known how long this effect lasts. Talk with the doctor.
- If you are a woman and you miss a period, have unprotected sex, or think that your birth control has not worked, call your doctor right away.
- If your child starts puberty while taking this medicine, talk with your child's doctor. Your child may be able to get pregnant, even if she has not started her menstrual period.
Tablets for suspension:
- If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
How is this medicine (Tracleer) best taken?
Use Tracleer (bosentan) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food.
- To gain the most benefit, do not miss doses.
- Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
Tablets for suspension:
- Mix with water as you have been told before drinking.
- The tablets may be broken in half. Do not break into quarters.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
See also: Dosage Information (in more detail)
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Feeling very tired or weak.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Very bad dizziness or passing out.
- A heartbeat that does not feel normal.
- Joint pain.
What are some other side effects of Tracleer?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Nose irritation.
- Signs of a common cold.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
See also: Side effects (in more detail)
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Tracleer?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
Tablets for suspension:
- If you have broken tablets, store the tablet pieces in the opened blister for up to 7 days.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Tracleer is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take Tracleer or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tracleer. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: November 1, 2017
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