Pronunciation: boe-SEN-tan
Generic Name: Bosentan
Brand Name: Tracleer
Tracleer may cause serious liver problems. Liver function tests should be done before and during treatment with Tracleer to monitor for side effects. Be sure to keep all doctor and lab appointments. You should usually not take Tracleer if you have abnormal liver function tests. Contact your doctor immediately if you experience nausea, vomiting, fever, stomach pain, yellowing of the skin or eyes, dark urine, pale stools, or unusual tiredness.
Tracleer may cause major birth defects if taken during pregnancy. Do not take Tracleer if you are pregnant or planning to become pregnant. You will need to have a pregnancy test before you start to take Tracleer, and monthly while you take it. Tracleer may interfere with the effectiveness of hormonal birth control, including oral, patch, injectable, and implantable forms. Talk with your doctor about using reliable methods of birth control while you are taking Tracleer.
Tracleer is used for:
Treating high blood pressure in the lungs (pulmonary arterial hypertension).
Tracleer is an endothelin receptor antagonist. It works by blocking a certain substance in the lungs, which helps to decrease blood pressure in the lungs.
Do NOT use Tracleer if:
- you are allergic to any ingredient in Tracleer
- you are pregnant
- you have abnormal liver function tests
- you are taking cyclosporine, glyburide, or lopinavir/ritonavir or other ritonavir-containing HIV medicines
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tracleer:
Some medical conditions may interact with Tracleer. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver problems, heart problems (eg, congestive heart failure), or blood problems (eg, anemia)
- if you are taking warfarin
Some MEDICINES MAY INTERACT with Tracleer. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amiodarone, azole antifungals (eg, ketoconazole), cyclosporine, fluconazole, lopinavir/ritonavir, ritonavir-containing HIV medicines, or tacrolimus because they may increase the risk of Tracleer's side effects
- Glyburide or rifampin because the risk of liver problems may be increased
- HMG-CoA reductase inhibitors (eg, simvastatin), hormonal contraceptives (eg, oral, injected, patch, implanted birth control), or medicines for diabetes because their effectiveness may be decreased by Tracleer
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tracleer may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Tracleer:
Use Tracleer as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tracleer comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tracleer refilled.
- Take Tracleer by mouth with or without food.
- Take Tracleer on a regular schedule to get the most benefit from it. Taking Tracleer at the same times each day will help you to remember to take it.
- Continue to take Tracleer even if you feel well. Do not miss any doses.
- If you miss a dose of Tracleer, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Tracleer.
Important safety information:
- Tracleer may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Tracleer with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not stop taking Tracleer without checking with your doctor. Some conditions may become worse when the medicine is suddenly stopped.
- Women who are able to become pregnant must have a pregnancy test before starting Tracleer. This test must occur during the first 5 days of a normal menstrual period and at least 11 days after the last unprotected sexual intercourse. Pregnancy tests must also be done each month during treatment with Tracleer.
- Tracleer may decrease the effectiveness of hormonal birth control pills, injections, patches, and implants. Use at least 2 reliable forms of birth control while you are taking Tracleer. Talk with your doctor or pharmacist for more information.
- Tracleer may decrease sperm count in men, which could impair the ability to father a child. Contact your doctor with any questions or concerns.
- Lab tests, including liver function tests and complete blood cell counts, may be performed while you use Tracleer. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Tracleer should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Tracleer may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tracleer while you are pregnant. It is not known if Tracleer is found in breast milk. Do not breast-feed while taking Tracleer.
Possible side effects of Tracleer:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Flushing; headache; nose or throat irritation; stomach upset; tiredness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; coughing up blood; dark urine; dizziness; fainting; fever; irregular heartbeat; lightheadedness; nausea; pale stools; severe or persistent stomach pain; shortness of breath; sudden weight gain; swelling of the ankles or legs; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Tracleer side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; fainting; fast heartbeat; lightheadedness.
Proper storage of Tracleer:
Store Tracleer at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tracleer out of the reach of children and away from pets.
General information:
- If you have any questions about Tracleer, please talk with your doctor, pharmacist, or other health care provider.
- Tracleer is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Tracleer. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
More Tracleer resources
- Tracleer Side Effects (in more detail)
- Tracleer Use in Pregnancy & Breastfeeding
- Tracleer Drug Interactions
- Tracleer Support Group
- 0 Reviews for Tracleer - Add your own review/rating
- Tracleer Prescribing Information (FDA)
- Tracleer Advanced Consumer (Micromedex) - Includes Dosage Information
- Tracleer Concise Consumer Information (Cerner Multum)
- Tracleer Monograph (AHFS DI)
- Bosentan Professional Patient Advice (Wolters Kluwer)
Compare Tracleer with other medications
- Pulmonary Arterial Hypertension
No comments:
Post a Comment