GENERIC NAME: BOSENTAN - ORAL (boe-SEN-tan)
BRAND NAME(S): Tracleer
WARNING: Because bosentan can have serious side effects, you must be enrolled in a special program (Tracleer Access Program) to receive it. Talk with your doctor about the benefits and risks of taking this medication.
Bosentan may rarely cause serious (possibly fatal) liver damage. Rarely, liver problems have happened in people after stopping treatment with bosentan. Your doctor will perform liver function tests before you start treatment and once a month during treatment. Tell your doctor right away if you notice dark urine, loss of appetite, persistent nausea/vomiting, stomach/abdominal pain, or yellowing eyes/skin.
Bosentan must not be used during pregnancy because it may cause serious harm (such as birth defects) in an unborn baby. Women of childbearing age must have a negative pregnancy test before starting this medication and monthly during treatment. Use at least two reliable forms of birth control while taking bosentan and for at least one month after stopping bosentan as directed by your doctor to prevent pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. (See also Precautions section.)
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USES: Bosentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms from the disease, and improve your ability to exercise.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using bosentan and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth with or without food, usually twice daily (in the morning and evening) or as directed by your doctor.Dosage is based on your medical condition, weight, and response to treatment. Your doctor will usually start you on a lower dose of this medication and then increase the dose after several weeks.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Women who are pregnant or who may become pregnant should not handle the tablets or breathe the dust from this medication. Do not crush the tablets because doing so will increase exposure to the dust.Tell your doctor if your condition persists or worsens.
SIDE EFFECTS: See also Warning section.Dizziness, flushing, upset stomach, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.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: fast/pounding heartbeat, extreme tiredness, swelling of the ankles/feet, sudden/unexplained weight gain.Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, shortness of breath, coughing up blood.In men, this medication can decrease sperm production, which may affect the ability to father a child. Talk to your doctor for more details.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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: See also Warning section.Before taking bosentan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, anemia.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can increase the effects of dizziness and also increase the risk of serious liver problems.This medication must not be used during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while using this medication. Discuss the use of at least two reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: cyclosporine, glyburide.Other medications can affect the removal of bosentan from your body, which may affect how bosentan works. Examples include amiodarone, cimetidine, tacrolimus, St. John's wort, anti-seizure drugs including carbamazepine, azole antifungals including itraconazole/ketoconazole, macrolide antibiotics including erythromycin, HIV protease inhibitors including ritonavir, rifamycins including rifabutin, among others.This drug can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include "statin" cholesterol medications (such as simvastatin, lovastatin), warfarin, among others.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist about using an additional reliable birth control method while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
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. Symptoms of overdose may include: severe headache, severe dizziness, nausea, vomiting.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as liver function tests, pregnancy tests, hemoglobin, hematocrit) should be performed before you start treatment, and periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use 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 away from light and moisture. Do not store in the bathroom. Keep all medications 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.
Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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Pulmonary hypertension is an increase pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur, for example:
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