bosentan - oral, Tracleer (cont.)
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: This drug is controlled through a special program. Someone will call you each month to remind you to have your liver function test (and pregnancy test for women of child-bearing age). See also Warning and Precautions sections.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.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.
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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