Tracleer

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.

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.

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.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using 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 anti-seizure drugs including carbamazepine, azole antifungals including itraconazole/ketoconazole, macrolide antibiotics including erythromycin, HIV protease inhibitors including ritonavir, rifamycins including rifabutin, amiodarone, cimetidine, tacrolimus, St. John's wort, 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 combination-type hormonal birth control (e.g., pills, patch). This effect can result in pregnancy. You may need to use an additional form of reliable, non-hormonal birth control (e.g., condom, diaphragm with spermicide) while using this medication. Consult your doctor or pharmacist for details. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (e.g., monthly liver function test, monthly pregnancy test, hemoglobin level) will be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline 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.

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. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of child-bearing age must have a negative pregnancy test before starting this medication and monthly while taking it. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women using this medication use 2 effective forms of birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. (See also Drug Interactions section.) 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.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. 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.

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.

Bosentan has rarely caused very serious liver problems. Your doctor will monitor your liver function blood tests monthly. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, dark urine, yellowing eyes/skin. This medication must not be used during pregnancy because it can cause harm to a fetus/unborn baby. See also Precautions section.