Bosentan, Oral

What are other names for this medicine?

Type of medicine: antihypertensive

Generic and brand names: bosentan, oral; Tracleer

What is this medicine used for?

This medicine is taken by mouth to treat pulmonary arterial hypertension (high blood pressure in the blood vessels between the heart and lungs).

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• blood disorders (such as anemia)
• congestive heart failure
• liver disease

This medicine may make you sterile (unable to have children) if you are a man. If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine has been reported to cause birth defects. Read the information that comes in the medicine package. You must meet certain conditions and sign a consent form. Use an effective birth control method while you are taking this medicine and for a month after stopping it. Hormone-based forms of birth control may not be reliable when taking this medicine. Use a nonhormonal form of birth control such as a condom, diaphragm or sponge while taking this medicine. You may need to have regular pregnancy tests and use 2 forms of birth control while taking this medicine. Talk to your healthcare provider about this. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

This medicine will be mailed to you from a special central pharmacy. It is not available through local pharmacies. Talk with your healthcare provider about this.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Your dose may be adjusted after 4 weeks. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Take this medicine with a full glass of water.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache, nausea, vomiting, fast heartbeat, fainting, dizziness.

What should I watch out for?

This medicine may cause serious liver problems. If you develop nausea, vomiting, a fever, abdominal pain, yellowing of your eyes or skin, or severe fatigue, stop taking this medicine and contact your healthcare provider right away. These may be signs of liver damage.

Avoid alcohol while taking this medicine. Alcohol may increase the risk of liver problems.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Diabetics: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Nausea, vomiting, fever, abdominal pain, yellowing of your eyes or skin, fatigue, dark-colored urine, light-colored stools, irregular or fast heart beats, unusual weakness or tiredness.

Other: Headache, flushing, swelling of legs or ankles, stomach upset, lightheadedness, dizziness, sore throat, runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antifungal medicines such as ketoconazole (Nizoral), fluconazole (Diflucan), itraconazole (Sporanox), and voriconazole (VFEND)
• anti-HIV medicines such as indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), delavirdine (Rescriptor), ritonavir (Norvir), and saquinavir (Fortovase, Invirase)
• medicine that reduces the chance of blood clots forming such as warfarin (Coumadin)
• diabetes medicines such as glyburide (DiaBeta, Glynase, Micronase), glipizide (Glucotrol), repaglinide (Prandin), glimepiride (Amaryl), rosiglitazone (Avandia), and pioglitazone (Actos)
• heart medicine such as amiodarone (Cordarone, Pacerone)
• hormone-based birth control such as pills, implants, shots, patches, or rings
• immunosuppressants such as cyclosporine (Sandimmune, Neoral), sirolimus (Rapamune), and tacrolimus (Prograf, Protopic)
• medicines to lower cholesterol such as simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol), atorvastatin (Lipitor), and fluvastatin (Lescol)
• medicines to treat erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra)
• rifampin (Rifadin)

Keep a list of all your medicines (prescription, supplements, natural remedies, vitamins, nonprescription) with you. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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