Generic Name: bosentan (boe SEN tan)Brand Names: Tracleer
Bosentan prevents thickening of the blood vessels, especially those in the lungs and heart. Bosentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.
Bosentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.
Bosentan may also be used for other purposes not listed in this medication guide.
Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.Do not use this medication if you are allergic to bosentan, or if you are also taking cyclosporine (Sandimmune, Neoral, Gengraf), glyburide (Micronase, DiaBeta, Glynase Pres Tab), or HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir). Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment. Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.
are also taking HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir);
are also taking using glyburide (Micronase, DiaBeta, Glynase Pres Tab);
are pregnant or might become pregnant during treatment; or
are also using cyclosporine (Sandimmune, Neoral, Gengraf).
Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.It is not known whether bosentan passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.
Take bosentan exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take each dose with a full glass (8 ounces) of water.
Bosentan can be taken with or without food.
Bosentan is usually taken twice a day, morning and evening.Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store bosentan at room temperature away from moisture and heat.
See also: Bosentan dosage in more detail
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose can cause headache, nausea, vomiting, increased heart rate and fainting or dizziness (low blood pressure).
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using bosentan.
nausea, stomach pain, loss of appetite;
dark urine, clay-colored stools; or
jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
swelling of the feet, ankles, or legs;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Pulmonary Hypertension:
greater than or equal to 40 kg: Initial dose: 62.5 mg twice daily for 4 weeks Maintenance dose: increase to a maintenance dose of 125 mg twice dailyless than 40 kg: Initial dose: 62.5 mg twice daily for 4 weeks Maintenance dose: continue dosing of 62.5 mg twice daily
amiodarone (Cordarone, Pacerone);
diltiazem (Tiazac, Cartia, Cardizem);
erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
an antifungal medication such as ketoconazole (Nizoral), fluconazole (Diflucan), or itraconazole (Sporanox);
a blood thinner such as warfarin (Coumadin); or
a cholesterol-lowering medicine such as simvastatin (Zocor), lovastatin (Mevacor), or atorvastatin (Lipitor).
This list is not complete and there may be other drugs not listed that can affect bosentan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.