Generic Name: bosentan (boe SEN tan)
Brand Names: Tracleer
What is Bosentan?
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.
What is the most important information I should know about bosentan?
This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.
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.
What should I discuss with my healthcare provider before taking bosentan?
Do not use this medication if you are allergic to bosentan, or if you:
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).
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. FDA pregnancy category X. This medication can cause birth defects. Do not use bosentan if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.
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.
How should I take bosentan?
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)
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose can cause headache, nausea, vomiting, increased heart rate and fainting or dizziness (low blood pressure).
What should I avoid while using bosentan?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using bosentan.
Bosentan side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
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:
headache;
flushing;
swelling of the feet, ankles, or legs;
dizziness;
upset stomach;
fatigue; or
itching.
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.
Bosentan Dosing Information
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 daily
less than 40 kg:
Initial dose: 62.5 mg twice daily for 4 weeks
Maintenance dose: continue dosing of 62.5 mg twice daily
Usual Pediatric Dose for Pulmonary Hypertension:
Full Term Neonate: Oral: 1 mg/kg/dose orally twice daily short-term use (2 to 16 days) in three full term neonates has been reported. In the initial report, two full term neonates (8 days and 14 days old) with persistent pulmonary hypertension of the newborn (PPHN) and transposition of the great arteries received bosentan prior to cardiac surgery; patients also received other therapies. A case report describes the use of bosentan monotherapy for PPHN in a full term neonate as primary course of treatment initiated at 29 hours of life; therapy was weaned after 72 hours through the following dose reductions: 0.5 mg/kg/dose orally twice daily followed by 0.5 mg/kg once daily and subsequent discontinuation at 96 hours of treatment.
1 month to 12 years:
less than 10 kg: Initial: 1 to 2 mg/kg orally twice daily for 4 weeks; increase to maintenance dose of 2 to 4 mg/kg orally twice daily.
10 to 20 kg: Initial: 31.25 mg orally daily for 4 weeks; increase to maintenance dose of 31.25 mg orally twice daily.
over 20 to 40 kg: Initial: 31.25 mg orally twice daily for 4 weeks; increase to maintenance dose of 62.5 mg orally twice daily.
over 40 kg: Initial: 62.5 mg orally twice daily for 4 weeks; increase to maintenance dose of 125 mg orally twice daily.
over 12 years:
less than 40 kg: 62.5 mg orally twice daily.
40 kg or more: 62.5 mg orally twice daily for 4 weeks; increase to maintenance dose of 125 mg twice daily.
What other drugs will affect bosentan?
Do not take bosentan without first talking to your doctor if you are taking any of the following medicines:
amiodarone (Cordarone, Pacerone);
diltiazem (Tiazac, Cartia, Cardizem);
erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
tacrolimus (Prograf);
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.
More bosentan resources
- Bosentan Side Effects (in more detail)
- Bosentan Dosage
- Bosentan Use in Pregnancy & Breastfeeding
- Bosentan Drug Interactions
- Bosentan Support Group
- 0 Reviews for Bosentan - Add your own review/rating
- bosentan Advanced Consumer (Micromedex) - Includes Dosage Information
- Bosentan Professional Patient Advice (Wolters Kluwer)
- Bosentan Monograph (AHFS DI)
- Bosentan MedFacts Consumer Leaflet (Wolters Kluwer)
- Tracleer Prescribing Information (FDA)
Compare bosentan with other medications
- Pulmonary Arterial Hypertension
Where can I get more information?
- Your doctor or pharmacist can provide more information about bosentan.
See also: bosentan side effects (in more detail)
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