bosentan

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bosentan

Pronunciation:boe SEN tan
Brand:Tracleer

What is the most important information I should know about bosentan?

nopregThis 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.

donotDo 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).
emtBosentan 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.
donotDo 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 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 should I discuss with my healthcare provider before taking bosentan?

donotDo 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).
emtBosentan 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.
nopregFDA 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.

nobrfeedIt 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.

waterTake 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.

donotDo not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.
rtStore bosentan at room temperature away from moisture and heat.

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?

emtSeek 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.

What are the possible side effects of bosentan?

emtGet 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.
emtCall 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.

What other drugs will affect bosentan?

donotDo 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.

Where can I get more information?

Your doctor or pharmacist can provide more information about bosentan.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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