Do not use this medication if you are allergic to Bosentan, or if you:
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are also using glyburide (Micronase, DiaBeta, Glynase Pres Tab);
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are pregnant or might become pregnant during treatment; or
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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.
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.
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.
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.
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:
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nausea, stomach pain, loss of appetite;
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dark urine, clay-colored stools; or
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jaundice (yellowing of the skin or eyes).
Other less serious side effects are more likely to occur, such as:
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headache;
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flushing;
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swelling of the feet, ankles, or legs;
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dizziness;
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upset stomach;
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fatigue; or
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itching.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
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.
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.
There are no restrictions on food, beverages, or activity during treatment with Bosentan unless otherwise directed by your doctor.
Do not take Bosentan without first talking to your doctor if you are taking any of the following medicines:
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an antifungal antibiotic such as ketoconazole (Nizoral), fluconazole (Diflucan), itraconazole (Sporanox), or voriconazole (Vfend);
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tacrolimus (Prograf);
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a blood thinner such as warfarin (Coumadin);
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rifampin (Rifadin, Rifater, Rifamate, Rimactane);
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ritonavir (Norvir); or
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a cholesterol-lowering medicine such as simvastatin (Zocor), lovastatin (Mevacor), or atorvastatin (Lipitor).
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.
Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a Bosentan overdose may include headache, nausea, vomiting, increased heart rate and fainting or dizziness (low blood pressure).
