BOSENTAN

(boe SEN tan) Brand: Tracleer

What is the most significant information I must know about bosentan?

• This medicine can reason birth defects in an unborn child. Do not use if you are pregnant. Speak 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 satis to prevent pregnancy during your treatment.

• Your doctor may have you take a pregnancy test till you start using this medication, to create certain you are not pregnant. You may also be re-tested every month during your treatment.

• Do not use this medicine 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 medicine that contains lopinavir or ritonavir (Kaletra, Norvir).

• Bosentan can reason 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 till you start taking bosentan, and again every month during your treatment.

• Do not stop taking bosentan without first talking to your doctor. You may need to use smaller and smaller till you stop the medicine 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 exhaust blood more efficiently.

• Bosentan is used to treat pulmonary arterial hypertension (PAH). It improves your capacity to exercice and prevents your condition from getting worse.

• Bosentan may also be used for another purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking bosentan?

• Do not use this medicine if you are allergic to bosentan, or if you:

· are also taking HIV/AIDS medicine 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).

• FDA pregnancy category X. This medicine can reason birth defects. Do not use bosentan if you are pregnant. Speak 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 satis to prevent pregnancy during your treatment.

• Your doctor may have you take a pregnancy test till you start using this medication, to create certain you are not pregnant. You may also be re-tested every month during your treatment.

• It is not known whether bosentan passes into breast milk or if it could harm a nursing child. Do not take this medicine without telling your doctor if you are breast-feeding a baby.

How must I take bosentan?

• Take bosentan exactly as it was predesigned for you. Do not take the medicine in larger or less amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

• Take every doze with a full glass (8 ounces) of water.

• Bosentan can be taken with or without food.

• Bosentan is generally taken twice a day, morning and evening.

• Do not stop taking bosentan without first talking to your doctor. You may need to use smaller and smaller till you stop the medicine completely.

• Store bosentan at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. If it is nearly time for your following doze, skip the missed doze and take the medication at the following regularly scheduled time. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention if you think you have used too many of this medicine.

• Overdose can reason headache, nausea, vomiting, heighten heart course and fainting or dizziness (low blood pressure).

What must 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?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, 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).

• Smaller serious side effects may include:

· headache;

· flushing;

· swelling of the foots, 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect bosentan?

• Do not take bosentan without first talking to your doctor if you are taking any of the next 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 medicine such as ketoconazole (Nizoral), fluconazole (Diflucan), or itraconazole (Sporanox);

· a blood thinner such as warfarin (Coumadin); or

· a cholesterol-lowering medication such as simvastatin (Zocor), lovastatin (Mevacor), or atorvastatin (Lipitor).

• This list is not complete and there may be another drugs not listed that can affect bosentan. Speak your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal commodity, and drugs predesigned by another doctors. Do not start using a new medicine without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about bosentan.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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