Bosentan (Systemic)

Brand Names : Tracleer

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bosentan, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to bosentan. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy - Bosentan is not recommended during pregnancy. It has been shown to cause serious birth defects or other problems in animals. Be sure you have discussed this with your doctor.

Monthly pregnancy tests are needed, and a gynecologist should help to decide what contraceptives should be used. Your doctor should be notified immediately if there is any delay in the start of your menstrual cycle, and any other reason to think that you may be pregnant.

Breast-feeding - It is not known whether bosentan passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children - Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of bosentan in children with use in other age groups.

Older adults - Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of bosentan in the elderly with use in other age groups.

Other medicines - Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. When you are taking bosentan, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Cyclosporin A (e.g., Neoral) or
  Use of this medicine with bosentan can cause both medicines to not work properly

• Cytochrome P450 inhibitors (e.g., Ketoconazole) - These medicines may increase the effects of bosentan

• Hormonal Contraceptives that are implantable (e.g., NuvaRing), injectable (e.g., Lunelle), or oral (e.g., Triphasil) - Bosentan may prevent contraceptives from working properly and may result in an unplanned pregnancy

• Hypoglycemic agents, oral (e.g., Glyburide) - Use of this medicine with bosentan can cause both medicines to not work properly

• Statins, such as:
  Atorvastatin (e.g. Lipitor) or
  Lovastatin (e.g., Mevacor) or
  Simvastatin (e.g. Zocor) - bosentan may decrease the effects of these medicines

Other medical problems - The presence of other medical problems may affect the use of bosentan. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease - bosentan may make make these conditions worse in patients who have moderate or severe liver disease