Bosentan (Generic Tracleer)


Product Name: Bosentas

Active Ingredient: Bosentan

Dosage Form: Oral Tablets

Strength: 62.5 MG / 125 MG

Indication: Pulmonary Arterial Hypertension

Manufacturer: Cipla

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Product Description

What Is Bosentan?

Bosentan is a medication that helps to lower the blood pressure in your lungs. It is mainly used to treat a condition called pulmonary hypertension (high blood pressure of the lungs). Bosentan is an Endothelin Receptor Antagonist, a class of drug that relaxes the blood vessels in the lungs and makes it easier for your heart to pump blood to your lungs. The brand name of bosentan in the United States is Tracleer. It is commonly used with PDE5 inhibitors such as tadalafil and sildenafil to treat pulmonary hypertension.

What is the most important information I should know about bosentan?
Do not use bosentan if you are pregnant or think you might be pregnant. You will need to take a pregnancy test before, during, and after treatment with bosentan. Use highly effective birth control to prevent pregnancy while using this medicine and for at least 30 days after your last dose.

Certain other medicines can interact with bosentan and should not be used at the same time. Tell your doctor about all your current medicines. Bosentan can cause severe liver problems. Your liver function will need to be tested often. Call your doctor right away if you have have signs of liver problems such as nausea, vomiting, fever, upper stomach pain, tiredness, or jaundice (yellowing of the skin or eyes).

What should I discuss with my healthcare provider before taking bosentan?
You should not use bosentan if you are allergic to it, or if you are pregnant or might become pregnant during treatment.

Some medicines can interact with bosentan and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cyclosporine; or
  • glyburide

To make sure bosentan is safe for you, tell your doctor if you have:

  • liver disease;
  • fluid retention;
  • diabetes;
  • an autoimmune disorder such as rheumatoid arthritis or psoriasis; or
  • if you have had or will have a heart or kidney transplant.

Do not use bosentan if you are pregnant or think you might be pregnant. This medicine can cause serious birth defects, especially if taken during early pregnancy. Tell your doctor right away if you miss a menstrual period or think you may have become pregnant during treatment.

You will need to have a negative pregnancy test before starting this treatment. You will be re-tested every month during your treatment, and 1 month after you stop taking this medicine.

Even if you are not planning a pregnancy, you are considered able to become pregnant if:

  • you have entered puberty (even if you have not yet started having periods);
  • you have never had a hysterectomy or had your ovaries removed; or
  • you have not gone through menopause (you have never gone 12 months in a row without a menstrual period).

While taking bosentan and for at least 30 days after your last dose, you must use a highly effective form of birth control or two methods together.

  • A tubal ligation alone is an effective birth control method.
  • An intrauterine device (IUD) alone is also an effective birth control method.
  • If you use birth control pills, implants, injections, skin patches, or vaginal rings, you must use a back-up barrier form of birth control, such as a condom or diaphragm or cervical cap. Always use a spermicide gel or insert together with a barrier form of birth control.
  • If you use only a barrier method, you must use a second barrier method as a back-up. For example, use a diaphragm or cervical cap in addition to a condom, plus a spermicide gel or insert.
  • If your sexual partner has had a vasectomy, you must still use a second method of birth control–either a barrier method or a hormonal form (birth control pills, injections, skin patch, or vaginal ring).
  • Bosentan comes with patient instructions about acceptable forms of birth control to use while taking this medicine. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
  • If you are the parent or caregiver of a female child taking this medicine, talk to the child’s doctor once you notice any signs of puberty (breast development or pubic hair), even if menstrual periods have not yet begun.

Bosentan can decrease sperm count and may affect fertility in men (your ability to have children). It is not known whether bosentan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How Should I Take Bosentan?

Bosentan is usually taken 2 times per day. Your doctor may change your dose after 4 weeks of treatment. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. You may take bosentan with or without food.

Bosentan can cause severe liver problems. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment. Your blood cells may also need to be tested during treatment and for up to 3 months after you stop taking this medicine.

You should not stop using bosentan suddenly. Stopping suddenly may make your condition worse. Follow your doctor’s instructions about tapering your dose. Store at room temperature away from moisture and heat.

Bosentan dosing information
Usual Adult Dose for Pulmonary Hypertension:

Initial dose: 62.5 mg orally twice a day for 4 weeks
Maintenance dose: Following initial dose, increase to 125 mg orally twice a day

-Doses above 125 mg twice a day did not appear to confer additional benefit sufficient enough to offset increased risk of hepatotoxicity.

Use: For the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and to decrease clinical worsening.

What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line.

What should I avoid while using bosentan?
Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Bosentan Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, bosentan may cause a severe drug reaction that can affect many parts of the body. This type of reaction can start several weeks after you begin using this medicine. Seek medical treatment if you have new or worsening symptoms of:

  • fever, flu symptoms, swollen glands, feeling weak or tired;
  • facial swelling;
  • a red or blistering skin rash, severe tingling or numbness;
  • cough, chest pain, trouble breathing;
  • weight loss; or
  • pain or burning when you urinate, lower back pain, swelling in your legs or feet.

Call your doctor at once if you have:

  • swelling in your legs or ankles, with or without weight gain;
  • pale skin, feeling short of breath, rapid or irregular heart rate, trouble concentrating;
  • a light-headed feeling, like you might pass out;
  • liver problems–nausea, vomiting, fever, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • new lung problems–anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Common side effects may include:

  • headache;
  • flushing (warmth, redness, or tingly feeling);
  • irregular heartbeats;
  • low blood pressure, fainting;
  • joint pain; or
  • cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.

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.


What other drugs will affect bosentan?
Tell your doctor about all your current medicines and any you start or stop using, especially:

  • rifampin;
  • tacrolimus;
  • warfarin (Coumadin, Jantoven);
  • antifungal medication–fluconazole, itraconazole, ketoconazole, voriconazole;
  • HIV/AIDS medication that contains ritonavir–Norvir, Kaletra, Technivie, Viekira, and others;
  • hormonal forms of birth control–birth control pills, injections, skin patches, or implants; or
  • “statin” medicine to treat high cholesterol–Crestor, Lipitor, Mevacor, Pravachol, Vytorin, Zocor, and others.

This list is not complete. Other drugs may interact with bosentan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.




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