BOSENTAN - ORAL

BOSENTAN - ORAL

PHONETIC PRONUNCIATION: (boe-SEN-tan)

COMMON BRAND NAME(S): Tracleer

GENERIC NAME(S): bosentan

Uses

USES: Bosentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms from the disease, and improve your ability to exercise.


How to use BOSENTAN - ORAL

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using bosentan and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually twice daily (in the morning and evening). The dosage is based on your medical condition, weight, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may start you on a lower dose of this medication and then increase the dose after several weeks. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Women who are pregnant or who may become pregnant should not handle the tablets or breathe the dust from this medication. Do not crush the tablets because doing so will increase exposure to the dust. Tell your doctor if your condition persists or worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Dizziness, flushing, stuffy nose, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat, unusual tiredness, swelling ankles/feet, unusual/sudden weight gain, fainting, shortness of breath, coughing up blood. In men, this medication can decrease sperm production, which may affect the ability to father a child. Talk to your doctor for more details. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Warning section. Before taking bosentan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, anemia. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Alcohol may also increase the risk of serious liver problems. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication must not be used during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while using this medication. Discuss the use of at least two reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of bosentan from your body, which may affect how bosentan works. Examples include cyclosporine, HIV protease inhibitors (such as atazanavir), among others. This drug can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include glyburide, certain products used to treat chronic hepatitis C (asunaprevir, ombitasvir/paritaprevir/ritonavir), among others. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist about using an additional reliable birth control method while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe headache, severe dizziness, nausea, vomiting.

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Faq for BOSENTAN - ORAL

Bosentan Oral is a medication used to treat pulmonary arterial hypertension (PAH), a condition in which the blood pressure in the arteries of the lungs is abnormally high.

Bosentan Oral belongs to a class of drugs called endothelin receptor antagonists. It works by blocking the action of a substance called endothelin, which constricts the blood vessels and increases blood pressure. By reducing the effects of endothelin, Bosentan Oral helps to relax and widen the blood vessels, thereby lowering blood pressure in the lungs.

Bosentan Oral is usually taken twice daily by mouth, with or without food. It is important to follow the dosage instructions provided by your doctor. Do not stop taking Bosentan Oral without consulting your doctor.

Common side effects of Bosentan Oral may include headache, flushing, nasal congestion, runny nose, and stomach upset. However, if you experience severe side effects such as liver problems, shortness of breath, swelling, or chest pain, seek immediate medical attention.

No, Bosentan Oral can harm an unborn baby. It is recommended to use effective birth control methods while taking Bosentan Oral and for at least 30 days after stopping the medication. Consult your doctor if you are pregnant or planning pregnancy.

Bosentan Oral may interact with other medications, including hormonal contraceptives, blood thinners, and certain antifungal medications. Make sure to inform your doctor about all the medications you are taking before starting Bosentan Oral, as drug interactions can occur.

The effects of Bosentan Oral may take several weeks to become noticeable. It is important to continue taking the medication as prescribed and not to exceed the recommended dosage.

Bosentan Oral is usually taken long-term to maintain the therapeutic effects. It is important to follow your doctor's instructions and attend regular check-ups to monitor your condition.

It is recommended to avoid alcohol while taking Bosentan Oral, as it may worsen certain side effects and increase the risk of liver damage.


Warning

WARNING: Talk with your doctor about the benefits and risks of taking this medication. Because bosentan can have serious side effects, you must be enrolled in a special program (Tracleer REMS Program) to receive it. This requirement applies in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations. Bosentan may rarely cause serious (possibly fatal) liver damage. Rarely, liver problems have happened in people after stopping treatment with bosentan. Your doctor will perform liver function tests before you start treatment and once a month during treatment. Tell your doctor right away if you notice dark urine, loss of appetite, persistent nausea/vomiting, stomach/abdominal pain, or yellowing eyes/skin. Bosentan must not be used during pregnancy because it may cause serious harm (such as birth defects) in an unborn baby. Women of childbearing age must have a negative pregnancy test before starting this medication and monthly during treatment. Use at least two reliable forms of birth control while taking bosentan and for at least one month after stopping bosentan as directed by your doctor to prevent pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. (See also Precautions section.)


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.