Tracleer

Pulmonary Arterial Hypertension, ocular bacterial infections, Conjunctivitis
Treatment
2 FDA approvals
0 Active Studies for Tracleer

What is Tracleer

BosentanThe Generic name of this drug
Treatment SummaryBosentan (brand name Tracleer) is a medication used to treat pulmonary hypertension, a condition that causes high blood pressure in the arteries of the lungs. It works by blocking endothelin molecules, which are responsible for narrowing the blood vessels and raising blood pressure.
Tracleeris the brand name
image of different drug pills on a surface
Tracleer Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Tracleer
Bosentan
2001
30

Approved as Treatment by the FDA

Bosentan, also called Tracleer, is approved by the FDA for 2 uses which include NYHA Functional Class II-IV Pulmonary arterial hypertension and Pulmonary Arterial Hypertension .
NYHA Functional Class II-IV Pulmonary arterial hypertension
Helps manage NYHA Functional Class II-IV Pulmonary arterial hypertension
Pulmonary Arterial Hypertension
Helps manage NYHA Functional Class II-IV Pulmonary arterial hypertension

Effectiveness

How Tracleer Affects PatientsBosentan is a drug that works by blocking the effects of a protein (endothelin) that can cause blood vessels to become too narrow. People with Pulmonary Arterial Hypertension (PAH) have higher levels of endothelin in their bodies and Bosentan helps to reduce this.
How Tracleer works in the bodyEndothelin-1 is a hormone in the body that causes blood vessels to narrow when it binds to either ET A or ET B receptors. In patients with pulmonary arterial hypertension, the level of endothelin-1 is higher than normal. Bosentan is a drug that blocks endothelin-1 from binding to these receptors, and thus helps widen the blood vessels, reducing symptoms of the disease.

When to interrupt dosage

The measure of Tracleer is based upon the diagnosed disorder, for example Pulmonary Arterial Hypertension, ocular bacterial infections and Ocular Inflammation. The amount of dosage is contingent upon the method of delivery (e.g. Tablet, film coated - Oral or Tablet, soluble - Oral) featured in the table beneath.
Condition
Dosage
Administration
Pulmonary Arterial Hypertension
, 62.5 mg, 125.0 mg, 32.0 mg
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, for suspension, Tablet, for suspension - Oral, Tablet, soluble, Tablet, soluble - Oral, Tablet, coated, Tablet, coated - Oral
ocular bacterial infections
, 62.5 mg, 125.0 mg, 32.0 mg
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, for suspension, Tablet, for suspension - Oral, Tablet, soluble, Tablet, soluble - Oral, Tablet, coated, Tablet, coated - Oral
Conjunctivitis
, 62.5 mg, 125.0 mg, 32.0 mg
, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, for suspension, Tablet, for suspension - Oral, Tablet, soluble, Tablet, soluble - Oral, Tablet, coated, Tablet, coated - Oral

Warnings

Tracleer Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
There are 20 known major drug interactions with Tracleer.
Common Tracleer Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The metabolism of Abemaciclib can be increased when combined with Bosentan.
Acalabrutinib
Major
The metabolism of Acalabrutinib can be increased when combined with Bosentan.
Alectinib
Major
The metabolism of Alectinib can be increased when combined with Bosentan.
Amifostine
Major
Bosentan may increase the hypotensive activities of Amifostine.
Aminophylline
Major
The metabolism of Aminophylline can be increased when combined with Bosentan.
Tracleer Toxicity & Overdose RiskBosentan has been tested as a single dose of up to 2400 mg and as an ongoing dose of up to 2000 mg per day. The most common side effect is mild to moderate headache. When combined with cyclosporine A, bosentan levels increased 30-fold, leading to severe headaches, nausea, and vomiting. Low blood pressure and increased heart rate have also been reported. If a patient takes too much bosentan, they may experience a dangerously low blood pressure that requires medical attention.
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Tracleer Novel Uses: Which Conditions Have a Clinical Trial Featuring Tracleer?

There are currently 4 active studies investigating the potential of Tracleer in treating ocular bacterial infections, Ocular Inflammation and Pulmonary Arterial Hypertension.
Condition
Clinical Trials
Trial Phases
ocular bacterial infections
0 Actively Recruiting
Conjunctivitis
0 Actively Recruiting
Pulmonary Arterial Hypertension
0 Actively Recruiting

Tracleer Reviews: What are patients saying about Tracleer?

5Patient Review
1/9/2012
Tracleer for Pulmonary Arterial Hypertension
I'm not sure if this is related to the medication, but I've had pancreatitis twice in less than three months since starting Tracleer. Does anyone else know of this problem? I'm only 3 years old, and I don't even know if it's helping my pulmonary hypertension.
5Patient Review
10/27/2010
Tracleer for Increased Pressure of Pulmonary Circulation
I'm still experiencing some side effects like headaches and coughing, but I definitely feel stronger overall.
5Patient Review
9/19/2018
Tracleer for Pulmonary Arterial Hypertension
After only six days of taking this medication, I had to stop because the side effects were unbearable. headaches, more shortness of breath, a stuffed up nose so that I couldn't breathe well through my cannula, and feeling nauseous all the time. On top of that, I was really aggressive towards everyone around me. A couple days after stopping the medication, my shortness of breath came back--but at least I'm not angry anymore!
5Patient Review
3/27/2010
Tracleer for Pulmonary Arterial Hypertension
4.7Patient Review
8/17/2013
Tracleer for Pulmonary Arterial Hypertension
I am breathing a little better, but I have experienced some negative side effects like fainting, nausea, and joint pain. It's hard to say if the benefits outweigh the risks at this point.
View All Reviews
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Patient Q&A Section about tracleer

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who manufactures Tracleer?

"Actelion Pharmaceuticals US, Inc., a subsidiary of Johnson & Johnson, announced today that the U.S. Food and Drug Administration (FDA) has approved a new 32 mg tablet for oral suspension for TRACLEER® (bosentan) for use in pediatric patients."

Answered by AI

What is Tracleer used for?

"Tracleer is used to lower blood pressure in the lungs and improve your ability to exercise by working as an endothelin receptor antagonist. PAH, or pulmonary arterial hypertension, is a condition in which the blood pressure in your lungs is too high. Tracleer can help prevent your PAH from getting worse."

Answered by AI

Is there a generic for Tracleer?

"Hikma is introducing bosentan tablets as a generic for Actelion's Tracleer. The tablets come in dosages of 62.5 mg and 125 mg. Bosentan is indicated for treating pulmonary arterial hypertension in adults to improve exercise ability and decrease clinical worsening."

Answered by AI

What is bosentan used for?

"Bosentan is a medication used to lessen the symptoms of pulmonary arterial hypertension in children aged 3 years or older, as well as adults. This drug has the ability to improve a patient's capabilities when it comes to exercise, and can also help to prevent a further deterioration in physical condition."

Answered by AI
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