Tracleer (Bosentan)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Prescription Required
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Product Details
Description
Tracleer (Bosentan) works as an endothelin receptor antagonist (ERA), which means it blocks the effects of endothelin, a substance that constricts blood vessels and elevates blood pressure in the lungs. This medication treats pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries that supply the lungs. Tracleer may help support patients' ability to exercise and prevent the condition from worsening over time. By doing so, Tracleer can help manage symptoms and improve the quality of life for individuals living with PAH.
Fact Table
Formula
C27H29N5O6S
License
US FDA (2001)
Bioavailability
50%
Legal status
Prescription only (?)
Chemical Name
4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide
Elimination half-life
5.4 hours
Dosage (Strength)
62.5 mg, 125 mg tablets
Pregnancy
Contraindicated (Category X)
Brands
Tracleer
Protein binding
98%
PubChem CID
104865
MedlinePlus
a603007
ChEBI
CHEBI:51232
ATC code
C02KX01
DrugBank
DB00559
KEGG
D03160
Routes of administration
Oral
Directions
Tracleer is taken orally, with an initial dosage typically starting at 62.5 mg twice daily for four weeks, before increasing to the maintenance dose of 125 mg twice daily. The actual dosage can vary depending on the patient’s age and weight. Patients may take Tracleer with or without food, but they must swallow the tablets whole—do not crush or split them. Always follow a healthcare provider’s instructions for taking Tracleer.
Ingredients
The active ingredient in Tracleer is Bosentan. It may also contain inactive ingredients, such as corn starch, ethylcellulose, glyceryl behenate, and hydroxypropylmethylcellulose.
Contraindications
If patients fall under any of the categories listed below, they should not take Tracleer:
- Pregnancy: Bosentan can cause harm to an unborn baby and must not be used during pregnancy
- Use with Cyclosporine A: Concurrent use can lead to increased levels of bosentan and potential toxicity
- Use with Glyburide: Can lead to an increased risk of liver injury and is not recommended
- Hypersensitivity to Bosentan: Patients with a known allergy to bosentan or any of its components should avoid this medication
Cautions
- It’s important to discuss the following with a healthcare provider before starting treatment:
- Any medications you take
- Other medical conditions you have
- Whether you have any allergies
- Whether you’re pregnant or breastfeeding
- Tracleer may cause fluid retention in some patients, which might require medical intervention. Monitoring for signs of fluid retention, such as swelling in the ankles or feet and sudden weight gain, is important.
- If you experience symptoms of pulmonary edema, such as shortness of breath or difficulty breathing, it could be a sign of pulmonary veno-occlusive disease (PVOD), a rare but serious lung disease. In such cases, discontinuation of Tracleer should be considered.
- Decreased sperm counts have been observed in patients taking Tracleer. This could be an important consideration for men looking to father children.
- Tracleer can lead to decreases in hemoglobin and hematocrit levels. It’s recommended to monitor hemoglobin levels after the first and third months of treatment, and then every three months thereafter.
Side Effects
Tracleer may cause side effects. The most common ones include respiratory tract infections, headaches, fainting, flushing, low blood pressure, sinusitis, joint pain, and irregular heartbeats. Serious side effects of Tracleer may include fluid retention, leading to ankle and leg swelling. Men may experience lower sperm counts, potentially affecting fertility. Anemia is another serious side effect, characterized by low red blood cell levels. Patients should inform their healthcare provider about any significant swelling, breathing difficulties, or concerns about fertility. Regular blood tests to monitor red blood cells are recommended during treatment. Prompt medical attention is recommended for severe symptoms.
References:
- Tracleer (Bosentan) Product Monograph. San Francisco: Actelion Pharmaceuticals, Inc.; 2023.
- Tracleer (Bosentan) Drug Label Information. San Francisco: Actelion Pharmaceuticals, Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 9869
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