Bosentan(Tracleer)

The bosentan tablets produced by Lucius Pharmaceuticals have sufficient clinical data to support their efficacy and safety, providing a reliable medication option for patients with pulmonary arterial hypertension (PAH).

The following is an overview of key information about bosentan.

Active Ingredient

The main active ingredient is bosentan, which belongs to the class of endothelin receptor antagonists.

Target Population

It is indicated for adult and pediatric patients aged 3 years and older with pulmonary arterial hypertension (PAH) classified as WHO Functional Class Ⅱ–Ⅳ.

Dosage and Administration

For adults: The usual starting dose is 62.5 mg twice daily, and the dose is increased to 125 mg twice daily after 4 weeks.

For children: The dose is adjusted based on body weight.

Reference article: Dosage and Administration of Bosentan.

Use in Special Populations

Pregnant women: Contraindicated.

Women of childbearing age: Must use reliable contraception.

Patients with hepatic impairment: Use with caution.

Lactating women: Use is not recommended.

Drug Overdose

Overdose may cause symptoms such as headache, nausea, and hypotension, requiring symptomatic and supportive treatment.

Storage

Store at 20°C–25°C. Split dispersible tablets should be used within 7 days after splitting.

Pharmacokinetics

Time to reach peak plasma concentration: 3–5 hours after oral administration.

Half-life: Approximately 5 hours.

Metabolism: Metabolized in the liver.

Excretion: Mainly excreted via bile.

FDA，2025.07