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Another NameLuciBose,Tracleer,波生坦
IndicationsIt is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults and children aged 3 years and older, which can improve exercise tolerance and delay clinical deterioration.
Reg No.03 L 1319/25
Inspection NO.553-25
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.
The main active ingredient is bosentan, which belongs to the class of endothelin receptor antagonists.
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.
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.
Pregnant women: Contraindicated.
Women of childbearing age: Must use reliable contraception.
Patients with hepatic impairment: Use with caution.
Lactating women: Use is not recommended.
Overdose may cause symptoms such as headache, nausea, and hypotension, requiring symptomatic and supportive treatment.
Store at 20°C–25°C. Split dispersible tablets should be used within 7 days after splitting.
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
