All Names： Bosentan，Bosentas，TRACLEER
Indications：pulmonary arterial hypertension (PAH)
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INDICATIONS AND USAGE（适应症）
Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%).
in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to results in an improvement in exercise ability.
Administer bosentan tablets orally following the dosing recommendations below. Doses above 125 mg twice daily did not appear to confer additional benefit sufficient to offset the increased risk of hepatotoxicity.
For patients >12 years of age and >40 kg, in initial 4 weeks, the recommended dose is 62.5 mg twice daily; and during maintenance (after 4 weeks), it is 125 mg twice daily.
For Patients >12 years of age and <40 kg, in initial 4 weeks, the recommended dose is 62.5 mg twice daily; and during maintenance (after 4 weeks), it is 62.5 mg twice daily.
For Patients ≤12 years of age ≥ 4-8 kg, >8-16 kg, >16-24 kg, and >24-40 kg, in initial 4 weeks, the recommended dose is 16 mg twice daily, 32 mg twice daily, 48 mg twice daily, and 64 mg twice daily; and during maintenance (after 4 weeks), it is 16 mg twice daily, 32 mg twice daily, 48 mg twice daily and 64 mg twice daily.
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