bosentan 62.5 MG Oral Tablet

1 INDICATIONS AND USAGE 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%) [see Clinical Studies (14.1) ] . Bosentan is an endothelin receptor antagonist 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%). ( 1 )

Amneal Pharmaceuticals LLC

FDA Reported Adverse Reactions
`[1] toxicity to various agents` `[2] completed suicide` `[3] dyspnoea` `[4] drug ineffective` `[5] drug abuse` `[6] fatigue` `[7] nausea` `[8] headache` `[9] off label use` `[10] death`

4 years ago

ROUND ORANGE AN 873

16 HOW SUPPLIED/STORAGE AND HANDLING

BOSENtan Tablets, 62.5 mg are supplied as orange, round, biconvex, film-coated tablets, debossed with “AN” on one side and “873” on the other side, packaged in a white high-density polyethylene bottle and a white polypropylene child-resistant cap. They are available as: Bottles of 60: NDC 65162-873-06

BOSENtan Tablets, 125 mg are supplied as orange, oval, biconvex, film-coated tablets, debossed with “AN” on one side and “874” on the other side, packaged in a white high-density polyethylene bottle and a white polypropylene child-resistant cap. They are available as: Bottles of 60: NDC 65162-874-06 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.

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Amneal Pharmaceuticals LLC

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