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] death` `[10] diarrhoea`

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.

More pills like ROUND AN 873

Related Pills

bosentan 125 MG Oral Tablet

Amneal Pharmaceuticals LLC

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

PillSync may earn a commission via links on our site