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) ] . in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. 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 ). in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability ( 1 ).
actavis pharma, inc.
ROUND ORANGE WPI 62 5
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actavis pharma, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
BOSENtan Tablets are available as follows: 62.5 mg – Light orange, round, biconvex, film-coated tablets, debossed with ‘WPI’ on one side and ‘62.5’ on the other side contains 64.541 mg of
BOSENtan monohydrate, equivalent to 62.5 mg of
BOSENtan base. Tablets are supplied in bottles of 60 (NDC 0591-2511-60) with a child-resistant closure. 125 mg – Light orange, oval, biconvex, film-coated tablets, debossed with ‘WPI’ on one side and ‘125’ on the other side contains 129.082 mg of
BOSENtan monohydrate, equivalent to 125 mg of
BOSENtan base. Tablets are supplied in bottles of 60 (NDC 0591-2512-60) with a child-resistant closure. Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep this and all medications out of the reach of children.
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