adempas riociguat tablet film coated
1 INDICATIONS AND USAGE Adempas is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with: • Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. ( 1.1 ) • Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening. ( 1.2 ) 1.1 Chronic-Thromboembolic Pulmonary Hypertension Adempas is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class [see Clinical Studies ( 14.1 )]. 1.2 Pulmonary Arterial Hypertension Adempas is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening. Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%) [see Clinical Studies ( 14.2 )] .
bayer healthcare pharmaceuticals inc.
ROUND RED Bayer Bayer R 2 5
Bayer Bayer R 2 5 ROUND RED
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Adempas (
RIOCIGUAT) tablets are film-coated, round, and debossed with the “Bayer cross” on one side. Color Debossing Side 2 NDC 50419-xxx-xx Bottle of 9 Bottle of 90 Blister of 42 0.5 mg white 0.5 R 250-91 250-01 250-03 1 mg Pale yellow 1 R 251-91 251-01 251-03 1.5 mg yellow-orange 1.5 R 252-91 252-01 252-03 2 mg Pale orange 2 R 253-91 253-01 253-03 2.5 mg red-orange 2.5 R 254-91 254-01 254-03 16.2 Storage and Handling Store at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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