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sildenafil 20 MG Oral Tablet

1 INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)] . Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II to III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies ( 14 )]. Sildenafil tablets are a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class II to III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). ( 1 ) Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. ( 1 , 14 )

camber pharmaceuticals, inc.


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6 months ago ROUND WHITE J 95 sildenafil 20 MG Oral Tablet

ROUND WHITE J 95

16 HOW SUPPLIED/STORAGE AND HANDLING

SILDENAFIL Tablets USP, are supplied as white to off white colored, round shaped, biconvex, film coated tablets debossed with 'J' on one side and '95' on the other side. The tablets are available as follows Bottle of 90's NDC 31722-776-90 Bottle of 500's NDC 31722-776-05 Blister card of 10 Unit dose tablets (PVC) NDC 31722-776-31 Blister pack of 100 (10 x 10's) Unit dose tablets (PVC) NDC 31722-776-32 Blister card of 10 Unit dose tablets (PVC/PVdC) NDC 31722-776-33 Blister pack of 100 (10 x 10's) Unit dose tablets (PVC/PVdC) NDC 31722-776-34 Recommended Storage for

SILDENAFIL Tablets: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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