Sildenafil 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-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). 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-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
BluePoint Laboratories
ROUND WHITE AN 351
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16 HOW SUPPLIED/STORAGE AND HANDLING
SILDENAFIL tablets, USP, 20 mg, are supplied as white to off-white, round shaped film-coated tablets with debossing ‘AN 351’ on one side and plain on the other side, containing
SILDENAFIL citrate, USP equivalent to the nominally indicated amount of
SILDENAFIL. They are available as follows: Bottles of 90: NDC 68001-176-05 Recommended Storage for
SILDENAFIL Tablets, USP: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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