sildenafil tablet film coated
1 INDICATIONS & 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%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [ see Clinical Studies ( 14 ) ]. Sildenafil is 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 ) Limitation of Use : Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. ( 1 , 14 )
Macleods Pharmaceuticals Limited
ROUND WHITE C89
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16 HOW SUPPLIED/STORAGE AND HANDLING
SILDENAFIL tablets, USP are supplied as white to off-white, film-coated, round tablets containing
SILDENAFIL citrate equivalent to the nominally indicated amount of
SILDENAFIL as follows:
SILDENAFIL Tablets Package Configuration Strength NDC Debossing on Tablet Bottle of 90 Tablets 20 mg 33342-121-10 “C 89” 10's Blister Pack 20 mg 33342-121-12 “C 89” Recommended Storage for
SILDENAFIL Tablets, USP: Store at controlled room temperature 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Dispense in tight containers (USP).
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