Sildenafil sildenafil 20 MG Oral Tablet
1 INDICATIONS AND USAGE Sildenafil is 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 was 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 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 ) Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14) ] .
Greenstone LLC
ROUND WHITE SDF 20
SDF 20 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
SILDENAFIL tablets are supplied as white, film-coated, round tablets containing
SILDENAFIL citrate equivalent to the nominally indicated amount of
SILDENAFIL as follows:
SILDENAFIL Tablets Package Configuration Strength NDC Engraving on Tablet Bottle of 90 Tablets 20 mg 59762-0033-1 SDF20 Bottle of 300 Tablets 20 mg 59762-0033-3 SDF20 Recommended Storage for
SILDENAFIL Tablets: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature].
SILDENAFIL powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of
SILDENAFIL citrate (equivalent to 1.12 g
SILDENAFIL). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg
SILDENAFIL/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.
SILDENAFIL Powder for Oral Suspension Package Configuration Strength NDC Powder for oral suspension – bottle 10 mg/mL (when reconstituted) 59762-2058-1 Recommended storage for
SILDENAFIL for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture. Reconstituted Oral Suspension Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36° F – 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.
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