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 (1 4) ] . 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 )

Apotex Corp.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] adverse drug reaction` `[3] toxicity to various agents` `[4] completed suicide` `[5] drug abuse` `[6] pain` `[7] arthralgia` `[8] covid-19` `[9] off label use` `[10] death`

4 years ago

ROUND WHITE APO SIL 20

16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP, are supplied as white to off white, round biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Sildenafil Tablets, USP Package Configuration Strength NDC Engraving on Tablet Bottle of 90 Tablets 20 mg 60505-3404-9 "APO" on one side and "SIL" over "20" on the other side Bottle of 500 Tablets 20 mg 60505-3404-5 "APO" on one side and "SIL" over "20" on the other side Recommended Storage for Sildenafil Tablets Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

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sildenafil 20 MG Oral Tablet

FDA Reported Adverse Reactions [1] drug ineffective [2] adverse drug reaction [3] toxicity to various agents [4] completed suicide [5] drug abuse [6] pain [7] arthralgia [8] covid-19 [9] off label use [10] death

ROUND WHITE APO SIL 20

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] adverse drug reaction` `[3] toxicity to various agents` `[4] completed suicide` `[5] drug abuse` `[6] pain` `[7] arthralgia` `[8] covid-19` `[9] off label use` `[10] death`