sildenafil 20 mg

1 INDICATIONS & USAGE Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies ( 14 )]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Adults Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. ( 1 )

macleods pharmaceuticals limited

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] nausea` `[5] dyspnoea` `[6] diarrhoea` `[7] headache` `[8] pain` `[9] pyrexia` `[10] death`

8 months ago

ROUND WHITE N7

16 HOW SUPPLIED/STORAGE AND HANDLING

SILDENAFIL Tablets, USP are supplied as white to off white, round shaped, film-coated tablets containing

SILDENAFIL citrate equivalent to the nominally indicated amount of

SILDENAFIL as follows:

SILDENAFIL Tablets, USP Package Configuration Strength NDC Debossing on Tablet Bottle of 90 Tablets 20 mg 33342-536-10 "N7" 10’s Blister Pack 20 mg 33342-536-66 "N7" 6500’s TLP bulk pack 20 mg 33342-536-58 "N7" Recommended Storage for

SILDENAFIL Tablets, USP: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight containers (USP).

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