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Label Changes for:

Levitra (vardenafil hydrochloride) Tablets

September 2015

Changes have been made to the CONTRAINDICATIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

Including:

  • Cialis (tadalafil) Tablets
  • Levitra (vardenafil hydrochloride) Tablets
  • Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets
  • Stendra (avanafil) Tablets
  • Viagra (sildenafil citrate) Tablets 

September 2015

CONTRAINDICATIONS

Guanylate Cyclase (GC) Stimulators
  • Do not use <drug name> in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including <drug name> may potentiate the hypotensive effects of GC stimulators.

PATIENT COUNSELING INFORMATION

Guanylate Cyclase (GC) Stimulators
  • Inform patients that <drug name> is contraindicated in patients who use guanylate cyclase stimulators, such as riociguat.
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