Label Changes for:

Nitrostat (nitroglycerin, USP) Sublingual Tablets

July 2011

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011

 

CONTRAINDICATIONS

  • Administration of NITROSTAT is contraindicated in patients who are using a phosphodiesterase-5 (PDE-5) inhibitor.....

PRECAUTIONS

Drug Interactions
  • Administration of nitroglycerin is contraindicated in patients who are using PDE-5 inhibitors (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride). These compounds have been shown......

PPI

  • updated with PDE-5 inhibitor information
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