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
