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Label Changes for:

Nitromist (nitroglycerin)

June 2016

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

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

June 2016

CONTRAINDICATIONS

PDE5 Inhibitor Use
  • Addition to the end of the paragaragh:  Do not use NitroMist in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension.

DRUG INTERACTIONS

PDE5 Inhibitors
  • Addition to the end of the first paragraph: Do not use NitroMist in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use may result in severe hypotension, syncope, or myocardial ischemia.
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