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NITROSTAT® (nitroglycerin) Contraindications

4 CONTRAINDICATIONS

4.1 PDE-5-Inhibitors and sGC-Stimulators

Do not use NITROSTAT in patients who are taking PDE-5 Inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1)].

Do not use NITROSTAT in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension.

4.2 Severe Anemia

NITROSTAT is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia).

4.3 Increased Intracranial Pressure

NITROSTAT may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g., cerebral hemorrhage or traumatic brain injury).

4.4 Hypersensitivity

NITROSTAT is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient.

4.5 Circulatory Failure and Shock

NITROSTAT is contraindicated in patients with acute circulatory failure or shock.

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