Nitroglycerin

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin Lingual Spray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease (1).

• Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). (4.1, 7.1)
• Severe anemia. (4.2)
• Increased intracranial pressure. (4.3)
• Hypersensitivity to Nitroglycerin Lingual Spray or to other nitrates or nitrites or any excipient. (4.4)

4.1PDE-5-Inhibitors

and sGC-Stimulators Do not use Nitroglycerin Lingual Spray in patients who are taking PDE-5-Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1) ] . Do not use Nitroglycerin Lingual Spray in patients who are taking soluble guanylate cyclase (sGC) stimulators, such as riociguat. Concomitant use can cause hypotension.

4.2Severe Anemia Nitroglycerin Lingual

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

4.3Increased Intracranial Pressure Nitroglycerin Lingual

Spray 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