Indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

Sublingual nitroglycerin therapy is contraindicated in patients with early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin.

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

The benefits of sublingual nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used because of the possibility of hypotension and tachycardia.

Only the smallest dose required for effective relief of the acute anginal attack should be used. Excessive use may lead to the development of tolerance. NITROSTAT tablets are intended for sublingual or buccal administration and should not be swallowed.

Severe hypotension, particularly with upright posture, may occur with small doses of nitroglycerin. This drug should therefore be used with caution in patients who may be volume-depleted or who, for whatever reason, are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.

Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates.

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).

Patients receiving sublingual nitroglycerin should avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible.

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

Administration of NITROSTAT is contraindicated in patients who are using a phosphodiesterase-5 (PDE-5) inhibitor (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride) since these compounds have been shown to potentiate the hypotensive effects of organic nitrates.

Concomitant use of NITROSTAT with soluble guanylate cyclase stimulators is contraindicated. Do not use NITROSTAT in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Co-administration of nitroglycerin with high dose aspirin (1000 mg) results in increased exposure to nitroglycerin.

Limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage.Sublingual nitroglycerin has not been studied in lactating women.

It is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production. 

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• Use in patients under the age of 18. GoToSource 

• Non-small cell lung cancer. GoToSource 

• Acute pain from suspected symptomatic cholelithiasis. GoToSource 

• Prevention of radial artery occlusion. GoToSource 

• Esophageal chest pain. GoToSource 

• Prevention of contrast-induced nephropathy. GoToSource

Mitochondrial damage and tolerance with chronic use. GoToSource

Long-term oral nitrate therapy associated with major adverse cardiovascular events following elective coronary artery revascularization by PCI in patients with type II diabetes. GoToSource 

Hypotension (low blood pressure). GoToSource 

Bradycardia (slow heart rate). GoToSource

No major injury lawsuits reported.