The principal pharmacological action of nitroglycerin is the relaxation of vascular smooth muscle, producing a vasodilator effect on both peripheral arteries and veins, with more prominent effects on the latter. Dilation of the post-capillary vessels, including large veins, promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure (preload). Arteriolar relaxation reduces systemic vascular resistance and arterial pressure (afterload).
Nitrin® Sublingual Spray is indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
At the onset of an attack, one or two metered sprays should be administered under the tongue. No more than three metered sprays are recommended within a 15-minute period. If chest pain persists, prompt medical attention is recommended. Nitrin® Sublingual Spray may be used prophylactically five to ten minutes prior to engaging in activities that might precipitate an acute attack.
Nitroglycerin is contraindicated in patients who are allergic to it. Nitrin® Sublingual Spray is contraindicated in patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors) and in conditions such as hypotensive shock, narrow-angle glaucoma, severe anemia, cerebral hemorrhage, and brain trauma.
A mild, transitional burning sensation in the mouth may occur. Other possible side effects include pulsation in the head, facial flushing, headache, dizziness, palpitations, a sensation of heat, nausea, and sweating. In cases of overdose, methemoglobinemia and cyanosis may occur.
Severe hypotension, particularly with an upright posture, may occur even with small doses of nitroglycerin. Therefore, the drug should be used with caution in patients who may have volume depletion due to diuretic therapy or in those with low systolic blood pressure (e.g., below 90 mm Hg). Paradoxical bradycardia and increased angina pectoris may accompany nitroglycerin-induced hypotension. Nitrate therapy may aggravate angina caused by hypertrophic cardiomyopathy.
Pregnancy: Pregnancy Category C.
Nursing Mothers: It is not known whether nitroglycerin is excreted in human milk.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Nitroglycerin should be used with caution when taken together with antihypertensives, tricyclic antidepressants (as they may enhance hypotension).
Do not puncture, break, or incinerate the canister, even when empty.
Avoid storage in direct sunlight or heat.
Store below 25°C.
Keep away from eyes.
Dispense only with a prescription from a registered doctor.
Each pack contains one canister of Nitrin® Sublingual Spray. Each canister contains a minimum of 200 doses, with each actuation delivering Nitroglycerin USP 400 mcg.
Sit down if possible.
Remove the cap. Hold the canister upright with your forefinger on top of the white button.
Open your mouth and bring the canister as close as possible, aiming under the tongue.
Press the button firmly to spray under the tongue.
Close your mouth immediately but do not inhale the spray.
If necessary, repeat the process once more.
Practice First!
Since you may need to use it urgently or in the dark, if you have never used it before, practice by spraying a few puffs into the air.
Medicine: Keep out of reach of children.
