Nitroglycerin (Sublingual Spray): Uses,Dosage,Side Effects

Generic Name
Nitroglycerin (Sublingual Spray)
Therapeutic Class Nitrates: Cardiovascular (Coronary vasodilators)

Indications:
Nitroglycerin sublingual spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Presentation:

Spray: Each metered dose spray contains Nitroglycerin BP 400 mcg.

Description
Nitroglycerin, an organic nitrate, is a vasodilator that has effects on both arteries and veins. This is a metered-dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 200 metered sprays) in the form of spray droplets under the tongue.

Description:
Nitroglycerin Spray acts on the smooth muscle of blood vessels. It dilates the peripheral veins, arteries, coronary vessels, thereby decreases cardiac pre and afterload, cardiac work oxygen demand. It also reduces venous return, lowers end-diastolic pressure in the right and left ventricles, and improves myocardial function. Nitroglycerin Spray increases the tolerance of anginal patients to exercise. Nitroglycerin applied on the buccal mucosa is absorbed quickly; its effect becomes apparent within 1 minute.

Dosage & Administration:
In case of attack one or two doses should be administered under the tongue to a sitting patient. If necessary, more doses can be given but not more than 3 doses within 15 minutes. For prevention, one dose should be applied 5-10 minutes before physical exercise.
Use in Children: Nitroglycerin Spray is not recommended for children.

HOW TO USE TRACER SPRAY
  • Sit down if possible as soon as you feel an attack of angina coming on.
  • Remove the plastic cap, do not shake the container.
  • Hold the container upright with a forefinger on top of the white button.
  • Open the mouth and bring the container as close to it as possible, aiming it under the tongue.
  • Press the button slowly on the top of the container to spray under the tongue
  • Release button and close mouth. Avoid swallowing immediately after administering the spray. Do not take water to mouth within 5-10 minutes after administering the spray
  • If you require a second administration to obtain relief, repeat steps 4, 5 & 6. Put the plastic cap in position.
SPECIAL INSTRUCTIONS
  • In case of angina patients, it is important to carry Trocer (Nitroglycerin) Spray all times (We recommend keeping a second supply at home on a bedside table or wherever it can be reached easily).
  • This drug is not for routine use. It is only to be used at the onset of chest pain.
  • Do not drink alcoholic beverages after taking this medication.
  • Keep in safe place away from children.
  • DO NOT take sildenafil, vardenafil, or tadalafil while using any nitroglycerin product. Using these drugs together can result in a severe lowering of blood pressure, loss of consciousness, heart attack, or death.
Interaction:
Use of alcohol with Nitroglycerin may produce severe hypotension and collapse. Oral Nitroglycerin may enhance the bioavailability of dihydroergotamine. Orthostatic hypotension may occur with the combined use of calcium channel blockers, phenothiazines, and tricyclic antidepressants.

Contraindications:
Hypersensitivity to nitrates or any constituents of the formulation. Hypotension, hypovolaemia, severe anemia, cerebral hemorrhage and brain trauma, mitral stenosis, and angina caused by hypertrophic obstructive cardiomyopathy. Concomitant administration of phosphodiesterase inhibitors used for the treatment of erectile dysfunction.

Side Effects:
A number of nitrate-related adverse effects may occur including headache, facial flushing, dizziness, nausea, vomiting, feelings of weakness, postural hypotension, and reflex tachycardia .

Pregnancy & Lactation:
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Nitroglycerin should be given to pregnant women only if clearly needed. It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nitroglycerin spray is administered to a nursing woman.

Precautions & Warnings:
The use of Nitroglycerin during the early days of acute myocardial infarction requires particular attention to monitoring hemodynamics and clinical status. Nitroglycerin should be used with caution in patients with severely impaired renal or hepatic function, hypothyroidism, malnutrition, or hypothermia.

Use in Special Populations:
The safety and effectiveness of nitroglycerin in pediatric patients have not been established.

Overdose Effects:
Nitrate overdosage may result in severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse, heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions and possibly death due to circulatory collapse.

Methemoglobinemia: Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates. The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.

Treatment of Overdosage: Keep the patient recumbent in a shock position and comfortably warm. Passive movement of the extremities may aid venous return. Administer oxygen and artificial ventilation, if necessary. If methemoglobinemia is present, administration of methylene blue (1% solution), 1-2 mg per kilogram of body weight intravenously, may be required. If an excessive quantity of Nitroglycerin spray has been recently swallowed, gastric lavage may be of use.

Storage:

Store in a cool and dry place away from light and heat. Keep all medicines out of the reach of children.
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