Anril-200 metered spray

Nitroglycerin Tablet is indicated for the prophylaxis of chronic stable angina pectoris. Nitroglycerin Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin Injection is indicated for the treatment of peri-operative hypertension; for controlling of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and beta blockers and for induction of Intraoperative hypotension.

Nitrates: Coronary vasodilators

The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (after load). Dilatation of the coronary arteries also occurs.

Tablet or Capsule-

Adults and Elderly Patients: Dosage should be adjusted to the requirements of the individual patient but will usually be 1 or 2 tablets taken three times daily. The lowest effective dose should be used.

Spray-

At the onset of an attack, 1 or 2 metered sprays should be administered under the tongue. No more than 3 metered sprays are recommended within a 15-minute period. If the chest pain persists, prompt medical attention is recommended. Nitroglycerin Spray may be used prophylactically 5 to 10 minutes prior to engaging in activities which might precipitate an acute attack.

Intravenous Infusion-

Nitroglycerin injection is a concentrated, potent drug which must be diluted in dextrose (5%) injection or sodium chloride (0.9%) injection prior to its infusion. Nitroglycerin injection should not be mixed with other drugs. This is not for direct intravenous injection. Initial Dilution: Aseptically transfer the contents of one nitroglycerin ampoule (containing 50 mg of nitroglycerin) into a 500 ml glass bottle of either Dextrose (5%) Injection or Sodium Chloride Injection (0.9%). This yields a final concentration of 100mcg/ml. Maintenance Dilution: It is important to consider the fluid requirements of the patient as well as the expected duration of infusion in selecting the appropriate dilution of Nitroglycerin Injection. After the initial dosage titration, the concentration of the solution may be increased, if necessary, to limit fluids given to the patient. The nitroglycerin concentration should not exceed 400 mcg/ml.

Orthostatic hypotension may occur with the combined use of calcium channel blockers, antihypertensive agents, phenothiazine, and tricyclic antidepressants. Use of alcohol with nitroglycerin may produce severe hypotension and collapse. Oral nitroglycerin may enhance the bioavailability of dihydroergotamine.

Hypersensitivity to nitrates. Obstructive hypertrophic cardiomyopathy. Low cardiac output secondary to hypovolemia. Inferior myocardial infarction with right ventricular involvement. Raised intracranial pressure. Mitral valve propalpse. Glaucoma.

Side-effects include facial flushing, headache, dizziness and postural hypotension which may be associated with reflex tachycardia or paradoxical bradycardia. Toxic effects of Nitroglycerin include vomiting, restlessness, cyanosis, methaemoglobinaemia and syncope.

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. Nursing Mothers: 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.

Only the smallest dose required for effective control of the acute anginal attack should be used. Excessive use may lead to the development of tolerance. This drug should be used with caution in patients who may be volume-depleted or are already hypotensive.

Use in neonates: Safety and efficacy for use in infants and children have not been established. Use in children: Safety and efficacy for use in children has not been established.

Symptoms: Hypotension, reflex tachycardia, pallor, sweating, diarrhoea, weak pulse, collapse, syncope, dizziness, headache, asthenia, nausea, vomiting, methaemoglobinaemia. Bradycardia, psychosis and resp depression may occur in severe poisoning. Management: Increase central fluid volume through passive elevation of patient’s legs. IV infusion of normal saline or similar fluid may also be necessary. Methylene blue infusion may be given in case of methaemoglobinaemia. Administer oxygen if necessary.

Store between 15-30° C. Protect from light and moisture. Keep away from the reach of children.