Expiration date: 06/2026

DOSAGE FORMS

spray sublingual metered 0.4 mg/dose 300 doses

MANUFACTURERS

Microchem NPF (Ukraine)

GROUP

Anti-anginal agents - nitrates and nitrites

COMPOSITION

The active ingredient nitroglycerin

INTERNATIONAL NONPROPRIETARY NAME

Nitroglycerin

SYNONYMS

Deponit 10, Nirmin, Neath RET, Nitradisc, Nitro, Nitro Mac, Nitro Mak Ampoules, Nitro Mack retard, Paul Infus Nitro, Nitro-dur, Nitro, nick Nitro-time, Nitroglycerin, Nitroglycerin microgranules, Nitroglycerin Nycomed, Nitroglycerin prolonged, Nitrogranulong, Nitroderm TTS 10, TTS Nitroderm 5, Nitrogent, Nitrokor, Nitromist, Nitrong Forte, Nitromarketing TTS, Nitrosol, Nitrospray, Nitrospray-ICN, Perlinganit, Sustak Forte, Sustonit, Trinitrolong

PHARMACOLOGICAL ACTION

Nitroglycerin is an organic nitrogen-containing compound with a primary venodilation action. Effects of nitroglycerin due to its ability to release its molecule of nitric oxide, a natural endothelial relaxing factor. Nitric oxide increases the intracellular concentration of cyclic guanosine monophosphate, which prevents the penetration of calcium ions into smooth muscle cells and causes their relaxation. The relaxation of smooth muscles of the vascular wall and causes vasodilation, which reduces venous return to heart (preload) and the resistance of the systemic circulation (afterload). This reduces the load on the heart and the need of myocardium in oxygen. Expansion of coronary vessels and improves coronary blood flow and contributes to its redistribution in the region with reduced blood circulation, which increases oxygen delivery to the myocardium.The decrease in venous return leads to a decrease in filling pressure of the right atrium, improve blood supply of the upper subendocardialnah layers, reducing the pressure in the pulmonary circulation and regression of symptoms oteke light. Nitroglycerin relaxes smooth muscle cells of the bronchi, urinary tract, gallbladder, bile ducts, esophagus, small and large intestine. The action begins quickly, the effect is for 1-1.5 minutes and lasts about 30 minutes. Nitroglycerin very quickly and adequately absorbed into the systemic circulation after sublingual application through the mucous membranes of the mouth. Bioavailability is approximately 100%, as it eliminates the effect of "first passage" through the liver. Relationship with blood plasma proteins is 60%. Maximum concetrate in the blood plasma is reached after 5 minutes. Rapidly metabolized with the participation nitratereductase, with the formation of di - and mononitrates, the final metabolite is glycerol. Excreted by the kidneys as metabolites. Total clearance is 25-30 l/min After administration of the drug under the tongue T1/2 from blood plasma is 2.5-4.4 minutes. Excreted by the kidneys, less than 1% of the dose excreted unchanged.

INDICATIONS FOR USE

Relief of angina, prophylaxis of angina prior to physical stress.

CONTRAINDICATIONS

Hypersensitivity to organic nitrates, shock, collapse, age of 18 years (efficacy and safety have not been established), concomitant use of inhibitors of phosphodiesterase 5 (like sildenafil, vardenafil or tadalafil), because they potentiate hypotensive effect of nitrates. With caution (comparing risk and benefit): intracranial hypertension, cardiac tamponade, uncontrollable hypovolemia in patients with heart failure with normal or low pulmonary artery pressure, hypotension (systolic blood pressure less than 90 mm Hg. century), form-closure glaucoma with high intraocular pressure, severe anemia, hyperthyroidism, toxic pulmonary edema, subarachnoid hemorrhage, recent head trauma, hemorrhagic stroke, conditions associated with reduction of pressure of filling of the left ventricle (acute myocardial infarction, isolated mitral stenosis, constrictive pericarditis), idiopathic hypertrophic subaortic stenosis, hypertrophic cardiomyopathy (may increase angina), cerebrovascular disease, severe renal and/or hepatic failure (risk of methemohlobinemia). Pregnancy and breast-feeding: drug use in pregnancy and during breast-feeding requires careful matching of benefits to the mother and the risk to the fetus or child, and shall be taken under strict medical supervision.

SIDE EFFECTS

From the side of cardiovascular system: tachycardia, decreased blood pressure, rarely - orthostatic collapse, cyanosis. From the digestive system: dry mouth. From the Central nervous system: dizziness, "nitrate" headache, weakness, and anxiety. Allergic reactions: rarely - skin rash, itching. Local reactions: burning sensation under the tongue, redness of the skin.

INTERACTION

The simultaneous use of vasodilators, angiotensin-converting enzyme, beta-adrenoblokatorami, blokatorami "slow" calcium channels, procainamide, tricyclic antidepressants, monoamine oxidase inhibitors, diuretics, inhibitors of phosphodiesterase-5 (sildenafil, vardenafil, tadalafil), and ethanol increases gipotenzivny effect. Against the background of quinidine and procainamide may occur orthostatic collapse. Concurrent use with dihydroergotamine may result in the increase of its concentration in the blood and to increase blood pressure (increase the bioavailability of dihydroergotamine). Simultaneous use of nitroglycerin and heparin reduces the effectiveness of the latter, which may require increasing the dose (after discontinuation of the drug may require lower doses of heparin).

METHOD OF APPLICATION AND DOSAGE

Spray, spray sublingual. When first using or after long periods of non-use of the drug is recommended before its use, one dose to reset in the air to fill the pump chamber. The drug should be used in "browsing", remove protective cap, hold the bottle upright, open the mouth and hold for several seconds, breath, push on the proportioning valve, sending a stream of medication under the tongue, close the mouth for a few seconds, do not swallow the drug. For the relief of angina – 0.4-0.8 mg (1-2 dose) under the tongue. If necessary, you can reapply in 5-minute intervals, but not more than 1.2 mg (3 doses). If within 15 minutes of the attack is not blocked, you should immediately consult a doctor.Prophylactic applied 0.4 mg (1 dose) for 5-10 minutes prior to the estimated load.

OVERDOSE

Symptoms: decreased blood pressure (below 90 mm Hg.St.), orthostatic hypotension, reflex tachycardia, headache, may develop asthenia, dizziness, hypersomnia, sensation of heat or chills, nausea, vomiting. Treatment: at the onset of overdose symptoms to give the patient horizontal position with raised legs and call a physician immediately.

SPECIAL INSTRUCTIONS

In acute myocardial infarction or congestive heart failure should be used only with careful monitoring of patients. To prevent an increase in angina should avoid abrupt discontinuation of the drug. A drug Nitrosprint, like all organic nitrates, with the frequent use develop tolerance. On the background of the drug Nitrosprint may be a significant reduction of blood pressure and the appearance of dizziness with a sharp transition in the vertical position of "lying" or "sitting", when alcohol, exercise and hot weather.The severity of headache in patients receiving the drug Nitrosprint can be reduced by reducing the dose and/or simultaneous reception mentolosoderzhaschih products (including medicines). During the period of treatment must be careful when driving and occupation of other potentially hazardous activities in view of the fact that the drug Nitrosprint can lead to reduce the speed of motor and mental reactions.

STORAGE CONDITIONS

List B. the temperature is not above 30°C, away from fire, out of reach of children. The expiration date. 4 years. Do not use after expiration date.