Active substanceNitroglycerineNitroglycerine
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  • Dosage form: & nbspsublingual tablets
    Composition:

    For one tablet:

    active substance: nitroglycerin with dextrose (nitroglycerin with glucose) - 0.5 mg (in terms of 100% substance);

    Excipients: aspartame 0.3 mg, silicon dioxide colloid (aerosil) 0.9 mg, stearic acid 0.4 mg, croscarmellose sodium 1.0 mg, potato starch 2.6 mg, microcrystalline cellulose 34.8 mg .

    Description:

    Tablets are white or almost white, flat-cylindrical, with a bevel.

    Pharmacotherapeutic group:vasodilator - nitrate
    ATX: & nbsp

    C.01.D.A.02   Nitroglycerine

    Pharmacodynamics:

    Peripheral vasodilator with predominant effect on venous vessels. The effect of nitroglycerin is mainly due to a decrease in myocardial oxygen demand due to a reduction in preload (peripheral veins and a decrease in the flow of blood to the right atrium) and postnagruzki (a decrease in the total peripheral vascular resistance).

    Has a central inhibitory effect on the sympathetic tone of blood vessels, inhibits the vascular component of the formation of pain syndrome. It causes the expansion of meningeal vessels, which explains the headache when it is used.

    When using sublingual forms, the attack of angina pectoris usually stops after 1.5 minutes, the hemodynamic and antianginal effect persists for 30 to 60 minutes.

    Pharmacokinetics:

    Quickly and completely absorbed from the surface of the mucous membranes. With sublingual admission in a dose of 0.5 mg nitroglycerine immediately enters the systemic circulation, bioavailability is 100%. The maximum concentration in the blood plasma is reached after 5 minutes. The preparation has a large volume of distribution. The connection with plasma proteins is 60%.

    Indications:

    Kupirovanie and short-term prophylaxis of attacks of a stenocardia.

    Contraindications:

    Increased sensitivity to nitrates, shock, collapse, simultaneous administration of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil, etc.), age to 18 years (efficacy and safety not established for age younger than 18 years).

    Carefully:

    Cranial hypertension, cardiac tamponade, uncontrolled hypovolemia, in patients with heart failure with normal or low pulmonary arterial pressure, arterial hypotension (systolic blood pressure less than 90 mm Hg), closed-angle glaucoma with high intraocular pressure, severe anemia , hyperthyroidism, pulmonary edema, subarachnoid hemorrhage, recent head trauma, hemorrhagic stroke, conditions accompanied by decreased left ventricular filling pressure (acute myocardial infarction, isolated mitral stenosis, constrictive pericarditis), idiopathic hypertrophic subaortic stenosis, cerebral circulation disorder, severe renal and / or hepatic insufficiency (risk of development of methemoglobinemia).

    Pregnancy and lactation:

    It is possible only for vital indications.

    Dosing and Administration:

    Nitroglycerin is recommended for use as directed by a physician.

    Nitroglycerin should be taken immediately with the first signs of an attack of angina pectoris:

    1 tablet Nitroglycerin placed under the tongue and kept until completely dissolved, not swallowing.The usual dose of the drug is 1 tablet under the tongue.

    If the attack of angina is not stopped within 5 minutes, you need to take another 1 tablet of Nitroglycerin.

    In the absence of therapeutic effect after taking 2 tablets, you must call a doctor.

    With frequent attacks of angina pectoris, it is advisable to use prolonged drugs of the nitroglycerin series.

    Side effects:

    From the central nervous system: blurred vision, "nitrate" headache, dizziness and weakness, anxiety, psychotic reactions, inhibition, disorientation.

    From the cardiovascular system: lowering blood pressure; tachycardia; rarely (especially with an overdose) - orthostatic collapse, cyanosis, reddening of the facial skin.

    From the gastrointestinal tract: dry mouth, nausea, vomiting, abdominal pain.

    Allergic reactions, hypothermia are possible.

    Overdose:

    Symptoms: decrease in blood pressure (below 90 mm Hg) with orthostatic dysregulation, severe dizziness, headache, fainting, shortness of breath, severe weakness, palpitations, fever, seizures, asthenia, drowsiness.

    At application of high doses (more than 20 mkg / kg) - a collapse, cyanosis, methemoglobinemia, dyspnea and tachypnea.

    When symptoms of an overdose occur, immediately put the patient, raise his legs and call a doctor immediately.

    Interaction:

    The hypotensive effect of the drug may be excessive in the case of uncontrolled simultaneous administration of vasodilators, antihypertensive agents, angiotensin converting enzyme (ACE) inhibitors, phosphodiesterase inhibitors, slow calcium channel blockers, tricyclic antidepressants, ethanol, diuretics, beta adrenoblockers, monoamine oxidase inhibitors (MAO), procainamide, co-enzyme synthesis of nitric oxide (sapropteryon).

    The appointment with dihydroergotamine can lead to an increase in its content in the blood and an increase in blood pressure (due to an increase in the bioavailability of dihydroergotamine).

    Simultaneous administration of nitroglycerin and heparin reduces the effectiveness of the latter (after drug cancellation, a significant reduction in blood coagulability, which may require a reduction in the dose of heparin).

    Special instructions:

    Against the background of taking Nitroglycerin tablets, a significant reduction in blood pressure and the appearance of dizziness can occur with a sharp transition to the vertical position from the "sitting" or "lying" position; at the use of alcohol, performance of physical exercises and hot weather.

    To Nitroglycerinum, as well as to other organic nitrates, at frequent application the accustoming demanding increase of a dosage can develop.

    If the clear vision or dry mouth is retained or strongly pronounced, treatment should be discontinued.

    The severity of the headache associated with Nitroglycerin intake can be reduced by lowering its dose and / or concurrent administration of menthol-containing drugs.

    The drug contains dextrose, which must be considered when used in patients with diabetes mellitus; the drug is contraindicated in patients with phenylketonuria (the drug contains aspartame).

    Effect on the ability to drive transp. cf. and fur:

    When driving vehicles and managing mechanisms that require increased attention, it should be borne in mind that taking nitroglycerin can lead to a decrease in the rate of motor and mental reactions.

    Form release / dosage:

    Tablets are sublingual, 0.5 mg.

    Packaging:For 40 tablets in a test tube with a glass or polymer pencil case with a polyethylene plug.
    A test tube or a pencil case together with an instruction for use is placed in a pack of cardboard.
    Storage conditions:Store at a temperature of no higher than 25 ° C, away from fire.
    Keep out of the reach of children.
    Shelf life:

    2 years.

    The drug should not be used after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002532
    Date of registration:30.06.2010 / 12.12.2014
    The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.03.2016
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