Active substanceNitroglycerineNitroglycerine
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  • Dosage form: & nbspsublingual tablets
    Composition:

    Each tablet contains:

    active substance: nitroglycerin with glucose 5 mg (nitroglycerin - 0.5 mg, excipient: dextrose monohydrate - 4.5 mg);

    Excipients: lactose monohydrate (sugar milk) - 58.65 mg, corn starch - 7.88 mg, microcrystalline cellulose - 7.448 mg, povidone-K25 - 1.052 mg, silicon dioxide colloid - 2.501 mg, calcium stearate - 0.769 mg, crospovidone - 1, 7 mg.

    Description:

    Tablets from white to white with a yellowish hue of color, flat-cylindrical shape, with a facet on both sides and risk from one side.

    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. Causes the expansion of meningeal vessels, which explains the headache when it is used.

    When using sublingual forms, an attack of angina 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. At sublingual application at once gets to a system blood flow.

    At sublingual admission in a dose of 0.5 mg bioavailability - 100%, the maximum concentration in the blood plasma is determined 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:

    Hypersensitivity to nitrates, shock, collapse, age under 18 years (efficacy and safety not established for age younger than 18 years).

    Simultaneous administration of inhibitors of phosphodiesterase (sildenafil, tadalafil, vardenafil).

    Carefully:

    Comparing the risk and benefit: cerebral hypertension, cardiac tamponade, uncontrolled hypovolemia, in patients with heart failure with normal or low pressure in the pulmonary artery, 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, hypertrophic cardiomyopathy (possibly an increase in angina attacks), impaired cerebral circulation, severe renal and / or hepatic insufficiency (risk of methaemoglobinaemia).

    Pregnancy and lactation:

    The use during pregnancy and during breast-feeding is possible only according to vital signs.

    Dosing and Administration:

    Nitroglycerin should be taken as directed by a doctor.

    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 a sense of 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.

    Possible allergic reactions, hypothermia.

    Overdose:

    Symptoms: decrease in blood pressure (below 90 mm Hg.st.) with orthostatic dysregulation, severe dizziness, headache, fainting, shortness of breath, severe weakness, palpitations, fever, cramps, 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, alcohol, diuretics, beta adrenoblockers, monoamine oxidase inhibitors (MAO), procainamide.

    Special instructions:
    Against the background of taking nitroglycerin, a significant reduction in blood pressure and the appearance of dizziness can occur with a sharp transition to the vertical position from the "lying" or "sitting" position; at the use of alcohol, performance of physical exercises and hot weather.
    To nitroglycerin, as to all organic nitrates, with frequent use, addiction develops.
    If blurred vision or dry mouth persists or is severe, treatment should be discontinued.
    The severity of the headache with Nitroglycerin may be reduced by lowering its dose and / or concurrent administration of menthol-containing drugs (eg, Validol).
    Effect on the ability to drive transp. cf. and fur:
    When driving vehicles and controlling 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 reaction.
    Form release / dosage:

    Tablets sublingual, 0,5 mg.

    Packaging:

    For 10, 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 10, 20, 30, 40, 50 or 100 tablets in cans of polyethylene terephthalate or in cans of polymeric for medicines.

    One jar or 1, 2, 3, 4, 5, 6, 8 or 10 contour squares, together with the instructions for use, are placed in a cardboard package (bundle).

    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:P N002152 / 01
    Date of registration:09.02.2009 / 14.04.2015
    The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspOZONE LLC OZONE LLC Russia
    Information update date: & nbsp11.03.2016
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