Active substanceNitroglycerineNitroglycerine
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  • Dosage form: & nbspcapsules for oral hygiene
    Composition:

    1 capsule contains:

    active substance: nitroglycerin (a solution of nitroglycerin 4% in sunflower oil in terms of 100% substance) - 0.5 mg;

    Butylhydroxytoluene (ionol) - 0.0074 mg, sunflower oil - up to 50 mg; composition of the shell: gelatin medical - 17.1 mg, glycerol (glycerol) - 5.62 mg, methylparahydroxybenzoate (nipagin) - 0.14 mg, azorubin (acid red 2C) - 0.14 mg.

    Description:

    Capsules soft gelatinous spherical, red. The contents of the capsules are an oily liquid from light yellow to yellow, without a rancid odor.

    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 the demand for myocardium in oxygen due to a decrease in preload (the expansion of 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, 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 time to reach the maximum concentration in the blood plasma is determined after 5 minutes. The preparation has a very large volume of distribution. The connection with plasma proteins is 60%.

    Indications:Stenocardia, short-term prophylaxis.
    Contraindications:

    Hypersensitivity to nitrates, shock, collapse, simultaneous use of phosphodiesterase inhibitors (including sildenafil), age to 18 years (efficacy and safety not established).

    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, acute myocardial infarction with low left ventricular filling pressure, toxic pulmonary edema, subarachnoid hemorrhage, recently suffered head trauma, hemorrhagic stroke , A condition accompanied by left ventricular filling pressure reduction (isolated mitral stenosis, constrictive pericarditis), idiopathic hypertrophic subaortic stenosis, cerebral circulation, serious renal and / or liver failure (risk of mettemoglobinemii).

    Pregnancy and lactation:

    Application during pregnancy and during breast-feeding is possible only for vital indications.

    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 capsule Nitroglycerin placed under the tongue and kept until completely absorbed, not swallowing. The usual dose of the drug - 1 capsule under the tongue (in many patients with stable angina the effect comes and from a smaller dose, in this case, the remainder of the capsule, which did not have time to resolve, is recommended to be spit). Usually, the antianginal effect is manifested in 0.5-2 min; 75% of patients noted improvement during the first 3 min, and an additional 15% within 4-5 min.

    If the attack of angina is not stopped within 5 minutes, take another 1 capsule of Nitroglycerin.

    If there is no therapeutic effect after taking 2 capsules, you should immediately 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 (especially at the beginning of the course of treatment, with prolonged therapy decreases), dizziness and weakness, anxiety, psychotic reactions, inhibition, disorientation.

    From the side of 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: lowering blood pressure (below 90 mm Hg) with orthostatic dysregulation, severe dizziness, headache, fainting, shortness of breath, severe weakness, rapid heart rate; fever, seizures, asthenia, drowsiness. At application of high doses (more than 20 ml / kg) - a collapse, a cyanosis, a methemoglobinemia, a 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.

    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).

    Against the background of quinidine and novocainamide, orthostatic collapse may occur.

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

    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 Nitroglycerinum, as well as to other organic nitrates, at frequent application the habituation, demanding increase in a dosage can develop.

    If blurred vision or dry mouth persists or is severe, treatment should be discontinued.

    Severity of headache against the background of taking nitroglycerin can be reduced by lowering its dose and / or concurrent administration of Validol.

    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 reception of Nitroglycerinum can lead to decrease in speed of impellent and mental reaction.
    Form release / dosage:

    Capsules sublingual, 0,5 mg.

    Packaging:

    For 20 capsules in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

    For 1, 2, 4, 6, 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard or a hermetically sealed plastic bag made of light-proof polyethylene film, or a package of material combined on a paper and cardboard basis with a polyethylene coating, or the material of the combined "Boflen".

    5, 10, 20, 50, 100, 200, 400, 500, 600 contour squares, together with an equal number of instructions for use in a hermetically sealed polyethylene bag made of light-proof polyethylene film.

    It is allowed to put the full text of instructions for use on the package, package.

    Polyethylene bags are placed in a cardboard box.

    Group packing and shipping containers in accordance with GOST 17768-90.
    Storage conditions:

    In a dry, cool place protected from light, away from fire.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-000127/09
    Date of registration:14.01.2009
    The owner of the registration certificate:LYUMI, LLC LYUMI, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspLYUMI, LLCLYUMI, LLC
    Information update date: & nbsp11.03.2016
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