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ISO-MIC of 1.25 mg / dose 300 doses of 15 ml spray scrapper. sublingual


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The instruction for medical use of IZO-MIK medicine the Trade name of IZO-MIK the International unlicensed name of Isosorbide dinitrate the Dosage form Spray the Structure dosed hypoglossal 1.25 mg / a dose One bottle contains active agent – isosorbide dinitrate water in recalculation for 100% of isosorbide dinitrate of 0.375 g excipients: polyethylene oxide-400, alcohol of 96%. The description Transparent colourless liquid with an alcohol smell. Pharmacotherapeutic group Drugs for treatment of heart diseases. Vazodilatatora for treatment of heart diseases. Organic nitrates. Isosorbide dinitrate. The ATX CO1D A 08 code the Pharmacological Pharmacokinetics Later properties of dispersion in an oral cavity drug is quickly soaked up and begins to render hemodynamic and anti-anginal effect in 2-5 min. (i.e. stopping of an attack of stenocardia is observed in 2-5 min. after reception). The maximum concentration of active agent in blood plasma is reached in 5-6 min. The maximum effect after injection of drug IZO-MIK occurs on the 10-15th min. Isosorbide dinitrate is metabolized with formation of an active metabolite of isosorbide-5-mononitrate which elimination half-life makes 5 h and also isosorbide-2-mononitrate with elimination half-life of 2.5 h. Elimination half-life of isosorbide of dinitrate at sublingual use of drug makes 1 h. Elimination half-life can be extended at course use of drug. From 80 to 100% of the entered single dose are removed with urine during 24 h, mainly in the form of metabolites. At ISO-MICK’S use the attacks of stenocardia are stopped for 2 – 3 minutes, the effect proceeds about 1 h. IZO-MIK pharmacodynamics – a peripheral vazodilatator with the prevailing influence on venous vessels. Duration of therapeutic effect of drug is 60-120 minutes. This dosage form – short-term action. Effect of drug is connected with decrease in need of a myocardium for oxygen due to reduction of preload of heart (expansion of peripheral veins and reduction of inflow of blood to the right auricle) and afterloads (reduction of the general period of vascular resistance) and also with direct coronarodilator effect. Promotes redistribution of a coronary blood-groove in sites with reduced blood supply. At use of drug the increase in tolerance to physical activities at patients with stenocardia is noted. In heart failure drug promotes unloading of a myocardium due to reduction of preloading. Lowers pressure in a small circle of blood circulation. Indications stopping and prevention of attacks of stenocardia an acute myocardial infarction the acute left ventricular failure the Route of administration and doses of 0.05 ml contains In one dose of drug (one injection) 1.25 mg of isosorbide of dinitrate. Drug is sprayed under language. Not to inhale! In the absence of individual recommendations for stopping of attacks of stenocardia or before physical or emotional activity which can entail an attack it is necessary to vbryzgnut spray of 1 – 2 time at an interval of 30 seconds, breathing a nose at this time. In an acute myocardial infarction and an acute heart failure begin with 1 – 3 injections. In the absence of effect for 5 minutes under control of the doctor the injection can be repeated. If improvement did not occur, in the next 10 minutes it is possible to repeat injection under stringent control of arterial blood pressure. For prevention of attacks of stenocardia drug is usually appointed on 1-2 injections by 3-4 times a day. Duration of treatment is defined individually. At higher need for nitrates it is recommended to use tablets IZO-MIK 10 or 20 of mg. Side effects Often a headache (nitrate) most of which often passes in several days at further use of drug – dizziness drowsiness – orthostatic hypotension (sometimes in combination with bradycardia) – aggravation of stenocardia Infrequently – reflex tachycardia – an asthenia – burning sensation of language during spray injection nausea, vomiting erubescence of the person and allergic skin reactions, such as pour feeling of weakness a Quincke’s disease, inflows the condition of collapse, sometimes with bradycardia, a syncope is rare – an anoxemia (at patients with primary pulmonary disease due to relative redistribution of a blood-groove in the hypoventilated alveolar zones) – peripheral hypostases Very seldom – heartburn – a Quincke’s edema, Stephens-Johnson’s syndrome In isolated cases – exfoliative dermatitis With an unknown frequency – Contraindication hypotension hypersensitivity to nitrate compounds or other components of drug acute vascular insufficiency (shock, vascular collapse) the profound arterial hypotension (systolic arterial blood pressure is lower than 90 mm Hg., diastolic – it is lower than 60 mm Hg.) a heavy hypovolemia cardiogenic shock a hypertrophic subaortic stenosis chronic cardial compression, a cardiac tamponade heavy anemia a concomitant use of inhibitors of phosphodiesterase-5 (for example, sildenafit, vardenafit or tadalafit) children’s and teenage age up to 18 years (the efficiency and safety of drug are not established) With care: an acute myocardial infarction with a left ventricular failure an aortal and/or mitral stenosis tendency to orthostatic reactions of a disease, the followed by increase in intracranial pressure, hemorrhagic stroke, a craniocereberal injury advanced age (65 years are more senior) a heavy renal failure and/or a liver failure, closed-angle glaucoma Medicinal interactions strengthening of hypotensive action at simultaneous use of other vazodilatator, beta blockers, diuretics, blockers of slow calcium channels, inhibitors of angiotensin-converting enzyme, tricyclic antidepressants, neuroleptics, ethanol and etanolsoderzhashchy means, the medicines intended for treatment of erectile dysfunction – phosphodiesterase-5 inhibitors is possible (sildenafit, vardenafit or tadalafit). Simultaneous use of drug IZO-MIK with dihydroergotamine can lead to increase in concentration of dihydroergotamine in blood plasma and, thus, strengthen its hypotensive action. At simultaneous use of sympathomimetic means (adrenaline, ephedrine, noradrenaline, Naphthyzinum, a phenylephine hydrochloride, Isadrinum) the decrease in anti-anginal effect of isosorbide of dinitrate is possible. Special instructions With care apply in treatment of patients with disturbances of cerebral circulation, with an aortal and/or mitral stenosis, the patients inclined to orthostatic hypotension, patients with ischemia symptoms in various vascular beds arising against the background of a lowering of arterial pressure. During treatment, especially in case of gradual increase in a dose, control of arterial blood pressure and heart rate is necessary. Frequent reception of high doses can lead to emergence of nitrate tolerance. For overcoming tolerance to isosorbide dinitrate (at a possibility of cancellation of nitrates) is recommended not to increase frequency rate of reception or a dose of drug, and to refrain from its reception on 24-36 h, having replaced it with this time with other anti-anginal means, and then to continue treatment in the form of monotherapy in usual doses or in combination with other drugs. A break at regular administration of drug is recommended to be taken in 4-6 weeks. Developing of a nitrate headache in an initiation of treatment can be prevented gradual increase in a dose or prescribing of validol and non-narcotic analgetik (acetylsalicylic acid, paracetamol, analginum, captopril). During drug treatment it is recommended to refrain from alcohol intake. It was reported about development of heavy hypotensive reaction to organic nitrates which was followed by nausea, vomiting, pallor, perspiration, rapid breathing. At use of spray of isosorbide of dinitrate the temporary anoxemia connected with relative redistribution of a blood flow in the hypoventilated sites of alveoluses can be observed. At patients with coronary insufficiency it can lead to a myocardium hypoxia. Use in pediatrics the Researches on use of drug in pediatric practice were not conducted. Pregnancy and the period of a lactation Use of IZO-MIK during pregnancy and a lactation is possible only if the expected advantage for mother considerably exceeds potential risk for a fruit or the child and only under observation of the doctor. The danger of influence of medicine on ability to run the vehicle or potentially dangerous mechanism during treatment is not recommended to run vehicles and to be engaged in other potentially dangerous types of action as at regular use of isosorbide of dinitrate the ability to concentrate attention and speed of psychomotor reactions decreases. Overdose Symptoms: orthostatic disturbances of regulation and reflex tachycardia. In this regard it is possible to expect approach of headaches, attacks of weakness, dizziness, heartbeat, a hyperthermia, spasms, a dermahemia, nausea, vomiting, increase in intracranial pressure and a condition of catalepsy. Formation of a methemoglobin is possible that the tachypnea, is followed by feeling of alarm, a loss of consciousness, cardiac arrest. Treatment: therapeutic measures should be directed first of all to increase in blood pressure, and, in mild cases it is enough to lay the patient, to raise to it legs. In more serious cases, at a kollaptoidny state, it is necessary to hold events for fight against shock. It is necessary to restore the volume of the circulating blood (infusion of blood substitutes or normal saline solution), in hard cases it is possible to carry out infusion of noradrenaline and/or dopamine. In a methemoglobinemia – vitamin C, intravenous administration of 1% of methylene blue, 1–2 mg/kg or toluidine – blue. Oxygenotherapy. Artificial ventilation of the lungs, a hemodialysis if it is necessary, resuscitation actions, increase in volume of blood plasma, antishock therapy. A form of release and packing On 15 ml of drug in bottles from brown glass. Bottles supply with the mechanical pump of the dosing action with the spray. On each bottle paste the label – self-bonding. Each bottle together with the spray, a protective cap and the instruction for medical use in the state and Russian languages is placed in a pack from cardboard consumer, according to the specification of the producer. To Store storage conditions at a temperature not higher than 30 wasps. To store out of children’s reach! 4 years not to use a period of storage on expiry date. Prescription status According to the prescription Ukraine LLC NPF Mikrokhim Producer, Luhansk Region, Rubezhnoye, Lenin St., 33. Ph./fax: (06453) 7-63-98 Owner of the registration certificate of LLC NPF Mikrokhim Ukraine, Luhansk Region, Rubezhnoye, Lenin St., 33. Ph./fax: (06453) 7-63-98 The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products of Stofarm LLP, 110007, Kostanay, Uralskaya St., 14 Ph./fax 8 (7142) 28-01-80
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