The instruction for medical use of medicine Nitrosorbidum the Trade name Nitrosorbidum the International unlicensed name of Isosorbide mononitrate the Dosage form of the Tablet of 10 mg Structure One tablet contains active agent – isosorbide mononitrate diluted 14.3 mg (in terms of 100% substance) (10.0), excipients: lactoses monohydrate, potato starch, talc, calcium stearate. Description of the Tablet of white color of a ploskotsilindrichesky form. On one party of a tablet there is a signature logo in the form of a cross. Pharmacotherapeutic group Drugs for treatment of heart diseases. Vazodilatatora for treatment of heart diseases. Organic nitrates. Isosorbide mononitrate. The ATX C01DA14 code the Pharmacological Pharmacokinetics Nitrosorbidum properties is well absorbed at intake. There is a direct dependence of concentration in blood from a dose of the taken drug. Nitrosorbidum is not exposed to effect of the first passing through a liver in this connection the absolute bioavailability after intake is 100%. At intake it is slowly soaked up from digestive tract, the effect occurs in 20-30 minutes and 3.5-5 hours proceed. At reception of a tablet of Nitrosorbidum under language the effect occurs in 2-5 minutes and lasts for 1-2 hours. After denitration or conjugation in a liver Nitrosorbidum is removed with urine mainly in the form of metabolites. T ½ – 5 h. It is removed by kidneys in the form of glucuronides. The pharmacodynamics Nitrosorbidum belongs to organic nitrates of long action. Nitrosorbidum – vazodilatiruyushchy, vasodilating, anti-anginal means. Causes reduction of need of a myocardium for oxygen due to reduction of preloading (expansion of peripheral veins and reduction of inflow of blood to the right auricle) and afterloads (reduction of OPSS – the general peripheric vascular resistance) and also has direct coronarodilator effect. Promotes redistribution of a coronary blood-groove in the area with reduced blood supply. At use of drug the increase in tolerance to physical activity at patients with an ischemic heart disease (coronary heart disease), stenocardia is noted. In heart failure drug promotes unloading of a myocardium due to reduction of preloading. Reduces pressure in a small circle of blood circulation. Indications – for prevention of attacks of stenocardia the Route of administration and doses it is necessary to take the Drug inside after a meal, without chewing and washing down with enough water two-three times a day (according to the recommendation of the doctor). Duration of administration of drug is established by the doctor. If necessary the course of treatment can repeat. In order to avoid possible sharp falling of arterial blood pressure at reception of a tablet it is necessary to sit down or lay down. Side effects Mark out the following categories of frequency of emergence of side effects: very frequent (≥1/10), frequent (from ≥1/100 to & lt, 1/10), infrequent (from ≥1/1000 to & lt, 1/100), rare (from ≥1/10000 to & lt, 1/1000), very rare (& lt, 1/10000), it is unknown (it is impossible to establish on the basis of the available data). Very often: – the passing headache the Frequency of appearance of a headache at continuous use gradually decreases over time. Often: At the beginning of therapy or at increase in a dose of drug the lowering of arterial pressure and/or orthostatic arterial hypotension is possible. Symptoms can be connected by it with dizziness, drowsiness, reflex tachycardia and weakness. Infrequently: – nausea, vomiting, – inflows – allergic reactions in the form of skin manifestations (rash) – exfoliative dermatitis – collapse, a syncope, bradi / arrhythmia – the considerable lowering of arterial pressure which is followed by short-term sweating or pallor of integuments – considerable hypotension can be followed by strengthening of symptoms of stenocardia Seldom: – heartburn, due to relaxation by Contraindication sphincter nitrates – hypersensitivity to nitro compounds or one of components – a closed-angle form of glaucoma – the diseases connected with the increased intracranial pressure (head injuries, a hemorrhagic stroke) – an acute myocardial infarction or heart failure with the low filling pressure of a left ventricle – the profound arterial hypotension (systolic arterial blood pressure less than 90 mm Hg) – the low pressure of warm fullness – a stenosis of aortal or mitral valves – cardiogenic shock – vascular collapse – a hypertrophic subaortic stenosis – an obstructive pericarditis – a cardiac tamponade – the profound anemia – a hypovolemia – simultaneous use of inhibitors of phosphodiesterase 5 of type (sildenafit, vardenafit, tadalafit) Medicinal interactions At simultaneous use with vazodilatator, tricyclic antidepressants and also alcohol is possible strengthening of hypotensive effect up to orthostatic collapse (its early symptoms – dizziness, weakness, etc.). Barbiturates accelerate biotransformation and reduce concentration of Nitrosorbidum in blood. Therefore it is necessary to follow Regulations of Admission of Nitrosorbidum and with care to combine it with the specified drugs. Against the background of long intake of Nitrosorbidum the reduction of activity of nitroglycerine is possible. The adsorbents knitting and enveloping means reduce absorption from digestive tract. Antihypertensive drugs (beta blockers, antagonists of calcium, other vazodilatator), dihydroergotamine, procaineamide, quinidine, tricyclic antidepressants, neuroleptics, a sildenafila citrate strengthen hypotension, sympathomimetics reduce anti-anginal effect, the combination with atropine increases the probability of increase in intraocular pressure. Special instructions With care apply at patients with recently postponed myocardial infarction. In an initiation of treatment the development of vascular insufficiency, especially at patients with labile circulation is possible. Drug can cause development of orthostatic hypotension, including a syncope. The expressed phenomena of orthostatic hypotension amplify against the background of alcohol intake. The hypotension caused by nitrates can be followed by paradoxical bradycardia and strengthening of an attack of stenocardia. As drug contains sucrose, the drug should not be taken to patients with such rare hereditary diseases as intolerance of fructose, malabsorption of glucose galactose or insufficiency of invertase-isomaltase in case of development of a bad attack of stenocardia it is not necessary to apply mononitrate isosorbite tablets. It is necessary to replace it with nitroglycerine spray. At misuse of drug the development of a symptom of accustoming is possible. It is necessary to use the smallest effective dose of drug. In need of cancellation the dose of drug should be reduced gradually, avoiding sharp cancellation. Nitrosorbidum has to be stored in the dry, cool, protected from light place. As drug is explosive, has to be stored far from fire. Pregnancy Data on clinical use of Nitrosorbidum during pregnancy are absent. Data on Nitrosorbidum discharge at the person or animals with breast milk are absent. It is impossible to exclude risk for the child who is on breastfeeding. The decision on the continuation/termination of breastfeeding or continuation/cancellation of treatment of drug should be accepted taking into account advantage of breastfeeding for the child and the relation advantage/risk of treatment of Nitrosorbidum for women. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms At administration of drug decline in the ability to fast mental and motor reactions in this connection, it is not recommended to run the vehicle is possible and to be engaged in other potentially dangerous types of activity. Overdose Symptoms: A headache, orthostatic hypotension, reflex tachycardia, nausea, vomiting, perspiration, vertigo, inflows of heat, the obscured sight, a syncope. When using drug the increased intracranial pressure with cerebral symptoms can sometimes develop. Very seldom drug can cause a methemoglobinemia (cyanosis, short wind, respiratory insufficiency, spasms, arrhythmias, vascular insufficiency and increase in intracranial pressure. Overdose treatment the General measures taken at overdose include oxygenotherapy and arrangement of the patient in horizontal position with the raised legs. Infusional intravenous therapy is in case of need appointed. Control of indicators of the vital functions has to be exercised in intensive care unit, at least within 12 hours after overdose. Other types of symptomatic treatment are appointed according to indications. It is reasonable to accept activated carbon within one hour after intake of potentially toxic amount of drug. A symptomatic methemoglobinemia it is necessary to treat by intravenous administration methylene blue (1-2 mg/kg). The hemodialysis and hemoperfusion are inefficient. In the heavy methemoglobinemia which is not responding to introduction of methylene blue performing exchange blood transfusion can be required. At development of spasms of cerebral character the administration of diazepam or clonazepam is necessary, at inefficiency of treatment the administration of phenobarbital, Phenytoinum is necessary or to carry out an anesthesia propofoly. A form of release and packing On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil. Blister strip packagings place in boxes of cardboard. On number of packs put instructions for medical use in each box in the state and Russian languages. To Store storage conditions in the dry, protected from light place, at a temperature not higher than 30 wasps. To store out of children’s reach! 3 years not to use a period of storage after an expiration date. Prescription status According to the prescription JSC Khimfarm Producer, the Republic of Kazakhstan, the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Khimfarm, Republic of Kazakhstan, Shymkent, Rashidov St., 81, Phone number 8 7252 (561342) Fax number 8 7252 (561342)
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