Improve Cerebral Circulation / Neurology and Psychiatry

Nemotan 30s 30 mg film-coated tablets

Brands: Medochemie (Cyprus)

$28.60

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Nemotan 30s 30 mg film-coated tablets quantity

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Brands:: Medochemie (Cyprus)

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The instruction for medical use of Nemotan Torgovoye medicine a name Nemotan Mezhdunarodnoye unlicensed name Nimodipin the Dosage form of the Tablet, film coated, 30 mg One tablet contains Structure: active agent – nimodipin 30 mg excipients: K25 povidone, cellulose microcrystalline (type 101), starch corn, krospovidon, magnesium stearate structure of a cover (Opadri white OU-V-28920): polyvinyl alcohol, the titan E 171 dioxide, talc, lecithin (soy), gum xanthane the Description of the Tablet, film coated white color, round shape, with a biconvex surface, with a diameter about 10.3 mm. Pharmacotherapeutic group Blockers of slow calcium channels. Blockers of slow calcium channels selection. Dihydropyridinic derivatives. Nimodipin. The ATX C08CA06 code the Pharmacological Pharmacokinetics At properties oral administration nimodipin is almost completely soaked up in a GIT. Increase in the maximum concentration in blood plasma and the area under a curve concentration – time has dose-dependent character (90 mg). Absolute bioavailability — 5–15% that is explained by intensive metabolism of a nimodipin at primary passing through a liver (85–95%). The rate of linking with proteins of blood plasma is 97–99%. The maximum concentration of drug in blood plasma is observed in 30-60 min. after intake. Elimination half-life of a nimodipin makes 1.1-1.7 h. The period of final removal — 5–10 h. It is metabolized in a liver by dehydrogenation of a dihydropyridinic ring and oxidizing splitting of ethers. Three main metabolites which are defined in blood plasma have no clinically significant activity. There are no data on influence of a nimodipin on activity of liver enzymes. Nimodipin is brought in the form of metabolites: with urine — 50%, with bile — 30%. A pharmacodynamics Nimodipin – a selection blocker of calcium channels, derivative dihydropyridine. Has vazodilatiruyushchy, neuroprotective, anti-aggregation effect. Specifically contacts the receptors located on cellular membranes regulating function of calcium channels of L-type. Brakes slow current of calcium ions in a depolarization phase, reduces calcium content in cells, relaxes unstriated muscles of resistive vessels (arteries and arterioles) and expands them. It is not coiled mainly influences brain vessels, normalizes brain blood supply, increases tolerance of neurons to ischemia. Has neuroprotective effect, stabilizes functions of neurons. Prevents or eliminates the spasm of blood vessels provoked by various vasoactive substances (including serotonin, to prostaglandins and a histamine), blood or decomposition products. Indications – prevention of ischemic neurologic disturbances after aneurysm of subarachnoidal hemorrhage. The route of administration and doses of the Tablet should be swallowed entirely, washing down with enough liquid, irrespective of meal. Intervals between receptions have to make not less than 4 h. It is necessary to avoid intake of grapefruit juice. Aneurysmal subarachnoidal bleeding: Preventive use for adults the Recommended dose – two tablets with 4-hour intervals (the general daily dose – 360 mg) with water. Preventive use has to begin within 4 days after the beginning of subarachnoidal bleeding and proceed within 21 days. In case of surgical intervention, Nemotan’s use should not stop (according to the above-stated mode of dosing) to finish a 21-day course of treatment. For patients at whom side reactions develop the dose has to be reduced as required or treatment has to be stopped. Traumatic subarachnoidal bleeding is not recommended as the advantage ratio to risk of use is not established. Special groups of the population Patients with a liver failure Seriously broken function of a liver, especially cirrhosis, can result in the increased bioavailability of a nimodipin because of decrease in the eefekt of the first passing and decrease in metabolic clearance. For example, lowering of blood pressure, this group of patients can have more expressed therapeutic effects and side effects. In such cases the dose should be reduced (depending on blood pressure) or to consider a question of the treatment termination. At combined use with inhibitors or inductors CYP 3A4 the dose adjustment can be required. Elderly patients For elderly people the dose adjustment is not required. The pediatric population Safety and efficiency of a nimodipin at patients of children’s and teenage age up to 18 years were not established. Side effects At use in subarachnoidal hemorrhage owing to a rupture of aneurysm Infrequently (& gt, 1/1000 and & lt, 1/100) – thrombocytopenia – allergic reactions, rash – a headache – tachycardia – arterial hypotension and a vazodilatation – nausea Seldom (& gt, 1/10000 and & lt, 1/1000) – bradycardia – Ilheus – tranzitorny increase in level of liver enzymes – reactions on the place of an injection and infusion, thrombophlebitis on the place of infusion At the significant dysfunctions of a brain at patients of advanced age the Frequency of the side reactions listed in the section is frequent, made less than 2%. Often (& gt, 1/100 and & lt, 1/10) – arterial hypotension and a vazodilatation Infrequently (& gt, 1/1000 and & lt, 1/100) – allergic reactions, rash – a headache, dizziness – hyperkinesias, a tremor – heartbeat, tachycardia – a faint, hypostases – a constipation, diarrhea, the Contraindication flatulention – the hypersensitivity to a nimodipin or to any of auxiliary components of a tablet, – is not appointed in time or within one month after a myocardial infarction or a case of unstable stenocardia, – use of a nimodipin in a combination with rifampicin or antiepileptic drugs – phenobarbital, Phenytoinum or carbamazepine – is contraindicated as Niemotang’s efficiency can be considerably reduced at the accompanying use. It is not necessary to appoint medicinal interactions of the Tablet Niemotang along with other dosage forms of a nimodipin. The drugs influencing on nimodipin Nimodipin it is metabolized through the system of P450 3A4 cytochrome located both in a mucous membrane of intestines, and in a liver. Therefore drugs which, as we know, inhibit or induce this fermental system, can affect effect of the first passing or clearance of a nimodipin. When assigning a nimodipin together with the following drugs it is necessary to consider degree and duration of interaction: Contraindicated accompanying use of oral forms of a nimodipin and the rifampicin or antiepileptic drugs inducing the system of P450 3A4 cytochrome, such as phenobarbital, Phenytoinum or carbamazepine. At the accompanying use of these drugs Niemotang’s efficiency can be reduced. At joint introduction of a nimodipin with the following inhibitors of a system of P450 3A4 cytochrome it is necessary to control arterial blood pressure and, if necessary, to consider the possibility of correction of a dose of a nimodipin: – makrolidny antibiotics (for example, erythromycin), – HIV protease inhibitors (for example, ritonavir), – azolny antifungal means (for example, ketokonazol), – nefazodon Though official researches for a research of potential interactions between nimodipiny and these drugs were not conducted, it is impossible to exclude a possibility of interaction of drugs and increase in concentration of a nimodipin in plasma. Azithromycin though it is structurally connected with a class of makrolidny antibiotics, does not inhibit CYP3A4. Simultaneous use of a nimodipin with anticonvulsant valproic acid or H2 antagonist Cimetidinum can lead to increase in concentration of a nimodipin in plasma. On the basis of experience of use of the antagonist of calcium of nifedipine, joint introduction of a hinupristina/dalfopristin can lead to increase in concentration of a nimodipin in plasma. Other types of interactions the Medicines reducing arterial blood pressure. Nimodipin can increase hypotensive effect of the accompanying antihypertensives, such as: – diuretics, – beta-blockers, – APF inhibitors, – antagonists of a receptor of A1, – other blockers of calcium channels, – antagonists of alpha adrenoceptors, – inhibitors of phosphodiesterase of the 5th type, – alpha Methyldopum. However if the combination of this kind is inevitable, careful monitoring of the patient is necessary. Consumption of grapefruit juice in combination with nimodipiny is not recommended as it can lead to increase in concentration of a nimodipin in plasma because of inhibition of oxidizing metabolism of dihydropyridines. As a result, the hypotensive effect can be increased. Such effect can proceed not less than 4 days after the last intake of grapefruit juice. Without interaction At the accompanying use of an oral nimodipin and diazepam, digoxin, glibenclamide, indometacin, ranitidine and warfarin any opportunities for medicinal interaction are not revealed. Special instructions Niemotang should not be accepted patients with traumatic subarachnoidal hemorrhage due to the lack of information on a ratio of risks and experience of use in separate groups of patients. Nimodipin it is necessary to use with care at serious increase in intracranial pressure or hypostasis of a brain. Treatment nimodipiny is not shown because of risk of increase in intracranial pressure, careful control in such cases or when water content in tissues of a brain increases (generalized wet brain) is recommended. To take with caution the patient with hypotonia (systolic arterial blood pressure is lower than 100 mm Hg.). Reduction in the rate of removal of drug can happen at the patients with cirrhosis receiving Niemotang therefore it is recommended to carry out careful monitoring of arterial blood pressure. The general duration of therapy nimodipiny should not exceed seven (7) days. It is not necessary to appoint the tablets Niemotang along with other forms of a nimodipin. Drugs which, as we know, either inhibit or stimulate the fermental system of P450 3A4 cytochrome can change presistemny metabolism or clearance of a nimodipin as it is metabolized through this system. The drugs known as inhibitors of a system of P450 3A4 cytochrome, can lead to increase in concentration of a nimodipin in plasma and HIV-protease inhibitor (for example ritonavir), azolovy antifungal means (for example ketokonazol), antidepressants nefazodon and fluoxetine, Cimetidinum and valproic acid are makrolidny antibiotics (for example, erythromycin). At combined use with these drugs, it is necessary to control blood pressure and if necessary, to lower a dose of a nimodipin. Use in pediatrics For children and teenagers up to 18 years is not applied due to the lack of clinical experience. Pregnancy and the period of a lactation Adequate and well controlled researches with participation of pregnant women were not conducted. It is not coiled it is necessary to use carefully at pregnancy only if treatment is considered necessary, and also after thorough examination of expected advantage for mother and potential risk for a fruit. Nimodipin and his metabolites, can get into breast milk in the concentration similar to concentration in mother’s plasma. It is recommended to stop feeding by a breast during therapy nimodipiny. Fertility In isolated cases at in vitro fertilization the antagonists of calcium were connected with reversible biochemical changes in a spermatozoon head that can lead to dysfunction of spermatozoa. Falling of arterial blood pressure can cause features of influence of drug on ability to run the vehicle or potentially dangerous Niemotang mechanisms that results in weakness or to dizziness, patients have to be warned about possible risk when driving or in operating time with the equipment until they are not sure that drug does not cause similar reactions. Overdose Symptoms: considerable lowering of arterial pressure, tachycardia and bradycardia and also gastrointestinal disturbances, including nausea. Treatment: Niemotang’s use has to be immediately stopped. Emergency measures depend on symptoms. First aid includes gastric lavage and intake of activated carbon. If the noticeable lowering of arterial pressure is noted, it is necessary to enter intravenously dopamine or noradrenaline. Due to the lack of specific antidote, the subsequent treatment has to be symptomatic. The patient has to be under careful clinical observation. Because of high linking with proteins of a nimodipin dialysis is not effective. The form of release and packing On 10 tablets place in blister strip packaging from a film of polyvinylchloride/polyvinyldichloride and aluminum foil. On 3 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. Storage conditions In the dry, protected from light place, at a temperature not above 25 °C. To store out of children’s reach! A period of storage 3 years After an expiration date not to use drug. Prescription status According to the prescription Medokemi Ltd Producer, Limassol, Cyprus of 2 Michael Erakleous Street, Agios Athanassios Industrial Area, Limassol, 4101, Cyprus the Holder of the registration certificate and the packer of Medokemi Ltd, Limassol, Cyprus the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine Representative office of Medokemi Ltd in the Republic Kazakstan 050010 Almaty, Kazybek bi 41 And
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