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Arepleks 28’s 75 mg coated tablets




The instruction for medical use of Areplex Torgovoye medicine a name of Areplex the International unlicensed name Klopidogrel Lekarstvennaya the Tablet form, coated, 75 mg Structure One tablet contains active agent: Klopidogrela hydrosulphate (it is equivalent to a klopidogrel to the basis of 75 mg) 97.857 mg excipients: Mannitolum (E421), cellulose microcrystalline from silicon dioxide colloidal anhydrous (type 90 HD), hydroxypropyl cellulose low-substituted (LH-11 type), starch prezhelatinizirovanny, the castor oil hydrogenated structure of a cover of Opadray II pink 31K 24015 (lactoses monohydrate, a gipromelloza (type 2910) (E464), the titan dioxide (E171), triacetin, gland (III) oxide red (E172), gland (III) oxide yellow (E172), gland (III) oxide black (E172). The description of the Tablet of round shape, with a biconvex surface, coated pink color, Pharmacotherapeutic group with a diameter of 9 mm Anticoagulants. Inhibitors of aggregation of thrombocytes. Klopidogrel ATX B01AC04 Code Pharmacological Pharmacokinetics Absorption properties. At single and course intake, in a dose of 75 mg a day, Klopidogrel is quickly soaked up. Average peak concentration not changed klopidogrelya in blood plasma (about 2.2-2.5 ng/ml after intake of a single dose of 75 mg) are reached approximately in 45 minutes after reception. According to excretion of metabolites klopidogrelya with urine its absorption is about 50%. Distribution. Linking with proteins of blood plasma of a klopidogrel and the main metabolite makes 98% and 94% respectively. Metabolism. Klopidogrel is intensively metabolized in a liver. Klopidogrel is metabolized in two ways: the first – through esterases and the subsequent hydrolysis with education inactive derivative carboxyl acid (85% of the circulating metabolites), and the second way – through the system of isoenzymes of P450 cytochrome. Its active metabolite, tiolny derivative, is formed by oxidation of a klopidogrel in 2-oxo-klopidogrel and the subsequent hydrolysis. The oxidizing step is regulated by isoenzymes of CYP2B6 and CYP3A4, to a lesser extent CYP1A1, CYP1A2, CYP2C19. An active tiolny metabolite quickly it is also irreversible contacts receptors of thrombocytes, blocking, thus, their aggregation. Discharge. Within 120 hours of the accepted dose about 50% with urine and about 46% with stool are allocated. After single dose in a dose in 75 mg the elimination half-life of medicine makes about 6 hours. After single dose and reception of repeated doses the elimination half-life of the main inactive metabolite circulating in blood makes 8 hours. The pharmacodynamics Klopidogrel is inhibitor of aggregation of thrombocytes. Klopidogrel is exposed to metabolism by means of CYP2C19 enzymes, the active metabolite which suppresses aggregation of thrombocytes is as a result formed. The active metabolite of a klopidogrel selectively inhibits linking of adenosinediphosphate (ADF) with his platelet receptor of P2Y12 and the subsequent, caused by ADF activation of the glycoprotein GPIIb/IIIa complex, interfering thereby aggregations of thrombocytes. Owing to irreversibility of binding the thrombocytes which were affected are damaged for all remained term of the life (about 7-10 days), and restoration of normal function of thrombocytes is carried out with a speed corresponding to a platelet cycle. The aggregation of thrombocytes caused by agonists other than ADF is suppressed by blocking of strengthening of the activation of thrombocytes which is carried out under the influence of the released ADF too. As the active metabolite is formed by means of CYP450 enzymes some of which are polymorphic or are suppressed with other medicinal connections, not at all patients the extent of oppression of thrombocytes is sufficient. At daily reception klopidogrelya in a dose of 75 mg from the first day of reception considerable suppression ADF-indutsiruyemoy of aggregation of thrombocytes which gradually increases within 3-7 days is noted and then reaches constant level (at achievement of an equilibrium state). In an equilibrium state the aggregation of thrombocytes is suppressed on average for 40-60%. After the reception termination klopidogrelya aggregation of thrombocytes and a bleeding time gradually return to initial level, on average, within 5 days. Indications Klopidogrel apply as prophylactic of aterotrombotichesky disturbances at patients: after the postponed myocardial infarction (from several days to less than 35 days), an ischemic stroke (from 7 days to not less than 6 months) or the diagnosed disease of peripheral arteries, at a sharp coronary syndrome without raising of a segment of ST (unstable stenocardia or a myocardial infarction without pathological tooth Q), including patients to whom stenting at percutaneous coronary intervention, in combination with acetylsalicylic acid was carried out, in an acute myocardial infarction with raising of a segment of ST, in combination with acetylsalicylic acid, at conservative treatment and a possibility of performing thrombolytic therapy. Route of administration and doses to Adults and patients of advanced age: klopidogret appoint in a dose 75 mg of 1 times a day irrespective of meal. To patients with a sharp coronary syndrome without raising of a segment of ST (unstable stenocardia or a myocardial infarction without tooth Q): treatment klopidogrely there begin with a single load dose 300 mg, and then continue by a dose 75 mg/days in combination with acetylsalicylic acid in a dose of 75-325 mg/days. As higher doses of ASK were accompanied by the increased risk of bleeding, it is recommended that the dose of ASK did not exceed 100 mg. An acute myocardial infarction with raising of a segment of ST: treatment klopidogrely there begin with a single load dose 300 mg, and then continue by a dose 75 mg/days in a combination with acetylsalicylic acid and trombolitikam (or without trombolitik). For patients it has to is more senior 75 years treatment klopidogrely to be carried out without use of a load dose. Combination therapy is begun as soon as possible after emergence of symptoms and continued during, at least 4 weeks. The positive effect of simultaneous use klopidogrelya and acetylsalicylic acid lasting treatment more than 4 weeks according to this scheme of treatment is not studied. A renal failure Experience of treatment of patients with disturbance of renal function is limited (see. Special instructions). Side effects their frequency is defined as follows: often (≥1/100 to & lt, 1/10), infrequently (≥1/1000 to & lt, 1/100), it is rare (≥1/10,000 to & lt, 1/1000), is very rare (& lt, 1/10,000). Within each group of systems and bodies the frequency of side effects is provided in decreasing order of weight. often (≥1/100 to & lt, 1/10) hematomas nasal bleeding gastrointestinal bleeding, diarrhea, abdominal pains, dyspepsia bleeding in the place of a puncture infrequently (≥1/1000 to & lt, 1/100) thrombocytopenia, a leukopenia, an eosinophilia intracranial bleeding (it is reported about several cases with a lethal outcome), a headache, paresthesia, dizziness eye hemorrhage (conjunctival, in fabrics and a retina of an eye) disturbances from an organ of hearing and labyrinth disturbances a peptic ulcer of a stomach and duodenum, gastritis, vomiting, nausea, a constipation, a meteorism rash, an itching, hemorrhage in skin (purple) a hamaturia lengthening of a bleeding time, decrease in number of neutrophils, decrease in number of thrombocytes is rare (≥1/10,000 to & lt, 1/1000) a neutropenia, including a heavy neutropenia vertigo, the retroperitoneal bleeding connected with a disease of a labyrinth of an inner ear is very rare (& lt, 1/10,000) a Werlhof’s trombogemolitichesky disease, aplastic anemia, a pancytopenia, an agranulocytosis, heavy thrombocytopenia, a granulocytopenia, anemia a serum disease, anaphylactoid reactions of a hallucination, confusion of consciousness change of flavoring feelings heavy bleeding, bleeding from an operational wound, a vasculitis, hypotension bleeding from respiratory organs (pneumorrhagia, pulmonary bleeding), a bronchospasm, interstitial pneumonia bleeding from digestive tract, retroperitoneal bleeding with a lethal outcome, pancreatitis, colitis (including ulcer or lymphocytic), stomatitis an acute liver failure, hepatitis, deviations in indicators of laboratory tests of function of a liver bullous dermatitis (a toxic epidermal necrolysis, a syndrome Stephens-Johnson, a mnogoformny erythema), an angioedema, erythematic rash, a small tortoiseshell, eczema and flat deprive skeletal and muscular bleeding (a hemarthrosis, arthritis, an arthralgia, myalgia) a glomerulonephritis, increase in level of creatinine in blood Contraindication fever hypersensitivity to active ingredient or other components of drug heavy abnormal liver functions acute bleeding, including a peptic ulcer of a stomach or intracraneal hemorrhage intolerance of a galactose, deficiency of Lappa lactase and a sprue of glucose galactose children’s age up to 18 years pregnancy and the period of a lactation Medicinal interactions: Oral anti-thrombolytic drugs: the concomitant use of oral anti-thrombolytic drugs together with klopidogrely can increase intensity of bleedings therefore use of this combination is not recommended. IIb/IIIa glycoprotein inhibitors: prescribing of inhibitors of a glycoprotein of IIb/IIIa together with klopidogrely demands care from the patients having the increased risk of developing bleeding in injuries, surgical interventions or other morbid conditions. Acetylsalicylic acid: acetylsalicylic acid does not change effect klopidogrelya, inhibiting ADF-indutsiruyemuyu aggregation of thrombocytes, but Klopidogrel exponentiates influence of acetylsalicylic acid on collagen – the induced aggregation of thrombocytes. Nevertheless, intake of acetylsalicylic acid, simultaneous with klopidogrely, on 500 mg two times a day within one day did not cause significant increase in the bleeding time caused by reception klopidogrelya. Between klopidogrely and acetylsalicylic acid perhaps pharmakodinamichesky interaction which leads to increase in risk of bleeding. Therefore at their simultaneous use it is necessary to be careful though patients received combination therapy klopidogrely and acetylsalicylic acid up to one year. Heparin: according to the clinical trial which is carried out with participation of healthy faces at reception klopidogrelya change of a dose of heparin was not required and its anticoagulating action did not change. Simultaneous use of heparin did not change antiagregantny effect klopidogrelya. Between klopidogrely and heparin perhaps pharmakodinamichesky interaction which can increase risk of developing bleedings therefore simultaneous use of these drugs demands care. Trombolitiki: safety of simultaneous use klopidogrelya, fibrinspetsifichesky or fibrinnespetsifichesky thrombolytic drugs and heparin was investigated at patients with an acute myocardial infarction. Frequency of clinically significant bleedings was similar to that which was observed in case of combined use of thrombolytic means and heparin with acetylsalicylic acid. Non-steroidal anti-inflammatory drugs (NPVP): due to the lack of researches on interaction klopidogrelya with other NPVP, it is unknown now whether there is an increased risk of gastrointestinal bleedings at reception klopidogrelya together with other NPVP. Therefore purpose of NPVP, including TsOG-2 inhibitors, in combination with klopidogrely it is necessary to carry out with care. Other combination therapy: as Klopidogrel is metabolized before formation of the active metabolite partially by means of CYP2C19 system, simultaneous use of the drugs inhibiting this system can lead to decrease in level of an active metabolite klopidogrelya and to reduction of its clinical performance. The concomitant use of the drugs inhibiting CYP2C19 system is not recommended. Inhibitors of a proton pomp: despite existence of various data demonstrating that drugs from group of inhibitors of a proton pomp can inhibit activity of CYP2C19 cytochrome the data of researches indicate a possibility of interaction klopidogrelya and practically all drugs of this group. Therefore it is necessary to avoid co-administration klopidogrelya with inhibitors of a proton pomp, except for emergency cases. The data indicating influence of other drugs suppressing products of gastric juice, for example, of blockers of H2 receptors or antiacid drugs on antithrombocytic action klopidogrelya are not revealed. At use klopidogrelya together with atenolol, nifedipine or with both drugs of at the same time clinically significant pharmakodinamichesky interaction it was not observed. Besides, simultaneous use of phenobarbital, Cimetidinum and estrogen had no significant effect on a pharmacodynamics klopidogrelya. Pharmacokinetic indicators of digoxin and theophylline did not change at their combined use with klopidogrely. Antiacid drugs did not reduce absorption klopidogrelya. The carboxyl metabolite klopidogrelya can inhibit activity of P4502C9 cytochrome that can lead to increase in plasma concentration of some medicines, for example, of Phenytoinum, tolbutamide and some NPVP which are metabolized by means of P4502C9 cytochrome. Phenytoinum and tolbutamide which are metabolized by means of CYP2C9 can be applied with safety along with klopidogrely. Special instructions Because of risk of bleeding and hematologic undesirable reactions during treatment at emergence of the clinical symptoms indicating bleeding it is necessary to make at once the general blood test and/or to carry out other corresponding analyses. As well as at treatment by other thrombolytic drugs, it is necessary to be careful at use klopidogrelya at the patients subject to the increased risk of bleeding connected with an injury, surgical interventions or other morbid conditions and also at the patients accepting acetylsalicylic acid, heparin, IIb/IIIa glycoprotein inhibitors and also non-steroidal anti-inflammatory drugs, including TsOG-2 inhibitors (cyclooxygenases-2). It is necessary to conduct careful observation of patients regarding an exception of symptoms of bleeding, including hidden, especially within the first weeks of treatment and (or) after the invasive cardiological procedures or other surgical interventions. Simultaneous use klopidogrelya and oral anticoagulants is not recommended as it can lead to increase in intensity of bleeding. At planned surgical interventions at which the antithrombocytic effect is undesirable the course of treatment klopidogrely should be stopped in 7 days prior to surgical intervention. Patients have to report to the doctor (including the dentist) about reception klopidogrelya before any forthcoming operation and before intake of any new medicine. Klopidogrel increases a bleeding time and has to be applied with care at patients with the diseases contributing to development of bleedings (especially, gastrointestinal and intraocular). Patients have to be warned that at reception klopidogrelya (including in a combination with acetylsalicylic acid) for a stop of bleeding more time can be required and also that in case of emergence at them unusual (on localization or duration) bleedings they should report about it to the attending physician. The doctor has to warn the patient about need to report to the doctor (including the dentist) about reception klopidogrelya before any forthcoming operation and before intake of any new medicine. Very seldom, including at short reception klopidogrelya, cases of development of the Werlhof’s trombogemolitichesky disease (WTD) which is characterized by the thrombocytopenia and mikroangiopatichesky hemolytic anemia which are followed by neurologic disorders or a renal failure or fever were noted. The TPP is potentially zhizneugrozhayushchy state demanding immediate treatment including a plasma exchange. P
iy klopidogrelya it is not recommended in an acute ischemic stroke with prescription less than 7 days as there are no data on its use at this state. As Klopidogrel is metabolized before formation of the active metabolite partially by means of CYP2C19 system, use of the drugs inhibiting this system can lead to decrease in level of an active metabolite klopidogrelya and to reduction of its clinical performance. The concomitant use of the drugs inhibiting CYP2C19 system is not recommended. Therapeutic experience of use of drug for patients with a renal failure is limited therefore it is necessary to apply with care Klopidogrel at such patients. Therapeutic experience of use of drug for patients with moderate abnormal liver functions which can provoke bleedings is limited therefore it is necessary to apply with care Klopidogrel in this population. The product contains the hydrogenated castor oil which can cause dyspepsia and diarrhea. Pregnancy and period of a lactation. As a precautionary measure the reception klopidogrelya is not recommended during pregnancy due to the lack of clinical data on its reception by pregnant women. Whether gets into breast milk of the person – it is unknown. As a precautionary measure the feeding by a breast in case of treatment by Areplex medicine should be stopped. Features of influence on ability to run the vehicle or potentially dangerous mechanisms At reception appearance of dizziness and headache is possible that needs to be considered during the driving or work with potentially dangerous mechanisms. Overdose Symptoms. The overdose klopidogrelya can lead to increase in a bleeding time with the subsequent complications in the form of development of bleedings. Treatment. At appearance of bleeding performing the corresponding treatment is required. Antidote klopidogrelya is not established. If fast correction of the extended bleeding time is necessary, then carrying out transfusion of platelet concentrate is recommended. A form of release and packing On 14 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1 or 2 blister strip packagings, together with the instruction for medical use in the state and Russian languages, put in a pack from cardboard Storage conditions to Store at a temperature not above 25 °C. To store out of children’s reach! 2 years not to use a period of storage after an expiration date. Prescription status According to the prescription. Pharmaceutical Works Polfa in Pabianice Joint Stock Company producer, 5, marsz. J. Piłsudskiego Str., 95-200 Pabianice, Poland the Owner of the registration certificate of Pharmaceutical Works Adamed Pharma Joint Stock Company, 33, Szkolna Str., 95-054 Ksawerów, Poland the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Pabianice Pharmaceutical Plant Polfa in PK 059000, Almaty, the street of Abay, house 109B, business center Globus, floor 13, office 13-2
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