Zylt coated pills 75mg N84
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Active ingredients
Clopidogrel
Release form
Pills
Composition
Clopidogrel (in the form of hydrogensulfate) 75 mg. Excipients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, macrogol 6000, hydrogenated castor oil, hypromellose, titanium dioxide (E171), iron dye red oxide (E172), talc, propylene glycol.
Indications
Prevention of atherothrombotic complications in adult patients with myocardial infarction (from several days to 35 days old), ischemic stroke (from 7 days to 6 months old) or diagnosed occlusive peripheral arterial disease. Prevention of atherothrombotic complications in adult patients with acute coronary syndrome: st segment (unstable angina or myocardial infarction without a q-wave), including patients who underwent stenting for percutaneous coronary intervention, in combination with acetya with salicylic acid. With the rise of the st segment (acute myocardial infarction) with drug treatment and the possibility of thrombolytic therapy, in combination with acetylsalicylic acid. Prevention of atherothrombotic and thromboembolic complications, including stroke, with atrial fibrillation (atrial fibrillation) Adult patients with atrial fibrillation (atrial fibrillation), who have at least one risk factor for the development of vascular complications, cannot take indirect anticoagulants and have a low risk of bleeding (in combination with acetylsalicylic acid).
Contraindications
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome. Pregnancy. Breastfeeding period. Children under 18 years old (safety and efficacy not established). With caution: moderate abnormal liver function with a predisposition to bleeding (limited experience of use). Impaired renal function (limited experience). Pathological conditions that increase the risk of bleeding (including trauma, surgery) (see "special instructions"). Diseases in which there is a predisposition to the development of bleeding (especially gastrointestinal and intraocular). Simultaneous use with npvs, including cog-2 inhibitors.The simultaneous use of warfarin, heparin or glycoprotein inhibitors iib / iiia. Patients with a low cyp2c19 isoenzyme activity (when using clopidogrel in recommended doses less active clopidogrel metabolite is formed and its antiaggregant effect is less pronounced. Therefore, when using clopidogrel in recommended doses in acute coronary syndrome or in the case of acute coronary arteries, the heart of a cardiometric system does not have an active hearth. than in patients with normal cyo2c19 isoenzyme activity). Hypersensitivity to other thienopyridines (for example, ticlopidine, prasugrel) (see “special instructions”).
Dosage and administration
Inside, regardless of the meal, 1 time per day. Adults and elderly patients with normal activity of the isoenzyme CYP2C19 Myocardial infarction, ischemic stroke, or diagnosed occlusive peripheral artery disease. The drug Zilt is taken in a dose of 75 mg (1 tab.) 1 time per day. Acute coronary syndrome without ST segment elevation (unstable stenocardia or myocardial infarction without Q wave). Treatment with Zilt should be started with a single dose of a loading dose (300 mg), and then continued with a dose of 75 mg once a day (in combination with acetylsalicylic acid in doses of 75–325 mg / day). Since the use of higher doses of acetylsalicylic acid is associated with a greater risk of bleeding, the recommended dose of acetylsalicylic acid should not exceed 100 mg. The maximum beneficial effect is observed by the 3rd month of treatment. The optimal duration of treatment for this indication is not officially defined. The results of clinical studies confirm the feasibility of receiving clopidogrel up to 12 months after the development of acute coronary syndrome without ST-segment elevation. Acute coronary syndrome with ST segment elevation (acute myocardial infarction) with drug treatment and the possibility of thrombolytic therapy, in combination with acetylsalicylic acid. The drug Zilt should be taken in a dose of 75 mg (1 tab.) 1 time per day, starting with a loading dose, in combination with acetylsalicylic acid with or without thrombolytic agents. For patients older than 75 years, Zylt treatment should be carried out without the use of a loading dose.Combination therapy begins as soon as possible after the onset of symptoms and continues for at least 4 weeks. The effectiveness of combination therapy with clopidogrel and acetylsalicylic acid with a duration of more than 4 weeks in these patients has not been studied. Atrial fibrillation (atrial fibrillation). The drug Zilt prescribed in a dose of 75 mg 1 time per day. In combination with clopidogrel, therapy should begin and then continue with acetylsalicylic acid at a dose of 75-100 mg / day. Skipping the next dose If less than 12 hours have passed after skipping the next dose, you should immediately take the missed dose of Zilt, and then take the next dose at the usual time. If more than 12 hours have passed after skipping the next dose, then you should take the next dose at the usual time; you should not double the dose. Adults and elderly patients with genetically determined reduced activity of the isoenzyme CYP2C19 Low activity of the isoenzyme CYP2C19 is associated with a decrease in the antiplatelet effect of clopidogrel. The use of Zilt in higher doses (loading dose of 600 mg, then 150 mg 1 time per day) in patients with low activity of the CYP2C19 isoenzyme leads to increased antiplatelet effect of clopidogrel (see "Pharmacokinetics"). However, in clinical studies on the clinical outcomes, the optimal dosage regimen for clopidogrel in patients with reduced metabolism due to the genetically determined low activity of the CYP2C19 isoenzyme has not been established. Special groups of patients Patients of advanced age. Elderly volunteers (over 75 years of age), when compared with young volunteers, showed no differences in platelet aggregation and bleeding time. Dose adjustment in elderly patients is not required. Impaired renal function. After repeated use of clopidogrel in a dose of 75 mg / day in patients with severe renal dysfunction (Cl creatinine 5–15 ml / min), the degree of inhibition of ADP-induced platelet aggregation is 25% lower than in healthy volunteers. However, the degree of prolongation of bleeding time was similar to that in healthy volunteers who received clopidogrel at a dose of 75 mg / day. The tolerability of the drug in all patients was good. Liver dysfunction.After applying clopidogrel in a dose of 75 mg / day for 10 days in patients with severely impaired liver function, the degree of inhibition of ADP-induced platelet aggregation and the average rate of bleeding time were comparable to those in healthy volunteers. Ethnic features. The prevalence of alleles of CYP2C19 isoenzyme genes associated with intermediate or reduced metabolism differs in members of different racial / ethnic groups (see Pharmacogenetics). There are limited literature data to evaluate the significance of the effect of genotyping of the CYP2C19 isoenzyme on clinical outcomes for patients of the Mongoloid race. Gender effects. When comparing the pharmacodynamic properties of clopidogrel in men and women, women showed less inhibition of ADP-induced platelet aggregation, but there were no differences in the lengthening of bleeding time. When comparing clopidogrel with acetylsalicylic acid in patients at risk of developing ischemic complications, the frequency of clinical outcomes, other side effects and abnormalities of clinical and laboratory parameters was the same in both men and women.
Side effects
The safety of clopidogrel was investigated in patients who received clopidogrel therapy for 1 year or more. The safety of clopidogrel in a dose of 75 mg / day was comparable to that when using acetylsalicylic acid in a dose of 325 mg / day, regardless of age, gender, and race. The following are unwanted reactions observed in clinical trials. In addition, spontaneous reports of undesirable reactions are indicated. In clinical studies and post-marketing follow-up, clopidogrel most frequently reported the development of bleeding, mainly during the 1st month of therapy. The classification of the incidence of side effects (WHO): very often ≥1 / 10. often from ≥1 / 100 to less than 1/10. infrequently - from ≥1 / 1000 to less than 1/100. rarely from ≥1 / 10000 to less than 1/1000. very rarely - less than 1/10000. frequency unknown - cannot be assessed based on available data. From the side of blood and lymphatic system, rarely - thrombocytopenia, leukopenia, eosinophilia. rarely, neutropenia, including cases of severe neutropenia. very rarely, thrombotic thrombocytopenic purpura (see"Special instructions"), aplastic anemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anemia. On the immune system: very rarely - serum sickness, anaphylactoid reactions. the frequency is unknown - cross-reactive hypersensitivity to thienopyridine (for example, ticlopidine, prasugrel). Mental disorders, very rarely - confusion, hallucinations. From the nervous system, infrequently - intracranial hemorrhage (several cases were fatal), headache, dizziness and paresthesia. very rarely - a violation of taste perception. On the part of the organ of vision, rarely - hemorrhage into the eyeball (conjunctiva, tissue and retina of the eye). On the side of the organ of hearing and labyrinth disorders, rarely - vertigo. On the side of blood vessels, often - hematoma. very rarely - serious bleeding from the surgical wound, vasculitis, a decrease in blood pressure. Of the respiratory system, organs of the chest and mediastinum, often - nosebleeds. very rarely - bleeding from the respiratory tract (hemoptysis, pulmonary hemorrhage), bronchospasm, interstitial pneumonitis. On the side of the gastrointestinal tract often - gastrointestinal bleeding, diarrhea, abdominal pain, dyspepsia. infrequently - gastric and duodenal ulcer, gastritis, vomiting, nausea, constipation, bloating. rarely retroperitoneal hemorrhage. very rarely - gastrointestinal and retroperitoneal hemorrhage with a fatal outcome, pancreatitis, colitis (including ulcerative colitis or lymphocytic colitis), stomatitis. From the side of the liver and biliary ducts, very rarely - hepatitis, acute liver failure, deviation from the norm of indicators functions of the liver. On the side of the skin and subcutaneous tissues are often subcutaneous bruises. infrequently - skin rash, pruritus, purpura (subcutaneous hemorrhages). very rarely, bullous dermatitis (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme), angioedema, erythematous rash, urticaria, eczema and lichen planus. frequency is unknown - drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS syndrome). On the part of the musculoskeletal and connective tissue is very rare - hemorrhages in muscles and joints (hemarthrosis), arthralgia, arthritis, myalgia. On the part of kidney and urinary tract infrequently - hematuria. very rarely - glomerulonephritis, an increase in the concentration of creatinine in the serum. General disorders and disorders at the injection site are often - bleeding from the puncture site.very rarely - fever. Laboratory and instrumental data often - lengthening the bleeding time, reducing the number of neutrophils, reducing the number of platelets.