In patients with acute coronary syndrome with ST segment elevation, Zilt is prescribed in a daily dosage of 75 mg with a single initial dose of the drug in combination with acetylsalicylic acid and thrombolytic drugs. For patients older than 75 years, do not use a dose of the drug. The effectiveness of the drug can be reduced in patients with a genetically-determined decrease in the function of the CYP2C19 isoenzyme.
Zilt coated tablets 75 mg In a blister pack of 7 tablets, In a pack of 2 blisters (4 bl., 8 bl., 12 blisters). In a blister pack of 10 tablets, In a pack of 3 blisters.
The combination of the drug with warfarin can lead to an increase in the intensity of bleeding. The risk of bleeding increases with the combination of Zilt with ASA, inhibitors of glycoprotein IIb / IIIa, heparin, NSAIDs. It is not recommended to combine the drug with the inhibitors of the CYP2C19 enzyme (omeprazole). Active clopidorgel metabolites are able to inhibit the activity of CYP2C9, which can lead to increase in plasma concentrations of tolbutamide, phenytoin and NSAIDs.
Zilt is contraindicated in patients with severe liver failure, hypersensitivity, acute bleeding (including intracranial hemorrhage and bleeding from peptic ulcers), children under 18 years of age, pregnant women and lactating women. The use of lactose-containing dosage forms of the drug is contraindicated in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome. Caution should be exercised when prescribing Zilt to patients with chronic renal failure, moderate liver failure, pathological conditions that increase the risk of bleeding (peptic ulcer of the duodenum and stomach in the acute stage, tuberculosis, ulcerative colitis, hyperfibrinolysis, lung tumors, and surgery and trauma), a tendency to bleeding, a hereditary decrease in the function of the CYP2C19 isoenzyme, more patients taking acetylsalicylic acid, NSAIDs (including COX-2 inhibitors), warfarin, inhibit glycoprotein IIb / IIIa tori and heparin.
Since there are no clinical data on the use of clopidogrel during pregnancy, the drug is not recommended for use during pregnancy. Animal studies have not revealed a direct or indirect adverse effect on pregnancy, embryo / fetal development, delivery or postnatal development.
Impaired renal function. After the use of clopidogrel at a dose of 75 mg / day in patients with severe renal impairment (creatinine Cl 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 is similar to that in patients receiving clopidogrel at a dose of 75 mg / day.
Ethnic features. The prevalence of alleles of CYP2C19 isoenzyme genes associated with intermediate or decreased metabolism differs among representatives of various racial / ethnic groups (see Pharmacogenetics). Limited literature data are available to evaluate the importance of genotyping of CYP2C19 isoenzyme for clinical outcomes in patients of the Mongoloid race.
Special information on excipients: Zilt® should not be taken in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome, because contains lactose. Zilt ® contains hydrogenated animal castor, which can cause indigestion and diarrhea in patients.
Excipients: anhydrous lactose - 108.125 mg, microcrystalline cellulose - 30 mg, pregelatinized starch - 12 mg, macrogol 6000 - 8 mg, hydrogenated castor oil - 4 mg.
The tablets, film-coated pink, are round, slightly biconvex; cross-sectional view - white or almost white rough mass with a pink film sheath.
The standard dose of Zyllt is one 75 mg tablet once a day, taken with or without food. In acute coronary syndrome, Zyllt is used together with a loading dose of four 75 mg tablets. This is followed by the standard 75 mg once-a-day dose for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
If you need more information about your medical condition or your treatment, read the leaflet package (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Zyllt is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). Zyllt can be given to the following groups of patients:
After oral administration at a dose of 75 mg, clopidogrel is rapidly absorbed from the digestive tract. However, the concentration in blood plasma varies slightly after this test (0.025 μg / L).
From the hemopoietic system: infrequently - thrombocytopenia, leukopenia, eosinophilia; rarely neutropenia, including severe neutropenia; very rarely - thrombotic thrombocytopenic purpura, aplastic anemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anemia.
Intensively metabolized in the liver. The main metabolite is an inactive derivative of carboxylic acid and makes up about 85% of the starting material circulating in the plasma. C max of this metabolite in plasma after repeated doses of clopidogrel is about 3 mg / l and is observed approximately 1 hour after administration.
After ingestion of 14 C-labeled clopidogrel, about 50% of the dose is excreted in the urine and approximately 46% with feces for 120 hours. T 1/2 of the main metabolite is 8 hours.
The drug is used with caution in patients with impaired renal function; with trauma, surgery and conditions that increase the risk of bleeding; with gastrointestinal, intraocular and other diseases predisposed to the development of bleeding; while taking COX-2 inhibitors and other non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin or glycoprotein IIb / IIIa inhibitors; with low activity of the CYP2C19 isoenzyme (due to an increased risk of cardiovascular complications); with hypersensitivity to prazogrel, ticlopidine and other thienopyridines.
The drug is contraindicated in children and adolescents under 18 years of age, and has been established.
It is not known whether clopidogrel with breast milk is excreted in humans. If necessary, use during lactation should decide on the termination of breastfeeding.
The composition of the film coat: hypromellose 6cp - 5.6 mg, titanium dioxide (E171) - 1.46 mg, talc - 0.5 mg, dye iron oxide red (E172) - 0.04 mg, propylene glycol - 0.4 mg.
Prevention of thrombotic complications in patients with myocardial infarction, ischemic stroke, or peripheral artery occlusion. In combination with acetylsalicylic acid for the prevention of thrombotic complications in acute coronary syndrome: with ST segment elevation with the possibility of thrombolytic therapy; without ST elevation segment (unstable angina, myocardial infarction without Q wave), including in patients undergoing stenting.
The use of the drug is associated with a risk of bleeding and undesirable hematologic phenomena, therefore, should be accompanied by clinical monitoring for signs of bleeding, especially at the beginning of clopidogrel, or after surgical procedures or invasive cardiac procedures. In the case of clinical signs of possible bleeding, the patient should conduct a blood test and determine the number of indicators of platelet function, activated partial thromboplastin time (APTT).
Clopidogrel hydrogen sulphate (a derivative of Clopidogrel) is reported as an ingredient of Zyllt in the following countries:
Bosnia & Herzegowina Croatia Czech Republic Estonia Latvia Lithuania Macedonia Netherlands Romania Russian Federation Serbia Slovakia Spain Sweden.
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