Zylt tablets 75mg, no. 84

prevention of atherothrombotic complications in adult patients with myocardial infarction (from several days to 35 days), ischemic stroke (from 7 days to 6 months), or diagnosed occlusive peripheral arterial disease;

prevention of atherothrombotic complications in adult patients with acute coronary syndrome:

- without ST segment elevation (unstable angina pectoris or myocardial infarction without Q wave), including patients who underwent stenting during percutaneous coronary intervention, in combination with acetylsalicylic acid;

- with ST segment elevation (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 vascular complications cannot take indirect anticoagulants and have a low risk of bleeding (in combination with acetylsalicylic acid).

Inside, regardless of food intake, 1 time per day.

Adults and elderly patients with normal activity of the isoenzyme CYP2C19

Myocardial infarction, ischemic stroke, or diagnosed occlusive peripheral arterial disease. ZyltЃ is taken at a dose of 75 mg (1 tab.) 1 time per day.

Acute coronary syndrome without ST-segment elevation (unstable angina or myocardial infarction without Q wave). Treatment with ZyltЃ should be started with a single loading dose (300 mg), and then continued with a 75 mg dose once a day (in combination with acetylsalicylic acid at doses of 75Ц325 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 has not been officially determined. The results of clinical studies confirm the advisability of taking 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. ZyltЃ should be taken at a dose of 75 mg (1 tab.) 1 time per day, starting with the loading dose, in combination with acetylsalicylic acid in combination with or without thrombolytics. For patients over 75 years of age, treatment with ZyltЃ should be carried out without using a loading dose. Combination therapy is started as early as possible after symptom onset and continued for at least 4 weeks. The effectiveness of combination therapy with clopidogrel and acetylsalicylic acid lasting more than 4 weeks has not been studied in these patients.

Atrial fibrillation (atrial fibrillation). ZyltЃ is prescribed at a dose of 75 mg once a day. In combination with clopidogrel, therapy should be started and then continued with acetylsalicylic acid at a dose of 75-100 mg / day.

Skipping the next dose

If less than 12 hours have passed since the next dose is missed, then the missed dose of ZiltЃ should be taken immediately, and then the next dose should be taken at the usual time.

If more than 12 hours have passed since the next dose is missed, then the next dose should be taken at the usual time; however, you should not double the dose.

Adults and elderly patients with a 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 ZiltЃ in higher doses (loading dose 600 mg, then 150 mg once a day) in patients with low activity of the isoenzyme CYP2C19 leads to an increase in the antiplatelet effect of clopidogrel (see Pharmacokinetics). However, in clinical studies to study clinical outcomes, the optimal dosage regimen of clopidogrel in patients with reduced metabolism has not been established due to genetically determined low activity of the isoenzyme CYP2C19.

Special patient groups

Elderly patients. In elderly volunteers (over 75 years old), when compared with young volunteers, no differences in terms of platelet aggregation and bleeding time were found. No dose adjustment is required in elderly patients.

Impaired renal function. After repeated use of clopidogrel at a dose of 75 mg / day in patients with severe renal impairment (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 bleeding time lengthening was similar to that in healthy volunteers who received clopidogrel at a dose of 75 mg / day. The drug was well tolerated in all patients.

Liver dysfunction. After using clopidogrel at a dose of 75 mg / day for 10 days in patients with severe hepatic impairment, the degree of inhibition of ADP-induced platelet aggregation and the mean prolongation of bleeding time were comparable to those in healthy volunteers.

Ethnic characteristics. The prevalence of alleles of the CYP2C19 isoenzyme genes associated with intermediate or decreased metabolism differs among representatives of different racial / ethnic groups (see Pharmacogenetics). There are limited literature data to assess the impact of genotyping of the isoenzyme CYP2C19 on clinical outcomes in Mongoloid patients.

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 deviations from the normal clinical and laboratory parameters was the same in both men and women.

hypersensitivity to clopidogrel or any excipients that make up the drug;

severe liver dysfunction;

acute bleeding, such as bleeding from a peptic ulcer or intracranial hemorrhage;

lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;

pregnancy;

breastfeeding period;

children under 18 years of age (safety and effectiveness have not been established).

With care: moderate hepatic dysfunction with a predisposition to bleeding (limited experience of use); impaired renal function (limited experience with use); 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); concomitant use with NSAIDs, including COX-2 inhibitors; concomitant use of warfarin, heparin or glycoprotein IIb / IIIa inhibitors; patients with low activity of the isoenzyme CYP2C19 (when using clopidogrel in recommended doses, less active metabolite of clopidogrel is formed and its antiplatelet effect is less pronounced;therefore, when using clopidogrel in recommended doses for acute coronary syndrome or percutaneous intervention in the coronary arteries, the incidence of cardiovascular complications may be higher than in patients with normal activity of the isoenzyme CYP2C19); hypersensitivity to other thienopyridines (eg ticlopidine, prasugrel) (see 'Special instructions').