Plavix tablets 75mg, No. 100

Prevention of atherothrombotic complications:

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

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 ASA);

- with ST segment elevation (acute myocardial infarction) with drug treatment and the possibility of thrombolysis (in combination with ASA).

Prevention of atherothrombotic and thromboembolic complications, including stroke, in atrial fibrillation (atrial fibrillation).

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 ASA).

Inside, regardless of the meal.

Adults and the elderly with normal activity of the isoenzyme CYP2C19

Myocardial infarction, ischemic stroke, and diagnosed occlusive peripheral arterial disease. The drug is taken at 75 mg 1 time per day.

Acute coronary syndrome without ST segment elevation (unstable angina pectoris, myocardial infarction without Q wave). Treatment with clopidogrel should be started with a single dose of a loading dose of 300 mg, and then continued with a dose of 75 mg 1 time per day (in combination with ASA at doses of 75Ц325 mg / day). Since the use of higher doses of ASA is associated with an increased risk of bleeding, the recommended dose of ASA for this indication should not exceed 100 mg. The optimal duration of treatment has not been officially determined. The data of clinical studies support taking the drug for up to 12 months, and the maximum beneficial effect was observed by the 3rd month of treatment.

ST-segment elevation acute coronary syndrome (acute ST-segment elevation myocardial infarction). Clopidogrel should be taken once a day at a dose of 75 mg with an initial single dose of a loading dose of clopidogrel 300 mg in combination with ASA in combination with thrombolytics or without a combination with thrombolytics. In patients over 75 years of age, clopidogrel treatment should be started without taking a loading dose. Combination therapy is started as early as possible after symptom onset and continued for at least 4 weeks. The effectiveness of using a combination of clopidogrel and ASA for this indication for more than 4 weeks has not been studied.

Atrial fibrillation (atrial fibrillation). Clopidogrel should be taken once a day at a dose of 75 mg. In combination with clopidogrel, it is necessary to start and then continue taking ASA (75-100 mg / day).

Skipping the next dose

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

2. If more than 12 hours have passed since the next dose is missed, the patient should take the next dose at the usual time (do not take a double dose).

Patients with a genetically determined decreased activity of the isoenzyme CYP2C19

Low activity of the isoenzyme CYP2C19 is associated with a decrease in the antiplatelet effect of clopidogrel. The regimen of higher doses (600 mg - loading dose, then 150 mg 1 time per day daily) in patients with low activity of the isoenzyme CYP2C19 increases the antiplatelet effect of clopidogrel (see Pharmacokinetics). However, at the moment, in clinical studies that take into account clinical outcomes, the optimal dosage regimen of clopidogrel for patients with its reduced metabolism has not been established due to the genetically determined low activity of the isoenzyme CYP2C19.

Special patient groups

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

Children. There is no experience of using the drug in children.

Patients with impaired renal function. After repeated doses of clopidogrel at a dose of 75 mg / day in patients with severe kidney damage (Cl creatinine from 5 to 15 ml / min), the inhibition of ADP-induced platelet aggregation (25%) was lower compared to that in healthy volunteers, however, the time was prolonged. bleeding was similar to that in healthy volunteers who received clopidogrel at a dose of 75 mg / day. In addition, all patients had good drug tolerance.

Patients with impaired liver function. After daily administration of clopidogrel at a daily dose of 75 mg for 10 days in patients with severe liver damage, inhibition of ADP-induced platelet aggregation was similar to that in healthy volunteers. The mean bleeding time was also comparable in both groups.

Patients of different ethnicity. The prevalence of alleles of the CYP2C19 isoenzyme genes responsible for the intermediate and reduced metabolism of clopidogrel to its active metabolite differs among representatives of different ethnic groups (see Pharmacogenetics). There are only limited data for representatives of the Mongoloid race to assess the effect of the CYP2C19 isoenzyme genotype on clinical resultant events.

Male and female patients. In a small study comparing the pharmacodynamic properties of clopidogrel in men and women, women had less inhibition of ADP-induced platelet aggregation, but there was no difference in lengthening bleeding time. In the large controlled study CAPRIE (clopidogrel versus ASA in patients at risk of ischemic complications), the incidence of clinical outcomes, other side effects, and abnormal clinical laboratory parameters was the same in both men and women.

hypersensitivity to clopidogrel or any of the excipients of the drug;

severe liver failure;

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

rare hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption;

pregnancy and lactation (see 'Application during pregnancy and lactation');

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

With caution in the following conditions: moderate hepatic failure, in which a predisposition to bleeding is possible (limited clinical experience of use); renal failure (limited clinical experience of use); trauma, surgery (see 'Special instructions'); in diseases in which there is a predisposition to the development of bleeding (in particular, gastrointestinal or intraocular), and especially with the simultaneous use of drugs that can cause damage to the gastrointestinal mucosa (such as ASA) and NSAIDs); in patients who have an increased risk of bleeding: due to trauma, surgery or other pathological conditions, as well as in patients receiving treatment with ASA, heparin, warfarin, glycoprotein IIb / IIIa inhibitors, NSAIDs, incl.selective inhibitors of COX-2, as well as other drugs, the use of which is associated with the risk of bleeding or SSRIs (see 'Interaction', 'Special instructions'); with simultaneous use with drugs that are substrates of the isoenzyme CYP2C8 (repaglinide, paclitaxel) (see 'Interaction'), in patients with low activity of the isoenzyme CYP2C19 (see 'Pharmacokinetics' subsection 'Pharmacogenetics', 'Dosing and Administration', 'Special instructions '); if there is a history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); with a recent transient violation of cerebral circulation or ischemic stroke (when combined with ASA, see 'Special instructions').the use of which is associated with the risk of bleeding or SSRIs (see 'Interaction', 'Special instructions'); with simultaneous use with drugs that are substrates of the isoenzyme CYP2C8 (repaglinide, paclitaxel) (see 'Interaction'), in patients with low activity of the isoenzyme CYP2C19 (see 'Pharmacokinetics' subsection 'Pharmacogenetics', 'Dosage and Administration', 'Special instructions '); if there is a history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); with a recent transient violation of cerebral circulation or ischemic stroke (when combined with ASA, see 'Special instructions').the use of which is associated with the risk of bleeding or SSRIs (see 'Interaction', 'Special instructions'); with simultaneous use with drugs that are substrates of the isoenzyme CYP2C8 (repaglinide, paclitaxel) (see 'Interaction'), in patients with low activity of the isoenzyme CYP2C19 (see 'Pharmacokinetics' subsection 'Pharmacogenetics', 'Dosing and Administration', 'Special instructions '); if there is a history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); with a recent transient violation of cerebral circulation or ischemic stroke (when combined with ASA, see 'Special instructions').with simultaneous use with drugs that are substrates of the isoenzyme CYP2C8 (repaglinide, paclitaxel) (see 'Interaction'), in patients with low activity of the isoenzyme CYP2C19 (see 'Pharmacokinetics' subsection 'Pharmacogenetics', 'Dosage and Administration', 'Special instructions '); if there is a history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); with a recent transient violation of cerebral circulation or ischemic stroke (when combined with ASA, see 'Special instructions').with simultaneous use with drugs that are substrates of the isoenzyme CYP2C8 (repaglinide, paclitaxel) (see 'Interaction'), in patients with low activity of the isoenzyme CYP2C19 (see 'Pharmacokinetics' subsection 'Pharmacogenetics', 'Dosage and Administration', 'Special instructions '); if there is a history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); with a recent transient violation of cerebral circulation or ischemic stroke (when combined with ASA, see 'Special instructions').'Pharmacokinetics' subsection 'Pharmacogenetics', 'Dosage and administration', 'Special instructions'); if there is a history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); 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