Coplavix tablets 100 + 75mg, No. 100

This combination drug is indicated for use in patients who are already receiving clopidogrel and ASA at the same time (see 'Dosage and Administration').

Prevention of atherothrombotic complications:

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;

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

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

adult patients with atrial fibrillation (atrial fibrillation) who have at least 1 risk factor for vascular complications cannot take indirect anticoagulants and have a low risk of bleeding.

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

Adults and elderly patients with normal activity of the isoenzyme CYP2C19

Acute coronary syndrome (ACS). Treatment is started as early as possible after the onset of symptoms. Taking CoplavixЃ begins after taking a single loading dose of clopidogrel in combination with ASA in the form of separate drugs, namely clopidogrel at a dose of 300 mg and ASA at doses of 75Ц325 mg / day, and in acute myocardial infarction with ST segment elevation - in combination with or without thrombolytics. 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. In acute myocardial infarction with ST segment elevation in patients over 75 years of age, clopidogrel treatment should be started without taking its loading dose.In patients with ACS without ST segment elevation (unstable angina pectoris or myocardial infarction without Q wave), the maximum beneficial effect is observed by the 3rd month of treatment. The optimal duration of treatment has not been officially determined. Clinical trial data support drug intake for up to 12 months. In patients with acute ST-segment elevation myocardial infarction, treatment should be continued for at least 4 weeks.

Atrial fibrillation. CoplavixЃ should be taken once a day, after starting treatment with clopidogrel at a dose of 75 mg and ASA at a dose of 100 mg as separate drugs.

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 application of higher doses of clopidogrel (600 mg - loading dose, then 150 mg once a 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

Children. The safety and effectiveness in children has not yet been established.

Elderly patients. In elderly patients, no dosage adjustment is required.

Patients with hepatic impairment. The therapeutic experience of using the drug is limited to its use in patients with moderately severe liver diseases, which may have a tendency to develop hemorrhagic diathesis. Therefore, caution should be exercised when using CoplavixЃ in such patients.

Patients with renal impairment. There is limited therapeutic experience with the drug in patients with mild to moderate renal impairment. Therefore, caution should be exercised when using CoplavixЃ in such patients.

hypersensitivity to any of the active or auxiliary substances of the drug;

severe liver failure (more than 9 points on the Child-Pugh scale);

severe renal failure (Cl creatinine less than 30 ml / min) - due to the content of ASA in the preparation);

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

bronchial asthma induced by the intake of salicylates and other NSAIDs; syndrome of bronchial asthma, rhinitis and recurrent polyposis of the nose and paranasal sinuses, hypersensitivity to NSAIDs (due to the content of ASA in the drug);

mastocytosis, in which the use of ASA can cause severe hypersensitivity reactions, including the development of shock, with hyperemia of the skin, a decrease in blood pressure, tachycardia and vomiting (due to the content of ASA in the preparation);

rare hereditary conditions: galactose intolerance; lactose intolerance due to lactase deficiency; glucose-galactose malabsorption syndrome (due to the content of lactose in the preparation);

pregnancy;

the period of breastfeeding (see 'Application during pregnancy and breastfeeding');

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

With caution: moderate hepatic impairment (7-9 points on the Child-Pugh scale), in which a predisposition to bleeding is possible (limited clinical experience of use); renal failure of mild and moderate severity (Cl creatinine 60-30 ml / min) (limited clinical experience of use); trauma, surgery, including invasive cardiac procedures or surgery (see 'Special instructions'); diseases in which there is a predisposition to the development of bleeding, especially intraocular or gastrointestinal (peptic ulcer of the stomach and duodenum or gastrointestinal bleeding in history, symptoms of disorders from the upper gastrointestinal tract); recently transferred transient cerebrovascular accident or ischemic stroke (see 'Special instructions');simultaneous use of NSAIDs, including selective inhibitors of COX-2 (see 'Interaction'); simultaneous use of warfarin, heparin, glycoprotein IIb / IIIa inhibitors, selective serotonin reuptake inhibitors (SSRIs) and thrombolytic drugs (see 'Interaction' and 'Special instructions'); history of bronchial asthma and allergies (increased risk of allergic reactions to ASA); gout, hyperuricemia (ASA, including in low doses, increases the concentration of uric acid in the blood); simultaneous intake of alcohol (ethanol) (due to the presence of ASA in the preparation, see 'Interaction' and 'Special instructions'). patients with a genetically determined decrease in the activity of the isoenzyme CYP2D9 (see 'Pharmacokinetics', subsection Pharmacogenetics, 'Dosage and Administration', 'Special instructions');patients with a deficiency of glucose-6-phosphate dehydrogenase (due to the risk of hemolysis) (see 'Side effects', 'Special instructions'); simultaneous use of methotrexate at a dose of more than 20 mg / week (see 'Interaction'); the presence of indications in the history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); the simultaneous use of drugs associated with the risk of bleeding and drugs that are substrates of the CYP2C8 isoenzyme (such as repaglinide, paclitaxel) - due to the identified drug interaction.the presence of indications in the history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); the simultaneous use of drugs associated with the risk of bleeding and drugs that are substrates of the CYP2C8 isoenzyme (such as repaglinide, paclitaxel) - due to the identified drug interaction.the presence of indications in the history of allergic and hematological reactions to other thienopyridines (such as ticlopidine, prasugrel) (the possibility of cross-allergic and hematological reactions, see 'Special instructions'); the simultaneous use of drugs associated with the risk of bleeding and drugs that are substrates of the CYP2C8 isoenzyme (such as repaglinide, paclitaxel) - due to the identified drug interaction.which are substrates of the CYP2C8 isoenzyme (such as repaglinide, paclitaxel) - due to the identified drug interactions.which are substrates of the CYP2C8 isoenzyme (such as repaglinide, paclitaxel) - due to the identified drug interactions.