Description
Trade name:
Clopex
Compound:
Each tablet contains:
Clopidogrel 75 mg
Auxiliary components:
Pregelatinized starch, anhydrous lactose (anhydrous milk sugar), macrogol (polyethylene glycol 6000), magnesium stearate, microcrystalline cellulose, hydrogenated castor oil.
Properties:
A specific and active inhibitor of platelet aggregation; has a coronary vasodilatory effect. Selectively reduces the binding of ADP to platelet receptors and the activation of GPIIb/IIIa receptors under the action of ADP, weakening platelet aggregation.
Reduces platelet aggregation induced by other agonists by preventing their activation by released ADP, does not affect phosphodiesterase (PDE) activity. Irreversibly binds to platelet ADP receptors, which remain resistant to ADP stimulation throughout the life cycle (about 7 days).
Indications:
Prevention of atherothrombotic events in patients with myocardial infarction, ischemic stroke or diagnosed peripheral arterial occlusive disease.
Prevention of atherothrombotic events (in combination with acetylsalicylic acid) in patients with acute coronary syndrome:
– without ST segment elevation (unstable angina or non-Q-wave myocardial infarction), including patients who underwent stenting during percutaneous coronary intervention;
– with ST segment elevation (acute myocardial infarction) with drug treatment and the possibility of thrombolysis.
Method of administration and dosage:
The drug is taken orally, regardless of food intake.
For adults and elderly patients, clopidogrel is prescribed at 75 mg 1 time/day.
Treatment should be started from the 1st day to the 35th day after myocardial infarction, from 7 days to 6 months after ischemic stroke.
In acute coronary syndrome without ST-segment elevation (unstable angina or non-Q-wave myocardial infarction), treatment begins with a single loading dose of 300 mg, then continues at a dose of 75 mg once a day (with ASA – 75-325 mg/day). Since the use of ASA in high doses is associated with a high risk of bleeding, the recommended dose should not exceed 100 mg. The maximum beneficial effect occurs after 3 months. The course of treatment is up to 1 year.
For acute coronary syndrome with ST-segment elevation (acute myocardial infarction with ST-segment elevation), 75 mg/day is prescribed with an initial single loading dose in combination with ASA and thrombolytics (or without thrombolytics).
Contraindications:
– severe liver failure;
– active bleeding (including bleeding from a peptic ulcer or intracranial hemorrhage);
-pregnancy;
lactation period;
age under 18 years (efficacy and safety of use have not been established);
– lactose intolerance, lactase deficiency, glucose/galactose malabsorption syndrome;
– hypersensitivity to the active substance or any excipient of the drug.
The drug should be prescribed with caution in cases of moderate liver failure; chronic renal failure; pathological conditions that increase the risk of bleeding (including trauma, surgery); concomitant use of ASA, warfarin, NSAIDs (including COX-2 inhibitors), heparin and glycoprotein IIb/IIIa inhibitors; hereditary decrease in the activity of the CYP2C19 isoenzyme.
Precautions:
During the treatment period, it is necessary to monitor the hemostasis system parameters (APTT, platelet count, platelet functional activity tests); regularly examine the functional activity of the liver.
Patients should be closely monitored for any signs of bleeding, including occult bleeding, especially during the first weeks of drug administration and/or after invasive cardiac procedures or surgery.
Clopidogrel should be used with caution in patients with an increased risk of bleeding due to trauma, surgery, other pathological conditions, diseases predisposing to the development of bleeding (especially gastrointestinal and ocular), as well as in patients receiving ASA, NSAIDs (including COX-2 inhibitors), heparin or glycoprotein IIb/IIIa inhibitors.
The concomitant use of clopidogrel and warfarin is not recommended as it may increase the intensity of bleeding (except in special rare clinical situations).
In case of surgical interventions, if the antiplatelet effect is undesirable, the course of treatment with clopidogrel should be discontinued 7 days before surgery.
Side effects:
From the cardiovascular system: often – hematoma; very rarely – severe bleeding, bleeding from the surgical wound, vasculitis, decreased blood pressure.
From the respiratory system: very often – nosebleed; very rarely – bronchospasm, interstitial pneumonitis, pulmonary hemorrhage, hemoptysis.
From the digestive system: often – gastrointestinal bleeding, diarrhea, abdominal pain, dyspepsia.
From the skin and subcutaneous tissues: often – subcutaneous hemorrhages; uncommon – purpura.
Others: often – bleeding at the injection site; very rarely – fever.
Storage method:
At a temperature not exceeding 30 degrees. In a dry place.
