Aterocard (clopidogrel) coated tablets 0.075 g. №10

Aterocard (clopidogrel) coated tablets 0.075 g. №10

$7.00

Manufacturer: Ukraine

Secondary prevention of manifestations of atherothrombosis in adults:

  • in patients who have had a myocardial infarction (beginning of treatment – after a few days, but no later than 35 days after the onset), ischemic stroke (beginning of treatment – after 7 days, but no later than 6 months after the onset) or who have been diagnosed with diseases peripheral arteries (damage to the arteries and atherothrombosis of the vessels of the lower extremities);
  • in patients with acute coronary syndrome:
  • with non-ST elevation acute coronary syndrome (unstable angina or non-Q wave myocardial infarction), including in patients who had a stent placed during percutaneous coronary angioplasty, in combination with acetylsalicylic acid (ASA);
  • with acute ST-segment elevation myocardial infarction, in combination with ASA (in patients who receive standard medical treatment and who are indicated for thrombolytic therapy).
Category:

Description

Ingredients

active ingredient: clopidogrel;

1 tablet contains clopidogrel 75 mg;

excipients: microcrystalline cellulose; lactose, monohydrate; pregelatinized starch; povidone; polyethylene glycol 6000; magnesium stearate;

shell: Opadry II Pink film coating mixture (aluminum varnishes charming red (E 129) and indigo carmine (E 132); hypromellose (hydroxypropyl methylcellulose); lactose, monohydrate; triacetin; polyethylene glycol; titanium dioxide (E 171)).

Dosage form

Film-coated tablets.

Basic physical and chemical properties: round-shaped tablets with a biconvex surface, film-coated pink.

Pharmacotherapeutic group

Antithrombotic agents. Antiplatelet agents. ATX code B01A C04.

Pharmacodynamics

Mechanism of action. Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to the platelet surface receptor and the subsequent activation of the GPIIb/IIIa complex by ADP, and thus inhibits platelet aggregation. For the formation of active inhibition of platelet aggregation, biotransformation of clopidogrel is necessary. Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the increase in platelet activity by released ADP. Clopidogrel irreversibly modifies platelet ADP receptors. Therefore, platelets that have come into contact with clopidogrel change until the end of their life cycle. Normal platelet function is restored at a rate corresponding to the rate of platelet turnover.

pharmacodynamic effects. From the first day of use in repeated daily doses of 75 mg of the drug, a significant slowdown in ADP-induced platelet aggregation is detected. This action progressively intensifies and stabilizes between days 3 and 7. At steady state, the average level of inhibition of aggregation under the influence of a daily dose of 75 mg is from 40 to 60%. Platelet aggregation and bleeding duration return to baseline on average 5 days after treatment is stopped.

Indications

Secondary prevention of manifestations of atherothrombosis in adults:

  • in patients who have had a myocardial infarction (beginning of treatment – after a few days, but no later than 35 days after the onset), ischemic stroke (beginning of treatment – after 7 days, but no later than 6 months after the onset) or who have been diagnosed with diseases peripheral arteries (damage to the arteries and atherothrombosis of the vessels of the lower extremities);
  • in patients with acute coronary syndrome:
  • with non-ST elevation acute coronary syndrome (unstable angina or non-Q wave myocardial infarction), including in patients who had a stent placed during percutaneous coronary angioplasty, in combination with acetylsalicylic acid (ASA);
  • with acute ST-segment elevation myocardial infarction, in combination with ASA (in patients who receive standard medical treatment and who are indicated for thrombolytic therapy).

Prevention of atherothrombotic and thromboembolic events in atrial fibrillation.

Aterocard (clopidogrel) in combination with ASA is indicated in adult patients with atrial fibrillation who have at least one risk factor for vascular events, who have contraindications to treatment with vitamin K antagonists (VKAs) and who have a low risk of bleeding, to prevent atherothrombotic and thromboembolic events , including stroke.

Contraindications

Hypersensitivity to the active substance or to any component of the medicinal product. Severe liver failure. Acute bleeding (eg, peptic ulcer or intracranial hemorrhage).

Dosage and administration

Adults, including elderly patients. Aterocard (clopidogrel) should be taken at 75 mg 1 time per day, regardless of food intake.

In patients with non- ST elevation acute coronary syndrome (unstable angina or myocardial infarction without a Q wave on the ECG), treatment with clopidogrel should be started with a single loading dose of 300 mg, and then continued with a dose of 75 mg 1 time per day (with ASA at a dose of 75− 325 mg per day). Since the use of higher doses of ASA increases the risk of bleeding, it is not recommended to exceed the dose of ASA 100 mg. The optimal duration of treatment has not been formally established. The results of clinical studies indicate in favor of the use of the drug up to 12 months, and the maximum effect was observed after 3 months of treatment.

In patients with ST- segment elevation acute myocardial infarction, clopidogrel should be taken at a dose of 75 mg once daily, starting with a single loading dose of 300 mg in combination with ASA, with or without thrombolytic agents. Treatment of patients older than 75 years should be started without a loading dose of clopidogrel. Combination therapy should be started as soon as possible after the onset of symptoms and continued for at least 4 weeks. The benefit of using a combination of clopidogrel with ASA for more than 4 weeks in this disease has not been studied.

In patients with atrial fibrillation, Aterocard (clopidogrel) should be used at a dose of 75 mg once daily. Together with clopidogrel, ASA should be started and continued (at a dose of 75-100 mg per day).

In case of missing a dose:

  • if less than 12 hours have passed since the next dose was due, the patient should immediately take the missed dose and take the next dose at the usual time;
  • if more than 12 hours have passed, the patient should take the next dose at the usual time and not double the dose to make up for the missed dose.

Renal failure. The therapeutic experience of using Aterocard (clopidogrel) in patients with renal insufficiency is limited.

Liver failure. Therapeutic experience with the drug in patients with moderate liver disease and the likelihood of hemorrhagic diathesis is limited.

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