Atrogrel (clopidogrel) coated tablets 75 mg. №60

$12.00

Manufacturer: Ukraine

Atrogrel (clopidogrel) prevents atherothrombotic and thromboembolic events in atrial fibrillation and manifestations of atherothrombosis.

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Description

Ingredients

active ingredient : clopidogrel;

1 tablet contains: clopidogrel in the form of clopidogrel bisulfate (in terms of 100% clopidogrel) – 75 mg;

other components : sodium croscarmellose, microcrystalline cellulose, lactose monohydrate, hydrogenated castor oil;

film shell : hydroxypropyl methylcellulose, lactose monohydrate, titanium dioxide (E 171), triacetin, carmine (E 120).

Dosage form

Film-coated tablets.

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

Pharmacotherapeutic group

Antithrombotic agents. ATX code B01A C04.

Pharmacodynamics

Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its receptors on the surface of platelets, blocks platelet activation and thus inhibits their aggregation. It also inhibits platelet aggregation caused by other agonists. Inhibition of platelet aggregation is observed 2 hours after oral administration of a single dose of the drug. With repeated use, the effect is enhanced, and a stable state is achieved after 3-7 days of treatment (the average level of inhibition is 40-60%). Platelet aggregation and bleeding time return to baseline on average 7 days after discontinuation of the drug in accordance with the recovery of platelets.

Indications

Prevention of manifestations of atherothrombosis:

  • in patients who have had a myocardial infarction (starting treatment – a few days, but no later than 35 days after the onset), ischemic stroke (starting treatment – 7 days, but no later than 6 months after the onset) or who have been diagnosed with a disease 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 in
  • during percutaneous coronary angioplasty, in combination with acetylsalicylic acid (ASA);
    with acute ST-segment elevation myocardial infarction in combination with ASA (in patients receiving standard medical treatment and for whom thrombolytic therapy is indicated).

Prevention of atherothrombotic and thromboembolic events in atrial fibrillation.

Atrogrel (clopidogrel) in combination with ASA is indicated in adult patients with atrial fibrillation who have at least one risk factor for vascular events, who are contraindicated in treatment with vitamin K antagonists (VKAs) and who have a low risk of bleeding, for the prevention of atherothrombotic and thromboembolic events. .

Contraindications

  • hypersensitivity to the active substance or other components of Atrogrel (clopidogrel) ;
  • severe liver failure;
  • acute bleeding (including intracranial hemorrhage) and diseases that contribute to their development (for example, peptic ulcer of the stomach and duodenum in the acute stage, ulcerative colitis).

Dosage and administration

Adults and elderly patients . Atrogrel (clopidogrel) is prescribed 1 tablet (75 mg) 1 time per day, regardless of the meal.

In patients with non-ST elevation acute coronary syndrome (unstable angina or non-Q wave myocardial infarction on ECG), treatment with clopidogrel should be initiated with a single loading dose of 300 mg and then continued with a dose of 75 mg once daily. dose of 75-325 mg/day). Since the use of higher doses of ASA increases the risk of bleeding, it is recommended not to exceed the dose of ASA 100 mg. The optimal duration of treatment has not been formally established. The research results support the use of the drug for up to 12 months, and the maximum effect was observed after 3 months of treatment.

In patients with acute ST-segment elevation myocardial infarction, clopidogrel should be given 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 over the age of 75 should be initiated without a loading dose of clopidogrel. Combination therapy should be initiated 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.

For patients with atrial fibrillation, clopidogrel should be used in a single daily dose of 75 mg. Together with clopidogrel, ASA should be started (at a dose of 75-100 mg / day) and continued.

If you miss 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.

Pharmacogenetics. The prevalence of CYP2C19 alleles that cause intermediate and reduced metabolic activity of CYP2C19 depends on race/ethnicity. The optimal dosing regimen in individuals with impaired CYP2C19 metabolism has not yet been established.

Kidney failure . The therapeutic experience of using the drug in patients with renal insufficiency is limited.

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