Clopex 75 mg 30 tablets

Tradename:

Clopex

Clopex

Composition:

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:

Specific and active inhibitor of platelet aggregation; has a coronary dilating effect. Selectively reduces the binding of ADP to platelet receptors and the activation of GPII Illa receptors by ADP, weakening platelet aggregation.

Reduces platelet aggregation induced by other agonists, preventing their activation by released ADP, does not affect the activity of phosphodiesterase (PDE). It binds irreversibly to platelet ADP receptors, which remain immune 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 myocardial infarction without Q wave), including patients who underwent stenting during percutaneous coronary intervention;
• with the rise of the ST segment (acute myocardial infarction) with drug treatment 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 75 mg 1 time / day.

Treatment should begin from day 1 to day 35 after myocardial infarction, from 7 days to 6 months after ischemic stroke.

In acute coronary syndrome without STsegment elevation (unstable angina pectoris or myocardial infarction without Q wave), treatment begins with a single dose of 300 mg loading dose, and then continues at a dose of 75 mg 1 time / 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.

In acute coronary syndrome with ST segme elevation (acute myocardial infarction with segment elevation), 75 mg / day is prescribed with an initial single dose of a 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 up to 18 years (efficacy and safety of use have not been established);

• lactose intolerance, lactase deficiency, glucose / galactose malabsorption syndrome;

-increased sensitivity to the active substance or any auxiliary component of the drug.

With caution, the drug should be prescrib for moderate hepatic insufficiency; chronic renal failure; pathological conditions that increase the risk of bleeding (including trauma, surgery); concomitant use of ASA, warfarin, NSAlDs (including COX-2 inhibitors), heparin and glycoprotein IIb / Illa inhibitors; hereditary decrease in the activity of the isoenzyme

CYP2C19.

Precautions:

During the treatment period, it is necessary to monitor the indicators of the hemostasis system (APTT, platelet count, tests of the functional activity of platelets); regularly examine the functional activity of the liver.

Patients should be closely monitored for any signs of bleeding, incl. hidden, especially during the first weeks of using the drug and / or after invasive procedures on the heart or surgery.

Clopidogrel should be used with caution in patients with an increased risk of bleeding due to trauma, surgery, other pathological conditions, diseases that predispose to the development of bleeding (especially gastrointestinal and ocular), as well as in patients receiving ASA, NSAlDs (incl. inclu Ing COX-2 inhibitors), heparin or inhibitors of

glycoprotein IIb / Illa.

The simultaneous use of clopidogrel and warfarin is not recommended, because it can increase the intensity of bleeding (with the exception of special rare clinical situations).

In the case of surgical interventions, if the antiplatelet effect is undesirable, the course of treatment with clopidogrel should be discontinued 7 days before the operation.

Side effects:

From the side of the cardiovascular system: often – hematoma; very rarely – heavy bleeding, bleeding from the surgical wound, vasculitis, lowering blood pressure.

From the respiratory system: very often nosebleeds; very rarely – bronchospasm, interstitial pneumonitis, pulmonary hemorrhage, hemoptysis.

From the digestive system: often gastrointestinal bleeding, diarrhea, abdomi pain, dyspepsia.

On the part of the skin and subcutaneous tissues: often – subcutaneous hemorrhages; infrequently – purpura.

Others: often – bleeding at the injection site; very rarely – an increase in temperature.

Storage method:

At a temperature not higher than 30 degrees. In a dry place.

Packaging:

The cardboard box holds 1, 2 or 3 blisters of 10 tablets.