Coplavix, 100 mg+75 mg 28 pcs

COPLAVIX is a prodrug, one of whose metabolites is active and inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to the P2Y12 receptor of platelets and the subsequent ADP-mediated activation of the glycoprotein IIb/IIIa complex, leading to suppression of platelet aggregation.

Indications

Prevention of atherothrombotic complications (in combination with acetylsalicylic acid) in patients with acute coronary syndrome:

Active ingredient

Composition

Active substance:

clopidogrel hydrosulfate in form II – 97.875 mg (in terms of clopidogrel 75 mg), acetylsalicylic acid – 100 mg.

Auxiliary substances:

Mannitol 68.925 mg,

Macrogol-6000 34.000 mg,

microcrystalline cellulose -144.764 mg,

low-substituted hyprolose – 19.567 mg,

hydrogenated castor oil – 3,300 mg,

stearic acid – 1,161 mg,

How to take, the dosage

Interaction

Special Instructions

Because of the risk of bleeding and hematologic adverse effects (see side effects), if clinical symptoms suspected of bleeding occur during treatment appear, a clinical blood count, an ACTV (activated partial thromboplastin time), platelet count, platelet function tests and other necessary tests should be performed urgently.

. Due to the presence of two antiplatelet agents in Coplavix® it should be used with caution in patients with increased risk of bleeding caused by trauma, surgery or other pathological conditions, as well as in patients receiving non-steroidal anti-inflammatory drugs (including COX-2 inhibitors), heparin, glycoprotein IIb/Sha inhibitors and thrombolytics. Patients should be closely monitored to exclude signs of bleeding, including hidden bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures/surgery. Co-administration of Clopidogrel with warfarin may increase the intensity of bleeding (see “Interaction with other drugs”), therefore, except for special rare clinical situations (such as the presence of a flotating thrombus in the left ventricle, stenting in patients with atrial fibrillation or other indications for indirect anticoagulants) co-administration of Coplavix and warfarin is not recommended.

If the patient is scheduled for surgery and there is no need for antithrombotic effect, Coplavix® should be discontinued 7 days prior to surgery. Coplavix® increases bleeding time and should be used with caution in patients with lesions that predispose to bleeding (especially from the gastrointestinal tract and intraocular hemorrhages).

Very rarely, after using clopidogrel (sometimes even short-term) there have been cases of thrombocytopenic thrombohemolytic purpura (TTP), which is characterized by thrombocytopenia and microangiopathic hemolytic anemia, accompanied by neurological disorders, impaired renal function and fever. TTP is a potentially life-threatening condition requiring immediate treatment, including plasmapheresis. It has been clearly shown that in patients with recent transient ischemic brain attack or stroke who have an increased risk of recurrent ischemia, the combination of acetylsalicylic acid and clopidogrel increases the possibility of major bleeding. Therefore, caution should be exercised when using Coplavix® in these patients in all cases, including those where a beneficial effect of the combination has been proven.

There may be an association between acetylsalicylic acid and the occurrence of life-threatening Reye’s syndrome in prodromal infections in children.

Coplavix® should be used with caution in patients with a history of peptic ulcers or gastrointestinal bleeding or in patients with even minor upper gastrointestinal symptoms that may be manifestations of gastric ulcers that may lead to gastric bleeding.

When treated with Coplavix®, upper gastrointestinal symptoms such as gastralgia, heartburn, nausea, vomiting and gastrointestinal bleeding may occur at any time. Although minor gastrointestinal side effects, such as dyspeptic complaints, are common with Coplavix® , the treating physician should always rule out gastrointestinal mucosal ulceration and bleeding, even if there is no history of gastrointestinal disease.

Patients should be informed about the symptoms of adverse gastrointestinal reactions. Patients should also be advised that it may take longer than usual to stop bleeding while taking Coplavix® and that they should inform their physician if they experience any unusual bleeding (in location or duration).

Patients should inform their physician (including their dentist) about their treatment with Coplavix® before any upcoming surgery and before starting any new medication. In patients with decreased metabolic function of the CYP2C19 isoenzyme, the use of clopidogrel at the recommended doses produces less of the active metabolite clopidogrel decreases its effect on platelet function. Therefore, patients with acute coronary syndrome or undergoing percutaneous coronary intervention and taking clopidogrel may have a higher incidence of cardiovascular events than patients with normal CYP2C19 isoenzyme function.

Patients with rare hereditary galactose intolerance disorders, lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medication (see “Composition”).

Impact on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and psychomotor reactions

Normally, Coplavix® has no significant effect on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and psychomotor reactions.

However, if the patient has adverse reactions from the nervous system and psyche (see section “Adverse effects”), concentration and speed of psychomotor reactions may decrease, which may prevent the patient from engaging in such activities.

In such cases, the question of the possibility of engaging in potentially hazardous activities should be decided by the attending physician.

Contraindications

Side effects

Overdose

Similarities