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:

without ST segment elevation (unstable angina or non-Q wave myocardial infarction), including patients who underwent stenting for percutaneous coronary intervention;
with ST segment elevation (acute myocardial infarction)

Pharmacological effect

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 platelet P2Y12 receptor and subsequent ADP-mediated activation of the glycoprotein IIb/IIIa complex, leading to suppression of platelet aggregation.

Special instructions

Due to the risk of bleeding and hematological undesirable effects (see “Side Effects”), if clinical symptoms suspicious for bleeding appear during treatment, you should urgently do a clinical blood test, determine the APTT (activated partial thromboplastin time), platelet count, indicators of platelet functional activity and conduct other necessary studies.

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

If the patient is undergoing elective surgery, and there is no need for an antithrombotic effect, then Coplavix® should be discontinued 7 days before surgery. Coplavix® increases bleeding time and should be used with caution in patients with lesions predisposing to the development of bleeding (especially from the gastrointestinal tract and intraocular hemorrhages).

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

There may be a relationship between acetylsalicylic acid and the occurrence of life-threatening Reye’s syndrome during prodromal infection in children.

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

Upper gastrointestinal symptoms such as gastralgia, heartburn, nausea, vomiting and gastrointestinal bleeding may occur at any time during treatment with Coplavix®. Despite the fact that minor side effects from the gastrointestinal tract, such as dyspeptic disorders, are common during treatment with Coplavix®, the attending physician should always rule out ulceration of the gastrointestinal mucosa and bleeding in these cases, even in the absence of a history of gastrointestinal pathology.

Patients should be informed about the symptoms of adverse reactions from the gastrointestinal tract. Patients should also be warned that while taking Coplavix® it may take longer than usual for bleeding to stop, and that if they experience any unusual bleeding (location or duration) they should report this to their doctor.

Before any upcoming surgery and before starting any new drug, patients should inform their doctor (including their dentist) about treatment with Coplavix®. In patients with reduced metabolic function of the CYP2C19 isoform, when clopidogrel is used in recommended doses, less of the active metabolite of clopidogrel is formed and its effect on platelet function is reduced. 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 function.

This drug should not be taken by patients with rare hereditary galactose intolerance disorders, lactase deficiency or glucose-galactose malabsorption syndrome (see “Composition”).

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

Typically, Coplavix® does not have a significant effect on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

However, if the patient experiences adverse side effects from the nervous system and psyche (see section “Side Effects”), concentration and speed of psychomotor reactions may decrease, which may interfere with such activities.

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

Active ingredient

Acetylsalicylic acid, Clopidogrel

Composition

Active ingredient:

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

Excipients:

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,

colloidal silicon dioxide -0.631 mg,

corn starch -11.111 mg.

Contraindications

Hypersensitivity to clopidogrel or any of the excipients of the drug.

Side Effects

Bleeding

Interaction

Warfarin: Concomitant use with clopidogrel may increase bleeding, so the use of this combination is not recommended.

Overdose

Symptoms
An overdose of clopidogrel can lead to an increase in bleeding time with subsequent complications in the form of bleeding.

Treatment
When bleeding occurs, appropriate treatment measures are required. An antidote for clopidogrel has not been established. If rapid restoration of prolonged bleeding time is necessary, platelet transfusion is recommended.

Storage conditions

Store at a temperature not exceeding 30 °C.

Shelf life

3 years

Manufacturer

Sanofi Winthrop Industries, France