Clopidogrel - instructions for use, reviews, analogs and forms of release (tablets 75 mg Teva, Richter) of a drug for the treatment and prevention of thrombosis and thrombotic complications of heart attack and stroke in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Clopidogrel. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Clopidogrel in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Clopidogrel in the presence of existing structural analogues.Use to treat and prevent thrombosis and thrombotic complications of heart attack and stroke in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Clopidogrel - inhibitor of platelet aggregation. Selectively inhibits the binding of adenosine diphosphate (ADP) to platelet receptors and activation of the GP2b / 3a complex, thereby inhibiting platelet aggregation. It also inhibits platelet aggregation caused by other agonists by blocking the increase in platelet activity released by ADP. Does not affect the activity of PDE.

Clopidogrel irreversibly changes ADP receptors on platelets, so platelets remain dysfunctional throughout "life", and normal function recovery occurs as they update (approximately 7 days later).

Composition

Clopidogrel + auxiliary substances.

Pharmacokinetics

After ingestion at a dose of 75 mg, clopidogrel is rapidly absorbed from the digestive tract. However, the concentration in the blood plasma increases slightly and after 2 hours after taking does not reach the level that can be determined (0.025 μg / l). Intensively metabolized in the liver.The main metabolite is an inactive derivative of carboxylic acid and constitutes about 85% of the starting material circulating in the plasma. Clopidogrel and the main metabolite irreversibly bind to blood plasma proteins (98% and 94%, respectively). After ingestion of labeled clopidogrel, approximately 50% of the dose taken is excreted in the urine and approximately 46% with feces for 120 hours.

Compared to healthy young volunteers, the plasma metabolism of the main metabolite is significantly higher in elderly patients (aged 75 years and older), with no changes in platelet aggregation and bleeding time. In severe kidney disease (KK 5-15 ml / min), the concentration of the main metabolite in the blood plasma is lower than in cases of kidney disease of moderate severity (KK 30-60 ml / min) and in healthy volunteers. Although the inhibitory effect on ADP-induced platelet aggregation decreased compared to that in healthy volunteers, bleeding time increased to the same extent as in healthy volunteers.

Indications

• prevention of thrombotic complications in patients with myocardial infarction, ischemic stroke or peripheral arterial occlusion;
• in combination with acetylsalicylic acid (aspirin) for the prevention of thrombotic complications in acute coronary syndrome: with elevation of the ST segment with the possibility of carrying out thrombolytic therapy; without ST segment elevation (unstable angina, myocardial infarction without Q-wave), incl. in patients undergoing stenting;
• prevention of thrombotic and thromboembolic complications, including stroke, with atrial fibrillation (atrial fibrillation) with at least one risk factor for vascular complications, the inability to take indirect anticoagulants and the low risk of bleeding (in combination with acetylsalicylic acid).

Forms of release

Tablets coated with 75 mg.

Instructions for use and dosage

Take inside once a day.

The initial and maintenance dose is 75 mg per day. The loading dose is 300 mg per day.

The scheme of application depends on the indications and the clinical situation and can not be taken by the patient independently without consulting a specialist.

Side effect

• bleeding;
• increased bleeding time;
• gastrointestinal bleeding;
• diarrhea, constipation;
• stomach ache;
• dyspepsia;
• stomach ulcer and duodenal ulcer;
• vomiting, nausea;
• bloating;
• retroperitoneal hemorrhage;
• pancreatitis;
• Colitis (including nonspecific ulcerative colitis or lymphocytic colitis);
• stomatitis;
• acute liver failure;
• hepatitis;
• thrombocytopenia, leukopenia, eosinophilia, neutropenia, including severe neutropenia, thrombotic thrombocytopenic purpura, aplastic anemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anemia;
• intracranial hemorrhage (several cases have been reported with a fatal outcome);
• headache;
• paresthesia;
• dizziness;
• violation of taste perception;
• hallucinations;
• confusion of consciousness;
• eye hemorrhage (conjunctival, in the tissue and retina of the eye);
• vasculitis;
• a decrease in blood pressure;
• nose bleed;
• bleeding from the respiratory tract (hemoptysis, pulmonary hemorrhage);
• bronchospasm;
• serum sickness;
• anaphylactoid reactions;
• subcutaneous bruising;
• rash;
• itching;
• bullous dermatitis (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme);
• angioedema;
• erythematous rash;
• hives;
• eczema;
• bleeding in the muscles and joints;
• myalgia;
• hematuria;
• glomerulonephritis;
• increase in the concentration of creatine in the blood;
• bleeding from the point of vascular puncture;
• fever.

Contraindications

• acute bleeding (including with peptic ulcer or intracranial hemorrhage);
• severe hepatic impairment;
• pregnancy;
• lactation period (breastfeeding);
• children and adolescents under 18;
• Hypersensitivity to clopidogrel.

Application in pregnancy and lactation

Adequate and strictly controlled clinical studies of the safety of clopidogrel during pregnancy have not been conducted. Application is possible only in cases of extreme necessity.

It is not known whether clopidogrel is excreted in human milk. If it is necessary to use during the lactation period, the question of stopping breastfeeding should be solved.

In experimental animal studies using clopidogrel at doses of 300-500 mg / kg per day, there was no teratogenic effect and a negative effect on fertility and fetal development. It has been established that clopidogrel and its metabolites are excreted in breast milk.

Use in children

Contraindicated in children and adolescents under the age of 18 years.

special instructions

With care apply clopidogrel with an increased risk of bleeding due to trauma, surgical interventions, violations of the hemostasis system. When planned surgical interventions (if antiaggregant effect is undesirable) clopidogrel should be canceled 7 days before surgery.

With caution apply clopidogrel in patients with severe violations of the liver, in which there may be a hemorrhagic diathesis.

When symptoms of excessive bleeding occur (bleeding gums, menorrhagia, hematuria), a study of the hemostatic system (bleeding time, platelet counts, platelet function tests) is shown. It is recommended that the laboratory indicators of the functional activity of the liver be regularly monitored.

With caution apply simultaneously with warfarin, heparin, non-steroidal anti-inflammatory drugs (NSAIDs), long-term with acetylsalicylic acid, t. At present, the security of such an application has not been finally established.

In experimental studies, there was no evidence of carcinogenic and genotoxic effects.

Impact on the ability to drive vehicles and manage mechanisms

The influence of clopidogrel on the ability to drive vehicles and control mechanisms has not been established.

Drug Interactions

When used simultaneously with NSAIDs (including naproxen), the risk of gastrointestinal bleeding increases.

When used simultaneously with Acetylsalicylic acid (aspirin), it is possible to increase the antiaggregant effect.

Since clopidogrel can inhibit isozyme CYP2C9, while the use of drugs metabolized involving this isozyme (including phenytoin, tolbutaminom) can not be excluded increasing their plasma concentrations.

Inhibitors of the proton pump (IPN) reduce the effect of clopidogrel (prevention of thrombosis). Recommendations for the use of IPNs with clopidogrel:

should be avoided taking IPN, which is known to reduce the effectiveness of clopidogrel (eg, omeprazole) strongly or moderately;

if it is necessary to administer an IPN to a patient who takes clopidogrel, IPN should be considered, which interacts less with it (for example, pantoprazole).

Analogues of the drug Clopidogrel

Structural analogs for the active substance:

• Agregal;
• Payplat 75;
• Detromb;
• Zilt;
• Kardogrel;
• Cardutol;
• Clopigrant;
• Clopidex;
• Clopidogrel Richter;
• Clopidogrel C3;
• Clopidogrel Teva;
• Clopidogrel hydrogen sulfate;
• Clopidogrel bisulfate;
• Clopilet;
• Coplavix (in combination with aspirin);
• Lirta;
• Listab 75;
• Lopyrel;
• Plavix;
• Plagril;
• Plyglare;
• Target;
• Troken;
• Thrombex;
• Thromboreal;
• Egitromb.

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