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Most popular brand: Plavix
Active ingredient: Clopidogrel
Available dosage forms: 75 mg

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Clopidogrel (Clopidogrel): instruction, and the use of a formula

Therapeutic agents Clopidogrel

The nosological classification (ICD – 10)

Code CAS

Pharmacology

Mode of action -. Antiagregatine

selectively and irreversibly blocks the binding of ADP to platelet receptors inhibits their activation, reduces the number of functioning ADP – receptor (without damage), prevents the adsorption of fibrinogen and inhibits the aggregation of platelets.

If ingestion is rapidly absorbed, it has high bioavailability. Time to reach C _max is about 1 hour. It is a prodrug biotransformed in the liver to the active metabolite. T _1/2 is about 8 hours. Return with urine and faeces.

starts Inhibition of aggregation after 2 hours after administration (40% inhibition) are recorded at an initial dose of 400 mg. The maximum effect (60% suppression of aggregation) was observed after 4 – 7 days of continuous use at a dose of 50 – 100 mg / day. Antiagregatsionnogo effect lasts the entire period of the life of platelets (7 – 10 days). In the presence of atherosclerotic vascular lesions prevents the development of atherothrombosis, irrespective of the nature of the process of vascular (cerebrovascular, cardiovascular or peripheral lesions).

In the treatment of clopidogrel versus aspirin relative total risk of ischemic stroke, myocardial infarction, and vascular death is reduced by 8,7%.

Application of the substance Clopidogrel

Prevention of atherothrombotic events in patients with myocardial infarction, ischemic stroke or diagnosed with occlusive peripheral arterial disease.

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

– segment elevation ST (unstable angina or myocardial infarction without tooth Q), including patients who underwent stenting during percutaneous coronary intervention;

– segment elevation ST (acute myocardial infarction) for medical treatment and the possibility of thrombolysis.

Contraindications

Hypersensitivity, hemorrhagic syndrome, acute bleeding, intracranial hemorrhage, and diseases that predispose to their development (gastric ulcer and duodenal ulcer in the acute stage, ulcerative colitis, tuberculosis, lung cancer, hyperfibrinolysis) expressed liver failure; for formulations containing lactose (optional): hereditary galactose intolerance, lactase deficiency and malabsorption syndrome glucose – galactose.

Restrictions on the use

The moderate hepatic impairment, where possible predisposition to bleeding (limited clinical experience), renal failure (limited clinical experience); Patients with increased risk of bleeding after trauma, surgery, or as a result of other pathological conditions, as well as patients with a propensity to bleed (particularly gastrointestinal – intestinal and intraocular); concomitant use of NSAIDs (including COX – 2); co-administration of warfarin, heparin, glycoprotein receptor inhibitors IIb / IIIa, age 18 years (safety and efficacy have not been determined).

Application of pregnancy and breastfeeding

It is not recommended during pregnancy because of – the lack of clinical data on the use of pregnant women, although studies in animals did not reveal any direct or indirect adverse effects on pregnancy, fetal development, childbirth and postnatal development.

Category effects on the fetus by FDA ; B.

breast-feeding should be discontinued at the time of treatment, since in rat studies have shown that clopidogrel and / or its metabolites excreted into breast milk. Gets or not clopidogrel in human breast milk ; unknown.

Side effects of substance Clopidogrel

From the nervous system and sensory organs: fatigue, asthenia, headache, dizziness, paresthesia, leg cramps, hyperesthesia, neuralgia, cataracts, conjunctivitis.

From the cardio – vascular system and blood (blood, hemostasis): peripheral edema, hypertension, heart failure, generalized edema, syncope, palpitations, thrombocytopenia, anemia (aplastic or hypochromic), agranulocytosis , leukopenia, neutropenia.

Coagulation disorders and bleeding: purpura, extravasates, epistaxis, gastro – intestinal bleeding, bleeding in the joints, bleeding from the urinary tract, hemoptysis, intracranial bleeding, retroperitoneal bleeding, bleeding from the surgical wound, intraocular hemorrhage , hemothorax, pulmonary hemorrhage, allergic purpura, thrombotic thrombocytopenic purpura.

From the digestive tract: abdominal pain, dyspepsia, diarrhea, nausea, vomiting, constipation, taste disturbance, perforation of the stomach ulcer, hemorrhagic gastritis, ulcers, bleeding from the upper gastrointestinal tract. increase in liver enzymes, hyperbilirubinemia, hepatitis, hepatic steatosis.

From the musculo – skeletal system: arthralgia, back pain, arthritis, arthrosis.

From the respiratory system: an inflammation of the upper respiratory tract, shortness of breath, rhinitis, bronchitis, cough, pneumonia, sinusitis.

With the genitourinary system: urinary tract infections, cystitis, menorrhagia.

For the skin: rash, itching, eczema, skin ulceration, bullous dermatitis, erythematous rash, maculopapular rash, urticaria.

Other: chest pain, injury, flu-like symptoms, pain. It was reported a few cases of hemolytic uremic syndrome, membranous nephropathy and hypersensitivity reactions (angioedema, bronchoconstriction, anaphylaxis).

Interaction

We do not recommend co-administration of clopidogrel and warfarin due to the increased risk of bleeding.

acetylsalicylic acid does not alter the ADP – induced platelet aggregation induced by clopidogrel. Recurring appointment of acetylsalicylic acid, 500 mg 2 times a day, it did not cause prolonged bleeding time. Clopidogrel can potentiate the effect of aspirin on platelet aggregation induced by collagen. Potential pharmacodynamic interaction between clopidogrel and acetylsalicylic acid increases the risk of bleeding, so their joint application may not be more than one year. The issue of joint use of these drugs should be fully appreciated.

Due to an increased risk of bleeding is recommended to be cautious while appointing clopidogrel and heparin or thrombolytic agents.

Co-administration of clopidogrel and NSAIDs increases the risk of gastrointestinal ulcers and ulcer bleeding. Therefore, caution should be exercised while appointing them.

There were no significant clinical interaction with concomitant administration of clopidogrel and drugs such as atenolol, ACE inhibitors. agents that reduce blood cholesterol, nifedipine, digoxin, phenobarbital, cimetidine, estrogens, theophylline.

Clopidogrel inhibits the activity of the enzyme CYP2C19 of the cytochrome P450 and while the use of drugs metabolized with the participation of the enzyme (phenytoin, tolbutamin), possibly increasing their plasma concentrations.

Antacids do not affect the absorption of clopidogrel.

The interaction of clopidogrel with proton pump inhibitors

proton pump inhibitors (PPIs) reduce the effect of clopidogrel (prevention of thrombus formation) to varying degrees, some of them have a strong influence on the efficacy of clopidogrel, while others – have
Recommendations for use when taking PPIs clopidogrel. :
– should avoid taking PPIs, which are known to be strongly or moderately reduce the effectiveness of clopidogrel (eg, omeprazole);
– if necessary purpose PPI patients who took clopidogrel, PPIs should consider that interact with him is not so much (eg, pantoprazole).
Patients taking clopidogrel should continue to take it as directed, and to discuss with the doctor any issues or concerns regarding the treatment.

Overdose

Symptoms: may increase bleeding time, bleeding complications.

Treatment: stop bleeding, transfusion of platelets.

Dosing and Administration

inside In myocardial infarction, ischemic stroke, or peripheral arterial occlusive disease .; 1 75 mg once a day, regardless of the meal. Treatment should begin within the period of a few days up to 35 days in patients after myocardial infarction and from 7 days to 6 months in patients after ischemic stroke.

In acute coronary syndrome without ST-segment elevation (unstable angina, myocardial infarction without tooth Q) ; begin with receiving a single loading dose (300 mg), followed by 75 mg 1 time per day (in combination with acetylsalicylic acid). The maximum beneficial effect occurs within 3 months of treatment. The course of treatment ; up to 1 year.

In acute coronary syndrome with ST segment elevation (acute myocardial infarction) ; 1 75 mg once a day with an initial loading dose once-daily in combination with acetylsalicylic acid, thrombolytics (or without thrombolysis). Combination therapy is started as soon as possible after the onset of symptoms, and continued for at least 4 weeks.

In patients older than 75 years of clopidogrel treatment should begin without a loading dose.

Precautions substance Clopidogrel

In the treatment of clopidogrel, especially during the first weeks of treatment and / or after invasive cardiac procedures / surgery, it is necessary to conduct a thorough monitoring of patients in order to exclude signs of bleeding, including hidden.

Because of the risk of bleeding and haematological undesirable effects in case of occurrence in the course of treatment of clinical symptoms suspicious for the occurrence of bleeding, should urgently make a complete blood count to determine the APTT. platelet count, platelet functional activity indicators and carry out other necessary research.

Clopidogrel, as well as other anti-platelet drugs should be used with caution in patients who have an increased risk of bleeding associated with trauma, surgery or other pathological conditions and in patients receiving aspirin, other NSAIDs. including COX – 2 inhibitors, heparin or glycoprotein receptor IIb / IIIa.

The combined use of clopidogrel with warfarin may increase the intensity of bleeding, so, except for special rare clinical situations (such as the presence of floating thrombus in the left ventricle, stenting in patients with atrial fibrillation) is not recommended the combined use of warfarin.

If the patient to be planned surgery and there is no need for antiplatelet effect, the 7 days prior to surgery clopidogrel should be discontinued.

Clopidogrel prolongs bleeding time and should be used with caution in patients with diseases predisposing to the development of bleeding (especially gastro – intestinal and intraocular).

Patients should be warned that while taking clopidogrel (alone or in combination with acetylsalicylic acid) to stop the bleeding may take more time, and that in case they have an unusual (for location or duration) bleeding they should report it to your doctor. Before any upcoming surgery and before taking any new medicines, patients should tell your doctor (including dental) of clopidogrel.

It is very rarely following use of clopidogrel (sometimes short), there have been cases of thrombotic thrombocytopenic purpura (TTP), 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.

In the period of treatment is necessary to control the functional activity of the liver. In severe liver damage should be aware of the risk of hemorrhagic diathesis.

clopidogrel is not recommended in acute stroke with the prescription of less than 7 days (since there are no data on its use in this condition).