Clopidogrel is an antiplatelet drug.
Release form and composition
Klopidogrel is produced in the form of film-coated tablets (7 pieces in blisters, 1, 2, 3, 4, 6, 8 packs in cardboard packs; 10 pieces in blister packs, 1, 2, 3, 5, 6, 10 packs in cardboard packs; 14, 15 and 30 pieces in blisters, 1, 2 packs in cardboard packs; 7, 10, 14, 20, 28, 30, 50, 56 , 60 or 100 pieces in glass jars or plastic bottles, 1 jar each or a bottle in carton packs.
The composition of 1 tablet contains the active substance: clopidogrel - 75 mg.
Indications for use
- Prevention of thrombotic complications in acute coronary syndrome: with elevation of the ST segment with the possibility of thrombolytic therapy; without ST segment elevation (myocardial infarction without Q wave, unstable stenocardia), incl. in patients undergoing stenting (simultaneously with acetylsalicylic acid);
- Prevention of thromboembolic and thrombotic complications, including stroke, in atrial fibrillation (atrial fibrillation) in the presence of at least one of the risk factors for the development of vascular complications, and in the presence of a low risk of bleeding and inability to receive indirect anticoagulants (simultaneously with acetylsalicylic acid);
- Prevention of thrombotic complications in patients with ischemic stroke, myocardial infarction or occlusion of peripheral arteries.
- Severe liver failure;
- Acute bleeding (including intracranial hemorrhage and bleeding with peptic ulcer);
- Pregnancy and breastfeeding (lactation);
- Age up to 18 years;
- Hypersensitivity to the drug.
Dosing and Administration
The drug is taken orally 1 time per day in a daily dose (initial and maintenance) - 75 mg. Loading dose - 300 mg per day.
The use of clopidogrel is determined by the indications and clinical situation.
During therapy may develop disorders of some body systems:
- The digestive system: very often - diarrhea, gastrointestinal bleeding, dyspepsia, abdominal pain; infrequently - vomiting, gastric and duodenal ulcers, nausea, bloating, constipation; rarely, retroperitoneal hemorrhage; very rarely, abnormalities in liver function, pancreatitis, gastrointestinal bleeding and fatal retroperitoneal hemorrhage, hepatitis, colitis (including ulcerative colitis or lymphocytic colitis), acute liver failure, stomatitis;
- Blood coagulation system: often - bleeding; infrequently - an increase in bleeding time;
- Nervous system: infrequently - dizziness, intracranial hemorrhage, paresthesia, headache; very rarely - hallucinations, taste disturbances, confusion;
- Immune system: very rarely - anaphylactoid reactions, serum sickness;
- Respiratory system: often - nosebleeds; very rarely - bleeding from the respiratory tract (pulmonary hemorrhage, hemoptysis), interstitial pneumonia, bronchospasm;
- Blood system: infrequently - eosinophilia, leukopenia, thrombocytopenia; rarely, neutropenia, including severe neutropenia; very rarely - aplastic anemia, thrombotic thrombocytopenic purpura, agranulocytosis, pancytopenia, granulocytopenia, severe thrombocytopenia, anemia;
- Urinary system: infrequently - hematuria; very rarely - an increase in the concentration of creatine in the blood, glomerulonephritis;
- Musculoskeletal system: very rarely - arthritis, hemorrhages in the joints and muscles, myalgia, arthralgia;
- Cardiovascular system: very rarely - vasculitis, lowering blood pressure;
- Subcutaneous tissue and skin: often - subcutaneous bruising; infrequently - itching, rash, purpura (subcutaneous hemorrhage); very rarely - bullous dermatitis (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), lichen planus, eczema, urticaria, erythematous rash, angioedema;
- Sense organs: infrequently - eye hemorrhages (conjunctival, retinal and tissue); rarely - vertigo;
- Other: often - bleeding from the site of puncture of the vessels; very rarely - fever.
Clopidogrel should be taken with caution if there is an increased risk of bleeding due to surgical interventions, injuries, disorders of the hemostatic system. In planned operations (if the antiplatelet effect is undesirable), the drug must be canceled 7 days before they are carried out.
Clopidogrel is prescribed with caution in patients with severely impaired liver function, in which hemorrhagic diathesis is possible.
If there are signs of excessive bleeding (menorrhagia, bleeding gums, hematuria), it is necessary to conduct a study of the hemostatic system (platelet count, bleeding time, tests of the functional activity of platelets). Recommended regular monitoring of laboratory parameters of the functional activity of the liver.
Clopidogrel should be used with caution simultaneously with heparin, warfarin, nonsteroidal anti-inflammatory drugs, and for a long time with acetylsalicylic acid, since the safety of this combination of drugs has not been completely established.
In experimental studies, no carcinogenic or genotoxic effect was identified.
The risk of gastrointestinal bleeding increases with simultaneous use with nonsteroidal anti-inflammatory drugs, including naproxen.
When combined with acetylsalicylic acid, antiplatelet effect may be enhanced.
Since Clopidogrel can inhibit the activity of the CYP2C9 isoenzyme, while being used with drugs that are metabolized with the participation of this isoenzyme (including with tolbutamine, phenytoin), it is impossible to exclude an increase in their plasma concentrations.
Terms and conditions of storage
Store in a dark, out of reach of children at a temperature up to 25 ° C.
Shelf life - 3 years.