Egithrombus
Egitrombus: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Egitromb
ATX code: B01AC04
Active ingredient: clopidogrel (Clopidogrel)
Producer: EGIS Pharmaceutical Plant, CJSC (EGIS Pharmaceuticals, PLC) (Hungary)
Description and photo updated: 30.11.2018
Prices in pharmacies: from 766 rubles.
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Egithrombus is an antiplatelet drug that prevents blood clots.
Release form and composition
Dosage form - tablets, film-coated: biconvex, round, from almost white to white, engraved on one side - "E 181", practically or completely odorless (in a blister 7 pcs., In a cardboard box 2 or 4 blisters and instructions for use of Egitromba).
Composition of 1 tablet:
- active substance: clopidogrel (in the form of hydrogen sulfate) - 75 mg;
- auxiliary components: hydrogenated castor oil, anhydrous colloidal silicon dioxide, microcrystalline silicon cellulose, hyprolosis (with a low degree of substitution);
- film shell: white opadry YI-7000 (macrogol 400, titanium dioxide, hypromellose).
Pharmacological properties
Pharmacodynamics
The active ingredient of Egitromba - clopidogrel, is an antiplatelet agent, a specific and active inhibitor of platelet aggregation. The drug selectively reduces the binding of adenosine diphosphate (ADP) to receptors on platelets and reduces the activation of glycoprotein (GP) IIb / IIIa receptors by ADP, thus weakening platelet aggregation.
Clopidogrel also reduces platelet aggregation caused by other agonists, preventing their activation by released ADP. It does not affect the activity of phosphodiesterase (PDE).
Clopidogrel binds irreversibly to platelet ADP receptors, which remain immune to ADP stimulation throughout the life cycle (approximately 7 days).
The onset of inhibition of platelet aggregation (40% inhibition) is noted 2 hours after taking the starting dose of clopidogrel. The maximum effect (60% suppression of aggregation) develops within 4–7 days of regular administration of the drug in a daily dose of 50–100 mg. The antiplatelet effect lasts the entire life of platelets (7-10 days).
In patients with atherosclerotic vascular lesions, the drug prevents the development of atherothrombosis, regardless of the localization of the vascular process (cardiovascular, peripheral and cerebrovascular lesions).
Pharmacokinetics
With repeated administration of the drug, 75 mg per day, clopidogrel is rapidly absorbed from the gastrointestinal tract.
It is characterized by high bioavailability, but in plasma it is present in low concentration and after 2 hours does not reach the measurement limit (0.025 μg / l).
94–98% binds to plasma proteins. It undergoes metabolism in the liver with the formation of the main metabolite - an inactive derivative of carboxylic acid.
After repeated administration of a dose of 75 mg, the maximum plasma concentration is reached within 1 hour and is approximately 3 mg / l.
It is excreted: 50% - by the kidneys (including half the dose in the form of a metabolite), 46% - through the intestines.
The half-life of the main metabolite (with a single and repeated use) is 8 hours.
In severe renal failure (creatinine clearance 5-15 ml / min), the plasma concentration of the main metabolite after taking clopidogrel in a daily dose of 75 mg is lower than in moderate renal failure (creatinine clearance 30-60 ml / min) and with healthy renal function.
Indications for use
Egithrombus is used to prevent atherothrombotic complications in adults in the following cases:
- myocardial infarction (period from several days to 35 days);
- ischemic stroke (period from 7 days to 6 months);
- occlusive peripheral arterial disease;
- acute coronary syndrome with ST segment elevation (in combination with acetylsalicylic acid; if thrombolytic therapy is possible);
- acute coronary syndrome without ST segment elevation (unstable angina pectoris, myocardial infarction without Q wave), including after stenting (in combination with acetylsalicylic acid).
Egithrombus in combination with acetylsalicylic acid (ASA) is used to prevent atherothrombotic and thromboembolic complications (including stroke) in atrial fibrillation in adult patients with at least one risk factor for vascular complications and the impossibility of using indirect anticoagulants (subject to a low risk of development bleeding).
Contraindications
Absolute:
- active bleeding (intracranial hemorrhage, peptic ulcer);
- severe liver failure;
- age up to 18 years;
- period of pregnancy and lactation;
- hypersensitivity to any component of the drug.
Relative (Egithromb tablets are used with caution, after assessing the benefits and risks):
- chronic renal failure;
- moderate hepatic impairment;
- pathological conditions that increase the risk of bleeding (including trauma and surgery);
- weak activity of the isoenzyme CYP2C19 (clopidogrel in recommended doses in such patients forms a smaller amount of the active metabolite, and its antiplatelet effect is less pronounced; as a result, taking clopidogrel in recommended doses for the treatment of acute coronary syndrome or percutaneous coronary intervention can contribute to the development of a higher frequency of cardiovascular complications than with normal activity of the isoenzyme CYP2C19);
- simultaneous use of acetylsalicylic acid, non-steroidal anti-inflammatory drugs (including COX-2 inhibitors), glycoprotein IIb / IIIa inhibitors, heparin, warfarin.
Egithrombus, instructions for use: method and dosage
Egitromb tablets should be taken orally. Meal timing doesn't matter.
Recommended dosage regimens for adult patients, including the elderly:
- heart attack, stroke: 75 mg 1 time per day, treatment should be started within a period from several days to 35 days after myocardial infarction, from 7 days to 6 months - after ischemic stroke;
- atrial fibrillation: 75 mg 1 time per day. At the same time, ASA is taken in a daily dose of 75-100 mg (it is continued after the cancellation of Egithrombus);
- acute coronary syndrome without ST segment elevation (unstable angina pectoris, myocardial infarction without Q wave): a single loading dose of 300 mg, then 75 mg once a day. At the same time, ASA is prescribed in a daily dose of 75–325 mg (preferably not more than 100 mg, since taking higher doses of ASA is associated with an increased risk of bleeding). The maximum effect develops within 3 months of treatment. There are no data on the effectiveness of therapy for more than 12 months;
- acute myocardial infarction with ST segment elevation: 75 mg 1 time per day. Treatment begins with a loading dose, the administration is combined with ASA and, if necessary, with thrombolytics. The effectiveness of therapy for more than 4 weeks has not been studied.
Recommendations in case of missed pills:
- less than 12 hours have passed: you should immediately take the missed dose, then adhere to the usual therapy schedule;
- more than 12 hours have passed: the next dose should be taken at the usual time, double dose is prohibited.
In patients with low activity of the isoenzyme CYP2C19, the antiplatelet effect of clopidogrel decreases. It can be enhanced by using Egithromb in higher doses (loading dose - 600 mg, then - 150 mg 1 time per day), however, at present, during clinical trials, taking into account possible outcomes, the optimal dosage regimen for such patients has not been established.
Side effects
Possible side effects of Egithrombus (classified as follows: often - from> 1/100 to 1/1000 to 1/10 000 to <1/1000, very rarely - <1/10 000):
- from the immune system: infrequently - skin rash; very rarely - urticaria, serum sickness, angioedema, anaphylactoid reactions;
- on the part of the hematopoietic system: often - bleeding (usually occurs during the first month of treatment; with the simultaneous use of ASA or ASA and heparin, possible cases of severe bleeding); infrequently - increased bleeding time, eosinophilia, neutropenia, leukopenia, decreased platelet count; very rarely - anemia (including aplastic), pancytopenia, granulocytopenia, agranulocytosis, severe thrombocytopenia (platelet count ≤ 30 × 10 9 / l), thrombotic thrombocytopenic purpura;
- on the part of the blood coagulation system: often - hemorrhage (hematoma);
- on the part of the cardiovascular system: very rarely - arterial hypotension, vasculitis;
- from the central and peripheral nervous system: infrequently - paresthesia, dizziness, headache; rarely - systemic dizziness; very rarely - disorders of taste, confusion, hallucinations;
- from the urinary system: very rarely - increased serum creatinine levels, glomerulonephritis;
- from the digestive system: often - abdominal pain, diarrhea, dyspepsia, gastrointestinal bleeding; infrequently - constipation, nausea, gastritis, intestinal distention, vomiting, stomach and / or duodenal ulcer, hemorrhagic stroke; very rarely - stomatitis, colitis (including lymphocytic and ulcerative), pancreatitis, impaired liver function tests, hepatitis, acute liver failure;
- from the musculoskeletal system: very rarely - arthritis, arthralgia, myalgia;
- from the respiratory system: very rarely - interstitial pneumonitis, bronchospasm;
- on the part of the skin: infrequently - itchy skin; very rarely - eczema, erythematous rash, lichen planus, bullous dermatitis (Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis);
- others: very rarely - an increase in body temperature.
Overdose
In case of an overdose of clopidogrel, bleeding time may be lengthened, due to which complications may develop.
Antidotes are unknown. If necessary, a rapid reduction in bleeding time is done with platelet transfusion.
special instructions
During therapy, the indicators of the hemostasis system (activated partial thromboplastin time, platelet count, tests of the functional activity of platelets), as well as the functional activity of the liver should be monitored.
Egithromb should be used with caution if there is a risk of bleeding (for example, during surgery or injury), a tendency to bleeding (especially intraocular and gastrointestinal), taking acetylsalicylic acid, non-steroidal anti-inflammatory drugs, glycoprotein IIb / IIIa inhibitors, heparin. Patients should be closely monitored by a physician who can promptly detect any signs of bleeding (including latent), especially in the first few weeks of antiplatelet therapy, after invasive cardiac procedures and surgical interventions. The simultaneous use of warfarin is not recommended, since the development of bleeding may increase.
If surgery is necessary, patients should inform the doctor about the use of the drug. If the antiplatelet effect is undesirable, Egithromb should be discontinued 7 days before the intervention.
If bleeding occurs while taking clopidogrel, it takes more time to stop it. For this reason, patients should inform their doctor about any unusual bleeding, and also coordinate any other medications with the doctor.
Due to the lack of data, clopidogrel is not recommended for use in acute (less than 7 days) ischemic strokes.
Very rarely, after taking clopidogrel (sometimes after short-term treatment), thrombotic thrombocytopenic purpura was found, characterized by thrombocytopenia and microangiopathic hemolytic anemia, which can be combined with impaired renal function, neurological signs, and fever. This condition is potentially fatal and therefore requires urgent treatment, including the use of plasmapheresis.
Influence on the ability to drive vehicles and complex mechanisms
The components of Egitromba do not affect or have a negligible effect on human abilities, including for performing potentially hazardous work and driving vehicles.
Application during pregnancy and lactation
There is no clinical experience with clopidogrel in pregnant women. Egithrombus is prohibited during this period.
It is not known whether the drug is excreted in breast milk, therefore, its use is contraindicated during lactation, or it is recommended to stop breastfeeding.
Pediatric use
The efficacy and safety of clopidogrel in children and adolescents under 18 years of age have not been proven, therefore Egithromb is not used in pediatrics.
With impaired renal function
Treatment of patients with chronic renal failure is carried out with caution, since the experience of using clopidogrel for functional renal impairment is limited.
For violations of liver function
In severe hepatic impairment, Egithrombus is contraindicated.
Treatment of patients with moderate hepatic impairment is carried out with caution, since experience with the drug is limited.
Use in the elderly
In old age, there is no need to adjust the dose of Egithrombus.
Drug interactions
- nonsteroidal anti-inflammatory drugs, acetylsalicylic acid, indirect anticoagulants, thrombolytics, heparin: the antiplatelet effect increases, the risk of bleeding from the gastrointestinal tract increases (special care is required when using such combinations);
- warfarin: increased bleeding is possible (it is recommended to avoid this combination);
- glycoprotein IIb / IIIa inhibitors: the risk of increased bleeding increases in the event of surgery or injury (caution required);
- theophylline and digoxin: clopidogrel does not affect their pharmacokinetics;
- antacid drugs: absorption of clopidogrel does not change under their action;
- nifedipine, atenolol or their combination, as well as phenobarbital, cimetidine, estrogens: there is no clinically significant interaction with their simultaneous use with Egithromb;
- nonsteroidal anti-inflammatory drugs, phenytoin, tolbutamide: an increase in their plasma concentration is possible, since the clopidogrel metabolite is able to suppress the activity of the CYP2C9 isoenzyme;
- drugs that inhibit the CYP2C19 system: may reduce the concentration of the active metabolite of clopidogrel; strong and moderate inhibitors of this system are not recommended to be used simultaneously with Egithromb, when such combination therapy is necessary, it is worth choosing a drug with the least inhibition of CYP2C19, for example, pantoprazole.
Analogs
The analogs of Egitromb are Aggregal, Agrenox, Aspirin Cardio, Acetylsalicylic acid of cardio, Brilinta, Detromb, Zylt, Integrilin, Cardiomagnil, Clopidex, Lirta, Pidogrel, Sanovask, Trombital, Fluder, Effient, etc.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C out of reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Egitromba
The drug is used for prophylactic purposes, so there are practically no reviews of Egithromb from patients.
Medical specialists evaluate the drug on a positive side, since it can significantly reduce the risk of atherothrombotic and thromboembolic complications in cardiovascular diseases, including preventing the development of stroke.
Price for Egithrombus in pharmacies
The approximate price for Egitromb is 870-1000 rubles. for a pack of 28 film-coated tablets.
Egithrombus: prices in online pharmacies
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Drug name Price Pharmacy |
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Egithromb 75 mg film-coated tablets 28 pcs. 766 RUB Buy |
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Egithromb tablets p.p. 75mg 28 Pcs. 832 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
