Egithromb tablets 75mg, No. 28
Expiration Date: 05/2027
Russian Pharmacy name:
Эгитромб таблетки 75мг, №28
prevention of atherothrombotic complications in adult patients with myocardial infarction (several to 35 days old), ischemic stroke (7 days to 6 months old) or diagnosed with occlusive peripheral arterial disease;
prevention of atherothrombotic complications in adult patients with acute coronary syndrome in combination with acetylsalicylic acid (ASA): with ST segment elevation if thrombolytic therapy is possible; without ST segment elevation (unstable angina pectoris, myocardial infarction without Q wave), incl. in patients undergoing stenting during percutaneous coronary intervention;
prevention of atherothrombotic and thromboembolic complications, including stroke, with atrial fibrillation. In adult patients with atrial fibrillation who have at least one risk factor for vascular complications, who cannot take indirect anticoagulants and have a low risk of bleeding (in combination with ASA).
Inside, regardless of the meal.
For adults and elderly patients, EgithrombЃ should be taken 75 mg once a day.
Treatment should begin within a few 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 pectoris or myocardial infarction without Q wave), EgithrombЃ should be taken with a single loading dose of 300 mg, and then continue to take 75 mg once a day in combination with ASA (at a dose of 75 Ц325 mg / day). Since higher doses of ASA are associated with an increased risk of bleeding, it is recommended to prescribe it in doses not exceeding 100 mg. The data of clinical trials indicate the possibility of using the drug EgitrombЃ for up to 12 months, and the maximum effect of therapy is noted by the 3rd month.
Acute ST-segment elevation myocardial infarction. EgithrombЃ should be taken at 75 mg 1 time per day; start treatment with a loading dose and combine with or without ASA and thrombolytics. The effectiveness of therapy for more than 4 weeks has not been studied.
Atrial fibrillation. EgithrombЃ should be taken 1 time per day at a dose of 75 mg. In combination with the drug EgithrombЃ, it is necessary to start and then continue taking ASA (75-100 mg / day).
Skipping the next dose. If less than 12 hours have passed since the next dose is missed, then the missed dose of the drug should be taken immediately, and then the next doses should be taken at the usual time. If more than 12 hours have passed since the next dose is missed, then the patient should take the next dose at the usual time (do not take a double dose).
Special patient groups
Patients with a genetically determined reduced activity of the isoenzyme CYP2C19. Low activity of the isoenzyme CYP2C19 is associated with a decrease in the antiplatelet effect of clopidogrel. The regimen of higher doses (600 mg - loading dose, then - 150 mg 1 time per day daily) in patients with low activity of the isoenzyme CYP2C19 increases the antiplatelet effect of clopidogrel. However, at the moment, in clinical studies that take into account clinical outcomes, the optimal dosage regimen of clopidogrel for patients with its reduced metabolism has not been established due to the genetically determined low activity of the isoenzyme CYP2C19.
Elderly patients. No dose adjustment is required for elderly patients.
Children. There is no experience of using the drug in children.
Patients with impaired renal function. The experience of use in patients with impaired renal function is limited.
Patients with impaired liver function. The experience of use in patients with moderate liver disease (who may have manifestations of hemorrhagic diathesis) is limited.
Film-coated tablets | 1 tab. |
active substance: | |
clopidogrel hydrogen sulfate | 97.86 mg |
(equivalent to 75 mg clopidogrel) | |
excipients: silicon microcrystalline cellulose (MCC - 194.236 mg, anhydrous colloidal silicon dioxide - 3.964 mg) - 198.2 mg; hyprolosis (with a low degree of substitution (L-HPC B1) - 12 mg; hydrogenated castor oil - 12 mg | |
film shell: Opadry white YI-7000 (hypromellose - 6.25 mg, titanium dioxide - 3.125 mg, macrogol 400 - 0.625 mg) |
hypersensitivity to the active or any auxiliary component of the drug;
severe liver failure;
active bleeding (including bleeding from a peptic ulcer or intracranial hemorrhage);
pregnancy and lactation (see 'Application during pregnancy and lactation');
age up to 18 years (efficacy and safety have not been proven).
With care: moderate hepatic impairment; chronic renal failure; pathological conditions that increase the risk of bleeding (including trauma, surgery); concomitant use of ASA, NSAIDs (including COX-2 inhibitors), warfarin, heparin and glycoprotein IIb / IIIa inhibitors; low activity of the isoenzyme CYP2C19 (because in such patients, when using clopidogrel in recommended doses, less active metabolite of clopidogrel is formed and its antiplatelet effect is weaker, therefore, when taking the usually recommended doses of clopidogrel in acute coronary syndrome or percutaneous coronary intervention, more a higher incidence of cardiovascular complications than in patients with normal activity of the isoenzyme CYP2C19).