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Clopidex pills 75mg №30
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Composition
Film Coated Tablets | 1 tab. |
active substance: | |
clopidogrel (in the form of Clopidogrel hydrosulfate form-I - 97,875) | 75 mg |
excipients: hyprolosis - 6.125 mg; mannitol - 120.175 mg; MCC (PH 102) - 17.15 mg; macrogol 6000 - 2.45 mg; hydrogenated castor oil - 1.225 mg | |
film cover: Opadry pink (lactose monohydrate - 2.8 mg, hypromellose (15 cps) - 1.921 mg, titanium dioxide (E171) - 1.656 mg, triacetin - 0.56 mg, iron dye red oxide (E172) - 0.063 mg) - 7 mg |
Mechanism of action
Pharmacological action - antiplatelet.
Dosage and administration
Adults
Inside, regardless of the meal.
Myocardial infarction (MI), ischemic stroke (IS) and diagnosed occlusive peripheral artery disease. The drug is taken at 75 mg 1 time per day.
In patients with MI, treatment can begin from the first days to the 35th day after MI, and in patients with AI, they can be started from 7 days to 6 months after AI.
Acute coronary syndrome without ST segment elevation (unstable stenocardia or MI without Q wave). Treatment with the drug begins with a single dose of a loading dose of 300 mg, and then 75 mg once a day (in combination with Acetylsalicylic acid (ASA) at doses of 75-325 mg / day). Since the use of higher doses of ASA is associated with an increased risk of bleeding, the dose of ASA recommended for this indication should not exceed 100 mg. The optimal duration of treatment is not officially defined.The results of clinical studies confirm the feasibility of taking the drug up to 12 months after the development of acute coronary syndrome without ST-segment elevation.
Acute coronary syndrome with ST-segment elevation (acute MI). The drug should be taken at 75 mg 1 time per day with an initial single dose of a loading dose of 300 mg in combination with ASA and thrombolytics (or without thrombolytics). Combination therapy begins as soon as possible after the onset of symptoms and continues for at least 4 weeks. The efficacy of combination therapy with clopidogrel and ASA with this indication for more than 4 weeks has not been studied.
Atrial fibrillation. In order to prevent thrombotic and thromboembolic complications, the drug should be taken at 75 mg 1 time per day in combination with taking ASA 75-100 mg / day.
Skip taking the next dose. If less than 12 hours have passed after skipping the next dose, you should immediately take the missed dose and then take the next dose at the usual time.
If more than 12 hours have passed after skipping the next dose, then the patient should take the next one at the usual time. Do not take a double dose.
Patients with a genetically determined reduction in the function of the isoenzyme CYP2C19. Low activity of the isoenzyme CYP2C19 is associated with a decrease in the antiplatelet effect of clopidogrel. The mode of use of higher doses (600 mg - loading dose, then 150 mg / day daily) in patients with low activity of the isoenzyme CYP2C19 increases the antiplatelet effect of clopidogrel.Currently, in clinical studies that take into account clinical outcomes, the optimal dosing regimen in these patients has not been established.
Special patient groups
Elderly age. In patients older than 75 years, treatment with clopidogrel should begin without taking a loading dose.
Children. Experience with the drug in children is missing.
Liver dysfunction. Clinical experience with clopidogrel in patients with moderate hepatic impairment is very limited, so caution should be exercised when using the drug in this group of patients.
Impaired renal function. Clinical experience with clopidogrel in patients with mild to moderate renal impairment (Cl creatinine 60–30 ml / min) is limited, so care should be taken when using the drug in this group of patients.
Storage conditions of the drug Clopidex®
At temperatures not above 25 ° C.
Keep out of the reach of children.