Clopidogrel film-coated tablets 75 mg blister No. 30




Clopidogrel tablets are indicated for:
Secondary prevention of atherothrombosis in adults. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation.Composition
Active ingredient: clopidogrel;
1 tablet contains clopidogrel bisulfate (clopidogrel hydrosulfate) equivalent to clopidogrel 75 mg;
Excipients: lactose, monohydrate; corn starch; microcrystalline cellulose (E 460); macrogol; (Polyethylene glycol 1500) (E +1521); croscarmellose sodium; calcium stearate; methylcellulose (E 461); titanium dioxide (E 171).
Contraindication
Hypersensitivity to the active substance or to any component of the drug. Severe hepatic insufficiency. Acute bleeding (e.g. ulcer or intracranial hemorrhage).Method of application
The drug should be taken at a dose of 75 mg once a day, regardless of meals.
In patients with acute coronary syndrome without ST segment elevation (unstable angina or non-Q wave myocardial infarction on ECG), treatment with clopidogrel should be started with a single loading dose of 300 mg, and then continued at a dose of 75 mg 1 time per day (with ASA) at a dose of 75-325 mg per day. Since the use of higher doses of ASA increases the risk of bleeding, it is recommended not to exceed a dose of acetylsalicylic acid 100 mg. The optimal duration of treatment has not been formally established. The results of clinical studies indicate in favor of using the drug for up to 12 months, and the maximum effect was observed after 3 months of treatment.
Application features
Pregnant women
Not recommended for use.
Children
Not recommended for use.
Drivers
No effect.
Overdose
In case of overdose, bleeding time may be prolonged with subsequent complications. In case of bleeding, symptomatic treatment is recommended.
The antidote is not known.
Side effects
Vascular disorders: hematoma. Respiratory, thoracic and mediastinal disorders: epistaxis. Gastrointestinal disorders: gastrointestinal bleeding, diarrhea, abdominal pain, dyspepsia. Skin and subcutaneous tissue disorders: subcutaneous hemorrhages. General disorders and administration site conditions: bleeding at the injection site.Interaction
Medicinal products associated with an increased risk of bleeding. Due to the potential additive effect, there is an increased risk of hemorrhagic complications, therefore the simultaneous use of such medicinal products with clopidogrel requires caution.
Oral anticoagulants. Concomitant use of the drug with oral anticoagulants is not recommended, as this combination may increase the intensity of bleeding. Although the use of clopidogrel at a dose of 75 mg per day does not change the pharmacokinetic profile of S-warfarin or the international normalized ratio (INR) in patients receiving long-term warfarin treatment, the simultaneous use of clopidogrel and warfarin increases the risk of bleeding due to the existence of independent effects on hemostasis.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 3 years.
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