Deplatt-75 pills 75 mg, 28 pcs.

Composition

Film-coated tablets 1 tab. clopidogrel 75 mg

Pharmacological action

Antiplatelet agent. Selectively reduces the binding of ADP to platelet receptors and the activation of glycoprotein IIb/IIIa receptors under the action of ADP, thus disrupting platelet aggregation. Reduces platelet aggregation caused by other factors. agonists, preventing their activation by released ADP, does not affect the activity of PDE. It irreversibly binds to platelet ADP receptors, which remain immune to ADP stimulation throughout the life cycle (about 7 days). Inhibition of platelet aggregation is observed 2 hours after administration (40% inhibition) of the initial dose of 400 mg. The maximum effect (60% suppression of aggregation) develops after 4-7 days of continuous administration at a dose of 50-100 mg / day. The antiplatelet effect persists for the entire period of platelet life (7-10 days).

Indications

Prevention of thrombotic complications in patients with myocardial infarction, ischemic stroke or peripheral artery occlusion. In combination with ASA for the prevention of thrombotic complications in acute coronary syndrome: with ST-segment elevation if thrombolytic therapy is possible; without ST-segment elevation (unstable angina, non-Q-wave myocardial infarction), including in patients undergoing stenting.6

Contraindications

Hypersensitivity, severe hepatic insufficiency, acute bleeding (including bleeding from a peptic ulcer or intracranial hemorrhage), pregnancy and lactation, children under 18 years of age. For medicinal products containing lactose (optional): lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome. With caution. Moderate hepatic insufficiency, CRF, pathological conditions that increase the risk of bleeding (including trauma, surgery), a tendency to bleed, simultaneous use of ASA, warfarin, NSAIDs (including COX-2 inhibitors), heparin and glycoprotein IIb/IIIa inhibitors, hereditary decrease in the function of the CYP2C19 isoenzyme.

Side effects

Frequency: very often-more than 1/10, often-more than 1/100 and less than 1/10, infrequently-more than 1/1000 and less than 1/100, rarely-more than 1/10000 and less than 1/1000, very rarely-less than 1/10000, including isolated cases. Hematopoietic disorders: infrequently-thrombocytopenia, leukopenia, eosinophilia; rarely-neutropepia, including severe; very rarely-thrombotic thrombocytopenic purpura, anemia including aplastic, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia. Allergic reactions: very rarely-anaphylactic reactions, serum sickness. From the nervous system: infrequently-headache, dizziness, paresthesia, intracranial bleeding, including with a fatal outcome; very rarely-confusion, hallucinations, taste disorders. From the sensory organs: infrequently – hemorrhage in the conjunctiva, eyes, retina; rarely-vertigo. From the cardiovascular system: often-hematoma; very rarely-severe bleeding, bleeding from the surgical wound, vasculitis, decreased blood pressure. From the respiratory system: very often – nosebleeds; very rarely-bronchospasm, interstitial pneumonitis, pulmonary hemorrhage, hemoptysis. From the digestive system: often – diarrhea, abdominal pain, dyspepsia, bleeding from the gastrointestinal tract; infrequently – stomach and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence; rarely-retroperitoneal bleeding; very rarely – pancreatitis, colitis, including ulcerative or lymphocytic, stomatitis, acute liver failure, hepatitis, impaired liver function tests, bleeding from the liver Gastrointestinal tract with a fatal outcome. From the skin: often-subcutaneous hemorrhage; infrequently-skin rash, pruritus, purpura; very rarely-angioedema, urticaria, erythematous rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, lichen planus. Musculoskeletal disorders: very rare – hemarthrosis, arthritis, arthralgia, myalgia. From the genitourinary system: infrequently-hematuria; very rarely-glomerulonephritis, hypercreatininemia. Local reactions: often-bleeding at the injection site. Laboratory parameters: infrequently-prolongation of bleeding time. Other: very rare – fever.

Interaction

Concomitant administration of warfarin with clopidogrel may increase the intensity of bleeding, so the use of this combination is not recommended. The use of glycoprotein IIb/IIIa inhibitors, ASA, and heparin together with clopidogrel increases the risk of bleeding. When used concomitantly with NSAIDs, the risk of bleeding may increase. Concomitant administration with CYP2C19 inhibitors (e. g. omeprazole) is not recommended. The active metabolite of clopidorgel inhibits the activity of the CYP2C9 isoenzyme, resulting in increased plasma concentrations of phenytoin, tolbutamide, and NSAIDs.

How to take, course of administration and dosage

Inside, regardless of food intake. For the prevention of thrombotic complications in patients with myocardial infarction, ischemic stroke or peripheral artery occlusion-75 mg once a day. In patients with myocardial infarction, treatment can be started from the first days to the 35th day of myocardial infarction, and in patients with ischemic stroke-in the period from 7 days to 6 months after the ischemic stroke. To prevent thrombotic complications in acute coronary syndrome without ST segment elevation (unstable angina, non-Q wave myocardial infarction) – start with a single loading dose of 300 mg, and then take 75 mg/day (in combination with ASA in doses of 75-325 mg/day, the recommended dose is 100 mg/day). The maximum beneficial effect occurs after 3 months. The course of treatment is up to 1 year. For the prevention of thrombotic complications in acute coronary syndrome with ST-segment elevation (acute myocardial infarction with ST-segment elevation) – 75 mg/day with an initial single loading dose in combination with ASA and thrombolytics (or without thrombolytics). Combination therapy should be initiated as early as possible after the onset of symptoms and continued for at least 4 weeks. In patients over 75 years of age, treatment with clopidogrel should begin without taking its loading dose. In patients with a genetically determined decrease in the function of the CYP2C19 isoenzyme, the effect of clopidogrel may decrease. The optimal dosage regimen for these patients has not been established. Experience with use in patients with CRF or moderate hepatic insufficiency is limited.

Overdose

Symptoms: prolonged bleeding time, hemorrhagic complications. Treatment: stopping bleeding, platelet transfusion.

Special instructions

In the case of surgical interventions, if the antiplatelet effect is undesirable, the course of treatment should be stopped 7 days before the operation. Patients should be warned that since stopping the bleeding that occurs during the use of the drug requires more time, they should inform the doctor about each case of unusual bleeding. Patients should also inform the doctor about taking the drug if they are going to undergo surgery (including dental surgery) or if the doctor prescribes a new drug for the patient. During treatment, it is necessary to monitor the parameters of the hemostatic system (APTT, platelet count, tests of platelet functional activity); regularly examine the functional activity of the liver. In severe hepatic impairment, the risk of hemorrhagic diathesis should be considered. It is not recommended for patients with ischemic stroke less than 7 days old. Medications containing hydrogenated castor oil can cause dyspepsia and diarrhea. Very rarely, thrombotic thrombocytopenic purpura developed while taking clopidogrel, sometimes after short-term use. The condition is characterized by thrombocytopenia and microangiopathic hemolytic anemia associated with neurological disorders, kidney damage, and fever. Thrombotic thrombocytopenic purpura is a potentially life-threatening condition that requires immediate treatment, including plasmapheresis.

Active ingredient

Clopidogrel

Conditions of release from pharmacies

By prescription

Dosage form

of the tablet

Purpose

For adults as directed by your doctor

Indications

Prevention of thrombosis, Prevention of heart attacks and strokes

Weight

Weight: 22 gr.