Deplatt-75, 75 mg 28 pcs

An antiplatelet agent. Selectively reduces the binding of ADP with receptors on platelets and the activation of glycoprotein IIb/IIIa receptors under the action of ADP, thus disrupting platelet aggregation. Reduces platelet aggregation caused by other agonists, preventing their activation by released ADP, does not affect FDE activity. Irreversibly binds to platelet ADP receptors, which remain immune to ADP stimulation during the life cycle (about 7 days). Inhibition of platelet aggregation is observed 2 h 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 dosing at a dose of 50-100 mg/day. The antiplatelet effect lasts 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 prevention of thrombotic complications in acute coronary syndrome: with ST-segment elevation if thrombolytic therapy is possible; without ST-segment elevation (unstable angina, myocardial infarction without Q-wave), including in patients undergoing stenting.

Active ingredient

Composition

Tablets, film-coated 1 tablet clopidogrel 75 mg

How to take, the dosage

Ingestion, regardless of meals. For prevention of thrombotic complications in patients with myocardial infarction, ischemic stroke or peripheral artery occlusion – 75 mg once daily. In patients with myocardial infarction, treatment can be started from the first day to the 35th day of myocardial infarction, and in patients with ischemic stroke – within 7 days to 6 months after ischemic stroke. For prevention of thrombotic complications in acute coronary syndrome without ST-segment elevation (unstable angina, myocardial infarction without Q wave), it is started with a single dose of 300 mg and then taken 75 mg/day (in combination with ASA at a dose of 75-325 mg/day, the recommended dose is 100 mg/day). The maximum favorable effect occurs after 3 months. The course of treatment is up to 1 year. For prevention of thrombotic complications in acute ST-segment elevation coronary syndrome (acute ST-segment elevation myocardial infarction), 75 mg/day with an initial single loading dose in combination with ASA and thrombolytics (or without thrombolytics). Combination therapy is started as soon as possible after the onset of symptoms and is continued for at least 4 weeks. In patients over 75 years old, treatment with clopidogrel should be started without its loading dose. In patients with genetically determined decreased CYP2C19 isoenzyme function, the effect of clopidogrel may be reduced. The optimal dosing regimen in such patients has not been established. The experience of use in patients with CKD or moderate hepatic impairment is limited.

Interaction

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

Special Instructions

In case of surgical interventions, if antiaggregant effect is undesirable, the treatment should be discontinued 7 days before surgery. Patients should be warned that since it takes longer to stop bleeding when using the drug, they should inform the physician about each case of unusual bleeding. Patients should also inform the doctor about taking the drug if they are going to have surgical interventions (including dental) or if the doctor prescribes a new drug for the patient. During the treatment it is necessary to control the indexes of hemostasis system (ABTV, platelet count, tests of platelet functional activity); regular examination of liver functional activity. In case of severe liver dysfunction, it is necessary to remember about the risk of hemorrhagic diathesis. It is not recommended to prescribe to patients with ischemic stroke of less than 7 days. LF containing hydrogenated castor oil may cause dyspepsia and diarrhea. Very rarely, thrombotic thrombocytopenic purpura has developed during clopidogrel administration, sometimes after short-term use. The condition is characterized by thrombocytopenia and microangiopathic hemolytic anemia, associated with neurological disorders, renal damage and fever. Thrombotic thrombocytopenic purpura is a potentially life-threatening condition requiring immediate treatment, including plasmapheresis.

Contraindications

Hypersensitivity, severe hepatic insufficiency, acute bleeding (including bleeding from peptic ulcer or intracranial hemorrhage), pregnancy and lactation, children under 18 years. For LF containing lactose (additionally): lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome. With caution. Moderate hepatic insufficiency, CPN, pathological conditions that increase the risk of bleeding (including. Trauma and surgery), propensity to bleeding, concomitant use of ASA, warfarin, NSAIDs (including COX-2 inhibitors), heparin and glycoprotein IIb/IIIa inhibitors, inherited decrease of CYP2C19 isoenzyme function.

Side effects

Frequency: very frequently – more than 1/10, frequently – 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 rare – less than 1/10000, including single cases. Blood organs: infrequent – thrombocytopenia, leukopenia, eosinophilia, rarely – neutropenia, including severe; very rare – thrombotic thrombocytopenic purpura, anemia including aplastic, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia. Allergic reactions: very rare – anaphylactic reactions, serum sickness. Nervous system: infrequent – headache, dizziness, paresthesia, intracranial hemorrhage, including fatal; very rare – confusion, hallucinations, taste disorders. Senses: infrequent – hemorrhage in the conjunctiva, eyes, retina; rarely – vertigo. Cardiovascular system: frequently – hematoma; very rarely – severe bleeding, bleeding from the operating wound, vasculitis, BP decrease. Respiratory system: very common – nasal bleeding; very rare – bronchospasm, interstitial pneumonitis, pulmonary bleeding, hemoptysis. The digestive system: frequently – diarrhea, abdominal pain, dyspepsia, gastrointestinal bleeding; infrequently – gastric and 12 duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence; rarely – retroperitoneal bleeding; very rarely – pancreatitis, colitis, including ulcerative or lymphatic ulcer.including ulcerative or lymphocytic, stomatitis, acute liver failure, hepatitis, abnormal liver function tests, gastrointestinal bleeding with lethal outcome. Skin: often – subcutaneous hemorrhage, infrequently – skin rash, itching, purpura, very rarely – angioedema, urticaria, erythematous rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, lichen planus red. Musculoskeletal system: very rare – hemarthrosis, arthritis, arthralgia, myalgia. Genitourinary system: infrequent – hematuria; very rare – glomerulonephritis, hypercreatininemia. Local reactions: often – bleeding at the injection site. Laboratory parameters: infrequent – prolongation of bleeding time. Other: very rarely – fever.

Overdose

Symptoms: prolongation of bleeding time, hemorrhagic complications. Treatment: stopping bleeding, transfusion of platelet mass.

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