$93.00
Manufacturer: USA
Prevention of venous thromboembolism in adult patients who have undergone elective knee or hip replacement surgery. Prevention of strokes and systemic embolism in adult patients with non-valvular atrial fibrillation who have one or more risk factors, such as a history of stroke or transient ischemic attack, age 75 or older, hypertension, diabetes mellitus, and symptomatic heart failure (at least class II according to the new York heart Association classification). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as prevention of relapses of DVT and PE in adults (for information about patients who suffer from PE and have unstable hemodynamics, see the section “application Features”).
Description
Elicvis Storage
active substance: apixaban;
1 film-coated tablet contains 2.5 mg of apixaban;
Elicvis Excipients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, Opadry® II Yellow (hypromellose 15 cP; lactose monohydrate; titanium dioxide (E 171); triacetin; iron oxide yellow).
Elicvis Dosage form
Film-coated tablets.
Main physical and chemical properties: yellow, round, biconvex film-coated tablets, engraved with “893” on one side and “2 1/2” on the other.
Pharmacotherapeutic group
Antithrombotic drugs. Direct inhibitors of factor Xa. ATX code B01 AF02.
Pharmacological properties
Pharmacodynamics.
Mechanism of action.
Apixaban is a potent reversible direct and highly selective oral factor Xa inhibitor for oral administration. It does not need antithrombin III for antithrombotic action. Apixaban inhibits free and thrombus-associated factor Xa and inhibits prothrombinase activity. Apixaban does not directly affect platelet aggregation, but indirectly inhibits the thrombin-induced platelet aggregation process. Due to the inhibition of factor Xa, apixaban prevents the formation of thrombin and thrombus formation. Preclinical studies of apixaban in animals have shown the effectiveness of the antithrombotic effect of the drug for the prevention of arterial and venous thrombosis when taken in doses that did not disrupt hemostasis.
Pharmacodynamic effects.
The pharmacodynamics of apixaban reflect its mechanism of action (inhibition of factor Xa). As a result of inhibition of factor Xa, apixaban increases the values of such indicators as prothrombin time (IF), international normalized ratio (MHC) and activated partial thromboplastin time (APTT). The changes observed in coagulation rates at therapeutic doses are minor and extremely variable, and are not recommended for the pharmacodynamic properties of apixaban. During the analysis of thrombin formation, apixaban reduced the endogenous potential of thrombin – a quantitative indicator of thrombin formation in human blood plasma.
Apixaban also exhibits factor Xa inhibition activity, as evidenced by a decrease in the enzymatic activity of factor Xa by evaluation using different commercial kits to detect inhibition of factor Xa activity, although the specific results for different sets differed. The results of clinical trials are only available for Rotachrom® heparin chromogenic analysis. Plasma factor Xa inhibition activity is related to apixaban plasma concentrations. This relationship is close to linear, with maximal factor Xa inhibition activity observed at peak apixaban plasma concentrations. The relationship between apixaban plasma concentrations and factor Xa inhibitory activity is approximately linear over a wide range of apixaban doses.
Indication
Prevention of venous thromboembolism in adult patients who underwent elective knee or hip replacement surgery.
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation who have one or more risk factors such as a history of stroke or transient ischemic attack, age 75 years, hypertension, diabetes mellitus, symptomatic heart failure (at least class II) according to the classification of the New York Cardiac Association).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (pulmonary embolism), as well as prevention of recurrence of DVT and pulmonary embolism in adults (information on patients with pulmonary embolism and unstable hemodynamics is given in the section “Features”).
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Clinically significant active bleeding.
Liver disease accompanied by coagulopathy and clinically significant risk of bleeding.
Pathology or condition associated with a significant risk of severe bleeding (eg gastrointestinal ulcer disease or recent history, high-risk malignancies, recent brain or spinal cord injuries, recent brain, spinal cord or ophthalmic surgery) recent intracranial hemorrhage, diagnosed or suspected varicose veins of the esophagus, arteriovenous malformations, vascular aneurysms, severe intravertebral or intracranial vascular abnormalities).
Concomitant use of any other anticoagulants, such as unfractionated heparin, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.). “Method of administration and dosage”): administration of unfractionated heparin in doses required to ensure patency of the central venous or arterial catheter, or administration of unfractionated heparin during catheter ablation for the treatment of atrial fibrillation (see sections “Features” and “Interaction with other medicinal products”). means and other types of interactions “).
Recent Reviews