Xarelto is prescribed in combination with acetylsalicylic acid (ASA) or in combination with ASA and clopidogrel or ticlopidine to prevent atherothrombotic events in adult patients after acute coronary syndrome (ACS) with an increased level of cardiac biomarkers.
Xarelto is prescribed in combination with acetylsalicylic acid (ASA) to prevent atherothrombotic events in adult patients with coronary artery disease (CAD) or recurrent peripheral arterial disease (PAD) with a high risk of ischemic events.
Active substance: rivaroxaban;
1 coated tablet contains 2.5 mg rivaroxaban;
Excipients: microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, lactose, magnesium stearate, sodium lauryl sulfate, iron oxide yellow (E172), polyethylene glycol, titanium dioxide (E 171).
Hypersensitivity to rivaroxaban or to any excipients of the preparation.
Clinically significant active bleeding.
Injury or conditions accompanied by a significant risk of bleeding, which include currently or recently diagnosed ulcers of the gastrointestinal tract, malignant tumors with a high risk of bleeding, recent brain or spinal cord injury, recent surgery on the main, spinal cord or eyes, recent intracranial hemorrhage, esophageal varices (detected or suspected), arteriovenous malformations, vascular aneurysms, or significant intraspinal or intracerebral vascular abnormalities.
Simultaneous use with any other anticoagulants, in particular unfractionated heparin, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexil and p. .), except for the specific circumstances of the transition to alternative anticoagulant therapy or cases when unfractionated heparin is prescribed in doses necessary for the functioning of an open catheter of the central veins or arteries.
Concomitant therapy with corticosteroids using antiplatelet agents in patients with a history of stroke or transient ischemic attack (TIA).
Concomitant therapy of coronary artery disease / OPA with the use of ASA in patients with a history of hemorrhagic or lacunar stroke, or with any stroke within the last month.
Liver diseases associated with coagulopathy and a clinically significant risk of bleeding, including class B and C liver cirrhosis (according to the Child-Pugh classification).
During pregnancy and breastfeeding.
For oral administration.
Xarelto can be taken with or without food.
For patients who find it difficult to swallow whole tablets, Xarelto tablet can be crushed and mixed with water or applesauce just before oral use.
Tablets of the preparation Xarelto in crushed form can be administered using a gastric tube (after checking the correct location in the stomach). Crushed tablets should be injected with a small amount of water through a gastric tube, after which the tube should be rinsed with water.
Pregnant
Contraindicated.
Children
Contraindicated.
Drivers
Carefully.
There have been rare cases of overdose (up to 600 mg) without complications such as bleeding or other adverse reactions. Due to limited absorption, when the preparation is administered at doses significantly higher than therapeutic doses (50 mg or higher), a satiety effect is expected without further increase in mean plasma level.
A specific neutralizing agent (andexanet alfa) that counteracts the pharmacological effects of rivaroxaban (see the Summary of Product Characteristics for andexanet alfa). In case of preparation overdose, activated charcoal can be used to reduce the absorption of rivaroxaban.
The most common reported adverse reactions in patients receiving rivaroxaban were bleeding. There were frequent reports of nosebleeds (4.5%) and bleeding from the gastrointestinal tract (3.8%).
Simultaneous use with any other anticoagulants, in particular unfractionated heparin, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexil and p. .), except for the specific circumstances of the transition to alternative anticoagulant therapy or cases when unfractionated heparin is prescribed in doses necessary for the functioning of an open catheter of the central veins or arteries.
Keep out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life is 3 years.
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