Rivarospire 20 mg 28 tablets
Inspire Pharmaceutical Company
Inspire Pharmaceutical Company
Compound
Each tablet contains
rivaroxaban micronized 20 mg
Auxiliary components
Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Properties
Rivaroxaban is a highly selective direct factor Xa inhibitor with high oral bioavailability.
Activation of factor X to form factor Xa via the intrinsic and extrinsic coagulation pathways plays a central role in the coagulation cascade. Factor Xa is a component of the emerging prothrombinase complex, the action of which leads to the conversion of prothrombin to thrombin. As a result, these reactions lead to the formation of a fibrin thrombus and activation of platelets by thrombin. One factor Xa molecule catalyzes the formation of more than 1000 thrombin molecules, which is called the “thrombin explosion”. The reaction rate of factor Xa bound in prothrombinase is increased by 300,000 times compared to that of free factor Xa, which provides a sharp jump in the level of thrombin. Selective factor Xa inhibitors can stop the “thrombin burst”. Thus, rivaroxaban affects the results of some specific or general laboratory tests used to evaluate clotting systems.
Indications
– prevention of stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation;
-treatment of deep vein thrombosis and pulmonary embolism and prevention of recurrence of DVT and PE.
Dosage and administration
For oral administration.
Rivarospir 15 mg and 20 mg should be taken with meals.
The dose and course of treatment is prescribed by the doctor after the examination.
Contraindications
Hypersensitivity to the active ingredient or to any of the excipients that make up the drug.
– Active clinically significant bleeding.
– Pathological change or condition, if it is considered as a significant risk of massive bleeding. These include:
– a recent ulcer of the gastrointestinal tract or peptic ulcer of the gastrointestinal tract in the active phase;
– the presence of malignant neoplasms with a high risk of bleeding;
– recent brain injury or spinal cord injury;
– recent surgery on the brain, spinal cord or eyes;
– recent intracranial hemorrhage;
– Established or suspected varicose veins of the esophagus;
– arteriovenous malformations;
– vascular aneurysms or extensive intraspinal or intracerebral vascular disorders.
– Concomitant treatment with any other anticoagulants, such as unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.). except under special circumstances when switching to another anticoagulant therapy.
– Liver disease associated with coagulopathy and a clinically significant risk of bleeding.
– Pregnancy and breastfeeding.
Precautionary measures
Rivarospir is not recommended for use in patients receiving systemic treatment with azole antifungals (eg, ketoconazole) or HIV protease inhibitors (eg, ritonavir). These drugs are strong inhibitors of the CYP3A4 isoenzyme and P-glycoprotein. As a consequence, these medicinal products may increase the plasma concentration of rivaroxaban to a clinically significant level (2.6-fold on average), which increases the risk of bleeding.
Side effects
From the blood and lymphatic system
Anemia (including related
laboratory parameters).
From the immune system
Allergic reaction, allergic dermatitis.
From the nervous system
Dizziness, headache.
From the side of the organ of vision
Hemorrhage in the eye (including hemorrhage in the conjunctiva).
From the vascular side
Pronounced decrease in blood pressure, hematoma.
From the respiratory system, chest organs
Nosebleeds, hemoptysis.
From the digestive system
Bleeding gums, gastrointestinal bleeding (including rectal bleeding), abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting.
From the skin and subcutaneous tissues
Skin itching (including infrequent cases of generalized itching), skin rash, ecchymosis, skin and subcutaneous hemorrhages.
Storage
Store at a temperature not exceeding 30 degrees.
Package
Cardboard box contains 2 blisters of 14 tablets, paper instructions.