Description
Xarelto (Rivaroxaban) Coated Tablets 20 mg. №28
Ingredients:
Each coated tablet contains 20 mg of rivaroxaban.
Mechanism of Action:
Rivaroxaban, the active ingredient in Xarelto, is a direct Factor Xa inhibitor that selectively blocks the active site of Factor Xa, an important component in the coagulation cascade. By inhibiting Factor Xa, rivaroxaban prevents the formation of thrombin and subsequent blood clot formation.
Pharmacological Properties:
Xarelto exerts its anticoagulant effects by inhibiting Factor Xa, thereby interfering with the blood clotting process. It offers predictable pharmacokinetics and pharmacodynamics without the need for routine monitoring.
Indications for Use:
Xarelto is indicated for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE.
Contraindications:
Do not use Xarelto in patients with active pathological bleeding or a history of a serious hypersensitivity reaction to rivaroxaban. Avoid concomitant use with other anticoagulants unless under specific medical guidance.
Side Effects:
Common side effects of Xarelto include bleeding, bruising, and anemia. Serious adverse reactions may include intracranial hemorrhage and gastrointestinal bleeding. Patients should be monitored for signs of bleeding complications.
Usage Instructions:
The recommended dosage is one 20 mg tablet taken orally once daily with the evening meal. Swallow the tablet whole with water. Do not crush, chew, or break the tablet before swallowing.
Benefits Compared to Analogues:
Xarelto offers the advantage of a rapid onset of action and a fixed dosage regimen without the need for routine coagulation monitoring, providing convenience for patients requiring anticoagulant therapy.
Suitable Patient Groups:
Xarelto is suitable for adult patients requiring anticoagulation therapy for the specified indications. Special caution should be exercised when prescribing to elderly patients or those with renal impairment.
Storage Conditions and Shelf Life:
Store Xarelto in a cool, dry place away from direct sunlight. Keep the tablets in the original packaging to protect from moisture. Check the expiration date on the packaging and do not use after the stated shelf life.
Packaging Description:
Xarelto is available in blister packs containing 28 coated tablets of 20 mg strength. The packaging is designed to ensure the integrity and stability of the tablets until use.
Clinical Evidence and Proven Effectiveness:
Clinical trials such as the ROCKET AF study have demonstrated the efficacy of rivaroxaban in reducing the risk of stroke and systemic embolism in patients with atrial fibrillation compared to warfarin. Studies like EINSTEIN-DVT and EINSTEIN-PE have shown rivaroxaban to be non-inferior to standard anticoagulants for the treatment and prevention of DVT and PE.
Additional Information:
It is important for patients to adhere to the prescribed dosage of Xarelto and not discontinue the medication without consulting a healthcare provider, as this may increase the risk of thrombotic events. Patients should be educated on the signs of bleeding and instructed to seek immediate medical attention if any unusual bleeding or bruising occurs while taking Xarelto.
