RivoXar tablet 15mg #28

Form

tableti

Dosage mg

15

Pack

28

International Nonproprietary Name - rivaroxaban Clinical-pharmacological group: Hemostasis → Antithrombotic and anticoagulant agents Composition Active substance: rivaroxaban 15 mg or 20 mg. Excipients: Pharmaceutical form Round, biconvex, red, film-coated tablets, with a score on one side "II" (rivarox (15 mg)). Round, biconvex, reddish-brown, film-coated tablets (rivarox (20 mg)). Clinical characteristics Therapeutic indications Rivaroxaban is indicated in adult patients for: - Prevention of stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation, with one or more risk factors, such as congestive heart failure, hypertension, age > 75 years, diabetes mellitus, history of stroke or transient ischemic attack. - Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE. Dosage and administration Dosage: For the prevention of stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation The recommended dose of rivaroxaban is 20 mg (1 tablet) once daily, which is the maximum recommended dose of the drug. Treatment should be continued as long as stroke and systemic thromboembolism risk factors are present. The duration of treatment depends on the balance between the benefits of treatment and the risk factors for potential complications that may develop as a result of treatment. If a dose is missed, the patient should take the medication immediately and continue taking the medication the next day according to the recommended regimen. The dose should not be doubled to compensate for a missed dose. Treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT, treatment of pulmonary embolism (PE) and prevention of recurrent PE The recommended starting dose of rivaroxaban is 15 mg twice daily for the first 3 weeks. From the fourth week onwards, for subsequent long-term therapy and prophylaxis, 20 mg once daily is prescribed. The minimum duration of the treatment course (at least 3 months) should be based on an assessment of reversible risk factors (recent surgery, trauma, period of immobilization). In cases of idiopathic DVT and PE, as well as in patients with a history of recurrent DVT and PE, the decision to prolong the treatment course should be made on a permanent basis based on the assessment of risk factors. When prolonged treatment is indicated for recurrent DVT and PE (after completion of 6 months of treatment), the recommended dose is 10 mg once daily. In patients at high risk of developing DVT and PE (in the presence of relevant comorbidities), or in patients who still have a risk of developing DVT and PE despite taking the drug at a dose of 10 mg, continuation of treatment at a dose of 20 mg daily should be considered. The duration of treatment and dose selection should be made individually for each patient and based on an assessment of the risk of bleeding. Contraindications: - Hypersensitivity to any component of the drug. - Active, clinically significant bleeding. - Pathological changes or conditions associated with the risk of massive bleeding, such as: - Recent gastrointestinal ulceration or active peptic ulcer disease. - Malignant neoplasm with a high risk of bleeding. - Recent trauma or injury to the brain or spinal cord. - Recent surgical operations on the head, spinal cord, or eyes. Pregnancy and lactation. - Children and adolescents under 18 years of age (efficacy and safety have not been established)