Neuroxaban 15 mg Tablets (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose of this medicine is 20 mg once daily. The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) is 15 mg once daily. The maximum daily dose of this medicine is 20 mg. There is limited experience in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement, using rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] in combination with a P2Y12 inhibitor for up to 12 months. Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: The recommended initial dose of this medicine for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. Thereafter, the recommended maintenance dose for the treatment of deep vein thrombosis and pulmonary embolism and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completing treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose for extended treatment to reduce the risk of recurrence is 10mg once daily. The duration and dose of treatment should be determined following an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, Days 1-21: 15mg twice daily, 30mg. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, from Day 22: 20mg once daily, 20mg. Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism, after at least 6 months of treatment: 10mg once daily, 10mg. The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg during the subsequent treatment period. Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement): The recommended dose of this medicine is 10 mg once daily. The first dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on the individual patient's risk of venous thromboembolism according to the type of surgery; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If you miss a dose of this medicine, take the missed dose as follows. Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at one time. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following day, continue taking one tablet once daily. The daily dose must not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine, reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Stop vitamin K antagonist therapy and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. Switching from a vitamin K antagonist to this medicine, treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism: Stop vitamin K antagonist therapy and start taking this medicine when the INR is ≤ 2.5. Regardless of the dose, INR values will be falsely elevated after taking this medicine. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR is ≥ 2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist based on INR testing. In patients receiving this medicine together with a vitamin K antagonist, INR testing must not be performed until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may be performed after 24 hours have elapsed since the last dose. Switching from a parenteral anticoagulant to this medicine: In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). Switching from this medicine to a parenteral anticoagulant: Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased significantly; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance below 15 mL/min, as there is no clinical experience in these patients. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) and severe renal impairment (creatinine clearance 15-29 mL/min) is 15 mg once daily. Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism / prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement): No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Avoid administering this medicine to patients with liver disease associated with coagulopathy and to patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. Immediately before use, this medicine may be crushed, mixed with a liquid such as water or applesauce, and administered orally. It may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medicine through a gastrointestinal tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This drug is used to prevent or treat blood from clotting. However, bleeding may occur during treatment, so it is important to carefully observe for signs of bleeding. In particular, if severe bleeding occurs, the use of this drug must be stopped immediately, and appropriate treatment must be administered according to a physician's instructions. This medication should not be administered to patients with certain diseases or conditions. For example, it should not be taken by patients who are allergic to this drug, those with severe bleeding, severe liver disease, pregnant or nursing women, or those with lactose intolerance. Additionally, caution is required for patients who have recently had conditions with a high risk of bleeding or have undergone certain surgeries, as well as for those concurrently using other anticoagulants or specific antifungal medications. Patients with reduced renal function or those with diseases that increase the risk of bleeding may experience elevated bleeding risk, hence should be used cautiously. This medication can cause various side effects beyond bleeding, including anemia, skin rash, allergic reactions, etc., and if any abnormal symptoms appear, the physician must be informed immediately. Particularly, if there are severe skin reactions, mucosal ulcers, high fever, or severe bleeding symptoms, the medication must be stopped immediately and the patient should visit a medical institution. This drug has many interactions with other medications; when used together with specific antifungal agents, antibiotics, other anticoagulants, or non-steroidal anti-inflammatory drugs, the risk of bleeding may increase, so consultation with a physician or pharmacist is essential. Pregnant or nursing women should not take this medication, and women of childbearing potential should practice contraception during treatment. Elderly individuals may have increased blood concentrations of this drug due to reduced renal function, but dosage adjustments are usually not required, although the risk of bleeding may be heightened. This medication is not recommended for children or adolescents under 18 years of age as safety and efficacy have not been established in this population. In case of overdose, the risk of bleeding may increase significantly, therefore the dosage must be strictly adhered to, and if overdose is suspected, the medical institution should be contacted immediately. Caution is advised when driving or operating machinery as this drug may cause dizziness or drowsiness. Finally, regular observation of bleeding symptoms and blood tests may be required during treatment with this medication, and dosage adjustments should be made according to a physician's directions in situations where the risk of bleeding increases.

• Hemorrhage
• anemia
• thrombocytosis
• tachycardia
• ocular hemorrhage
• gingival bleeding
• gastrointestinal bleeding
• stomach pain
• abdominal pain
• dyspepsia

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and safety.

Appearance

Red round film-coated tablet

Package unit

30 tablets/bottle