Rivaroxaban 10 mg (Rivaroxaban)

Adult dose

This 10 mg tablet may be taken with or without food, while the 15 mg and 20 mg tablets should be taken with food. 1. Adults 1) Reduction in 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 with concomitant administration of rivaroxaban 15 mg once daily [10 mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor for up to 12 months in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement. (See '12. Clinical Trial Information'.) 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of 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 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 of treatment and the dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Treatment period Dosing frequency Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence Days 1-21 15mg twice daily 30mg From day 22 20mg once daily 20mg Reduction in 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 thereafter. 3) 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 given 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; treatment for 5 weeks is recommended for patients undergoing hip replacement and for 2 weeks for patients undergoing knee replacement. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at once. Starting the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking 1 tablet once daily. Do not double the daily dose to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ① Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist therapy and start taking this medicine when the international normalized ratio (INR) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist therapy and start taking this medicine when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this medicine. The INR is not appropriate for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 2) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect the INR, causing it to increase. Patients switching from this medicine to a vitamin K antagonist should receive both medicines until the INR is ≥2.0. During the first 2 days after the switch, administer the standard dose of the vitamin K antagonist; thereafter, administer the dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine is discontinued, INR testing may be performed 24 hours after the last dose. 3) 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 product (e.g., low-molecular-weight heparin), or when a continuously administered parenteral product (e.g., intravenous unfractionated heparin) is discontinued. 4) 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. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment (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 are significantly increased; therefore, this medicine should be administered with caution. Use of this medicine is not recommended in patients with severe renal impairment (creatinine clearance less than 15 mL/min), as there is no clinical experience in these patients. 1) Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose in 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. 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrence of 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). 4. Patients with hepatic impairment 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. 5. Patients who cannot swallow tablets Immediately before use, this medicine may be crushed and mixed with a liquid such as water or applesauce and administered orally. This medicine 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 correctly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat the formation of blood clots by inhibiting blood coagulation. While taking this drug, signs of bleeding must be carefully monitored. The risk of bleeding may increase, so any symptoms of bleeding should be promptly reported to healthcare professionals. If severe bleeding occurs, discontinuation of this drug may be necessary, and appropriate treatment should be received if needed. This medication should not be administered to certain patients. For instance, patients who are allergic to this drug or its components, those who are currently bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, and those with hereditary issues such as lactose intolerance should not use this drug. Additionally, patients who have a recent history of gastrointestinal ulcers, intracranial hemorrhage, spinal or brain surgeries, or diseases that carry a high risk of bleeding should avoid this medication. When combined with other anticoagulants or certain antifungal agents, the risk of bleeding may increase, so caution is needed when co-administering. Patients with slightly impaired kidney function, conditions that increase the risk of bleeding, malignant tumors, and those taking medications that affect hemostasis should use this drug cautiously. This drug can have a range of side effects, especially symptoms related to bleeding, which are the most significant. Symptoms of bleeding may include dizziness, pallor, shortness of breath, excessive bruising, or bleeding. If serious side effects are suspected, immediate notification of healthcare professionals and proper testing should be conducted. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use contraception during treatment. Elderly individuals may have elevated drug concentrations due to decreased kidney function; however, specific dose adjustments are not necessary, though increased bleeding risk should be considered. The safety and efficacy of this medication have not been established in children and adolescents under the age of 18, and therefore it is not recommended for this group. In case of overdose, the risk of bleeding may significantly increase, so the prescribed dosage must be strictly followed, and immediate medical attention should be sought if an overdose is suspected. This drug may affect driving or machinery operation, so caution should be exercised if symptoms of drowsiness or dizziness occur. When surgery or invasive procedures are anticipated, discontinuation of this drug may be required before the procedure, and the timing for re-administration afterward should be determined with bleeding risk in mind. Regular health checks and blood tests may be required to reduce the risk of bleeding during treatment with this drug. Many drugs interact with this medication, so it is essential to inform healthcare professionals of any other medications being taken. The blood concentration of this medication may change when taken with drugs that inhibit or induce certain enzymes, necessitating caution with co-administration. If any adverse reactions such as skin rash, mucosal ulceration, high fever along with bleeding symptoms occur while taking this medication, healthcare professionals must be informed immediately.

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

This medication should be stored in a tightly closed container, protecting it from air and moisture. It is essential to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy over time.

Appearance

Bright red round film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP packaging x 3)]