Rivaroxaban 15 mg

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. 1. Adults 1) 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 with concomitant administration of rivaroxaban 15 mg once daily [10 mg once daily for 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. 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction of 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 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 10 mg once daily. The duration and dose of treatment should be determined following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism in relation to the risk of bleeding. Treatment period / Dosing frequency / Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 / 15 mg twice daily / 30 mg From day 22 / 20 mg once daily / 20 mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After treatment for 6 months or longer / 10 mg once daily / 10 mg 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. 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 initial 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. 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, two 15 mg tablets may be taken at one time. 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. The daily dose should not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue treatment with the vitamin K antagonist and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue treatment with the vitamin K antagonist 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. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 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 increase in INR. 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 according to INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, 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 For 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 the continuously administered parenteral agent (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). Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine was significantly increased; therefore, administer this medicine 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 this population. 1) 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. 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction of 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).

This drug is an anticoagulant that prevents blood clotting. During treatment, bleeding may occur, so signs of bleeding must be carefully monitored. If severe bleeding occurs, medication should be stopped immediately, and consultation with healthcare professionals is necessary. This drug should not be used in patients with certain diseases or conditions, such as those with severe bleeding, severely impaired liver function, pregnant or breastfeeding women, and certain hereditary lactose intolerance patients. Moreover, patients with recent gastrointestinal ulcers or a history of hemorrhagic stroke or diseases with a high risk of bleeding should also avoid this medication. Caution is required when used in combination with other anticoagulants or certain antifungal agents as it may increase the risk of bleeding. Use in patients with impaired kidney function or those with diseases that have a high risk of bleeding should be approached with caution, and care should be taken when combined with other drugs that increase bleeding risks. During the course of this drug, symptoms of anemia or bleeding may appear, so regular blood tests to monitor the condition are important. If severe bleeding occurs, proper treatment including physical compression, surgical hemostasis, and administration of blood products should be received, and coagulation enhancers may be used if necessary. This drug is contraindicated during pregnancy, and women of childbearing potential must use contraception while taking this medication. Breastfeeding should only resume after stopping this drug. Elderly patients may experience increased blood concentration due to renal impairment, but special dose adjustments may not be needed; however, the risk of bleeding may increase. Safety and efficacy in pediatric and adolescent populations have not been established and are not recommended. Overdosage may increase the risk of bleeding, and activated charcoal may be used to reduce absorption if necessary. Drowsiness or fainting may occur while driving or operating machinery; caution is advised if symptoms are present. This drug may interact with various medications, so inform healthcare professionals of any other medications being taken. In particular, the risk of bleeding may increase when used with CYP3A4 and P-gp inhibitors, anticoagulants, NSAIDs, and platelet aggregation inhibitors. Prior to surgery or invasive procedures, this drug should be discontinued for a period of time, and re-administration should occur when bleeding risks are appropriately managed. Abrupt discontinuation of this drug may increase the risk of thromboembolism, so consult healthcare professionals to ensure proper alternative therapy is in place during cessation. Special attention should be taken during neuraxial anesthesia or lumbar puncture due to the risk of nerve damage from bleeding, necessitating careful scheduling of procedures relative to drug administration. If abnormal symptoms such as skin rash, severe allergic reaction, or mucosal ulceration occur while taking this drug, immediate notification to healthcare professionals is needed. If symptoms such as bleeding or anemia, dizziness, headache, or respiratory distress occur during treatment, seek immediate medical attention.

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

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the drug's effectiveness and stability.

Appearance

Red round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP * 3]