Myungin Rivaroxaban Tablet 10 mg

Adult dose

This medicine 10 mg may be taken with or without food; the 15 mg and 20 mg doses should be taken with food. The dose 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 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor for up to 12 months. The dose 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, is 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. Days 1-21: 15mg twice daily, 30mg From day 22: 20mg once daily, 20mg After 6 months or more 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. The dose is 10 mg once daily. The first dose should be administered 6~10 hours after surgery, once hemostasis has been confirmed. A treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. 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 following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the following day, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. Start taking this medicine after discontinuing vitamin K antagonist treatment and when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. Start taking this medicine after discontinuing vitamin K antagonist treatment and when the INR is ≤ 2.5. For patients switching from this medicine to a vitamin K antagonist, the vitamin K antagonist should be administered concomitantly until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer the dose guided by INR testing. Start administration of the parenteral anticoagulant at the time the next dose of this medicine would have been due. No dose adjustment is required 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 increase significantly; therefore, administer this medicine with caution. As there is no clinical experience in patients with severe renal impairment (creatinine clearance less than 15 mL/min), use of this medicine is not recommended. 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. No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Avoid administering this medicine to patients with liver disease associated with coagulopathy or with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Immediately before use, this medicine may be crushed, mixed with water or a beverage such as applesauce, and administered orally. It may also be crushed and administered through a feeding tube with a small amount of water. Before administering this medicine through a feeding tube, confirm that the tube is correctly positioned, and flush the tube with water before administration.

This medication is an anticoagulant that prevents blood from clotting. However, bleeding can occur during treatment, so signs of bleeding should be monitored closely. If severe bleeding occurs, the use of this medication should be stopped immediately. This medication should not be administered to certain patients. For instance, patients allergic to the components of this medication, those with existing severe bleeding, patients with significant liver impairment, pregnant or breastfeeding women should not take this medication. Additionally, patients with genetic issues such as lactose intolerance should also not use this medication. Patients who have a high risk of bleeding, such as those with recent gastrointestinal ulcers or history of brain hemorrhage, or those who have undergone surgery on the brain or spinal cord, should avoid taking this medication. Taking this medication in combination with other anticoagulants or certain antifungals might pose risks, so caution is advised. It should be administered cautiously in patients with impaired kidney function or those with conditions that increase the risk of bleeding. Greater caution is required when taken with medications that increase the risk of bleeding, such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors. During treatment, bleeding symptoms and signs of anemia should be closely monitored, and, if necessary, blood tests should be conducted to check the patient's condition. If bleeding is suspected, consulting a doctor to adjust or stop the medication is crucial. This medication should be discontinued for a certain period before undergoing surgery or invasive procedures, and the timing of re-administration should be determined considering the bleeding risk after the procedure. Pregnant or breastfeeding women should not take this medication, and women of childbearing age must ensure effective contraception while on this medication. Elderly patients may have elevated blood concentrations due to reduced kidney function; although dose adjustments are not needed, the risk of bleeding may increase, requiring caution. The safety and efficacy of this medication in pediatric and adolescent patients under 18 years has not been established, so it is not recommended. In the case of overdose, the risk of bleeding increases, and appropriate treatment is necessary. Symptoms such as drowsiness or fainting may occur during driving or operating machinery, requiring caution when such symptoms are present. This medication may interact with other drugs, so patients should inform their doctor or pharmacist about any other medications they are taking.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Bright red round film-coated tablet

Package unit

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