Rivaro 10 mg (Rivaroxaban)

Adult dose

This drug 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered 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 drug 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 drug 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 in patients with nonvalvular atrial fibrillation who underwent 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 drug 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 and dose of treatment should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus 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 drug is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 3) Prevention of venous thromboembolism in adult patients who have undergone major orthopedic surgery of the lower limbs (knee or hip replacement) The recommended dose of this drug 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 miss a dose of this drug If you miss a dose of this drug, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this drug 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. 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 drug ① Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist treatment and start taking this drug 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 treatment and start taking this drug when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this drug. INR should not be used because it is not suitable for measuring the anticoagulant activity of this drug. 2) Switching from this drug to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this drug to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this drug may affect INR elevation. Patients switching from this drug to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR is ≥2.0. During 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 drug and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours after taking this drug. Once this drug has been discontinued, INR can be tested 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this drug In patients receiving a parenteral anticoagulant, start this drug 0~2 hours before the time of the next scheduled parenteral dose (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) Switching from this drug to a parenteral anticoagulant Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug 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 the plasma concentration of this drug increased significantly; therefore, administer this drug with caution. There is no clinical experience in patients with severe renal impairment with creatinine clearance less than 15 mL/min; therefore, administration of this drug is not recommended. 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 who have undergone 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 drug 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 drug and an increased risk of bleeding may occur in these patients. 5. Patients who cannot swallow tablets, Immediately before use, this drug may be crushed and mixed with a liquid such as water or applesauce for oral administration. This drug may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this drug 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 thrombus formation by inhibiting blood clotting. Careful monitoring for signs of bleeding is necessary during treatment, as bleeding may occur. In particular, if severe bleeding occurs, this medication should be discontinued immediately. This medication should not be administered to certain patients, for example, those allergic to this drug or its components, those with existing bleeding, patients with severely impaired liver function, pregnant or nursing women, and those with lactose intolerance. Additionally, caution is needed for patients with a history of diseases or surgeries associated with a high risk of bleeding and those using other anticoagulants or certain antifungal agents. Patients with impaired kidney function or diseases that increase the risk of bleeding should use this medication cautiously, and attention should be paid when taking it with other drugs that may increase the risk of bleeding. This medication can cause side effects such as bleeding, anemia, gastrointestinal disturbances, skin rashes, etc., and in severe cases, anaphylaxis or serious skin reactions may occur, so report any abnormal symptoms to medical staff immediately. In elderly patients, blood concentration may increase, but special dose adjustments are not necessary; however, the risk of bleeding may be higher. Pregnant women should avoid use due to potential harm to the fetus, and women who may become pregnant should use contraception during treatment. If surgery or invasive procedures are planned, the medicine should be discontinued before the procedure to reduce the risk of bleeding and should be resumed once bleeding is controlled after the procedure. In case of overdose, the risk of bleeding increases, so observe closely and receive appropriate treatment if necessary. Be cautious when driving or operating machinery as drowsiness or fainting may occur during symptoms.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized reduction in strength and energy, discomfort, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusion, wound discharge, vascular pseudoaneurysm, transaminase increase, elevated blood bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased transaminase, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cranial hemorrhage, syncope, urogenital bleeding, renal impairment, non-hemorrhage, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, bile duct obstruction, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, syncope, drowsiness

This medication should be stored in a tightly sealed container to protect it from exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will ensure the medication's effectiveness.

Appearance

Pink round film-coated tablets

Package unit

5 tablets/box [(5 tablets/PTP)], 30 tablets/box [(10 tablets/PTP X3)]