Zarokt Tablet 20 Milligrams (Rivaroxaban)

Adult dose

This 10 mg tablet may be taken with or without food, whereas the 15 mg and 20 mg tablets should be taken 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 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 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 of 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 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 after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment period Frequency of administration Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15mg twice daily 30mg 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 drug 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 drug is 10 mg once daily. The first dose should be administered 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 period 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. From the following day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following day, continue taking 1 tablet once daily. The daily dose must 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 of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist therapy and start taking this drug 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 vitamin K antagonist therapy 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 when switching to another anticoagulant. Note that this drug may affect the increase in INR. Patients switching from this drug to a vitamin K antagonist should take 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 a dose based on INR testing. However, in patients receiving this drug and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this drug. Once this drug is discontinued, INR testing may be performed 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 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). 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 blood concentrations of this drug increased significantly; therefore, administer this drug with caution. Administration of this drug is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min, as there is no clinical experience in these patients. 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). 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 are unable to swallow tablets Immediately before use, this drug may be crushed and mixed with water or a beverage such as 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 properly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat thrombus formation by inhibiting blood clotting. During treatment, there may be instances of bleeding, so careful observation for signs of bleeding is necessary. If severe bleeding occurs, immediately discontinue use and consult a physician. This medication should not be used by individuals allergic to the active ingredient or its components, those who are pregnant or breastfeeding, or those with severe liver or kidney issues. Additionally, caution is advised for individuals who have had recent bleeding or have diseases that pose a high risk of bleeding, and for those taking other anticoagulants or certain antifungal medications. Patients with compromised kidney function or diseases that increase bleeding risk should use this medication with caution, especially when combined with other drugs that may heighten bleeding risk. During this treatment, monitor closely for bleeding-related symptoms such as sudden bruising, nosebleeds, gum bleeding, hematuria, black stools, severe headaches, and dizziness. Moreover, elderly patients or those with specific diseases taking this medication may have a higher bleeding risk, necessitating regular check-ups and monitoring. If surgery or invasive procedures are planned, this medication should be discontinued at least 12 to 24 hours prior, and the timing of resuming administration post-procedure should consider the risk of bleeding. Women who are pregnant or planning to become pregnant must consult a physician and should use appropriate contraceptive methods during treatment. Overdose may increase the risk of bleeding, so it is crucial to strictly adhere to the prescribed dosage and report any side effects or unusual symptoms to medical personnel. Caution is needed, as dizziness or drowsiness may occur during driving or operating machinery. This medication may interact with other drugs, so be sure to inform healthcare providers of any other medications being taken.

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

This medication should be stored in a sealed container to prevent exposure to air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius. This way, the efficacy of the medication can be preserved.

Appearance

Dark red, bilaterally convex round film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP*10)]