Zaito 20 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. 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 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 have undergone percutaneous coronary intervention (PCI) with stent placement. Treatment of deep vein thrombosis and pulmonary embolism / Reduction in the risk of recurrent 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 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. The duration of treatment and dose should be determined following an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism compared with the risk of bleeding. 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 recurrent 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. 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 established. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; however, treatment for 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If you forget to take this medicine: Patients taking 15 mg twice daily: Take this medicine as soon as possible; in this case, two 15 mg tablets may be taken at once. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose as soon as possible. From the following day, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine: For reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, discontinue vitamin K antagonist treatment and start this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. For treatment of deep vein thrombosis and pulmonary embolism / reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism, discontinue vitamin K antagonist treatment and start 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. Switching from this medicine to a vitamin K antagonist: Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose based on INR testing. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing must not be performed until 24 hours after taking this medicine. If this medicine is discontinued, INR testing can be performed 24 hours after the last dose. 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 agent (e.g., low molecular weight heparin), or when a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 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. 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 were significantly increased; therefore, this medicine should be administered with caution. As there is no clinical experience in patients with severe renal impairment with creatinine clearance below 15 mL/min, administration of this medicine is not recommended. Reduction in 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. Treatment of deep vein thrombosis and pulmonary embolism / Reduction in the risk of recurrent 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). 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. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and taken 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, ensure that the tube is correctly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat thrombosis by inhibiting blood coagulation. When taking this medication, you should be cautious of bleeding signs such as nosebleeds, gum bleeding, or blood in urine or feces, as bleeding may occur. If serious bleeding occurs, you should immediately stop taking this medication and consult with a physician. This medication should not be taken by individuals with certain liver diseases, those who are pregnant or breastfeeding, or anyone allergic to its components. Additionally, it is advisable not to take this medication if you have recently undergone gastrointestinal ulcer, brain hemorrhage, spinal or brain surgery, or if you have diseases with a high risk of bleeding. Caution is necessary when used in conjunction with other anticoagulants or certain antifungal medications, as the risk of bleeding may increase. Patients with compromised kidney function or underlying diseases that pose a risk of bleeding should use this medication cautiously, and careful monitoring is required when taken together with medications that increase bleeding risk. It is recommended to conduct regular blood tests to monitor for bleeding and anemia symptoms while taking this medication. When undergoing surgery or invasive procedures, inform your physician that you are taking this medication, and you may need to discontinue it for a certain period before the procedure. This medication can be harmful to fetal development during pregnancy, so women who are pregnant or planning to become pregnant should consult with a doctor before taking it and ensure appropriate contraception while using it. Elderly patients may have increased blood concentration of this medication; however, adjustments in dosage are generally not required, but caution should be exercised due to increased risk of bleeding. In case of overdose, the risk of bleeding may significantly increase, so the prescribed dosage should be strictly followed, and you should consult healthcare professionals immediately if unusual symptoms occur. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating machinery.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, and the storage temperature should be maintained between 1 to 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and prevents degradation.

Appearance

Brownish red round film-coated tablet

Package unit

90 tablets/box [10 tablets/PTP packaging x 9]