Zaito Tablet 15 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. 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 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. (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 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 completion of treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose for extended administration to reduce the risk of recurrence is 10mg once daily. The duration of treatment and treatment dose should be determined following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Duration of administration 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 medicine 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 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 each 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 one 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 vitamin K antagonist therapy and start taking this medicine when the International Normalized Ratio (INR) 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 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, as 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 INR elevation. Patients switching from this medicine to a vitamin K antagonist should receive both medicines until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer the vitamin K antagonist dose according to INR test results. On the other hand, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be tested 24 hours after the last dose. 3) 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. 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start administration of the parenteral anticoagulant at the time of the next scheduled dose of this medicine. 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 medicine increased significantly; therefore, administer this medicine with caution. Administration 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 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 administration of this medicine in patients with liver disease associated with coagulopathy and in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. Patients unable to swallow tablets Immediately before use, this medicine may be crushed and mixed with water or a liquid such as applesauce for oral administration. 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, confirm that the tube is correctly positioned and flush the tube with water after administration.

This drug is used to prevent or treat the formation of clots by preventing the blood from coagulating. During the use of this medication, there is a risk of bleeding; therefore, signs and symptoms of bleeding should be monitored closely. In cases of severe bleeding, the medication should be stopped immediately and medical advice should be sought. This medication should not be administered to patients with certain conditions or diseases. For example, patients with severe bleeding, severely impaired liver function, pregnant or lactating women, and certain hereditary lactose intolerance patients should not use this medication. Patients with recent gastrointestinal ulcers, a history of cerebral hemorrhage, vascular abnormalities, or malignant tumors with a high risk of bleeding should also avoid this medication. When combined with other anticoagulants or certain antifungal agents, the risk of bleeding may increase; therefore, caution is required when co-administering. Patients with impaired kidney function or those with diseases that increase bleeding risk should be given this medication carefully, comparing the risk of bleeding with the therapeutic effect. Various adverse reactions may occur, including bleeding, anemia, allergic reactions, gastrointestinal symptoms, and skin rashes. Patients should consult their doctor immediately if any unusual symptoms occur. Particularly, if severe skin rashes, mucosal ulcers, or high fever symptoms appear, the medication should be stopped immediately. This medication should not be used during pregnancy as it may affect the fetus. Women who may become pregnant should use contraceptive measures while using this medication. Breastfeeding women are advised to avoid this medication and can only take it after stopping breastfeeding. Elderly patients may have increased drug concentration due to reduced kidney function, but generally, dose adjustment is not required; however, the risk of bleeding may increase. The safety and efficacy of this medication in children and adolescents under 18 years have not been established; therefore, it is not recommended. Overdosing may increase the risk of bleeding; patients should be closely monitored, and appropriate treatment should be provided if necessary. Caution should be exercised when driving or operating machinery, as side effects like drowsiness or fainting may occur. This medication may interact with specific drugs; therefore, patients should inform their doctor or pharmacist about any other medications they are taking. In particular, the risk of bleeding may increase when combined with strong CYP3A4 inhibitors, P-glycoprotein inhibitors, anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), or platelet aggregation inhibitors. If surgery or invasive procedures are scheduled, this medication should be discontinued for a certain period before the procedure, and the timing of re-administration should be determined considering the bleeding risk and hemostatic status after the procedure. When discontinuing this medication, there may be an increased risk of thrombosis; therefore, appropriate alternative treatment should be provided under medical supervision. Patients who have received nerve block anesthesia or spinal taps have a risk of serious complications related to bleeding; therefore, the administration and timing of this medication should be carefully managed.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy reduction, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated bilirubin levels, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, elevated transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and intracerebral hemorrhage, syncope, urogenital hemorrhage, renal dysfunction, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine hemorrhage, post-operative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and should be kept at room temperature between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for a long time.

Appearance

Round, film-coated tablet with a reddish-brown color

Package unit

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