International Rivaroxaban Tablet 10 mg

Adult dose

This medicine 10 mg may be taken with or without food, whereas 15 mg and 20 mg should be taken with food. 1) 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. (See '12. Clinical Study Information') 2) 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 completion of 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 after an individualized assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism in relation to the risk of bleeding. Treatment period / Frequency of administration / 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 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 during the remainder of the treatment period. 3) Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower extremities (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 confirmed. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; 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, 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 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 in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Stop treatment with the vitamin K antagonist and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / Reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism Stop treatment with the vitamin K antagonist and start taking this medicine when the INR is ≤ 2.5. Regardless of the dose, INR values 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. 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 concomitantly until the INR is ≥2.0. During the first 2 days after the switch, administer the standard dose of the vitamin K antagonist; thereafter, administer the dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours have elapsed after taking this medicine. Once this medicine has been discontinued, INR testing may be performed 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 time of the next scheduled dose of the parenteral product (e.g., low-molecular-weight heparin), or at the time of discontinuation of a continuously administered parenteral product (e.g., intravenous unfractionated heparin). 4) 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. 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 plasma concentrations of this medicine were significantly increased; therefore, this medicine should be administered with caution. There is no clinical experience in patients with severe renal impairment and creatinine clearance below 15 mL/min; use of this medicine is not recommended. 1) 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. 2) 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 extremities (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 medicine 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 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 beverage 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 properly positioned, and flush the tube with water after administration.

This drug is an anticoagulant used to prevent or treat the formation of blood clots by inhibiting blood clotting. While taking this drug, the risk of bleeding may increase, so patients should be monitored closely for signs and symptoms of bleeding. If severe bleeding occurs, the medication should be stopped immediately and appropriate treatment should be received under the direction of a physician. This drug should not be administered to certain patients such as those with active bleeding, liver disease, pregnant or breastfeeding women, and those with lactose intolerance. Patients with a history of gastrointestinal ulcer or intracranial hemorrhage, or those with conditions that increase the risk of bleeding should not use this drug. Caution should be taken when combined with other anticoagulants or certain antifungal drugs, as it may increase the risk of bleeding, thus avoiding concurrent use with these medications is recommended. Patients with renal impairment or those with diseases that have a high risk of bleeding should be particularly careful when using this drug, and the risks of bleeding versus the therapeutic effects must be considered carefully. This drug may cause various side effects such as gastrointestinal bleeding, anemia, skin rash, liver dysfunction, etc., and patients should consult a physician immediately if any unusual symptoms appear. Particularly, elderly patients or those with renal impairment may experience an increase in blood drug concentration and higher risk of bleeding, hence caution is required. Pregnant or breastfeeding women should not use this drug, and women who could become pregnant must use contraception during the treatment. While taking this medication, it is essential to inform a physician prior to any surgery or invasive procedures, as there may be a need to discontinue the medication for a certain period before the procedure. In case of overdose, the risk of bleeding significantly increases, hence the medication must be taken exactly as prescribed in terms of dosage and timing. Symptoms such as drowsiness or syncope may occur while driving or operating machinery, so care should be taken to avoid risky activities if such symptoms arise.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic weakness and energy loss, discomfort, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound discharge, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, elevated transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, genitourinary bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, eosinophilia, drug reactions accompanied by systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stool, melena, arthralgia, myocardial infarction, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, gastrointestinal motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urination disorders, nephrolithiasis, bladder carcinoma, prostatic hyperplasia, flu-like syndrome, drug hypersensitivity reaction, syncope, drowsiness

This medication should be stored in a sealed container that can block air and moisture, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. By storing it this way, the efficacy and safety of the drug can be maintained.

Appearance

Bright red round film-coated tablet

Package unit

30 tablets/(10 tablets/PTP x 3), 100 tablets/(10 tablets/PTP x 10)