Rivaroxaban 15 mg

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 coadministration 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 stenting. 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 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 10 mg once daily. The duration of treatment and dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism compared with 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 / 15 mg twice daily / 30 mg From day 22 onward / 20 mg once daily / 20 mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment / 10 mg once daily / 10 mg 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 who have undergone 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; 5 weeks of treatment 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 once. From the next day onward, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the next day onward, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. 2. Switching between medicines 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 Stop 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 Stop vitamin K antagonist therapy and start taking this medicine when the INR is ≤ 2.5. 2) Switching from this medicine to a vitamin K antagonist Patients switching from this medicine to a vitamin K antagonist should receive both medicines until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer the dose of the vitamin K antagonist based on INR testing. For patients receiving this medicine together with a vitamin K antagonist, INR testing should not be performed until 24 hours have elapsed after taking this medicine. Once this medicine is 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 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 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 blood concentrations of this medicine are significantly increased; therefore, this medicine should be administered with caution. Use 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 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 medicine to patients with liver disease associated with coagulopathy and to patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. 5. Patients who cannot 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 that may increase the risk of bleeding, so signs of bleeding should be closely monitored during treatment. If there is a significant bleed, therapy should be discontinued immediately and healthcare professionals should be informed if necessary. This drug should not be administered to certain patients, including those allergic to the active ingredient, those with significant bleeding, patients with severe hepatic impairment, women who are pregnant or breastfeeding, and patients with lactose intolerance. It is also advisable not to use this drug in patients with a high risk of bleeding, such as those with a history of gastrointestinal ulcers, intracranial bleeding, or brain or spinal cord injury. Additionally, caution should be exercised when taken with other anticoagulants or specific antifungal agents, as this may increase the risk of bleeding. Patients with impaired renal function may have elevated drug levels and increased bleeding risk, thus they should consult their doctor before use. Caution is also needed when used in conjunction with medications that increase bleeding risk, such as non-steroidal anti-inflammatory drugs or platelet inhibitors. If dizziness, headache, symptoms of anemia, abnormal bleeding or bruising occur during treatment, healthcare professionals should be notified immediately. This drug could potentially harm the fetus during pregnancy, so it is crucial to consult a doctor if pregnant or planning to conceive, and it is advisable to avoid use during breastfeeding. Elderly patients may have an increased bleeding risk due to decreased renal function, but generally, dose adjustments are not required. Safety and efficacy have not been established in children under 18 years of age, thus it is not recommended. Overdosing significantly increases the risk of bleeding, so strict adherence to the prescribed dosages is essential, and if an overdose is suspected, immediate medical attention is required. When undergoing surgery or invasive procedures, it is necessary to discontinue this drug for a specified period prior to the procedure, and the risk and status of bleeding should be closely monitored after the procedure. Caution is warranted as dizziness or drowsiness may occur while driving or operating machinery. It is important to consult with healthcare professionals about any other medications or dietary supplements that may increase bleeding risk while taking this drug.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gingival bleeding, gastrointestinal bleeding, gastric pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic reduction in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusion, wound exudate, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, genitourinary bleeding, renal dysfunction, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, vascular edema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is important to store the drug at room temperature, specifically between 1 and 30 degrees Celsius, to avoid degradation.

Appearance

Red circular film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP × 3)], 100 tablets/box [(10 tablets/PTP × 10)]