Rivaroxaban 10 mg Tablets (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 underwent 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 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. The recommended maintenance dose for subsequent 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 of treatment and dose should be determined after 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 first dose should be administered 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; 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 must 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 recurrent 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 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 the increase in INR. 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, and thereafter administer a dose of the vitamin K antagonist based on INR testing. However, in patients receiving this medicine concomitantly with a vitamin K antagonist, INR testing should not be performed until 24 hours 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 discontinuing a continuously administered parenteral agent (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 required in patients with mild renal impairment with a creatinine clearance of 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this medicine increased significantly; therefore, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment with a creatinine clearance of less than 15 mL/min, as there is no clinical experience in this population. 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 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 required 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 who cannot swallow tablets, Immediately before use, this medicine may be crushed, mixed with a liquid such as water or applesauce, and administered 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, 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. However, the risk of bleeding may increase during the use of this medication, so if signs of bleeding occur, it should be reported to healthcare professionals immediately. In particular, if severe bleeding occurs, the use of this medication should be discontinued, and professional treatment may be required in an emergency. Individuals with allergies to this medication, those already experiencing severe bleeding, individuals with severely impaired liver function, and women who are pregnant or nursing should not take this medication. It is also advisable not to use this medication in individuals who have recently experienced gastrointestinal ulceration, intracranial hemorrhage, or who have undergone brain or spinal surgery, as well as those with vascular anomalies. The risk of bleeding may further increase when taken with other anticoagulants or certain antifungal medications, so consulting a doctor is necessary. Patients with compromised kidney function or underlying diseases that pose a high bleeding risk should use this medication cautiously, and special care should be taken when taking it with other medications that may increase bleeding risk. This medication may cause anemia or bleeding symptoms, so it is important to regularly monitor the condition through blood tests. Prior to undergoing surgery or invasive procedures, this medication should be discontinued for a certain period, and patients at high risk of bleeding should closely monitor for any bleeding symptoms during treatment. This medication may harm the fetus if taken during pregnancy, so women who could become pregnant should use contraception while taking this medication, and it is advisable to avoid this medication while nursing. Elderly patients may have an increased risk of bleeding, but no separate dosage adjustment is needed. The safety and efficacy of this medication in children and adolescents under the age of 18 have not been established, so it is not recommended. Overdose may significantly increase the risk of bleeding, so strict adherence to the dosage is required, and any abnormal symptoms should be reported to healthcare professionals immediately. Caution is needed when driving or operating machinery, as drowsiness or fainting may occur with symptoms present. This medication can interact with several drugs, so if other medications are being taken, notify your doctor or pharmacist.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferring enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal dysfunction, non-hemorrhagic, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reactions, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions associated with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, blood in stool, melena, deep vein thrombosis, arthralgia, unspecified bleeding, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like syndrome, drug hypersensitivity reactions

This medication should be stored in a tightly sealed container to protect it from air and moisture, and should be kept at room temperature between 1 degrees and 30 degrees. Storing it this way will help maintain the potency of the medication for a longer period.

Appearance

Bright red, round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTPX3], 100 tablets/box [10 tablets/PTPX10]