Rivaroxaban Tablets 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. 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 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 are 20 mg once daily. After completing treatment for deep vein thrombosis or pulmonary embolism (at least 6 months), 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 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 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 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 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 treatment with the vitamin K antagonist 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 treatment with the vitamin K antagonist 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 when 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, and thereafter administer the dose of the vitamin K antagonist according to INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine is discontinued, INR testing can 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 parenteral dose (e.g., low-molecular-weight heparin), or at the time of discontinuation of 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 necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine increased significantly; therefore, administer this medicine 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 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 patients with 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 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 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 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 medication helps prevent blood from clotting, which can increase the risk of bleeding, so it is important to carefully monitor for signs of bleeding. If severe bleeding occurs, this medication should be discontinued immediately, and appropriate treatment for bleeding control is necessary. This medication should not be given to certain patients, such as those with allergies to this medication or its components, those currently experiencing severe bleeding, patients with very poor liver function, women who are pregnant or breastfeeding, and patients with specific inherited lactose metabolism disorders. Additionally, it is unsafe to use this medication in patients with recent gastrointestinal ulcers or history of intracranial hemorrhage, blood vessel abnormalities, specific tumors, or those taking other anticoagulants. Patients with reduced kidney function or those in a high bleeding risk state, as well as those taking medications that increase bleeding risk (such as non-steroidal anti-inflammatory drugs or platelet inhibitors) should use this medication with caution. While taking this medication, symptoms of bleeding as well as signs of anemia should be carefully monitored, and immediate consultation with healthcare personnel is necessary if bleeding is suspected. In the presence of bleeding, the medication may be delayed or discontinued, and treatment to assist with blood clotting may be administered as needed. When taken with certain antifungal or antiviral agents, blood concentrations may increase, thus it's advisable to avoid or use caution in such combinations. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential must practice contraception during treatment. Elderly patients may experience increased blood concentrations due to decreased kidney function; while special dose adjustments may not be necessary, the risk of bleeding may be higher. Safety and efficacy have not been established in children and adolescents under 18 years of age, so it is not recommended. Care should be taken in cases of overdose, as the risk of bleeding may increase, and any symptoms of bleeding should be immediately reported to healthcare personnel. Drowsiness or fainting may occur while driving or operating machinery during treatment, so caution is advised. If surgery or invasive procedures are planned, consult with a physician and discontinue this medication a certain time prior to minimize bleeding risk. Sudden discontinuation of this medication can increase the risk of thrombosis, hence it is essential to consult with a physician for alternative treatment upon stopping the medication. In cases of neuroanesthesia or spinal puncture, there is a serious risk of neurological damage due to bleeding, thus special care is required for patients taking this medication. If severe rash or allergic reactions occur, this medication should be stopped immediately and healthcare personnel should be consulted.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, gastrointestinal pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated blood bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, elevated transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, nasal bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions accompanied by systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, joint dislocation, arthralgia, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased heart enzymes, facial flushing, congestive heart failure, urinary tract infection, membrane colitis, asthma, pulmonary edema, pleural effusion, influenza-like syndrome, drug hypersensitivity reactions

This medication should be stored in a tightly closed container to protect from air and moisture exposure. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Red circular film-coated tablets with a brown tint.

Package unit

30 tablets/box [10 tablets/PTP x 3], 100 tablets/box [10 tablets/PTP x 10]