Rivaroxaban 20 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) 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 15 mg once daily [10 mg once daily for 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. 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction in 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 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 following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence Days 1-21: 15mg twice daily, total daily dose 30mg From day 22: 20mg once daily, total daily dose 20mg Reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment: 10mg once daily, total daily dose 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 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 administered within 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; 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. ①Patients 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. ②Patients 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 medicines 1) Switching from a vitamin K antagonist to this medicine ①Reduction in 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, International Normalized Ratio) is ≤ 3.0. ②Treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrence of 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 while switching to another anticoagulant. Note that this medicine may affect INR elevation. Patients switching from this medicine to a vitamin K antagonist should take the vitamin K antagonist concomitantly until the INR is ≥2.0. During 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 test results. 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 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 administering 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 with 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, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance below 15 mL/min, as there is no clinical experience in these patients. 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 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. 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 a liquid such as water or 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 medication is used to prevent or treat thrombosis by preventing blood from clotting. While taking this medication, signs of bleeding should be closely monitored, as bleeding may occur. If bleeding becomes severe, the use of this medication should be discontinued immediately. In particular, patients who are allergic to this medication or who have existing bleeding, those with severely impaired liver function, and pregnant or breastfeeding women should not take this medication. Furthermore, patients with a history of gastrointestinal ulcers, brain hemorrhage, vascular abnormalities, or recent surgery or trauma are at increased risk of bleeding and require caution. Taking this medication with other anticoagulants or certain antifungal agents may increase the risk of bleeding, so it should be discussed with a doctor. Patients with impaired kidney function, those at high risk of bleeding, and those taking certain medications should use this medication with more caution. While taking this medication, adverse reactions such as dizziness, headache, bleeding, rashes, etc., may occur. If such symptoms arise, medical consultation is necessary. If surgery or invasive procedure is planned, this medication should be discontinued at least 12 to 24 hours prior, and appropriate measures should be taken in case of bleeding risk. Women who are pregnant or planning to become pregnant must ensure contraception while taking this medication, and breastfeeding should be stopped before taking this medication. Elderly patients may experience increased blood levels of this medication due to impaired kidney function; however, dosage adjustments are generally not needed, but the risk of bleeding may increase. In cases of overdose, the risk of bleeding increases, so the dosage should be strictly followed, and symptoms should be reported to medical staff immediately. Caution is advised when driving or operating machinery while taking this medication. Activities should be avoided if symptoms like drowsiness or fainting occur.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gingival bleeding, gastrointestinal hemorrhage, stomach pain, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound secretion, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, nasal bleeding, hemoptysis, itching, rash, petechial bleeding, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, reported joint pain as a serious adverse event, unspecified hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, hematochezia, myocardial infarction, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine hemorrhage, syncope, drowsiness

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it should be stored at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication for a longer period.

Appearance

Dark red, double convex, round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP*3], 100 tablets/bottle