Rivaroxaban 20 mg Film-Coated 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 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 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 recurrence of deep vein thrombosis and pulmonary embolism The recommended initial dose 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 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. Treatment period / Dosing frequency / Total 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 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 limbs (knee or hip replacement) The recommended dose is 10 mg once daily. The first dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on the individual 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. ➀ Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. Starting the next day, continue taking 15 mg twice daily. ➁ Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking 1 tablet once daily. Do not take twice the recommended daily dose to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ➀ Reduction of 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. ➁ Treatment of deep vein thrombosis and pulmonary embolism/Reduction of the risk of recurrence of 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, the INR value will be falsely elevated after taking this medicine. The INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 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 INR, causing it to increase. 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, and 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 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 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 increased significantly; therefore, administer this medicine with caution. There is no clinical experience in patients with severe renal impairment with creatinine clearance less than 15 mL/min; therefore, use of this medicine is not recommended. 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 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 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. For 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 correctly positioned, and flush the tube with water after administration.

This medication prevents or treats blood clots by inhibiting blood coagulation. However, its use may increase the risk of bleeding; careful monitoring for bleeding symptoms is essential. If severe bleeding occurs, this medication should be stopped immediately. It should not be administered to certain patients, such as those with allergies to this medication or its components, patients with severe bleeding, patients with significantly impaired liver function, women who are pregnant or breastfeeding, and patients with lactose intolerance. Additionally, patients with recent gastrointestinal ulcers, intracranial hemorrhage, neurological surgery or trauma, vascular abnormalities, or cancers with a high risk of bleeding should refrain from using this medication. The risk of bleeding may be elevated when combined with other anticoagulants or specific antifungal agents, so caution is warranted. Careful use is particularly necessary in patients with renal impairment or bleeding disorders and those taking medications affecting bleeding, such as NSAIDs or antiplatelet agents. Monitor for bleeding or anemia symptoms during treatment, and report suspected bleeding to healthcare providers immediately to receive appropriate action. Furthermore, be aware of possible drug interactions with this medication; inform your healthcare provider of any other medications you are taking. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should take precautions against pregnancy while on this medication. Elderly patients or those with impaired renal function are at relatively higher risk of bleeding; caution is needed, although dose adjustment may not always be required. The safety and efficacy for children and adolescents have not been established, and use is not recommended. Overdose may lead to an increased risk of bleeding, requiring immediate medical attention, and this medication is not removed by dialysis, so special treatment may be necessary. While on this medication, be cautious as side effects such as drowsiness or fainting may occur when operating machinery or driving. Discuss with your healthcare provider the timing and method for stopping this medication before any surgical or invasive procedures, as the risk of bleeding may increase, especially with spinal or epidural anesthesia. This medication may affect tests that monitor blood clotting, so results should be interpreted accordingly. Finally, report any adverse reactions or side effects immediately to your healthcare provider and receiving appropriate care is crucial.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, 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 secretion, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, genitourinary tract bleeding, kidney dysfunction, 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, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, rectal bleeding, melena, deep vein thrombosis, arthralgia, unspecified bleeding, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, pseudomembranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, ischemic heart symptoms, compartment syndrome, renal failure, postoperative syncope, drowsiness

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage ensures the medication's efficacy is maintained over time and is safe to use.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP) x 3]