Hanwha Rivaroxaban Tablet 20 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 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 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 treatment of deep vein thrombosis and pulmonary embolism and the recommended dose for reducing the risk of recurrence is 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 treatment duration 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 Dose frequency Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence Days 1-21 15mg twice daily 30mg From day 22 20mg once daily 20mg Reduction in 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 treatment duration 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, two 15 mg tablets may be taken at once. Starting the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking 1 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 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 in the risk of recurrence of 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 when 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 the vitamin K antagonist dose according to INR testing. On the other hand, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours 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 For 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 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 with creatinine clearance 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, 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 in 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 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 who are unable to 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 is used to prevent or treat thrombosis by inhibiting blood coagulation. However, there is a risk of bleeding while taking this medication, so signs of bleeding should be observed closely. If severe bleeding occurs, discontinuation of the medication is necessary. Although this medication does not require monitoring of concentration with specific blood tests, checking the blood concentration may be helpful in cases of overdose or emergency surgery. It should not be used in patients with allergies to this medication, severe bleeding, severe liver impairment, women who are pregnant or breastfeeding, or certain genetic lactose intolerant patients. Moreover, it should not be administered to patients with recent history of gastrointestinal ulcers, intracranial hemorrhages, specific vascular abnormalities, malignant tumors, or other high-risk bleeding conditions. Caution is needed when used in conjunction with other anticoagulants or certain antifungal agents, as this may increase the risk of bleeding. Patients with renal impairment or conditions that increase bleeding risk should use this medication cautiously, especially when taken with other drugs that increase bleeding risk. This medication can cause various side effects such as bleeding, anemia, skin rash, gastrointestinal disturbances, so it is important to notify healthcare professionals immediately if any unusual symptoms occur. Especially elderly patients or those with reduced renal function may have higher blood levels of the drug, increasing the risk of bleeding. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing potential must take contraceptive measures while on this medication. It is not recommended for children or adolescents under 18 years of age as safety and efficacy have not been established. Caution is needed as the risk of bleeding increases with overdose, and appropriate treatment is required in case of severe bleeding. Care is also required when driving or operating machinery as drowsiness or fainting may occur. This medication can alter blood levels when taken with drugs that impact specific liver enzymes or proteins, thus caution regarding drug interactions is essential. Prior to surgery or invasive procedures, the medication should be discontinued for a certain period per the doctor's instructions. Abrupt discontinuation of this medication may increase the risk of thrombosis, so any discontinuation must be discussed with healthcare professionals.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general decrease in strength and energy, discomfort, local edema, liver dysfunction, jaundice, allergic reaction, allergic dermatitis, post-treatment bleeding, bruise, discharge from wound site, vascular pseudoaneurysm, increased transaminase, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital tract bleeding, renal dysfunction, non-bleeding, hemoptysis, itching, rash, petechial bleeding, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, bile stasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions associated with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, syncope, drowsiness

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C. This helps to ensure the safety and effectiveness of the medication.

Appearance

Round, red-brown film-coated tablet

Package unit

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