Daehan Rivaroxaban Tablet 15 mg

Adult dose

This 10 mg medicine may be taken with or without food, while the 15 mg and 20 mg doses should be taken with food. 1. Adults 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 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 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 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 relative to the risk of bleeding. Treatment period Dosing 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 duration of treatment depends on each patient's risk of venous thromboembolism based on 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 miss a dose of this medicine If you miss a dose of 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 one time. 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. 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 ① Reduction in 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. 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 when 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 the increase in INR. Patients switching from this medicine to a vitamin K antagonist should take both medicines concomitantly until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer the dose of the vitamin K antagonist based on INR testing. In contrast, patients receiving this medicine and a vitamin K antagonist concomitantly should not undergo INR testing 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 required 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), plasma concentrations of this medicine increased significantly; therefore, administer this medicine with caution. Administration 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 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 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 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 feeding tube. Before administering this medicine through a feeding tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat clots by inhibiting blood coagulation. During treatment, bleeding may occur, so patients should be carefully monitored for signs of bleeding. If severe bleeding occurs, this medication should be discontinued immediately, and healthcare professionals should be consulted. This drug should not be administered to patients with certain conditions or diseases, including those with existing bleeding, severely impaired liver function, pregnant or breastfeeding women, and those with lactose intolerance. Additionally, patients who have recently had gastrointestinal ulcers, intracranial hemorrhage, spinal or brain surgery, or have vascular malformations or malignant tumors are at high risk of bleeding; extreme caution should be exercised when using this medication for them. The risk of bleeding may increase when used in combination with other anticoagulants or certain antifungal agents, so it is crucial to consult a doctor if such drugs are taken together. Patients with renal dysfunction or high bleeding risk conditions should carefully consider the dose and administration of this medication, and regularly monitor for signs of bleeding and anemia. While taking this medication, symptoms such as pallor, dizziness, sudden pain, and shortness of breath may occur as signs of bleeding, which should be reported to healthcare professionals immediately. If surgery or an invasive procedure is upcoming, patients should discuss with healthcare professionals the timing and method of discontinuation of this medication before procedures and decide on the timing of re-administration after the procedure, considering the risk of bleeding. Women who are pregnant or planning to become pregnant should not take this medication; if they are currently taking it, reliable contraception is necessary. Elderly patients may experience increased blood levels due to decreased renal function, although dosage adjustments are not necessary, the risk of bleeding may increase. In cases of overdose, the risk of bleeding increases, so it is imperative to avoid exceeding the recommended dosage; if overdose is suspected, notify healthcare professionals immediately. This medication can cause drowsiness or dizziness; therefore, it is advisable to avoid driving or operating machinery when such symptoms occur. Lastly, regular blood tests to monitor for bleeding and overall blood health are recommended for safety during the course of this treatment.

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, contusion, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated bilirubin levels, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, elevated metabolizing enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscular bleeding, dizziness, headache, intracranial hemorrhage, syncope, urogenital bleeding, renal dysfunction, non-hemorrhage, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, vascular edema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction associated with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-associated kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stool, melena, deep venous thrombosis, arthralgia, fever, unexplained hemorrhage, myocardial infarction

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Red circular film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)