Daehan Rivaroxaban Tablet 10 mg

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered 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 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. (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 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 after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Duration of administration / 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 during the remainder of treatment. 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 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. 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. From the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From 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 treatment 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 recurrence of deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist treatment 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 receive both this medicine and the vitamin K antagonist 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 testing. However, in patients receiving this medicine together with a vitamin K antagonist, 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 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 required 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, administer this medicine 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 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 required 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 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 drug is an anticoagulant that prevents the formation of blood clots. Therefore, there may be an increased risk of bleeding, so it is essential to closely monitor for bleeding symptoms. In particular, if severe bleeding occurs, the use of this drug must be stopped immediately. This drug should not be administered to specific patients. For instance, individuals with allergic reactions to this drug or its components, those with severe bleeding, individuals with severely impaired liver function, pregnant or breastfeeding women, and patients with lactose intolerance should not take it. Patients with diseases that have a high risk of bleeding, those using it with other anticoagulants, certain antifungals in combination, and patients with a history of stroke undergoing acute coronary syndrome should be particularly cautious when using this drug. Patients with impaired kidney function or at high risk of bleeding, patients with malignancies, and those taking medications that affect bleeding, such as nonsteroidal anti-inflammatory drugs or antiplatelet agents, may have an increased risk of bleeding and should be careful. This drug may cause various adverse reactions, the most common being symptoms related to bleeding. Bleeding can occur in various areas such as the skin, gastrointestinal tract, and urogenital system and, in severe cases, can lead to anemia or shock. Additionally, rare but serious side effects, such as allergic reactions, liver dysfunction, skin rash, and agranulocytosis, have been reported, so if any abnormal symptoms occur, consultation with a doctor should be sought immediately. This drug may have increased blood concentration in elderly patients with decreased kidney function; however, dose adjustment is generally not necessary. However, elderly patients should be cautious as they are at higher risk of bleeding. Pregnant and nursing women should avoid using this drug as its safety is not established, and women of childbearing potential must use contraception while taking it. Drug interactions are also important. Particularly, taking this drug with specific antifungals or HIV treatments that inhibit CYP3A4 and P-gp can significantly increase the blood concentration of this drug, raising the risk of bleeding, so concurrent use should be avoided. Furthermore, when used with CYP3A4 inducers, the effectiveness of this drug may be reduced, so caution is needed. Caution should also be exercised when using this drug concurrently with other anticoagulants, nonsteroidal anti-inflammatory drugs, or platelet aggregation inhibitors as the risk of bleeding increases. If surgery or invasive procedures are planned, this drug should be discontinued for a certain period before the procedure and resumed once the bleeding risk decreases after the procedure. There have been no studies on the effects on driving or operating machinery; however, dizziness or fainting may occur during the use of this drug, so caution is necessary if symptoms arise. In case of overdose, the risk of bleeding may significantly increase, so it is essential to ensure that the dose is not exceeded, and immediate medical evaluation and treatment are required in the event of an overdose.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular 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 reaction, allergic dermatitis, post-treatment bleeding, contusion, wound secretion, vascular pseudoaneurysm, increased transaminases, elevated blood bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, elevated bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital tract hemorrhage, renal dysfunction, non-hemorrhagic, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, significant uterine bleeding, post-surgical hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, myocardial infarction, arthralgia, fever, hemorrhage of unspecified etiology

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. To maintain the efficacy of the drug, it is best to store it at room temperature, between 1°C to 30°C.

Appearance

Bright red, round, film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)