Rivaroxaban 10 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. 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 coadministration 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. 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. The recommended dose for extended treatment to reduce the risk of recurrence after completing treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism is 10 mg 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 of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, days 1-21: 15 mg twice daily, 30 mg. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, from day 22: 20 mg once daily, 20 mg. Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism, after at least 6 months of treatment: 10 mg once daily, 10 mg. The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower extremity (knee or hip replacement): The recommended dose of this medicine 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. Patients taking 15 mg twice daily: Take this medicine immediately; 2 tablets of 15 mg may be taken at once in this case. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following day, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. Start taking this medicine after discontinuing vitamin K antagonist therapy and when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. Start taking this medicine after discontinuing vitamin K antagonist therapy and when the INR is ≤ 2.5. Regardless of the dose, INR values will be falsely elevated after taking this medicine. INR is not appropriate for measuring the anticoagulant activity of this medicine and should not be used. Patients switching from this medicine to a vitamin K antagonist should receive both treatments 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. In patients receiving this medicine together with a vitamin K antagonist, 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. In patients receiving parenteral anticoagulants, start this medicine 0~2 hours before the next scheduled dose of the parenteral drug (e.g., low-molecular-weight heparin), or when discontinuing a continuously administered parenteral drug (e.g., intravenous unfractionated heparin). Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. No dose adjustment is necessary in patients with mild renal impairment and creatinine clearance 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates a significant increase in the blood concentration of this medicine; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min, as there is no clinical experience in these patients. 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. 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 extremity (knee or hip replacement): No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 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 increased risk of bleeding may occur in these patients. Immediately before use, this medicine may be crushed and mixed with water or a drink 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 thrombus formation by preventing excessive blood coagulation. However, this medication may increase the risk of bleeding, so if any signs or symptoms of bleeding occur, inform medical personnel immediately. If severe bleeding occurs, the use of this medication should be discontinued, and appropriate treatment should be provided as necessary. This medication should not be used in patients with certain blood coagulation disorders or severe liver diseases, in pregnant or breastfeeding women, and in patients with lactose intolerance. In addition, patients with a high risk of bleeding, such as those with recent gastrointestinal ulcers, intracranial hemorrhage, or those who have had brain or spinal surgery, should not take this medication. Caution is required when used in combination with other anticoagulants or certain antifungal agents, as it may increase the risk of bleeding. Patients with impaired renal function or with diseases that pose a high bleeding risk should use this medication carefully, weighing the risks of bleeding against the therapeutic benefits. Caution is also advised when taken with drugs that affect bleeding, such as non-steroidal anti-inflammatory drugs and platelet aggregation inhibitors, as the bleeding risk may increase. Various adverse reactions may occur during the use of this medication, including bleeding, anemia, liver function abnormalities, and allergic reactions, so if any adverse symptoms arise, consult medical personnel immediately. Particularly, elderly patients or those with impaired renal function may have elevated blood concentrations, thereby increasing the risk of bleeding. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential must use effective contraception while taking it. In cases of overdose, the risk of bleeding significantly increases, so it is crucial to adhere to the prescribed dosage and inform medical personnel immediately in the event of overdose. If surgery or invasive procedures are planned, the timing and method of discontinuing this medication before the procedure should be discussed with healthcare professionals. The effects on driving or operating machinery are unclear, but if drowsiness or fainting occurs after taking this medication, it is advisable to avoid driving or operating hazardous machinery. While taking this medication, it is important to carefully observe for signs and symptoms of bleeding or anemia, and to visit a hospital promptly for examination if any abnormalities are noted.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gum 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 exudate, vascular pseudo-aneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, increased LDH, elevated lipase, increased amylase, elevated transference enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial bleeding, syncope, urogenital bleeding, kidney dysfunction, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, bile stasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, hematochezia, arthralgia, myocardial infarction, deep vein thrombosis, facial flushing

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is also safe to store it at room temperature between 1 degree and 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance

Bright red, round film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP×3)], 100 tablets/box [(10 tablets/PTP×10)]