Rivaroxaban 10 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. 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 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') 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 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 completion of 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 of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, days 1-21: 15mg twice daily, 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, 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 during the treatment period. Prevention of venous thromboembolism in adult patients who have undergone major orthopedic surgery of the lower limbs (knee or hip replacement): The recommended dose of this medicine is 10 mg once daily. The first dose should be given 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on the individual patient's risk of venous thromboembolism based on the type of surgery; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If you miss a dose of this medicine: If you miss a dose of this medicine, take the missed dose as follows. Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at one time. Starting the next day, continue taking 15 mg twice daily. 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. Switching from a vitamin K antagonist to this medicine: Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Discontinue treatment with the vitamin K antagonist and start taking this medicine when the International Normalized Ratio (INR) is ≤ 3.0. Treatment of deep vein thrombosis and pulmonary embolism / Reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism: Discontinue treatment with the vitamin K antagonist and start taking this medicine when the INR is ≤ 2.5. The INR value will be falsely elevated after taking this medicine, regardless of the dose. INR should not be used, as it is not suitable for measuring the anticoagulant activity of this medicine. 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 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 receive the vitamin K antagonist concomitantly 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 a 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 can be performed 24 hours after the last dose. 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). 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. 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) has shown a significant increase in the blood concentration of this medicine; therefore, this medicine should be administered 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. 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. 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 who have undergone 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). 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. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with a liquid such as water or applesauce, and administered orally. 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 the formation of blood clots by inhibiting blood coagulation. During treatment, signs of bleeding should be carefully monitored, particularly in patients at high risk of bleeding. If severe bleeding occurs, the use of this medication should be stopped immediately and professional treatment should be sought if necessary. This drug should not be administered to patients with certain diseases or conditions, such as those with severe bleeding, severely impaired liver function, or women who are pregnant or breastfeeding. Patients with lactose intolerance should also avoid this medication. Caution should be exercised when administering this medication to patients with conditions that increase bleeding risk, such as gastrointestinal ulcers, history of intracranial hemorrhage, vascular abnormalities, or malignancies. Combining this medication with other anticoagulants or certain antifungal agents may increase the risk of bleeding, so dosing should be followed according to the physician's instructions. Patients with impaired kidney function or a high risk of bleeding should be particularly cautious as blood concentration may rise, further increasing the risk of bleeding. Caution is also needed when taking this medication with drugs that affect bleeding, such as non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors. Regular monitoring of bleeding symptoms or anemia symptoms should be conducted during treatment, and any abnormal symptoms should be discussed with a healthcare professional immediately. If bleeding occurs, appropriate treatment such as physical pressure, surgical hemostasis, or blood product administration may be necessary, and specific hemostatic agents may be used. Elderly patients or those with impaired kidney function may experience increased blood concentrations, but dosage adjustment is generally not needed; however, the risk of bleeding may be increased. Women who are pregnant or breastfeeding should avoid this medication as it may be harmful to the fetus or newborn, and women planning to become pregnant should consult a physician. This medication may affect driving or machine operation, so caution is advised if symptoms such as drowsiness or dizziness occur. In the event of overdose, the risk of bleeding becomes very high, necessitating immediate attendance at a medical institution for appropriate measures. Regular blood tests and monitoring as per physician's instructions are necessary during treatment.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and loss of energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased enzyme levels, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, nasal bleeding, hemoptysis, itching, rash, petechia, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylaxis, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms related to drug reactions, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, 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 ulcers, high fever, severe dysphagia, cardiac ischemic symptoms, compartment syndrome due to decreased perfusion, renal failure, syncope, drowsiness, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disorders, asthma, laryngitis, dysphagia, intestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, dysuria, renal calculi, bladder carcinoma, prostatic hyperplasia, influenza-like syndrome, drug hypersensitivity reaction

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance

Bright red round film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP packaging X 3)]