Rivaroxaban 20 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 of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose 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 in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement, in whom rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] was administered concomitantly with a P2Y12 inhibitor for up to 12 months. 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 for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. The recommended maintenance dose for subsequent treatment and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completion of treatment (at least 6 months), the recommended dose for extended administration to reduce the risk of recurrence is 10mg once daily. The duration of treatment and treatment dose should be determined following an individual assessment of the risk of recurrence in relation to the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence: 15mg twice daily on days 1-21, total daily dose 30mg; from day 22, 20mg once daily, total daily dose 20mg. Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism: After administration for at least 6 months, 10mg once daily, total daily dose 10mg. The maximum daily dose is 30 mg during the first 3 weeks of treatment and 20 mg during the subsequent 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 is 10 mg once daily. The initial dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of administration depends on each patient's risk of venous thromboembolism; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If a dose is missed: Patients taking 15 mg twice daily should take the missed dose immediately; two 15 mg tablets may be taken at one time. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily should take the missed dose immediately. From the following day, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine: Patients with nonvalvular atrial fibrillation should discontinue vitamin K antagonist treatment and start taking this medicine when the international normalized ratio (INR) is ≤ 3.0. Patients being treated for deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence should discontinue vitamin K antagonist treatment and start taking this medicine when the INR is ≤ 2.5. Switching from this medicine to a vitamin K antagonist: A vitamin K antagonist should be administered 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 the dose of the vitamin K antagonist according to INR testing. In patients receiving this medicine concomitantly with a vitamin K antagonist, INR testing must not be performed until 24 hours have elapsed after taking this medicine. If this medicine is discontinued, INR testing may be performed 24 hours after the last dose. Switching from a parenteral anticoagulant to this medicine: Start administration 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 administration of the parenteral anticoagulant at the time the next dose of this medicine would have been due. Patients with renal impairment: No dose adjustment is required in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Administration is not recommended because there is no clinical experience in patients with severe renal impairment with creatinine clearance less than 15 mL/min. Renal impairment in patients with nonvalvular atrial fibrillation: The recommended dose in 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. Administer with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Renal impairment in patients being treated for deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence: No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Administration is not recommended in patients with severe renal impairment with creatinine clearance 15-29 mL/min. Renal impairment in patients receiving prevention of venous thromboembolism after orthopedic surgery: No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Administer with caution in patients with severe renal impairment (creatinine clearance 15-29 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. Patients 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 administration through a gastrointestinal tube, confirm that the tube is correctly positioned, and administer after flushing the tube with water.

This medication is used to prevent or treat blood clot formation by inhibiting coagulation. During treatment, there may be a risk of bleeding; therefore, patients should be closely monitored for signs or symptoms of bleeding. If severe bleeding occurs, the medication should be stopped immediately and healthcare personnel should be informed. This medication should not be administered to patients with certain liver diseases, those at high risk of bleeding, pregnant women, women who are breastfeeding, and those with certain genetic disorders. Caution should be exercised in patients with decreased renal function, those with conditions that increase the risk of bleeding, and when taken with certain drugs; this medication should only be used when the benefits outweigh the risks. This medication may interact with other anticoagulants, certain antifungals, antibiotics, and non-steroidal anti-inflammatory drugs (NSAIDs), increasing the risk of bleeding when used concomitantly. Monitoring for symptoms of bleeding or anemia during treatment is essential, and patients should consult their healthcare provider if unusual symptoms occur. This medication should be discontinued before surgery or invasive procedures, and resuming treatment should only be done according to medical advice, as the risk of thrombosis may increase upon discontinuation. Additionally, patients undergoing neuraxial anesthesia or lumbar puncture procedures may have heightened bleeding risks and require special care. Women who are pregnant or could become pregnant must use contraception while taking this medication, and breastfeeding women should avoid using it. Elderly patients may experience increased drug concentration due to reduced renal function; although no separate dosage adjustment is necessary, the risk of bleeding may increase. In case of overdose, the risk of bleeding may increase, and immediate medical attention should be sought for appropriate treatment. Caution should be exercised when driving or operating machinery, as symptoms such as drowsiness or fainting may occur. During treatment, patients should not take or discontinue other medications without consulting their physician or pharmacist.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, xerostomia, fever, peripheral edema, general weakness and energy reduction, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin metabolites, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, epistaxis, hemoptysis, pruritus, rash, petechiae, cutaneous and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, myocardial infarction, arthralgia, fever, unexplained bleeding, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like syndrome, drug hypersensitivity reaction

Store this medication in a tightly closed container, protected from air and moisture. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius. This will help ensure the safety and efficacy of the medication.

Appearance

Brownish-red round film-coated tablet

Package unit

7 tablets/box [7 tablets/PI], 30 tablets/box [10 tablets/PI * 3], 100 tablets/box [10 tablets/PI * 10]