Aroxaban Tablet 10mg (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 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 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, is 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 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 compared with the risk of bleeding. Treatment and reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism: Days 1-21, 15 mg twice daily, 30 mg Treatment and reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism: From day 22, 20 mg once daily, 20 mg Reduction in 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 during the treatment period. 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. If you miss a dose of this medicine: 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 must 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 vitamin K antagonist therapy and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. Switching from a vitamin K antagonist to this medicine—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. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used. Switching from this medicine to a vitamin K antagonist: 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 the dose of the vitamin K antagonist according to the INR test results. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may 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. No dose adjustment is necessary in patients with mild renal impairment with a creatinine clearance of 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the plasma concentration of this medicine increased significantly; therefore, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment with a creatinine clearance below 15 mL/min, as there is no clinical experience in these patients. Patients with renal impairment—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. Patients with renal impairment—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 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. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a drink such as 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 drug is used to prevent or treat the formation of blood clots by preventing blood from clotting. However, bleeding may occur during the use of this drug, so signs or symptoms of bleeding should be closely monitored. If significant bleeding occurs, the use of this drug should be discontinued immediately, and medical consultation should be sought. This drug is not safe for use in certain patients, such as those with severe bleeding or severely impaired liver function, pregnant or nursing women, and patients with certain genetic lactose intolerance. Additionally, caution is needed for patients with diseases that have a high risk of bleeding or who are taking other anticoagulants. Patients with reduced kidney function or other diseases that could increase the risk of bleeding should use this drug carefully. Various adverse reactions, including bleeding, anemia, skin rashes, and gastrointestinal symptoms, may occur during the use of this drug, so any abnormal symptoms should be reported to medical personnel immediately. Special attention should be given to elderly patients or when combined with certain medications, as the risk of bleeding may increase. Women who are pregnant or of childbearing age should use contraception while taking this drug, and nursing women are advised to avoid this medication. Patients scheduled for surgery or procedures should stop taking this drug for a certain period before the procedure and follow medical guidance regarding the risk of bleeding afterward. Moreover, this drug may interact with specific antifungals, antivirals, and antibiotics, which could increase the risk of bleeding, so inform your healthcare provider of any other medications being taken. Caution is also needed when driving or operating machinery as drowsiness or dizziness may occur. In cases of overdose, the risk of bleeding may also increase, so it is essential to adhere to the correct dosage and seek medical attention immediately in the event of an overdose. Finally, regular blood tests and monitoring for bleeding symptoms are necessary while taking this drug, and if any abnormal symptoms appear, immediate consultation with a healthcare professional is advised.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, a decrease in overall strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound discharge, vascular pseudoaneurysm, increased transaminases, increased bilirubin in the blood, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, vascular edema, allergic edema, anaphylactic shock, cholestasis, 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, bloody stools, melena, myocardial infarction, arthralgia, facial flushing, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcers, high fever, severe dysphagia, angina

This drug should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Bright red round film-coated tablet

Package unit

PTP - 30 tablets/PTP[(10 tablets/PTPX3)]