Aroxaban 20mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, whereas 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 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 underwent 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. 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. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence: Days 1-21: 15mg twice daily, 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 at least 6 months of treatment: 10mg once daily, total daily dose 10mg The maximum daily dose of this medicine 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 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; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If you forget to take this medicine: Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at once. 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 must not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine: 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, International Normalized Ratio) is ≤ 3.0. 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. 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 medicines until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, followed by a dose of the vitamin K antagonist based on INR testing. However, patients receiving this medicine and a vitamin K antagonist concomitantly must not have their INR 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. 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 when a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. Switching from this medicine to a parenteral anticoagulant: Discontinue this medicine and start the parenteral anticoagulant at the time of the next scheduled dose of this medicine. Patients with renal impairment: No dose adjustment is required in patients with mild renal impairment and creatinine clearance of 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. Use of this medicine is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min because 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 who have undergone 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). 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 and mixed with a drink such as water or applesauce immediately before use and administered orally. This medicine may also be crushed and administered with a small amount of water through a gastric tube. Before administering this medicine through a gastric tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This medication is an anticoagulant that prevents blood clotting. Therefore, the risk of bleeding may increase, and signs of bleeding should be monitored closely. If severe bleeding occurs, discontinue taking this medication immediately. Regular monitoring of blood concentration is not necessary with specific blood tests, but measuring blood concentration may be helpful in case of overdose or emergency surgery. Patients who are allergic to this medication, have severe bleeding, have significantly impaired liver function, are pregnant or breastfeeding, or are lactose intolerant should not use it. Patients with recent history of gastrointestinal ulcer or intracranial hemorrhage, certain vascular abnormalities, or malignant tumors should also exercise caution. Patients with reduced renal function or those with diseases that increase bleeding risk, or those taking non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors may have a higher risk of bleeding and should use this medication carefully. While taking this medication, anemia or bleeding symptoms, dizziness, headache, or difficulty breathing may occur; if such symptoms arise, consult a healthcare professional immediately. Especially when using this medication in combination with certain antifungals, antibiotics, or other anticoagulants, the risk of bleeding may increase, so it is essential to inform the doctor or pharmacist. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential must use contraception while taking this medication. Elderly patients may have higher blood concentrations due to decreased renal function, though no specific dose adjustment is needed; however, the risk of bleeding may increase. This medication is not recommended for children and adolescents as its safety and efficacy have not been established. In cases of overdose, bleeding complications may occur, and immediate evaluation and treatment by a healthcare professional are necessary; dialysis does not remove this medication. During intake of this medication, drowsiness or fainting may occur, so caution should be taken when driving or operating machinery. If a surgical or invasive procedure is planned, this medication should be discontinued some time prior, and patients should consult healthcare professionals due to the bleeding risk. Abruptly stopping this medication may increase the risk of thrombosis, so if discontinuation is necessary, consult with a physician to consider alternative treatments. When combined with neuraxial anesthesia (epidural or spinal), the risk of bleeding increases, which may lead to serious complications such as paralysis; special caution is required. If severe skin rash or allergic reactions occur while taking this medication, discontinue use immediately and inform a healthcare professional.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic reduction in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increase in transaminases, increase in serum bilirubin, increase in alkaline phosphatase, increase in LDH, increase in lipase, increase in amylase, increase in transfer enzymes, increase in bilirubin complexes, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, fainting, genitourinary bleeding, renal dysfunction, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stool, melena

This medication must be stored in a tightly sealed container to protect it from exposure to air or moisture. It is also important to store it at a temperature between 1 and 30 degrees Celsius.

Appearance

Brownish-red, round film-coated tablets

Package unit

7 tablets/PTP, 30 tablets/PTP [10 tablets/PTP pack x3], 100 tablets/PTP [10 tablets/PTP pack x10]