Zarelto 10 mg (Rivaroxaban)

Adult dose

This medication 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose of this medication 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 medication is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15mg once daily [10mg 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 medication 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 relative to 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 medication is 30 mg during the first 3 weeks of treatment and 20 mg during the remainder of 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 medication is 10 mg once daily. The first dose should be given 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on each 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 medication immediately; in this case, 2 tablets of 15 mg may be taken at once. Starting the next day, continue taking 15 mg twice daily. Patients taking 10, 15, 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. Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Discontinue vitamin K antagonist therapy and start taking this medication 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 vitamin K antagonist therapy and start taking this medication when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this medication. The INR is not suitable for measuring the anticoagulant activity of this medication and should not be used for this purpose. Patients switching from this medication 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, followed by a dose based on INR testing. In patients receiving this medication concomitantly with a vitamin K antagonist, INR testing must not be performed until 24 hours after taking this medication. If this medication is discontinued, INR testing may be performed after 24 hours have elapsed since the last dose. In patients receiving a parenteral anticoagulant, start this medication 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. Discontinue this medication and start the parenteral anticoagulant at the time the next dose of this medication would have been due. No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance 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 medication increased significantly; therefore, administer this medication with caution. Use of this medication is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min, as there is no clinical experience in this population. 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). Avoid administering this medication 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 medication and an increased risk of bleeding may occur in these patients. Immediately before use, this medication may be crushed, mixed with water or a beverage such as applesauce, and administered orally. It may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medication through a gastrointestinal tube, confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication is an anticoagulant used to prevent or treat blood clotting. During the course of this medication, it is essential to monitor for signs of bleeding, and caution should be taken in patients at increased risk of bleeding. If serious bleeding occurs, discontinue the medication immediately and consult healthcare providers. This medication should not be administered to patients who are allergic to it, have serious bleeding conditions, have severely impaired liver function, are pregnant or breastfeeding, or have lactose intolerance. Moreover, caution is advised for patients with recent gastrointestinal ulcers, a history of intracranial hemorrhage, vascular abnormalities, or those taking other anticoagulants or specific antifungals. Patients with decreased renal function or those with multiple conditions that increase bleeding risk should use this medication cautiously and should also be careful when combined with other drugs that can increase bleeding risk. Possible side effects of this medication include bleeding, anemia, dyspepsia, headache, dizziness, skin rashes, etc., and if these symptoms occur, healthcare providers should be informed immediately. Specifically, signs of bleeding may manifest as weakness, pallor, dizziness, shortness of breath, unexplained swelling, or shock, and should be closely monitored. This medication may increase the risk of hemorrhagic nerve injury when used in conjunction with procedures such as neuraxial anesthesia or lumbar puncture, so it is essential to discuss the timing and method of administration before and after the procedures with healthcare providers. Additionally, this medication interacts with specific antifungals, antibiotics, anticoagulants, and non-steroidal anti-inflammatory drugs (NSAIDs), which can increase the risk of bleeding, so any other medications being taken should be reported. The safety of this medication during pregnancy or breastfeeding has not been established, so it should be avoided, and women of childbearing potential should take contraception while using it. In the elderly, the concentration of this medication may increase; while dosage adjustment is generally not necessary, the risk of bleeding may be heightened, so caution is required. In the case of overdose, the risk of bleeding is significantly increased, so immediate medical attention is necessary for appropriate action. Caution is necessary when driving or operating machinery while using this medication, and activities should be avoided if symptoms such as drowsiness or fainting occur. This medication is effective for the prevention and treatment of thrombosis, but it must always be taken under the guidance of a healthcare provider considering the risk of bleeding.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal hemorrhage, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, discharge from wound site, vascular pseudoaneurysm, increased transaminases, elevated bilirubin levels, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital hemorrhage, renal impairment, non-hemorrhagic, hemoptysis, itching, rash, petechiae, cutaneous and subcutaneous hemorrhage, urticaria, hypotension, hematoma, vascular edema, allergic edema, anaphylactic reactions, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, deep vein thrombosis, arthralgia, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like symptoms, drug hypersensitivity, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, parenchymal disorders, asthma, laryngitis, dysphagia, gastrointestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urological disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, Stevens-Johnson syndrome

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance

Bright red round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP x 3], 100 tablets/box [10 tablets/PTP x 10]