Jarelban 15mg Tablet (Rivaroxaban)

Adult dose

This medicine 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. 1. Adults 1) 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 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. (See '12. Clinical Trial Information') 2) 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 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 and dose of treatment 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 period Dosing frequency Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15mg twice daily 30mg From day 22 20mg once daily 20mg Reduction of 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. 3) 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 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. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ①Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. Starting the next day, continue taking 15 mg twice daily. ②Patients 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. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ①Reduction of 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. ②Treatment of deep vein thrombosis and pulmonary embolism / Reduction of 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 should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 2) 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 must 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 the dose of the vitamin K antagonist according to 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 may be performed 24 hours after the last dose. 3) 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 product (e.g., low-molecular-weight heparin), or when the continuously administered parenteral product (e.g., intravenous unfractionated heparin) is discontinued. 4) 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. 3. Patients with renal impairment No dose adjustment is required 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) indicates that plasma concentrations 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 creatinine clearance less than 15 mL/min because there is no clinical experience in these patients. 1) 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. 2) 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 undergoing 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). 4. Patients with hepatic impairment 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. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. For patients who are unable to swallow tablets, Immediately before use, this medicine may be crushed and 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 an anticoagulant that prevents blood clotting. Bleeding may occur during the use of this medication, so signs of bleeding should be carefully monitored. If serious bleeding occurs, the use of this medication should be stopped immediately and a physician should be consulted. This medication should not be administered to certain patients, such as those with hypersensitivity to the drug or those with severe bleeding, patients with serious liver disease, pregnant or breastfeeding women, and patients with lactose intolerance. Patients with conditions that carry a high risk of bleeding or those taking other anticoagulants should also avoid this medication. Caution is advised when administering this medication to patients with renal impairment or those with diseases that increase the risk of bleeding, particularly when taking other medications that may increase the risk of bleeding. This medication can cause various adverse reactions, particularly relating to bleeding symptoms. Symptoms of bleeding may include pallor, dizziness, difficulty breathing, unexplained swelling, and in severe cases, complications such as renal failure or compartment syndrome may occur. Caution is required when performing procedures with a high risk of bleeding, such as neuraxial anesthesia or lumbar puncture, where the timing of discontinuation or resumption of the medication pre- and post-procedure should be managed. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential should employ contraception during its use. In elderly patients, blood concentrations of this medication may be higher, though dosage adjustments are generally not required, but the risk of bleeding may increase. This medication is not recommended for children and adolescents under the age of 18, as its safety and efficacy have not been established. Caution is required in the case of overdose, as the risk of bleeding increases, and medical personnel should be notified immediately in case of overdose. While taking this medication, there may be symptoms such as drowsiness or fainting when driving or operating machinery. This medication may interact with other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Particularly with concurrent use of specific antifungals, antivirals, antibiotics, and medications affecting hemostasis, the risk of bleeding may increase, so caution is necessary.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudoaneurysm, increased transaminases, elevated bilirubin levels, increased alkaline phosphatase, increased LDH, elevated lipase, increased amylase, increased transaminase, elevated bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, epistaxis, hemoptysis, pruritus, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-associated kidney disease, severe uterine bleeding, deep vein thrombosis, arthralgia, unspecified hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulceration, high fever, severe dysphagia, ischemic heart symptoms, compartment syndrome, renal failure

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

Appearance

Red coated round film tablet

Package unit

30 tablets/box [10 tablets/PTP*3]