Jarelol Tablets 10mg (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) 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 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 for patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] was coadministered with a P2Y12 inhibitor for up to 12 months. (See '12. Clinical Trial Information') 2) Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrent 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 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 recurrent deep vein thrombosis and pulmonary embolism compared with the risk of bleeding. Treatment period Frequency of administration 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 recurrent 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 first dose should be administered 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on the individual patient's risk of venous thromboembolism based on the type of surgery; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for those undergoing knee replacement. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients 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. ② 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. 2. Switching between medicines 1) Switching from a vitamin K antagonist to this medicine ① 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) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrent 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. 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 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 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; thereafter, administer a dose based on INR testing. On the other hand, patients receiving this medicine and a vitamin K antagonist concomitantly should not have their INR checked until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be checked 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the time the next parenteral dose is scheduled (e.g., low molecular weight heparin), or when a continuously administered parenteral anticoagulant (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 necessary 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 the blood concentration of this medicine increased significantly; therefore, administer this medicine with caution. There is no clinical experience in patients with severe renal impairment and creatinine clearance below 15 mL/min; therefore, use of this medicine is not recommended. 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 recurrent 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). 4. 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. 5. Patients who cannot 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 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 thrombus formation by inhibiting blood clotting. During the course of this medication, bleeding may occur, and it is important to monitor for signs or symptoms of bleeding. If severe bleeding occurs, the medication should be discontinued immediately, and appropriate medical action should be taken if necessary. This medication should not be used in patients with certain bleeding disorders or high risk of bleeding, in pregnant or nursing women, or in those allergic to any of the components of this medication. Also, patients with liver disease or a recent history of intracranial hemorrhage or gastrointestinal bleeding should refrain from taking this medication. In patients with impaired renal function or other diseases with a high risk of bleeding, careful usage is advised due to the possibility of increased blood concentration and bleeding risk when taken with certain other drugs. Regular blood tests to check for bleeding or anemia symptoms are necessary while taking this medication. Immediate medical attention should be sought if any bleeding symptoms are suspected, and appropriate treatment should be obtained. The risk of bleeding may increase when used in combination with other anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory drugs, so caution is necessary when combining these treatments. Furthermore, when taken with certain antifungals, antibiotics, or antivirals that cause drug interactions, the risk of bleeding may increase, so it is essential to consult with a healthcare professional. This medication is contraindicated during pregnancy as it may pose risks to the fetus, and women of childbearing age must ensure contraception while on this medication. Nursing mothers should also avoid taking this medication. Elderly patients may experience elevated levels of this medication due to decreased kidney function; while no special dosage adjustment is necessary, caution is advised due to increased bleeding risk. Safety and efficacy have not been established in children and adolescents, and its use is not recommended. In case of overdose, the risk of bleeding can markedly increase; therefore, immediate medical attention should be sought for appropriate management. Driving or operating machinery may result in drowsiness or fainting due to side effects from this medication, so caution is necessary during such activities. Regular monitoring of health conditions and observation for symptoms is very important to reduce the risk of bleeding while taking this medication.

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, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital tract bleeding, kidney dysfunction, non-hemorrhage, hemoptysis, pruritus, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stool, melena

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is recommended to store this medication at room temperature between 1°C and 30°C.

Appearance

Bright red round film-coated tablet

Package unit

30 tablets per box [(10 tablets/PTP packaging x 3)]