Jarox 20 mg (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. 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 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 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 are 20 mg once daily. For extended treatment to reduce the risk of recurrence after completion of treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose 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 compared with 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, total daily dose 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, from day 22: 20mg once daily, total daily dose 20mg Reduction in 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 thereafter. 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 first dose should be given within 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on each patient's risk of venous thromboembolism based on the type of surgery; treatment for 5 weeks is recommended for patients undergoing hip replacement and for 2 weeks for patients undergoing knee replacement. If you forget to take this medicine, take the missed dose as follows. 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 should 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: Stop vitamin K antagonist treatment and start taking this medicine when the International Normalized Ratio (INR) 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: Stop vitamin K antagonist treatment and start taking this medicine when the INR is ≤ 2.5. After taking this medicine, the INR value will be falsely elevated regardless of the dose. INR is not appropriate for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 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 the increase in INR. 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; thereafter, administer the dose of the vitamin K antagonist according to INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, INR should not be tested until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be tested after 24 hours have passed since the last dose. 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). 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 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, this medicine should be administered with caution. Use of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. 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 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. Immediately before use, this medicine may be crushed, mixed with water or a beverage such as applesauce, and taken 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 inhibiting coagulation. However, bleeding may occur during the use of this drug, so careful monitoring for signs of bleeding is essential. In particular, if severe bleeding occurs, the use of this drug must be stopped immediately. This drug should not be administered to certain patients, such as those allergic to its ingredients, those with existing severe bleeding, severely impaired liver function, pregnant or breastfeeding women, and patients with lactose intolerance. Patients at high risk of bleeding, such as those with gastrointestinal ulcers, intracranial hemorrhage, or who have had brain or spinal surgery recently, should also not use this drug. Caution is required when this drug is taken with other anticoagulants or specific antifungal agents since the risk of bleeding may be increased. Patients with impaired kidney function or those with high bleeding risks should use this drug cautiously, balancing the risk of bleeding with therapeutic efficacy. During the use of this drug, regular checks for symptoms of bleeding or anemia should be performed, and if bleeding is suspected, healthcare professionals must be informed immediately. If planning a surgery or invasive procedure, the use of this drug should be discontinued for a certain period, and after the procedure, its use should be resumed while considering the risk of bleeding. Pregnant or breastfeeding women should not use this drug, and women of childbearing age must use contraception while taking this drug. In elderly patients, the blood concentration may increase due to declining kidney function, which could elevate the risk of bleeding, but no separate dosage adjustment is necessary. Overdosing on this drug may further increase the risk of bleeding, so care must be taken not to exceed the prescribed dosage. Symptoms like drowsiness or fainting may occur during driving or operating machinery, so these activities should be avoided if such symptoms arise. This drug can interact with various medications, so patients must inform their healthcare provider about any other medications they are taking.

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 weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, wound discharge, vascular pseudoaneurysm, increased transaminases, increased bilirubin in the blood, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, renal failure, nasal bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms drug reaction, eosinophilic pneumonia, anticoagulant-related kidney disease, recurrent VTE, deep vein thrombosis, arthralgia, unspecified bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine hemorrhage, postoperative hematoma, myocardial infarction

This drug must be stored in a tightly closed container to protect it from air and moisture. It is recommended to store it at room temperature between 1°C and 30°C.

Appearance

Round film-coated tablet with reddish-brown color

Package unit

30 tablets/PTP [10 tablets/PTP packaging X 3]