Jarelto Tablet 20 milligrams (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose is 20 mg once daily. For patients with moderate renal impairment (creatinine clearance 30-49 mL/min), the recommended dose 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 have undergone percutaneous coronary intervention (PCI) with stent placement. Treatment of acute deep vein thrombosis and pulmonary embolism: 15 mg twice daily for the first 3 weeks. Thereafter, the recommended maintenance dose is 20 mg once daily. Reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism: After completing treatment (at least 6 months), 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 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 during 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 is 10 mg once daily. The first dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. A treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If a patient taking 15 mg twice daily misses a dose: The patient should 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. If a patient taking 10, 15, or 20 mg once daily misses a dose: 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. Switching from a vitamin K antagonist to this medicine, reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Discontinue vitamin K antagonist therapy and start this medicine when the international normalized ratio (INR, International Normalized Ratio) 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: Discontinue vitamin K antagonist therapy and start this medicine when the INR is ≤ 2.5. Switching from this medicine to a vitamin K antagonist: 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, and thereafter administer the vitamin K antagonist dose according to INR testing. In patients receiving this medicine together with a vitamin K antagonist, INR testing must not be performed until 24 hours after taking this medicine. If this medicine is discontinued, INR testing may be performed after 24 hours have elapsed since the last dose. Switching from a parenteral anticoagulant to this medicine: 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 when the next dose of this medicine would have been due. No dose adjustment is required in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Use with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Administration is not recommended in patients with severe renal impairment with creatinine clearance below 15 mL/min. Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, patients with moderate renal impairment (creatinine clearance 30-49 mL/min) and severe renal impairment (creatinine clearance 15-29 mL/min): The recommended dose 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), patients with moderate renal impairment (creatinine clearance 30-49 mL/min): No dose adjustment is required. Avoid administration to patients with liver disease associated with coagulopathy and to patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. 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 administration through a gastrointestinal tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This medication prevents or treats clots by inhibiting blood clotting. Careful observation for unusual bleeding symptoms is essential while taking this medication due to the risk of bleeding. In case of serious bleeding, this medication should be discontinued immediately, and appropriate treatment should be received according to the physician's instructions if necessary. This medication is not recommended for patients with certain diseases or conditions. For example, patients with severe bleeding, significantly impaired liver function, women who are pregnant or breastfeeding, and those with lactose intolerance should avoid taking this medication. Patients with gastrointestinal ulcers at high risk of bleeding, recent brain hemorrhage, vascular abnormalities, severe trauma, or postoperative states should exercise caution when using this medication. Additionally, when taken with other anticoagulants or specific antifungal agents, the risk of bleeding may increase; therefore, concomitant use should be avoided or followed according to a physician's guidance. Patients with impaired renal function or those with diseases at high risk of bleeding, and patients taking other medications affecting blood coagulation should use this medication with caution. During treatment, various side effects such as bleeding, anemia, digestive disorders, skin rashes, etc., may occur, and if any unusual symptoms arise, immediate consultation with a physician is recommended. In particular, if severe rash or ulcers occur on the skin or mucous membranes, the medication should be stopped immediately and healthcare professionals informed. This medication may pose risks to the fetus if taken during pregnancy, therefore women who are pregnant or may become pregnant should strictly practice contraception. Breastfeeding women should also avoid taking this medication. Elderly patients may have increased concentrations of this medication due to impaired renal function, but no separate dose adjustments are necessary; however, the risk of bleeding may be increased. This medication is not recommended for individuals under 18 years of age as its safety and efficacy in this population have not been established. In cases of overdose, the risk of bleeding increases; if overdose is suspected, medical attention should be sought immediately for appropriate treatment. Drowsiness or fainting may occur during the use of this medication, so caution should be taken while driving or operating machinery. Before surgery or invasive procedures, this medication should be discontinued for a specified period, and consultation with a physician is necessary to minimize the risk of bleeding. Abrupt discontinuation of this medication may increase the risk of thrombosis; therefore, if discontinuing, it must be done per physician guidance. This medication can interact with various drugs, so it is crucial to notify the physician or pharmacist about any other medications being taken.

• Hemorrhage
• anemia
• thrombocytosis
• tachycardia
• ocular hemorrhage
• gingival hemorrhage
• gastrointestinal bleeding
• abdominal pain
• dyspepsia
• nausea

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is at room temperature between 1 to 30 degrees Celsius. This ensures that the drug's efficacy is safely maintained over time.

Appearance

Brownish red circular film-coated tablet

Package unit

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