Zarokte 15 mg Tablets (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. Adults 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 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. (See '12. Clinical Trial Information') 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 compared with the risk of bleeding. 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 during the subsequent treatment period. 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 started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; however, a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. If you forget to take this medicine Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following 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 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. Treatment 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, INR values will be falsely elevated after taking this medicine. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. Switching from this medicine to a vitamin K antagonist 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 the switch, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR testing. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should 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 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 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 administration of the parenteral anticoagulant at the time the next dose of this medicine would have been due. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment with a creatinine clearance of 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) has shown a significant increase in the blood concentration of this medicine; therefore, this medicine should be administered with caution. As there is no clinical experience in patients with severe renal impairment with a creatinine clearance of less than 15 mL/min, administration of this medicine is not recommended. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose in 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 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 necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 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. Patients unable to swallow tablets Immediately before use, this medicine may be crushed and mixed with water or a drink 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 acts to prevent blood clotting. Like other anticoagulants, there is a risk of bleeding, so signs of bleeding must be carefully monitored. If severe bleeding occurs, this medication should be discontinued immediately. In some cases, blood concentration testing may be done for reference during overdose or emergencies. Patients with allergies to this drug's active ingredient or components, those with clinically significant bleeding, severe liver disease patients, women who are pregnant or nursing, and those with lactose intolerance should not take this medication. Additionally, treatment should be avoided in patients who have recently experienced bleeding risks or underwent surgery, and in cases where it is used in combination with other anticoagulants or specific antifungal agents. Patients with impaired kidney function or diseases with high bleeding risks should use this medicine cautiously, and caution is needed when taking it with other medications that can increase the risk of bleeding. This drug may cause various side effects, including bleeding, anemia, gastrointestinal disturbances, allergic reactions, etc., so any unusual symptoms should be consulted with a physician immediately. Particularly in elderly patients or those with decreased kidney function, blood concentration may rise, increasing the risk of bleeding, so caution is necessary. Pregnant women should avoid its use due to potential effects on the fetus, and women of childbearing age should use contraception during use. This drug is also not recommended for breastfeeding women, so drinking should stop before commencing treatment. In case of overdose, the risk of bleeding significantly increases, so the dosage must be strictly adhered to and adjustments should be made under medical guidance. Caution is needed when driving or operating machinery as drowsiness or fainting may occur. This medication can interact with several drugs, so it is essential to inform healthcare professionals of any other medications being taken. Before surgeries or invasive procedures, this medication should be discontinued for a certain period, and instructions from healthcare professionals should be followed due to increased bleeding risks. Sudden discontinuation of this drug can increase the risk of thromboembolism, so any discontinuation should be discussed with a physician for alternative treatment.

• Bleeding
• anemia
• thrombocytosis
• tachycardia
• ocular hemorrhage
• gum bleeding
• gastrointestinal bleeding
• stomach pain
• abdominal pain
• dyspepsia

This medicine must be stored in a tightly sealed container to prevent air or moisture from entering. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help to preserve the medication's effectiveness.

Appearance

Brown, double convex, round film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP*10)]