Zarex Tablet 20 Milligrams (Rivaroxaban (Unmodified))

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 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. Treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism: The initial recommended 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 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 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 recurrent 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 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 the individual 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 miss a dose of this medicine, patients taking 15 mg twice daily should take it immediately; in this case, 2 tablets of 15 mg 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 should 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: For reduction in 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, International Normalized Ratio) is ≤ 3.0. For treatment of deep vein thrombosis and pulmonary embolism/reduction in 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. 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≥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 test results. 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 at the time the 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 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 creatinine clearance 50-80 mL/min. Administration 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. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine are significantly increased; therefore, administer this medicine with caution. Treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism: No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance 15-29 mL/min. 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). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine are significantly increased; therefore, administer this medicine with caution. 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. Immediately before use, this medicine may be crushed, mixed with water or a beverage such as 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 used to prevent or treat the formation of blood clots by inhibiting blood clotting. A careful observation for signs of bleeding should be maintained during treatment, as bleeding may occur. If severe bleeding occurs, the use of this medication should be stopped immediately, and appropriate treatment to stop the bleeding must be received if necessary. Regular checking of blood concentration is not required for this medication using specific blood tests; however, measuring the blood concentration may be beneficial in emergency situations. Patients with hypersensitivity to this medication, active severe bleeding, severe liver dysfunction, pregnant or breastfeeding women should not take this medication. Patients with genetic issues like lactose intolerance should also avoid this medication. Patients at high risk for bleeding due to recent gastrointestinal ulcers, intracranial hemorrhage, vascular abnormalities, surgical history, etc. should refrain from taking this medication. Caution is required when used with other anticoagulants due to an increased risk of bleeding. Particularly, when used concurrently with azole antifungals or certain antiviral medications, the blood concentration of this medication may rise, thus increasing the risk of bleeding. Patients with decreased kidney function or those taking certain medications may also face increased bleeding risk while taking this medication, necessitating careful administration. This medication can cause side effects such as bleeding, anemia, dyspepsia, headache, dizziness, and in severe cases, life-threatening bleeding may occur. Any signs of bleeding should be reported immediately to healthcare providers, and appropriate treatment such as blood tests should be received if necessary. This medication may harm the fetus during pregnancy; therefore, women who are pregnant or planning to become pregnant must consult with a doctor, and nursing mothers should also preferably avoid it. Elderly patients may experience elevated drug concentrations due to decreased kidney function; while special dosage adjustments are generally not needed, the risk of bleeding may increase. Its safety and efficacy have not been established in children or adolescents under 18 years of age, and it is not recommended for them. The risk of bleeding significantly increases in cases of overdose, so strict adherence to dosing is essential, and if overdose is suspected, healthcare providers should be informed immediately. Caution is advised as symptoms like drowsiness or fainting may occur during driving or operating machinery. This medication should be temporarily discontinued for a certain period before surgery or invasive procedures, and it should be resumed post-procedure as per the physician's instructions. This medication has many interactions with other drugs; thus, one must consult with a doctor or pharmacist regarding medications taken concurrently. Extra caution is particularly needed when combined with drugs that increase the risk of bleeding. Sudden discontinuation of anticoagulant therapy may pose a risk for clot formation; hence, one must always discuss alternative treatment options with a physician upon stopping this medication. If there are any adverse reactions or uncomfortable symptoms while taking this medication, healthcare professionals should be informed immediately.

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

This medication should be stored in a closed container protected from air and moisture, and the storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Storing it this way will help preserve the effectiveness of the medication for a longer duration.

Appearance

Brownish red round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTPX3)], 100 tablets/box [(10 tablets/PTPX10)]