GENUWIN Rivaroxaban Tablets 10 mg (Rivaroxaban)

Adult dose

This drug 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered with food. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: The recommended dose of this drug 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 drug is 20 mg. There is limited experience with coadministration 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 of the risk of recurrence of deep vein thrombosis and pulmonary embolism: The recommended initial dose of this drug 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 of treatment and dose should be determined following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism in relation to 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. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, 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 drug is 30 mg during the first 3 weeks of treatment and 20 mg during the remainder of treatment. Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement): The recommended dose of this drug is 10 mg once daily. The first dose should be given 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 a dose of this drug is missed: Patients taking 15 mg twice daily should take this drug immediately; in this case, 2 tablets of 15 mg may be taken at one time. From the following day, continue treatment with 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily should take the missed dose immediately. From the following day, continue treatment with 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 drug: For reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment with this drug should be started after discontinuing the vitamin K antagonist and when the International Normalized Ratio (INR) is ≤ 3.0. For treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism, treatment with this drug should be started after discontinuing the vitamin K antagonist and when the INR is ≤ 2.5. Switching from this drug to a vitamin K antagonist: Patients switching from this drug to a vitamin K antagonist should receive both drugs 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 dose of the vitamin K antagonist based on INR testing. In patients receiving this drug and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this drug. If this drug is discontinued, INR testing may be performed 24 hours after the last dose. Switching from a parenteral anticoagulant to this drug: Start this drug 0~2 hours before the time of 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 drug to a parenteral anticoagulant: Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug would have been due. Patients with renal impairment: No dose adjustment is required in patients with mild renal impairment with creatinine clearance 50-80 mL/min. The recommended dose for patients with nonvalvular atrial fibrillation and moderate renal impairment (creatinine clearance 30-49 mL/min) or severe renal impairment (creatinine clearance 15-29 mL/min) is 15 mg once daily. No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) for 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). Use with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Use of this drug is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min. Patients with hepatic impairment: Avoid administration of this drug in patients with liver disease associated with coagulopathy and in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.

This medication is used to prevent or treat thrombus formation by inhibiting blood clotting. However, there is a risk of bleeding during treatment, so any bleeding symptoms should be reported to the healthcare personnel immediately. If severe bleeding occurs, the medication should be discontinued, and appropriate treatment will be administered by healthcare personnel. This medication should not be used in patients with a known hypersensitivity to it, those with serious bleeding, patients with severe liver function impairment, pregnant or breastfeeding women, and certain genetically linked lactose intolerant patients. Caution is also advised in patients with a recent history of gastrointestinal ulcers, intracranial hemorrhage, or surgery involving the brain or spinal cord, as well as in patients taking other anticoagulants or certain antifungal medications. There is an increased risk of bleeding in patients with renal impairment or those with conditions that elevate bleeding risk, and when combined with nonsteroidal anti-inflammatory drugs or platelet aggregation inhibitors. The medication may cause various adverse reactions, especially bleeding-related symptoms. Symptoms such as pallor, dizziness, shortness of breath, or sudden pain should prompt immediate consultation with healthcare personnel. Additionally, this medication may interact with other drugs, so it is crucial to inform healthcare personnel if you are taking any other medications. Its use is not recommended for pregnant or breastfeeding individuals, and fertile women must use contraception while taking it. Also, elderly patients or those with renal impairment may face higher bleeding risks with this medication and should follow healthcare personnel's instructions. Overdosing may significantly increase bleeding risk, so prescribed dosage and frequency must be strictly followed, and healthcare facilities should be visited immediately if side effects occur. Caution should be exercised when driving or operating machinery, as symptoms such as dizziness and drowsiness may occur.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is recommended to store the medication at room temperature, ideally between 1 to 30 degrees Celsius, and avoid temperatures that are too hot or too cold.

Appearance

Bright red, round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTPX3)]