Rivaroxaban 30 mg (Rivoraxaban Tosylate Hydrate)

Adult dose

This medicine should be taken with water, with or without food. 1. Adults 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation • Body weight ≤ 60kg: The recommended dose of this medicine is 30mg once daily. • Body weight > 60kg: The recommended dose of this medicine is 60mg once daily. However, for patients with one or more of the following factors, the recommended dose of this medicine is 30mg once daily. ‣ Moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) ‣ Concomitant use of P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) For elderly patients at high risk of bleeding, a dose of 15mg once daily may be administered depending on age and condition. (See “9. Use in the Elderly” under Precautions for Use.) 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Administer this medicine after at least 5 days of parenteral anticoagulant therapy. • Body weight ≤ 60kg: The recommended dose of this medicine is 30mg once daily. • Body weight > 60kg: The recommended dose of this medicine is 60mg once daily. However, for patients with one or more of the following factors, the recommended dose of this medicine is 30mg once daily. ‣ Moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min) ‣ Concomitant use of P-gp inhibitors (cyclosporine, dronedarone, erythromycin, ketoconazole) 2. Switching medications 2.1 Switching from another medication to this medicine 1) Switching from a vitamin K antagonist to this medicine Discontinue vitamin K antagonist therapy and start this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 2.5. 2) Switching from an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, apixaban) to this medicine Discontinue oral anticoagulant therapy and start this medicine at the time of the next scheduled dose of the oral anticoagulant. 3) Switching from a parenteral anticoagulant to this medicine (1) Low-molecular-weight heparin (LMWH) Discontinue LMWH and start this medicine at the time of the next scheduled LMWH dose. (2) Unfractionated heparin (UFH) Discontinue the intravenous UFH infusion and start this medicine 4 hours later. 2.2 Switching from this medicine to another medication 1) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulant effect should be maintained continuously while switching to another anticoagulant. (1) Oral option For patients taking 60mg of this medicine, administer 30mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. For patients taking 30mg of this medicine, administer 15mg of this medicine once daily together with an appropriate dose of a vitamin K antagonist. During the first 14 days of concomitant administration, it is recommended that INR be measured at least 3 times. To minimize the effect of this medicine on INR measurement, measure INR before administering this medicine. Once INR ≥ 2.0 is stably achieved, discontinue this medicine and continue vitamin K antagonist therapy. (2) Parenteral option Discontinue this medicine and administer a parenteral anticoagulant and a vitamin K antagonist at the time of the next scheduled dose of this medicine. Once INR ≥ 2.0 is stably achieved, discontinue the parenteral anticoagulant and continue vitamin K antagonist therapy. 2) Switching from this medicine to an oral anticoagulant other than a vitamin K antagonist (dabigatran, rivaroxaban, apixaban) Discontinue this medicine and start the oral anticoagulant at the time of the next scheduled dose of this medicine. 3) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time of the next scheduled dose of this medicine. 3. Patients with renal impairment Dose adjustment of this medicine is not required in patients with mild renal impairment (50 < CrCL ≤ 80mL/min). The recommended dose of this medicine is 30mg once daily in patients with moderate to severe renal impairment (15 ≤ CrCL ≤ 50mL/min). For reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a dose of 15mg once daily should be considered, depending on age and condition, for elderly patients at high risk of bleeding with creatinine clearance of 15 ≤ CrCL < 30 mL/min (see “9. Use in the Elderly” under Precautions for Use). 4. If you miss a dose of this medicine If you miss a dose, take this medicine as soon as possible on the same day, and take the next dose the following day according to the recommended dosage and administration. Do not take twice the recommended daily dose to make up for a missed dose. 5. Patients who cannot swallow tablets For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and administered orally. Alternatively, this medicine may be crushed, suspended in a small amount of water, and administered through a nasogastric tube; the tube should then be flushed with water. Crushed this medicine is stable in water and applesauce for up to 4 hours.

This medication is used to prevent or treat the formation of blood clots by thinning the blood. Increased risk of bleeding may occur while taking this medication; therefore, symptoms of bleeding or unexplained reductions in blood counts should be reported to a healthcare professional immediately. If serious bleeding occurs, discontinuation of this medication should be considered, and the bleeding site should be promptly examined. Patients at high risk of bleeding should be closely monitored for bleeding or anemia symptoms after starting this medication. Patients allergic to this medication or those with serious bleeding, significantly impaired kidney or liver function, certain bleeding risk disorders, pregnant or nursing women should not take this medication. The risk of bleeding may be further increased when this medication is combined with other anticoagulants or medications that affect blood coagulation; caution is especially needed in these cases. Regular kidney and liver function tests should be conducted during the duration of this medication, and it should be discontinued before surgical or invasive procedures to reduce the risk of bleeding. Serious neurological damage may occur during central nervous system anesthesia or spinal puncture as a result of using this medication; therefore, careful consultation with healthcare professionals is advised. Sudden discontinuation of this medication may increase the risk of thrombosis, so it must be discussed with a physician when stopping. Pregnant or nursing women should not take this medication, and women of childbearing age should consult their doctor regarding pregnancy plans. Elderly patients or those with declining kidney function may require dosage adjustments and should follow healthcare provider instructions. Overdose of this medication significantly increases the risk of bleeding; thus, adherence to the prescribed dosage must be maintained, and immediate contact with a medical institution is necessary in case of overdose. Using general blood coagulation tests may not accurately assess the effectiveness of this medication; therefore, specialized tests to confirm anticoagulant effects are conducted only in special cases. Driving or operating machinery is generally not significantly impacted, but care should be taken in the presence of symptoms like bleeding or dizziness.

Hemorrhage, soft tissue hemorrhage, nasal hemorrhage, vaginal hemorrhage, anemia, rash, abnormal liver function tests, thrombocytopenia, hypersensitivity, anaphylactic reaction, allergic edema, dizziness, headache, intracranial hemorrhage, subarachnoid hemorrhage, conjunctival/scleral hemorrhage, intraocular hemorrhage, pericardial hemorrhage, other hemorrhage, hemoptysis, abdominal pain, lower gastrointestinal tract hemorrhage, upper gastrointestinal tract hemorrhage, oral/pharyngeal hemorrhage, nausea, retroperitoneal hemorrhage, increased serum bilirubin, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased transaminases, increased aspartate aminotransferase, pruritus, urticaria, intramuscular hemorrhage, intracartilaginous hemorrhage, gross hematuria/urethral hemorrhage, anticoagulant-related nephropathy, puncture site hemorrhage, abnormal liver function tests, surgical site hemorrhage, subdural hemorrhage, procedure-related hemorrhage, interstitial lung disease, shortness of breath, dyspnea, cough, fever, abnormal breath sounds, severe uterine hemorrhage, worsening or prolonged menstrual bleeding, weakness, pallor, unexplained edema, dyspnea, unexplained shock

This medication should be stored in a tightly sealed container to protect it from air or moisture, and it is best kept at a cool room temperature between 1 degree Celsius and 30 degrees Celsius. This storage condition helps maintain the medication's efficacy for a longer period.

Appearance

Pink round film-coated tablets

Package unit

28 tablets/box