Roxaban Tablet 15 mg (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. 1. Adults 1) 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 is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15 mg once daily [10 mg 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.”) 2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent 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 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 and dose of treatment should be determined after an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Duration of administration / Frequency of administration / Daily dose 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 recurrent 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 thereafter. 3) 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 administered 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. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at one time. From the following day, continue taking 15 mg twice daily. ② 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. 2. Switching between medicines 1) Switching from a vitamin K antagonist to this medicine ① Reduction of 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) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism/reduction of 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. Regardless of the dose, the INR value will be falsely elevated after taking this medicine. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 2) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation must be maintained continuously while switching to another anticoagulant. Note that this medicine may affect the INR, causing it to increase. 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; thereafter, administer the dose of the vitamin K antagonist according to INR test results. On the other hand, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine has been discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the time of the next scheduled parenteral dose (e.g., low molecular weight heparin), or when continuous administration of a parenteral anticoagulant (e.g., intravenous unfractionated heparin) is discontinued. 4) 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. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased significantly; therefore, administer this medicine with caution. There is no clinical experience in patients with severe renal impairment with creatinine clearance less than 15 mL/min, and use of this medicine is not recommended. 1) Reduction of 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. 2) Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrent 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). 4. Patients with hepatic impairment 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. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. 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 administering this medicine through a gastrointestinal tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This drug is used to prevent or treat the formation of blood clots. Careful observation for signs of bleeding should be maintained during use, particularly in cases with a high risk of bleeding. In the event of severe bleeding, discontinue the medication immediately and follow a doctor's instructions. Patients allergic to this drug or with severe bleeding, significantly impaired liver function, pregnant or nursing women, and those with specific hereditary lactose intolerance should not take it. Patients with a history of gastrointestinal ulcers, intracranial hemorrhage, brain or spinal surgery, or certain diseases with a high risk of bleeding should also avoid taking this medication. Patients with slightly impaired kidney function or diseases that increase bleeding risk should use this drug with caution and especially when used with other anticoagulants or medications that increase bleeding risk. It is advisable to check for bleeding regularly through blood tests during the period of taking this drug, and if bleeding symptoms occur, consult a doctor immediately. Certain antifungals, specific antivirals, and some antibiotics may increase the blood concentration of this medication, raising the risk of bleeding. Therefore, patients should inform their doctor if prescribed these drugs. Pregnant or nursing women should not take this medication, and women of childbearing age must use contraception during treatment. Elderly patients may experience elevated blood concentration due to decreased kidney function; however, specific dosage adjustments are not necessary, but caution is advised due to increased bleeding risk. This medication is not recommended for children or adolescents under 18 years of age, as safety and efficacy have not been established. Overdose can increase the risk of bleeding, so do not exceed the recommended dosage, and in case of overdose, consult medical assistance immediately. Symptoms such as drowsiness or fainting may occur when driving or operating machinery, so such activities should be avoided if these symptoms are present. The risk of bleeding complications may be elevated when used in conjunction with neuroblocking procedures, thus thorough consultation with medical personnel is warranted when used around these procedures. If bleeding symptoms or severe skin reactions occur, discontinue the medication immediately and seek medical attention.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gum bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increase in transaminases, elevated serum bilirubin, increase in alkaline phosphatase, increase in LDH, increase in lipase, increase in amylase, increase in transferases, increase in bilirubin complex, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial hemorrhage, syncope, urogenital hemorrhage, renal dysfunction, epistaxis, hemoptysis, itching, rash, petechial hemorrhage, cutaneous and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reaction accompanied by systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, recurrent VTE, recurrent PE, recurrent DVT, myocardial infarction, hemorrhagic duodenal ulcer, blood in stool, black stools, arthralgia, undetermined hemorrhage, postoperative hematoma, deep vein thrombosis, joint dislocation, Pseudomonas wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine hemorrhage, syncope, drowsiness

Store this medication in a tightly sealed container to protect it from air and moisture, at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness.

Appearance

Red round film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP x 3)]