Rivaroxam Tablet 15 mg (Rivaroxaban)

Adult dose

This medicine 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 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 in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement, 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. 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 is 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 treatment dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus 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 medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 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 initial dose should be started 6~10 hours after surgery, once hemostasis has been confirmed. The duration of administration 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. Patients taking 15 mg twice daily: Take this medicine 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: 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—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, International Normalized Ratio) is ≤ 3.0. Switching from a vitamin K antagonist to this medicine—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 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 is not suitable for measuring the anticoagulant activity of this medicine and should not be used. Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect INR elevation. 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 switching, administer the standard dose of the vitamin K antagonist; thereafter, administer a dose of the vitamin K antagonist based on INR testing. On the other hand, patients receiving this medicine and a vitamin K antagonist concomitantly should not undergo INR testing until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may be performed 24 hours after the last dose. In patients receiving a parenteral anticoagulant, start this medicine 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 of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). Discontinue this medicine and start administration of the parenteral anticoagulant at the time the next dose of this medicine would have been due. No dose adjustment is necessary in patients with mild renal impairment and a creatinine clearance of 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the blood concentration of this medicine increased significantly; therefore, this medicine should be administered with caution. There is no clinical experience in patients with severe renal impairment and a creatinine clearance of less than 15 mL/min; therefore, 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 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. 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). 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. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 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 properly positioned, and flush the tube with water after administration.

This medication prevents or treats thrombosis by inhibiting blood coagulation. However, there may be a risk of bleeding during treatment, so signs of bleeding should be carefully monitored. It should not be administered to patients who are already bleeding or at high risk of bleeding. Patients with allergies to this medication, severely impaired liver function, pregnant or breastfeeding women, and those with certain genetic disorders should also avoid this medication. Patients with reduced kidney function or conditions that pose a high bleeding risk should use this medication cautiously, and care should be taken when used with other drugs that may increase the risk of bleeding. While taking this medication, any symptoms of bleeding, such as easy bruising, nosebleeds, gum bleeding, hematuria, black stools, severe headaches, or dizziness, should prompt immediate consultation with a doctor. If bleeding is severe, the medication should be discontinued and appropriate treatment sought. Additionally, this medication may interact with certain antifungals, antivirals, antibiotics, etc., altering blood concentration, so patients must inform their doctor or pharmacist if they are taking other drugs. Women who are pregnant or planning to become pregnant must use contraception while taking this medication, and breastfeeding should be avoided during this treatment. The elderly may have an increased risk of bleeding, but no specific dosage adjustment is necessary. Its safety and efficacy have not been established for children and adolescents under 18 years of age, therefore it is not recommended. Overdosing significantly increases the risk of bleeding, so it is important to adhere to the prescribed dosage. If a dose is missed, adjustments for the next dosing schedule should be considered. Finally, during treatment with this medication, dizziness or drowsiness may occur while driving or operating machinery, so caution is advised.

Bleeding, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusion, wound discharge, vascular pseudoaneurysm, increase in transaminases, increased blood bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial bleeding, fainting, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, deep vein thrombosis, arthralgia, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flush, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, flu-like syndrome, drug hypersensitivity reaction, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, intestinal motility disorder, fracture, arthritis, joint disease, rhabdomyolysis, urinary tract infection, dysuria, kidney stones, bladder carcinoma, prostatic hyperplasia, Stevens-Johnson syndrome, fainting, drowsiness

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Red round film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)