Rivaroxaban 10 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. 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 with concomitant administration for up to 12 months of rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor 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 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 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 and dose of treatment 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 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 medicine is 10 mg once daily. The first dose should be given within 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; treatment for 5 weeks is recommended for patients undergoing hip replacement and for 2 weeks for patients undergoing knee replacement. If you miss a dose of this medicine: Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at once. 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 should 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, INR values 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 for this purpose. 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 should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect the increase in INR. 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 the switch, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours after taking this medicine. Once this medicine has been discontinued, INR testing can be performed 24 hours after the last dose. 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 a 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 (creatinine clearance 50-80 mL/min). Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), the blood concentration of this medicine was significantly increased; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment (creatinine clearance less than 15 mL/min), as there is no clinical experience in these patients. 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). Patients with hepatic impairment: 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. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as applesauce, and taken 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, ensure that the tube is correctly positioned, and flush the tube with water after administration.

This medication is used to prevent and treat blood clots by inhibiting blood coagulation. While taking this medication, it's important to vigilantly observe for signs of bleeding. Particular caution should be taken for patients at higher risk of bleeding. If serious bleeding occurs, the administration of this medication should be stopped immediately, and appropriate treatment should be received at a hospital if necessary. This medication should not be administered to certain patients, including those allergic to the active ingredient or other components, pregnant or breastfeeding women, those with severe bleeding disorders, and patients with severe liver disease. Patients with a history of gastrointestinal ulcers, cerebral hemorrhage, vascular abnormalities, or recent surgeries at higher risk of bleeding should also avoid this medication. Care must be taken when co-administering with other anticoagulants or certain antifungal agents, as the risk of bleeding may increase. Patients with impaired kidney function or any bleeding disorders, as well as those taking medications that could affect bleeding, should use this medication with caution. This medication can cause various side effects, including bleeding, anemia, gastrointestinal discomfort, and skin rashes; immediate consultation with a healthcare professional is advised if abnormal symptoms appear. Symptoms of bleeding, such as pallor, dizziness, shortness of breath, and unexplained swelling, require immediate treatment. Regular blood tests are recommended to monitor for bleeding and blood status while on this medication. Additionally, patients scheduled for surgery or invasive procedures should discontinue this medication for a specified period before the procedure and resume afterward based on their condition. Women who are pregnant or planning to become pregnant should avoid this medication, and appropriate contraception is necessary while taking it. Elderly patients may have increased drug concentrations due to decreased kidney function, although dosage adjustments are generally not required; however, the risk of bleeding may be increased. This medication is not recommended for children and adolescents under 18, as its safety and efficacy have not been established. In case of overdose, the risk of bleeding significantly increases, thus immediate evaluation and treatment by a healthcare professional are required, as this medication is not removed through dialysis. Caution is advised as dizziness or drowsiness may occur while driving or operating machinery. During treatment, do not co-administer other anticoagulants or specific medications without consulting a physician, and be mindful of drug interactions.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment hemorrhage, contusion, wound exudate, vascular pseudoaneurysm, increased transaminases, elevated blood bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscular hemorrhage, dizziness, headache, intracranial and cerebral bleeding, syncope, urogenital bleeding, hematuria, menorrhagia, kidney dysfunction, epistaxis, hemoptysis, pruritus, rash, petechial bleeding, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, joint dislocation, arthralgia, pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulceration, high fever, severe dysphagia, cardiac ischemic symptoms, compartment syndrome, renal failure, postoperative syncope, drowsiness, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, cough disorder, asthma, laryngitis, dysphagia, bowel motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, micturition disorders, nephrolithiasis, bladder carcinoma, prostatic hyperplasia, flu-like symptoms, drug hypersensitivity reactions, Stevens-Johnson syndrome

Store this medication in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Bright red round film-coated tablet

Package unit

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