Rivaroxaban 15 mg Tablets

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 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 of treatment and dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative 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, total daily dose 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence: From day 22: 20mg once daily, total daily dose 20mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism: After 6 months or longer of treatment: 10mg once daily, total daily dose 10mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg during the subsequent treatment period. 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 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. If you miss a dose of this medicine: Patients taking 15 mg twice daily should take this medicine immediately; in this case, two 15 mg tablets may be taken at once. From the following day, continue taking 15 mg twice daily. If you miss a dose of this medicine: Patients taking 10, 15, or 20 mg once daily should 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. Switching from a vitamin K antagonist to this medicine: For reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, discontinue vitamin K antagonist therapy 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: For 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 therapy 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 must 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 switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR testing. In patients receiving this medicine together with a vitamin K antagonist, 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. Switching from a parenteral anticoagulant to this medicine: In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before 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). 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 required in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Based on limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min), blood concentrations of this medicine were significantly increased; 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. Patients with renal impairment, 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. Patients with renal impairment, 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 required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 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 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 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 correctly positioned, and flush the tube with water after administration.

This drug is used to prevent or treat blood clot formation by inhibiting coagulation. During the course of taking this drug, bleeding may occur, so careful monitoring for signs of bleeding is necessary. If severe bleeding occurs, administration should be stopped immediately. This drug should not be used in certain patients. For example, it should not be administered to those who are allergic to this medication or its ingredients, patients with severe bleeding, patients with significantly impaired liver function, pregnant or breastfeeding women, and patients with lactose intolerance. Additionally, it is advisable not to use this drug in patients who have recently undergone gastrointestinal ulcers, cerebral hemorrhage, or brain or spinal surgery, as well as patients with high bleeding risk due to malignant tumors. Caution should be taken as combining with other anticoagulants or certain antifungal agents may increase the risk of bleeding. This drug should be used carefully in patients with impaired renal function or diseases with a high risk of bleeding. The risk of bleeding can be heightened when used with non-steroidal anti-inflammatory drugs, platelet aggregation inhibitors, or selective serotonin reuptake inhibitors. During the use of this drug, if symptoms of bleeding or anemia appear, such as pallor, dizziness, fatigue, or abnormal bleeding, an immediate consultation with a doctor is necessary. Prior to surgery or invasive procedures, it may be necessary to discuss the temporary suspension of this medication with a physician. This drug may cause harm to the fetus if taken during pregnancy, so if pregnant or planning to become pregnant, consultation with a physician is essential, along with appropriate contraception during therapy. In the case of nursing, this drug can only be administered after the cessation of breastfeeding. Elderly patients may experience increased blood concentration due to decreased renal function, but specific dose adjustments are not needed although the risk of bleeding may increase. Overdose of this drug may increase the risk of bleeding, so the prescribed dosage and frequency must be strictly followed. Caution is required as symptoms such as drowsiness or dizziness may occur when driving or operating machinery. This drug may interact with various medications, so it is essential to inform the physician or pharmacist about any other medications being taken.

Hemorrhage, anemia, thrombocythemia, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized fatigue and energy decrease, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, wound drainage, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased enzyme transfer, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, kidney dysfunction, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, deep vein thrombosis, arthralgia, unspecified hemorrhage, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, agranulocytosis, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, phlegm-related diseases, asthma, laryngitis, dysphagia, intestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, voiding disorders, nephrolithiasis, bladder carcinoma, prostatic hyperplasia, flu-like syndrome, drug hypersensitivity reaction

This drug should be stored in a tightly sealed container to protect it from air and moisture, and it is recommended to keep it 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/PTP [10 tablets/PTP packaging x 3]