Rivaroxaban 15 mg Tablet (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food; 15 mg and 20 mg should be administered with food. 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 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. 15 mg twice daily for the first 3 weeks. Thereafter, the recommended maintenance dose 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. Days 1-21: 15mg twice daily, 30mg From day 22: 20mg once daily, 20mg After 6 months or more 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 subsequent treatment period. 10 mg once daily. Treatment should be started 6~10 hours after surgery. 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; two 15 mg tablets 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 total daily dose should not be doubled to make up for a missed dose. Start taking this medicine after discontinuing vitamin K antagonist therapy and when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. Start taking this medicine after discontinuing vitamin K antagonist therapy and when the INR is ≤ 2.5. After taking this medicine, the INR value will be falsely elevated. INR should not be used, as it is not suitable for measuring the anticoagulant activity of this medicine. In patients receiving this medicine together with a vitamin K antagonist, do not test INR until 24 hours have elapsed after taking this medicine. INR may be tested after 24 hours have elapsed since the last dose. Start this medicine 0~2 hours before the next scheduled dose of a parenteral agent (e.g., low molecular weight heparin), or when continuous administration of a parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. Start administration of the parenteral anticoagulant at the time of the next dose of this medicine. No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates a significant increase in the blood concentration of this medicine; therefore, administer with caution. As there is no clinical experience in patients with severe renal impairment with creatinine clearance below 15 mL/min, use of this medicine is not recommended. 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. No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Avoid use in patients with liver disease associated with coagulopathy and in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Immediately before use, this medicine may be crushed, mixed with water or a drink such as applesauce, and administered orally. It may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administration through a gastrointestinal tube, confirm that the tube is properly positioned and flush the tube with water after administration.

This drug is used to prevent or treat blood clots by stopping blood from clotting. However, the risk of bleeding may increase while taking this medication, so care must be taken to monitor for signs and symptoms of bleeding. If serious bleeding occurs, the medication should be stopped immediately and a healthcare professional consulted. This drug should not be administered to patients with certain conditions or diseases, such as those with bleeding, severe liver impairment, those who are pregnant or breastfeeding, and patients with lactose intolerance, among others. Additionally, caution is warranted for patients with recent bleeding risks or a history of surgery. Patients with impaired kidney function or those with diseases that pose a bleeding risk should be particularly careful, and especially cautious when combined with other medications that may increase bleeding risk. While taking this medication, side effects such as bleeding, anemia, gastrointestinal symptoms, skin rashes, and others may occur, and any such symptoms should be reported to a healthcare professional. As the drug is metabolized and excreted by the liver and kidneys, dose adjustment or monitoring may be required for patients with impaired liver or kidney function. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing potential must ensure appropriate contraception while taking this drug. The elderly may experience increased blood concentrations due to reduced kidney function, though specific dose adjustments are generally not required, but the risk of bleeding may be higher. Safety and efficacy in children and adolescents have not been established; therefore, its use is not recommended. In case of overdose, the risk of bleeding increases, and immediate medical attention and appropriate treatment should be sought. This medication may affect driving or operation of machinery, thus caution is advised if symptoms such as drowsiness or dizziness occur. Additionally, this drug may interact with other medications, particularly antifungals, anticoagulants, antiplatelet drugs, and certain antibiotics, so consultation with a healthcare professional is essential. Before undergoing surgery or invasive procedures, it may be necessary to discontinue this medication for a certain period, as directed by a healthcare professional. Abrupt cessation of this medication may increase the risk of thrombosis, so any discontinuation should follow a physician's instructions. Finally, any unusual symptoms such as bleeding, skin rashes, or severe allergic reactions should be reported to a healthcare professional immediately.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gum bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, hepatic impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminase, elevated bilirubin levels, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, kidney impairment, nasal bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, deep vein thrombosis, arthralgia, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membrane colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcers due to agranulocytosis, high fever, severe dysphagia, angina, postoperative syncope, drowsiness

This medication must be stored in a tightly closed container to protect it from air and moisture. It is advisable to keep the medication at room temperature, between 1 to 30 degrees Celsius, away from excessive heat or cold. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance

Red, round, film-coated tablet

Package unit

30 tablets/box [30 tablets (10 tablets/PTP x 3)], 100 tablets/box [100 tablets (10 tablets/PTP x 10)]