Barelto 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. Reduction in 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 the 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. Treatment of deep vein thrombosis and pulmonary embolism/reduction in 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 10 mg once daily. The duration of treatment and dose should be determined after an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence: Days 1-21: 15 mg twice daily, total daily dose 30 mg Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence: From day 22: 20 mg once daily, total daily dose 20 mg Reduction in the risk of recurrent deep vein thrombosis or pulmonary embolism: After at least 6 months of treatment: 10 mg once daily, total daily dose 10 mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg during the remainder of the 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 started 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. Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. Starting the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the following day, continue taking one 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 in 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) is ≤ 3.0. Switching from a vitamin K antagonist to this medicine—treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent 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 appropriate for measuring the anticoagulant activity of this medicine and should not be used. 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 the dose of the vitamin K antagonist according to INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed 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 parenteral dose (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 the parenteral anticoagulant at the time the next dose of this medicine would have been due. No dose adjustment is required in patients with mild renal impairment and 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 plasma concentration of this medicine increased significantly; therefore, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min, as there is no clinical experience in this population. Reduction in 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 in 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 required 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. 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 medication is used to prevent or treat the formation of blood clots by stopping the blood from clotting. However, while taking this medication, the risk of bleeding may increase, so signs or symptoms of bleeding should be carefully monitored. If bleeding occurs significantly, the use of this medication should be stopped immediately and a physician should be consulted. This medication should not be administered to certain patients. For instance, patients who have an allergy to any of its ingredients, those with active significant bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, and patients with genetic issues such as lactose intolerance should avoid using this medication. Furthermore, patients with recent gastrointestinal ulcers or a history of intracranial hemorrhage, certain vascular abnormalities, malignant tumors, or those who are taking other anticoagulants should also avoid using this medication. Patients with impaired renal function or those having a high risk of bleeding should use this medication cautiously, and extreme caution is advised when taking it together with other medications that might increase bleeding risk. Possible side effects of this medication include anemia, bleeding, dyspepsia, headache, dizziness, and in severe cases, skin rashes or allergic reactions. If bleeding is suspected or severe side effects occur, medical personnel should be notified immediately. This medication may pose risks to the fetus during pregnancy, so pregnant women should not take this medication, and women planning to become pregnant should consult with a physician. Breastfeeding women are also advised to avoid using this medication. The blood concentration of this medication may increase in elderly patients, but dose adjustments are usually not necessary; however, they should be cautious due to the increased risk of bleeding. In cases of overdose, the risk of bleeding may significantly increase, so the dosage should be strictly adhered to and medical personnel should be consulted immediately in case of overdose. Moreover, caution is needed when driving or operating machinery while taking this medication. Symptoms such as drowsiness or dizziness may occur, leading to the risk of accidents, so driving or operating machinery should be avoided if these symptoms appear. Finally, this medication can interact with several other drugs, so it is essential to inform your physician or pharmacist if you are taking other medications. Particularly, when used along with antifungals, certain antibiotics, anticoagulants, and non-steroidal anti-inflammatory drugs (NSAIDs), the risk of bleeding may increase, so caution is necessary.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, decreased overall strength and energy, discomfort, local swelling, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusion, wound secretion, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, brain and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, epistaxis, hemoptysis, itching, rash, petechiae, cutaneous and subcutaneous bleeding, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions associated with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, arthralgia, Pseudomonas aeruginosa 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, angina, significant skin rash, mucosal lesions, syncope, drowsiness

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to safely preserve the effectiveness of the drug.

Appearance

Red round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3), 100 tablets (10 tablets/PTP x 10)