Barelto 10 mg (Rivaroxaban)

Adult dose

This drug 10 mg may be administered with or without food, whereas 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 drug is 20 mg. There is limited experience with 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. The recommended initial dose for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. The recommended maintenance dose for subsequent treatment and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completing treatment (at least 6 months), the recommended dose for extended administration to reduce the risk of recurrence is 10 mg once daily. 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 drug is 30 mg during the first 3 weeks of treatment and 20 mg during the remainder of the treatment period. The recommended dose for adult patients who have undergone major orthopedic surgery of the lower limbs (knee or hip replacement) is 10 mg once daily. The first dose should be given 6~10 hours after surgery, once hemostasis has been confirmed. 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 drug 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. This drug should be started after discontinuing vitamin K antagonist therapy and when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. This drug should be started after discontinuing vitamin K antagonist therapy and when the INR is ≤ 2.5. Patients switching from this drug to a vitamin K antagonist should receive the vitamin K antagonist concomitantly with this drug until the INR reaches ≥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 results. In patients receiving this drug and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this drug. If this drug is discontinued, INR testing may be performed 24 hours after the last dose. In patients receiving parenteral anticoagulants, start this drug 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). Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug would have been due. No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Use with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Administration of this drug is not recommended in patients with severe renal impairment and creatinine clearance below 15 mL/min. For patients with nonvalvular atrial fibrillation and moderate renal impairment (creatinine clearance 30-49 mL/min) or severe renal impairment (creatinine clearance 15-29 mL/min), the recommended dose is 15 mg once daily. Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence / prevention in adult patients who have undergone major orthopedic surgery of the lower limbs: No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Avoid administering this drug to patients with liver disease associated with coagulopathy and to patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Immediately before use, this drug may be crushed, mixed with a liquid such as water or applesauce, and administered orally. This drug may be crushed and administered with a small amount of water through a gastrointestinal tube. Confirm that the tube is properly positioned, and flush the tube with water after administration.

This medication is used to prevent or treat blood clot formations by inhibiting blood coagulation. During treatment, bleeding may occur, so signs or symptoms of bleeding should be carefully monitored. If severe bleeding occurs, this medication should be discontinued immediately and healthcare professionals should be consulted. This medication should not be given to certain patients, for example, those allergic to this drug or its components, patients with severe bleeding, patients with severely impaired liver function, pregnant or breastfeeding females, and patients with lactose intolerance should not use this medication. Patients with a history of gastrointestinal ulcers or intracranial hemorrhages, those with vascular abnormalities or malignant tumors with a high risk of bleeding, and those who are co-administering other anticoagulants or certain antifungals should also use caution. For patients with impaired kidney function or those with diseases that have a high risk of bleeding, and for those taking non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors, the risk of bleeding may be increased, so it should be administered with caution. This medication may cause anemia or various bleeding symptoms; if bleeding is suspected, healthcare professionals should be notified immediately. Especially in the elderly or patients with impaired kidney function, it is necessary to be cautious as blood concentrations may increase, leading to a higher risk of bleeding. This medication can interact with certain drugs, and the risk of bleeding may be heightened when used in combination with azole antifungals, some antibiotics, strong CYP3A4 inhibitors or inducers, other anticoagulants, NSAIDs, and platelet aggregation inhibitors. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant must use contraception during treatment. This medication should be discontinued prior to surgery or invasive procedures, and after surgery, dosing should be resumed according to a doctor's instructions after assessing the risk of bleeding. Use in children or adolescents under 18 years is not recommended as its safety and efficacy have not been established. Overdose significantly escalates the risk of bleeding, so strict adherence to dosing is required, and in case of overdose, immediate medical attention is necessary. Drowsiness or fainting may occur, which can affect driving or operation of machinery, so these activities should be avoided if such symptoms develop.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival 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, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound site discharge, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial hemorrhage, syncope, urogenital bleeding, hematuria, menorrhagia, renal dysfunction, nasal bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, significant uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, arthralgia, myocardial infarction, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, intestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urination disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, influenza-like syndrome, drug hypersensitivity reaction, syncope, drowsiness

This medication should be stored in tightly sealed containers to prevent air and moisture exposure. Additionally, it is best stored at room temperature between 1°C and 30°C, avoiding extremely hot or cold conditions.

Appearance

Bright red round film-coated tablets

Package unit

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