Javareto 10 mg Tablet (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be administered 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 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 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 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 administration to reduce the risk of recurrence is 10mg once daily. The duration of treatment and treatment dose should be determined following 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 in the risk of recurrence: Days 1-21, 15mg twice daily, 30mg. From day 22, 20mg once daily, 20mg. Reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism: After administration for 6 months or longer, 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. Prevention of venous thromboembolism in adult patients who have undergone 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 administration 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, 2 tablets of 15 mg may be taken at once. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following 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: For 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) is ≤ 3.0. For treatment of deep vein thrombosis and pulmonary embolism/reduction in 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. No dose adjustment is required in patients with mild renal impairment and creatinine clearance 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations 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 these patients. 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 recurrence of deep vein thrombosis and pulmonary embolism / Prevention of venous thromboembolism in adult patients who have undergone 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 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 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 thrombosis by inhibiting blood clotting. Observations should be made for signs of bleeding, as bleeding may occur while taking this medication. If severe bleeding occurs, stop taking the medication immediately and consult a physician. This medication should not be administered to patients with certain liver diseases, those at high risk of bleeding, pregnant or nursing women, and patients with lactose intolerance. It must be used cautiously in patients with renal impairment or those with high bleeding risk, with careful consideration of the bleeding risks versus treatment benefits. The risk of bleeding may increase when used with other anticoagulants or specific antifungal medications, so caution is advised with combined use. During treatment, continue to monitor for signs of bleeding or anemia, and report any suspected bleeding symptoms immediately to healthcare professionals. Before surgery or invasive procedures, the medication should be discontinued for a specified period, and after the procedure, its resumption should be considered in light of bleeding risk. The safety of this medication in pregnant and lactating women has not been established, so it should be avoided during pregnancy, and women of childbearing potential must use contraception during treatment. In the elderly, renal function may decline leading to increased plasma concentrations, though no special dose adjustment is needed, the bleeding risk may be elevated. It is not recommended for use in children and adolescents under 18, as safety and efficacy have not been established. Overdose may result in bleeding complications; if overdose is suspected, seek appropriate medical attention immediately. Drowsiness or dizziness may occur while taking this medication, so caution is advised when driving or operating machinery. Before starting this medication, discuss potential interactions with current medications, particularly when combining with anticoagulants, antifungals, some antibiotics, and non-steroidal anti-inflammatory drugs.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular bleeding, gingival bleeding, gastrointestinal bleeding, stomach ache, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general decrease in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusions, wound exudate, 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 bleeding, dizziness, headache, cerebral and intracranial bleeding, fainting, urogenital bleeding, renal impairment, nosebleeds, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, deep vein thrombosis, arthralgia, unexplained bleeding, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, flu-like symptoms, drug hypersensitivity reactions

This medication should be stored in a sealed container to protect it from air and moisture and kept at room temperature between 1 to 30 degrees Celsius.

Appearance

Bright red, round, film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)