Javareto 20 mg (Rivaroxaban)

Adult dose

This 10 mg medicine may be administered with or without food, while the 15 mg and 20 mg doses should be administered with food. 1. Adults 1) 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 once daily at 15 mg [10 mg once daily for 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. (See '12. Clinical Trial Information'.) 2) 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 treatment dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment period Dosing frequency Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15mg twice daily 30mg 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 medicine is 30 mg during the first 3 weeks of treatment and 20 mg during the subsequent treatment period. 3) 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 initial 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. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at one time. Starting the next day, continue taking 15 mg twice daily. ② 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 must not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ① 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) is ≤ 3.0. ② 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, the INR value 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. 2) 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 should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect the elevation of the 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; thereafter, administer the vitamin K antagonist dose based on INR testing. However, in patients receiving this medicine together with a vitamin K antagonist, 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. 3) Switching from a parenteral anticoagulant to this medicine 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 when a continuously administered parenteral medicine (e.g., intravenous unfractionated heparin) is discontinued. 4) 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. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that plasma concentrations of this medicine increased significantly; therefore, this medicine should be administered with caution. Since 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. 1) 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. 2) 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 necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) 5. For patients who cannot swallow tablets, Immediately before use, this medicine may be crushed, mixed with a liquid such as water or 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 properly positioned and flush the tube with water before administration.

This medication is an anticoagulant used to prevent or treat blood clots by preventing blood from clotting. During the course of taking this drug, there is a risk of easy bleeding, so signs of bleeding should be carefully monitored. If severe bleeding occurs, the use of this medication must be stopped immediately and a doctor must be consulted. This medication should not be used in patients with certain blood coagulation disorders, severe liver disease, or those who are pregnant or breastfeeding. Moreover, patients with certain genetic conditions such as lactose intolerance should also avoid its use. Use of this medication is not recommended in patients with conditions that have a high risk of bleeding, such as recent gastrointestinal ulcer, intracranial hemorrhage, vascular abnormalities, or malignant tumors. Be cautious as the risk of bleeding may increase when taken with other anticoagulants or certain antifungal agents. This medication should be administered carefully to patients with impaired kidney function or those with diseases that pose a high risk of bleeding, weighing the risk of bleeding against the benefits of treatment. The risk of bleeding may also increase when taken with medications affecting bleeding such as non-steroidal anti-inflammatory drugs or antiplatelet agents. This medication can cause various side effects such as bleeding, anemia, gastrointestinal disturbances, and skin reactions, so if any abnormal symptoms occur, consult a doctor immediately. In particular, if there are severe rashes or mucosal ulcers on the skin, administration must be stopped immediately. Women who are pregnant or breastfeeding should not take this medication as it may pose risks to the fetus or newborn, and women who may become pregnant should use contraception while taking this medication. Elderly patients may have an increased risk of bleeding due to higher drug concentrations from decreased kidney function, but no separate dose adjustment is necessary. During the treatment, it is advisable to stop taking this medication for a certain period before surgery or invasive procedures, and to carefully decide on resuming once the risk of bleeding is considered negligible. An overdose may significantly increase the risk of bleeding, so strict adherence to the prescribed dosage is vital. If an overdose is suspected, inform medical personnel immediately. Caution is needed as drowsiness or fainting may occur while driving or operating machinery. This medication may interact with several other drugs, so if other medications are being taken, it is essential to inform a doctor or pharmacist. It is advisable to regularly monitor blood tests for bleeding status and blood condition during the medication period.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, exudate from wound area, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, elevated transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, genitourinary bleeding, renal impairment, nasal bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, 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 nephropathy, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stool, 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 ulceration, high fever, severe dysphagia, angina, influenza-like symptoms, drug hypersensitivity reactions, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum diseases, asthma, laryngitis, dysphagia, gastrointestinal motility disorders, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, voiding disorders, renal stones, bladder carcinoma, prostatic hyperplasia, Stevens-Johnson syndrome

This medication can be sensitive to air or moisture, so it should be stored in a tightly closed container. Moreover, it should be stored at room temperature, between 1 and 30 degrees Celsius, avoiding extreme hot or cold conditions.

Appearance

Brownish-red round film-coated tablets

Package unit

30 tablets/PTP [(10 tablets/PTP packaging x3)]