Javareto 15 mg (Rivaroxaban)

Adult dose

This medication 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 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 medication 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 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. For extended administration to reduce the risk of recurrence after completing treatment (at least 6 months), the recommended dose is 10mg once daily. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence: Days 1-21, 15mg twice daily, daily dose 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence: From day 22, 20mg once daily, daily dose 20mg Reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism: After at least 6 months of treatment, 10mg once daily, daily dose 10mg The maximum daily dose of this medication 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 is 10 mg once daily. The initial dose should be started within 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 medication as soon as possible; in this case, 2 tablets of 15 mg may be taken at one time. Starting the next day, continue taking 15 mg twice daily. Patients taking 10, 15, 20 mg once daily: Take the missed dose as soon as possible. Starting the next 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 medication—Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Discontinue vitamin K antagonist therapy and start taking this medication when the International Normalized Ratio (INR) is ≤ 3.0. Switching from a vitamin K antagonist to this medication—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 therapy and start taking this medication when the INR is ≤ 2.5. No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Use this medication with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Administration of this medication is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min. 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 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). Patients switching from this medication to a vitamin K antagonist should receive concomitant vitamin K antagonist therapy until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer a dose of the vitamin K antagonist based on INR testing. In patients receiving a parenteral anticoagulant, start administration of this medication 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or when discontinuing a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). Discontinue this medication and start administration of a parenteral anticoagulant at the time the next dose of this medication would have been due. Immediately before use, this medication may be crushed and mixed with water or a beverage such as applesauce for oral administration. This medication may also be crushed and administered with a small amount of water through a gastrointestinal tube.

This medication is used to prevent or treat thrombosis by inhibiting blood clotting. However, bleeding may occur during treatment, so signs of bleeding should be carefully monitored. If severe bleeding occurs, discontinue the medication immediately and consult a physician. This medication should not be administered to patients with certain conditions or diseases, such as those with severe bleeding, severely impaired liver function, pregnant or nursing women, or patients with lactose intolerance. Additionally, patients who have recently undergone surgery or have suffered damage to the brain or spinal cord, as well as those with diseases at high risk for bleeding, should take this medication with caution. The risk of bleeding may increase when used in conjunction with other anticoagulants, certain antifungal agents, or antiplatelet agents, so caution is needed during combination therapy. Patients with impaired kidney function may experience increased blood concentration of this medication, raising the risk of bleeding; therefore, it should be taken strictly according to a physician's instructions. During treatment, careful observation of symptoms of bleeding and anemia is required, and if there are unexplained drops in blood pressure or signs of anemia, a physician must be informed immediately. If bleeding occurs, the medication can be delayed or discontinued, and appropriate treatment should be sought if necessary. This medication can interact with certain drugs; therefore, if other medications are being taken, it is essential to inform a physician or pharmacist. Pregnant or nursing women should not take this medication, and women of childbearing potential must ensure proper contraception during use. Elderly patients may have increased blood concentration due to reduced kidney function; however, specific dose adjustments are not necessary, but the risk of bleeding may be increased. The safety and effectiveness of this drug have not been established in pediatric and adolescent patients under 18 years of age and it is not recommended. Caution is advised in overdose cases as bleeding complications may occur, and symptoms should be promptly addressed in a medical facility. Caution is needed when driving or operating machinery during treatment, and if symptoms such as drowsiness or fainting occur, one should avoid driving or hazardous tasks.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general decrease in strength and energy, discomfort, localized edema, liver damage, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound site discharge, pseudoaneurysm, increase in transaminases, increase in serum bilirubin, increase in alkaline phosphatase, increase in LDH, increase in lipase, increase in amylase, increase in transferases, increase in bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reactions, bile stasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, fever reported as an adverse event in re-evaluation, unspecified bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, deep vein thrombosis, arthralgia, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, agranulocytosis, oral mucosal ulcer, high fever, severe dysphagia, angina, syncope, drowsiness

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. This will help maintain the efficacy of the medication for a longer period.

Appearance

Red round film-coated tablets

Package unit

30 tablets/PTP [(10 tablets/PTP packaging x 3)]