Rivasa 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 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 for 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 to reduce 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 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 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 is 10 mg once daily. The initial dose should be started within 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 medicine immediately; in this case, two 15 mg tablets 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. Switching from a vitamin K antagonist to this medicine — Patients with nonvalvular atrial fibrillation: Discontinue vitamin K antagonist therapy and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) 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 recurrence: Discontinue vitamin K antagonist therapy and start taking this medicine when the INR is ≤ 2.5. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the vitamin K antagonist dose based on INR testing. No dose adjustment is necessary in patients with mild renal impairment and a creatinine clearance of 50-80 mL/min. This medicine should be administered with caution to patients with severe renal impairment (creatinine clearance 15-29 mL/min). Administration of this medicine is not recommended in patients with severe renal impairment and a creatinine clearance below 15 mL/min. Patients with renal impairment — 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. Patients with renal impairment — Treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrence/prevention of venous thromboembolism 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). For patients who cannot swallow tablets, this medicine may be crushed immediately before use, 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.

This medication is used to prevent or treat the formation of blood clots by preventing blood from coagulating. During treatment, bleeding may occur, so you must report any signs of bleeding immediately. If severe bleeding occurs, treatment with this medication must be stopped, and professional medical treatment may be necessary in emergency situations. This medication should not be used by individuals who are allergic to it, those who already have severe bleeding, patients with significantly impaired liver function, or women who are pregnant or breastfeeding. Additionally, patients with a history of gastrointestinal ulcers, cerebral hemorrhage, vascular abnormalities, malignant tumors, and others at high risk of bleeding may also be at risk when using this medication. The risk of bleeding may increase when used in combination with other anticoagulants or certain antifungal agents, so consultation with a physician is essential. Patients with impaired renal function or suffering from diseases that increase bleeding risk should use this medication cautiously and carefully evaluate the risks of bleeding versus the benefits of treatment. Regular blood tests may be helpful since signs of anemia or bleeding can develop during treatment with this medication. If bleeding is suspected, inform your doctor immediately, and if there is severe bleeding, appropriate emergency treatment should be received. Particularly when undergoing procedures such as nerve anesthesia or spinal punctures, the risk of bleeding increases, so precautions are needed before and after procedures. This medication should not be taken during pregnancy, and women of childbearing age must use contraception while taking the drug. Elderly patients may have increased blood concentration due to impaired renal function; although dosage adjustment is typically unnecessary, the risk of bleeding may be increased. Children and adolescents under 18 years of age are not recommended to use this medication as its safety and efficacy have not been established. In case of overdose, the risk of bleeding may increase; hence, strict adherence to the dosage is crucial, and side effects like drowsiness or dizziness may arise, necessitating caution when driving or operating machinery. During treatment with this medication, interactions with other drugs may occur, so it is vital to inform healthcare providers about any medications being taken.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival hemorrhage, gastrointestinal hemorrhage, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized reduction of strength and energy, discomfort, local edema, liver dysfunction, jaundice, allergic reaction, allergic dermatitis, post-treatment hemorrhage, contusion, secretion from wound area, pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugate, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital hemorrhage, kidney dysfunction, non-hemorrhage, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, deep vein thrombosis, joint dislocation, 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 ulcer, high fever, severe dysphagia, angina, cardiac ischemic symptoms, compartment syndrome, renal failure, syncope after surgery, drowsiness

Store this medication in a tightly closed container to avoid exposure to air or moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication.

Appearance

Red round film-coated tablet

Package unit

7 tablets/box [(7 tablets/PTP)], 30 tablets/box [(10 tablets/PTP x 3)], 100 tablets/box [(10 tablets/PTP x 10)]