AhnGook NewPharm Rivaroxaban Tablet 10 mg

Adult dose

This medicine 10 mg may be taken with or without food, while 15 mg and 20 mg should be taken with food. Adults 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 the 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. (See '12. Clinical Trial Information') 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 treatment to reduce the risk of recurrence is 10mg once daily. The duration and dose of treatment should be determined after an individualized assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Duration of administration / Frequency of administration / Daily dose 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 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 thereafter. 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 the individual patient's risk of venous thromboembolism according to the type of surgery; treatment for 5 weeks is recommended for patients undergoing hip replacement and for 2 weeks for patients undergoing knee replacement. If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. From the next day onward, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the next day onward, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. Switching medications Switching from a vitamin K antagonist to this medicine Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Stop vitamin K antagonist treatment and start taking this medicine when the International Normalized Ratio (INR) is ≤ 3.0. Treatment of deep vein thrombosis and pulmonary embolism/Reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism Stop vitamin K antagonist treatment and start taking this medicine when the INR is ≤ 2.5. The INR value will be falsely elevated after taking this medicine, regardless of the dose. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. 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 increase in INR. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, followed by a dose based on INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be measured until 24 hours after taking this medicine. Once this medicine is discontinued, INR can be measured 24 hours after the last dose. Switching from a parenteral anticoagulant to this medicine In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low-molecular-weight heparin), or when the continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant when the next dose of this medicine would have been due. 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) has shown a significant increase in blood concentrations of this medicine; therefore, administer this medicine with caution. Use of this medicine is not recommended in patients with severe renal impairment and creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose in 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 with hepatic impairment Avoid administration of this medicine in patients with liver disease associated with coagulopathy and in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. Patients who cannot swallow tablets, 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 properly positioned and flush the tube with water after administration.

This medication is used to prevent or treat clots by inhibiting blood coagulation. During treatment, bleeding may occur, so careful observation for signs of bleeding is necessary. If severe bleeding occurs, discontinue this medication immediately. Routine blood test monitoring is generally not required; however, special tests may be helpful in cases of overdosing or emergency surgery. It should not be used in patients with allergies to the components of this medication, those with significant clinical bleeding, severe liver dysfunction, pregnant women, or nursing mothers. Moreover, patients with lactose intolerance should avoid taking it. It should also be avoided in patients with a high risk of bleeding, such as those with a history of gastrointestinal ulcers, intracranial hemorrhage, vascular malformations, or recent history of brain or spinal surgery or trauma. When taken with other anticoagulants or certain antifungal agents, the risk of bleeding may increase, so caution is necessary. Patients with impaired renal function or those with diseases that pose a high bleeding risk, or those taking non-steroidal anti-inflammatory drugs or platelet inhibitors, should use this medication cautiously. This medication can cause various side effects, including bleeding, anemia, gastrointestinal disturbance, and skin rashes; consult healthcare providers immediately for any unusual symptoms. Particularly in the elderly or patients with reduced kidney function, increased blood concentration may elevate bleeding risk, so monitoring is essential. It should be avoided during pregnancy due to potential risk to the fetus, and women of childbearing age should practice contraception during treatment. It may be necessary to discuss temporarily stopping this medication with a doctor before surgery or invasive procedures. In cases of overdose, the risk of bleeding increases, so inform healthcare providers immediately, and dialysis is ineffective in removing this medication. While taking this medication, drowsiness or dizziness may occur, requiring caution when driving or operating machinery. There are many potential drug interactions, so inform the doctor or pharmacist of any other medications being taken.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic weakness and energy reduction, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, transaminase elevation, increased serum bilirubin, elevated alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, brain and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, hematochezia, deep vein thrombosis, arthralgia, Pseudomonas aeruginosa wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, cardiac enzyme elevation, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like symptoms, drug hypersensitivity reaction

Store this medication in a tightly closed container to protect it from air and moisture. It is best to keep it at room temperature, between 1 to 30 degrees Celsius.

Appearance

Bright red round film-coated tablet

Package unit

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