Donga Rivaroxaban Tablets 15 mg

Adult dose

This drug 10 mg is administered without regard to meals, while 15 mg and 20 mg are 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 drug 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 drug 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. 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 drug 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 following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21: 15mg twice daily, total daily dose 30mg From day 22: 20mg once daily, total daily dose 20mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment: 10mg once daily, total daily dose 10mg The maximum daily dose of this drug 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 drug is 10 mg once daily. The first dose should be given within 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 a dose of this drug is missed ① Patients taking 15 mg twice daily: Take this drug immediately; in this case, two 15 mg tablets may be taken at once. Starting the following day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the following 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 drug 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 drug when the international normalized ratio (INR, International Normalized Ratio) 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 drug when the INR is ≤ 2.5. 2) Switching from this drug to a vitamin K antagonist In patients switching from this drug to a vitamin K antagonist, the vitamin K antagonist should be administered concomitantly 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. 3) Switching from a parenteral anticoagulant to this drug In patients receiving a parenteral anticoagulant, start this drug 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. 4) Switching from this drug to a parenteral anticoagulant Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug would have been due. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment with a creatinine clearance of 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 drug were significantly increased; therefore, this drug should be administered with caution. Since there is no clinical experience in patients with severe renal impairment with a creatinine clearance below 15 mL/min, use of this drug 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 required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min).

This medication is used to prevent or treat blood clot formation by inhibiting coagulation. However, bleeding may occur while taking this medication, so it is essential to carefully watch for signs of bleeding. If bleeding becomes severe, the use of this medication should be discontinued immediately and medical advice sought. Regular checks of blood concentration are not generally required, but in special situations such as overdose or emergency surgery, measuring blood concentration may be helpful. This medication should not be administered to patients with certain disorders or conditions. For example, those allergic to this medication, individuals with severe bleeding, patients with very poor liver function, pregnant or nursing women, and those with lactose intolerance should not use this medication. Patients with recent gastrointestinal ulcers, intracranial hemorrhage, spinal or brain surgery, brain or spinal cord injury, esophageal varices, vascular malformations, or high-risk malignancies for bleeding should also avoid this medication. Caution is warranted when used in conjunction with other anticoagulants or certain antifungal agents. Patients with reduced kidney function or those with conditions that increase bleeding risk should use this medication cautiously. Notably, taking it alongside non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors may increase bleeding risk. This medication may cause various side effects, including bleeding, anemia, rash, liver function abnormalities, digestive symptoms, etc., and any unusual symptoms should be reported immediately to healthcare professionals. Pregnant or nursing women should not take this medication, and women of childbearing age should adhere to contraception during its use. Older adults may have increased blood concentration of this medication due to decreased kidney function, though dose adjustment is not required, the bleeding risk may increase. In case of overdose, the risk of bleeding increases so medical consultation should be sought immediately, and this medication is not removed by dialysis, requiring special treatment. Caution is needed during driving or operation of machinery while taking this medication, as dizziness or fainting may occur. Lastly, this medication can interact with certain drugs, so it's crucial to inform healthcare providers of concurrent medications, and it may be necessary to discontinue use for a certain period before surgery or invasive procedures.

Hemorrhage, anemia, thrombocytosis, tachycardia, eye hemorrhage, gingival bleeding, gastrointestinal bleeding, gastric pain, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, general weakness and energy loss, discomfort, local edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminase, increased conjugated bilirubin, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, vascular edema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms related to drug reactions, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, 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, agranulocytosis, oral mucosal ulcer, high fever, severe dysphagia, angina, syncope, drowsiness

This medication should be stored in a tightly closed container to protect it from air and moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and ensures safe use.

Appearance

Red round film-coated tablets

Package unit

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