Donggu Rivaroxaban Tablets 20 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. 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 15 mg once daily [10 mg 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 of the risk of recurrent 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 the dose should be determined following an individual assessment of the risk of recurrent 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, daily dose 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, from day 22: 20mg once daily, 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, 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 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; a treatment duration of 5 weeks is recommended for patients undergoing hip replacement and 2 weeks for patients undergoing knee replacement. 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 one time. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following day, continue taking one tablet once daily. The daily dose must not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine: Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Discontinue 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 of the risk of recurrent deep vein thrombosis and pulmonary embolism: Discontinue vitamin K antagonist treatment 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 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: Patients switching from this medicine to a vitamin K antagonist should receive both medicines until the INR is ≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer the dose of the vitamin K antagonist according to INR test results. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing must not be performed until 24 hours after taking this medicine. Once this medicine is discontinued, INR testing may be performed 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 discontinuing a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 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. No dose adjustment is necessary in patients with mild renal impairment and creatinine clearance 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 medicine increased significantly; therefore, administer this medicine with caution. Administration of this medicine is not recommended in patients with severe renal impairment and creatinine clearance below 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 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 of the risk of recurrent 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). 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. For patients unable to swallow tablets, this medicine may be crushed immediately before use 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 correctly positioned and flush the tube with water after administration.

This medication is designed to prevent or treat the formation of blood clots by hindering blood clotting. During treatment, there may be a risk of bleeding, so be vigilant about observing symptoms of bleeding. If severe bleeding occurs, stop taking the medication immediately and consult a physician. This medication should not be used in patients with certain liver diseases, in women who are pregnant or breastfeeding, and in individuals who are hypersensitive to the drug. Patients with recent histories of intracranial hemorrhage or gastrointestinal bleeding or those with malignant tumors at high risk of bleeding should also avoid this medication. Caution is advised when using this drug in patients with impaired kidney function or those with poorly controlled hypertension or gastrointestinal diseases as they may be at increased risk of bleeding. Use with non-steroidal anti-inflammatory drugs or antiplatelet agents may increase the risk of bleeding. This drug is metabolized and excreted by the liver and kidneys, so dosage adjustments or caution is necessary if hepatic or renal function is impaired. During pregnancy, it may pose risks to the fetus, so contraception is necessary, and it is preferable to avoid use while breastfeeding. Elderly patients may have increased blood levels, raising the risk of bleeding, though dosage adjustment is generally not required. Safety and efficacy in children and adolescents have not been established, so it is not recommended for this age group. In the case of overdose, the risk of bleeding may increase; hence, immediate medical attention is necessary. Dizziness or drowsiness may occur, so caution is advised when driving or operating machinery. Interactions with specific antifungals, antivirals, and antibiotics may affect blood concentration, so patients should always consult their physician or pharmacist about any other medications they are taking. You may need to discontinue this medication before surgery or invasive procedures, so inform your healthcare provider of any upcoming surgical plans in advance. During treatment, if symptoms such as bleeding, skin rash, mucosal ulcers, or fever arise, inform medical personnel immediately. This medication may affect the results of blood coagulation tests, so it is essential to inform testers that you are taking this medication.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival hemorrhage, gastrointestinal bleeding, stomachache, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and fatigue, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, vascular pseudoaneurysm, transaminase elevation, increased serum bilirubin, alkaline phosphatase elevation, LDH elevation, lipase elevation, amylase elevation, enzyme elevation, increased 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 shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, reported arthralgia as an abnormal case for re-evaluation, unspecified hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, hematochezia, myocardial infarction, deep vein thrombosis, facial flushing, cardiomyopathy, elevated cardiac enzymes, congestive heart failure, urinary tract infection, pseudomembranous colitis, asthma, pulmonary edema, pleural effusion, flu-like syndrome, drug hypersensitivity reaction

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is crucial to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Round, film-coated tablets with a reddish-brown color

Package unit

7 tablets in PTP packaging, 30 tablets (10 tablets in PTP packaging x 3), 100 tablets (10 tablets in PTP packaging x 10)