Daehan Rivaroxaban Tablet 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 in 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 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 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 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 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 in the risk of recurrence: Days 1-21: 15mg twice daily, daily dose 30mg. From day 22: 20mg once daily, daily dose 20mg. Reduction in the risk of recurrent 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 thereafter during the 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 of this medicine is 10 mg once daily. The first dose should be taken 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; treatment for 5 weeks is recommended for patients undergoing hip replacement and for 2 weeks for patients undergoing knee replacement. If you miss a dose of this medicine: Patients taking 15 mg twice daily should take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at once. Starting the next day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily should take the missed dose immediately. Starting the next day, continue taking 1 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: For reduction in the risk of stroke and systemic embolism in 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. For treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism, discontinue vitamin K antagonist therapy and start taking this medicine when INR is ≤ 2.5. During the switch to a vitamin K antagonist, this medicine and the vitamin K antagonist should be administered concomitantly. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until INR≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist based on INR testing. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours after taking this medicine. If this medicine is discontinued, INR testing may be performed 24 hours after the last dose. Switching from a parenteral anticoagulant to this medicine: Start this medicine 0~2 hours before the time of the next scheduled dose of the parenteral agent (e.g., low-molecular-weight heparin), or when a 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 at the time 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). Use with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Use is not recommended in patients with severe renal impairment with creatinine clearance below 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 recurrent deep vein thrombosis and pulmonary embolism / prevention of venous thromboembolism in adult patients who have undergone 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 use 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 who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or a beverage such as 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 an anticoagulant that prevents blood from clotting. During the use of this medication, bleeding may occur, so signs of bleeding should be closely monitored. Especially, if severe bleeding occurs, the use of this medication should be stopped immediately, and medical attention should be sought. This medication should not be given to certain patients, such as those with an allergy to the components of this drug, those with severe bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, and those with lactose intolerance. Additionally, patients with a history of recent gastrointestinal ulcers or intracranial hemorrhage, or those with conditions at high risk of bleeding should not use this medication. Caution is needed when used in combination with other anticoagulants or certain antifungals, as it may increase the risk of bleeding. It should be administered carefully to patients with impaired kidney function or those with conditions that increase bleeding risk, and care should also be taken when taken with other medications that may elevate the risk of bleeding. Side effects of this medication may include bleeding, anemia, gastrointestinal symptoms, skin rashes, and rarely, serious allergic reactions or skin disorders. Elderly patients or those with impaired kidney function may have elevated blood concentration, increasing the risk of bleeding, hence caution is needed. Pregnant or breastfeeding women should not take this medication, and women who could become pregnant should take contraceptive measures during treatment. Overdosing on this medication significantly increases the risk of bleeding, so the dosage must be strictly adhered to, and if an overdose occurs, immediate consultation with medical personnel is necessary. Patients scheduled for surgery or invasive procedures should stop taking this medication before the procedure and should follow the doctor's instructions regarding resuming after the procedure by considering the bleeding risk. Care is required while driving or operating machinery when using this medication, and if dizziness or drowsiness occurs, driving should be avoided. There are many drug interactions with this medication, so it is essential to inform the doctor or pharmacist of any other medications being taken during treatment. If symptoms of bleeding or adverse reactions occur during this medication, immediate medical attention is necessary.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, localized 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 transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, cutaneous and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related nephropathy, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, hematochezia, melena, arthralgia, myocardial infarction, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disease, asthma, laryngitis, dysphagia, intestinal motility disorder, fracture, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, dysuria, kidney stones, bladder carcinoma, prostatic hyperplasia, influenza-like symptoms, drug hypersensitivity

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the effectiveness of the medication for a longer period.

Appearance

Brownish red circular film-coated tablet

Package unit

7 tablets/PTP, 30 tablets (10 tablets/PTP packaging X 3), 100 tablets (10 tablets/PTP packaging X 10)