Dabigatran 20 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. 1) 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 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. 2) 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, is 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 10 mg once daily. The duration of treatment and dose should be determined following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence Days 1-21: 15 mg twice daily, 30 mg From day 22: 20 mg once daily, 20 mg Reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment: 10 mg once daily, 10 mg The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 3) 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 administered 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on the individual 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 you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① 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. ② 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. Start taking this medicine after discontinuing vitamin K antagonist therapy and when the International Normalized Ratio (INR) is ≤ 3.0. Start taking this medicine after discontinuing vitamin K antagonist therapy and 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 is ≥2.0. During 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. INR values will be falsely elevated after taking this medicine. INR should not be used to measure the anticoagulant activity of this medicine, as it is not suitable for this purpose. Patients receiving this medicine concomitantly with a vitamin K antagonist should not have INR testing until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may be performed 24 hours after the last dose. In patients receiving parenteral anticoagulants, start this medicine 0~2 hours before the time of the next scheduled parenteral dose (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. No dose adjustment is necessary in patients with mild renal impairment and creatinine clearance of 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 the blood concentration of this medicine; therefore, use 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 this population. Reduction in 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 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). 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. Immediately before use, this medicine may be crushed, mixed with water or a beverage such as applesauce, and taken 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 inhibiting blood coagulation. However, it may cause bleeding during treatment, so signs and symptoms of bleeding should always be closely monitored. If serious bleeding occurs, stop taking this medication immediately and follow your physician's instructions. This medication is not to be prescribed to patients with certain liver diseases, pregnant or breastfeeding women, or patients with a high risk of bleeding. Additionally, combining it with other anticoagulants or certain antifungal agents may increase the risk of bleeding, so consult with a healthcare provider. It should be administered with increased caution in patients with impaired kidney function or with high risk of bleeding, and careful attention is needed when combined with other drugs. Various adverse reactions such as bleeding, anemia, skin rashes, allergic reactions, etc., may occur during treatment, so symptoms should be reported to a healthcare provider immediately. Especially in elderly patients or those with impaired kidney function, the risk of bleeding may be greater, so caution is advised. If surgical or invasive procedures are planned, the timing of resuming and stopping this medication must be discussed with healthcare providers. Women who are pregnant or planning a pregnancy must consult a physician before taking this medication and should use appropriate contraception during treatment. Overdose of this medication significantly increases the risk of bleeding, so be sure to adhere strictly to the prescribed dosage, and seek medical attention immediately in case of overdose. Drowsiness or dizziness may occur when driving or operating machinery, so caution is necessary if these symptoms are present. This medication may interact with various drugs, so inform your healthcare provider if you are taking any other medications and do not discontinue or change any medication without consulting them.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy loss, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment hemorrhage, contusion, wound discharge, pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased enzyme levels, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial hemorrhage, syncope, genitourinary bleeding, renal impairment, nasal bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, blood in stool, melena, deep vein thrombosis, arthralgia, Pseudomonas wound infection, nasopharyngitis, myocardial infarction, cardiomyopathy, increased cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, influenza-like syndrome, drug hypersensitivity reactions, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, cough disorders, asthma, laryngitis, dysphagia, intestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urination disorders, renal calculi, bladder carcinoma, prostatic hyperplasia, Stevens-Johnson syndrome

Store this medication in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance

Brownish red round film-coated tablet

Package unit

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