Casaban Tablet 20 mg (Rivaroxaban)

Adult dose

The 10 mg dose of this medicine may be taken with or without food, while the 15 mg and 20 mg doses should be taken 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 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 of 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 following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Duration of treatment Frequency of administration Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15mg twice daily 30mg From day 22 20mg once daily 20mg Reduction of 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. 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 medicine is 10 mg once daily. The first dose should be given 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on the individual patient's risk of venous thromboembolism based on 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 following day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the following day, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. 2. Switching therapy 1) Switching from a vitamin K antagonist to this medicine 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 medicine 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 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. 2) 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 elevation of the INR. Patients switching from this medicine to a vitamin K antagonist should receive both medicines 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 the dose of the vitamin K antagonist based on INR testing. However, 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. 3) 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 a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) 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. 3. Patients with renal impairment No dose adjustment is required 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) indicates that plasma concentrations of this medicine are significantly increased; therefore, administer this medicine with caution. Use of this medicine is not recommended in patients with severe renal impairment (creatinine clearance less than 15 mL/min) because there is no clinical experience in this population. 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). 5. Patients unable to swallow tablets, Immediately before use, this medicine may be crushed and 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. 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 thrombosis by inhibiting blood coagulation. During the use of this medication, bleeding may occur easily, so it is important to monitor carefully for any signs or symptoms of bleeding. If serious bleeding occurs, it is essential to stop taking this medication immediately and consult a physician. This medication should not be used in certain patients, such as those who have an allergy to this medication or its components, patients currently experiencing severe bleeding, patients with severe liver dysfunction, pregnant or breastfeeding women, and patients with lactose intolerance. Furthermore, caution is necessary for patients with recent gastrointestinal ulcers, cerebral hemorrhages, brain surgeries, or injuries to the brain or spinal cord, or for those with malignancies at high risk for bleeding, or those taking other anticoagulants or specific antifungal agents. In patients with impaired kidney function or those with disorders at high risk for bleeding, or those taking medications that increase bleeding risk such as non-steroidal anti-inflammatory drugs or platelet inhibitors, use should be approached with caution due to the increased risk of bleeding. During treatment, side effects such as anemia, bleeding, skin rash, dyspepsia, and dizziness may occur. Especially, if severe bleeding or allergic reactions occur, immediate medical attention should be sought. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should ensure adequate contraception while taking this medication. Elderly patients may have elevated drug levels in the blood due to reduced kidney function; however, dosage adjustment is generally not necessary, but the risk of bleeding may be increased. This medication is not recommended for children or adolescents under 18 years of age as the safety and efficacy have not been established. In cases of suspected overdose, the risk of bleeding is increased; immediate consultation with medical personnel is required as this medication cannot be removed by dialysis and may require special treatment. This medication may affect driving or operating machinery; caution should be exercised when experiencing drowsiness or dizziness. If surgical or invasive procedures are planned, it is important to inform medical personnel of this medication before the procedure and a period of discontinuation may be required before the procedure to reduce the risk of bleeding. This medication can interact with various drugs, so inform your physician or pharmacist if you are taking other medications. Particularly, co-administration with strong CYP3A4 or P-gp inhibitors, inducers, other anticoagulants, NSAIDs, and platelet inhibitors may increase the risk of bleeding. When discontinuing this medication, the risk of thrombosis may increase, so appropriate substitute therapy should be obtained as per the physician's instructions.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival hemorrhage, gastrointestinal bleeding, stomach pain, abdominal pain, indigestion, 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 bleeding, bruising, wound discharge, vascular pseudoaneurysm, increased transaminases, increased bilirubin levels, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferase levels, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal dysfunction, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia, drug reactions associated with systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, myocardial infarction, arthralgia, fever, unspecified bleeding, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, elevated cardiac enzymes, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, deep vein thrombosis, facial flushing

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advised to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help to retain the medication's efficacy over time.

Appearance

Brownish-red, round film-coated tablet

Package unit

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