Zatol Tablets 15 mg (Rivaroxaban)

Adult dose

This medicine 10 mg may be administered with or without food, while 15 mg and 20 mg should be 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 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 for 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. (Refer to '12. Clinical Trial Information') 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 completion of 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 recurrence of deep vein thrombosis and pulmonary embolism versus 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 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 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; 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 miss a dose of this medicine If you miss a dose of this medicine, take the missed dose as follows. ①Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at one time. Starting the next day, continue taking 15 mg twice daily. ②Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking 1 tablet once daily. The daily dose should not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ①Reduction 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. ②Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of 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, INR values will be falsely elevated after taking this medicine. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 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 increase in INR. Patients switching from this medicine to a vitamin K antagonist should receive the vitamin K antagonist concomitantly until the INR is ≥2.0. For 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 according to INR testing. On the other hand, in patients receiving this medicine concomitantly with a vitamin K antagonist, INR testing should 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. 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 administration of the parenteral agent (e.g., low-molecular-weight heparin), or at the time the 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 administration of the parenteral anticoagulant at the time 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 and creatinine clearance 50-80 mL/min. Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that the plasma concentration of this medicine increased significantly; therefore, this medicine should be administered with caution. Administration of this medicine is not recommended in patients with severe renal impairment and creatinine clearance less than 15 mL/min, as 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 who have undergone 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). 4. Patients with hepatic impairment 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. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. Patients who cannot swallow tablets, Immediately before use, this medicine may be crushed and mixed with a liquid such as water or 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 properly positioned and flush the tube with water after administration.

This drug prevents or treats the formation of clots by inhibiting blood coagulation. As a result, it may cause bleeding easily; hence, symptoms of bleeding should always be monitored carefully. If severe bleeding occurs, this medication should be discontinued immediately. This drug should not be administered to patients with certain blood coagulation disorders, severe liver disease, or to women who are pregnant or breastfeeding. In addition, patients with genetic problems such as lactose intolerance should not take this medicine. Patients with a high risk of bleeding, such as those with gastrointestinal ulcers, intracranial hemorrhages, or brain and spinal cord injuries, should also avoid taking this drug. There may be an increased risk of bleeding when taken with other anticoagulants or certain antifungal agents. Patients with reduced kidney function may have increased blood concentration of this medication, leading to a higher risk of bleeding, and should use it with caution. If used in combination with other medications such as non-steroidal anti-inflammatory drugs or platelet inhibitors, the risk of bleeding may also increase. During the use of this medicine, bleeding symptoms and signs of anemia should be carefully monitored, and if there is unexplained low blood pressure or decreased hemoglobin, the healthcare provider should be consulted immediately. Before surgery or invasive procedures, this drug should be discontinued for a certain period, as proceeding with surgery while at an increased risk of bleeding can be dangerous. Additionally, this medication can be harmful to the fetus if administered to a pregnant woman, so it should not be used during pregnancy, and women who may become pregnant should ensure they use contraception while taking it. Elderly patients may have increased concentrations of this drug due to reduced kidney function; however, dose adjustment is usually not required, although the risk of bleeding may increase. It is not recommended for children or adolescents under 18 years of age, as safety and efficacy have not been established. In case of overdose, the risk of bleeding increases, so immediate contact with a medical facility for appropriate action is necessary. Caution is advised when driving or operating machinery during treatment, as dizziness or drowsiness may occur. Interactions with other medicines taken with this drug may increase the risk of bleeding; therefore, it is essential to inform healthcare providers of all medications currently being taken. Patients with specific diseases such as cardiovascular diseases or thrombosis must consult a physician before administering this drug.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, digestive disorders, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized loss of strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, discharge from the wound, vascular pseudoaneurysm, transaminases elevation, increased blood bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, hematuria, heavy menstruation, kidney disorders, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, fever, bleeding of unidentified origin, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, deep vein thrombosis, joint dislocation, 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, serious skin reactions, oral mucosal ulcers, high fever, severe dysphagia, angina, severe uterine hemorrhage, syncope, drowsiness

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. This will help preserve the drug's efficacy and safety for a long time.

Appearance

Red round film-coated tablets

Package unit

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