Jatol Tablet 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. 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 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 underwent percutaneous coronary intervention (PCI) with stent placement. (See '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 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 10 mg 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. Treatment period Frequency of administration Daily dose Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21 15 mg twice daily 30 mg From day 22 20 mg once daily 20 mg Reduction of 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 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 established. 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. 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 one tablet once daily. The daily dose should not be doubled to make up for a missed dose. 2. Switching between medicines 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 treatment with the vitamin K antagonist and start taking this medicine when the international normalized ratio (INR) 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 treatment with the vitamin K antagonist 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 INR and increase it. Patients switching from this medicine to a vitamin K antagonist should take 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, and thereafter administer the dose 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. 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 dose of the parenteral agent (e.g., low molecular weight heparin), or at the time of discontinuation of a continuously administered parenteral agent (e.g., intravenous unfractionated heparin). 4) 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. 3. Patients with renal impairment No dose adjustment is necessary 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 blood concentrations 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 with creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. 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 necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 4. Patients with hepatic impairment Avoid administering this medicine to patients with liver disease associated with coagulopathy and to 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. For patients who cannot swallow tablets, Immediately before use, this medicine may be crushed 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 used to prevent or treat blood clot formation by inhibiting blood coagulation. During the use of this drug, careful observation for bleeding symptoms is required. The risk of bleeding may increase, so immediate discontinuation of the medication is necessary if severe bleeding occurs. This medication should not be used in patients with certain liver diseases, pregnant or breastfeeding women, and specific genetically predisposed patients with lactose intolerance. Additionally, it is not safe to administer to patients with a recent history of gastrointestinal ulcers or intracranial hemorrhages, or those with high bleeding risk conditions. When taken in combination with other anticoagulants or certain antifungal agents, the risk of bleeding may increase, so caution is especially required in such cases. Patients with impaired renal function or those prone to bleeding should use this drug cautiously, and the bleeding risk should be carefully compared with the therapeutic effectiveness of this medication. Monitoring for bleeding through blood tests while on this medication may be helpful, and if bleeding signs appear, immediate consultation with a healthcare professional is necessary. There is no need for dosage adjustment in the elderly, but caution is necessary as the risk of bleeding may increase with age. Pregnant or breastfeeding women should avoid using this medication, and women of childbearing potential must use contraception while on this medication. Overdosing on this medication may significantly increase the risk of bleeding, so the prescribed dosage must be strictly adhered to, and in the event of an overdose, immediate contact with a medical institution is needed. If you are about to undergo surgery or invasive procedures, consult with your doctor to determine when to discontinue the medication before the procedure, and necessary measures should be taken to minimize bleeding risk. While on this medication, there may be drowsiness or dizziness during driving or operating machinery, so caution is needed. This medication can cause severe allergic skin reactions; if skin rashes, blisters, or mucosal damage occur, discontinue use immediately and consult a physician. During the use of this medication, be cautious of interactions with other drugs, especially when combined with certain antifungals, antibiotics, anticoagulants, and non-steroidal anti-inflammatory agents, as this may increase the risk of bleeding. It is important to inform healthcare providers about all medications being taken.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic reduction in strength and energy, discomfort, localized edema, hepatic impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound discharge, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, elevated LDH, increased lipase, increased amylase, increased transferase, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, eosinophilia, drug reaction, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, syncope, drowsiness

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance

Red-brown round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTPX3], 100 tablets/box [10 tablets/PTPX10]