Janet 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 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 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. (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 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 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 of treatment and dose 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 / Dose frequency / 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 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 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; 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 If you miss a dose, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take the medicine immediately; in this case, two 15 mg tablets may be taken at one time. From the next day, 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, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. 2. Switching from or to other 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 vitamin K antagonist therapy 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 vitamin K antagonist therapy 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 INR elevation. Patients switching from this medicine to a vitamin K antagonist should receive both medicines 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 test results. In contrast, patients receiving this medicine and a vitamin K antagonist concomitantly should not have INR testing 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 time of the next scheduled parenteral dose (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 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 plasma concentrations of this medicine are significantly increased; therefore, administer this medicine with caution. There is no clinical experience in patients with severe renal impairment (creatinine clearance less than 15 mL/min); use of this medicine is not recommended. 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 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 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 the formation of blood clots by inhibiting blood coagulation. There may be an increased risk of bleeding while taking this medication, so careful observation for signs or symptoms of bleeding is necessary. In the event of severe bleeding, discontinue this medication immediately and seek medical attention. This medication should not be administered to patients with certain liver diseases, pregnant or breastfeeding women, and specific genetic lactose intolerant patients. Caution should be exercised in patients at high risk of bleeding or using it in combination with other anticoagulants. Patients with impaired renal function or bleeding disorders need special attention when taking this medication. The risk of bleeding may increase when taken in conjunction with non-steroidal anti-inflammatory drugs or platelet aggregation inhibitors. During treatment, monitor closely for symptoms of bleeding, symptoms of anemia, dizziness, severe headache, unusual bruising or bleeding, etc. This medication can interact with certain antifungal agents, antibiotics, anticoagulants, and other drugs, so inform the doctor or pharmacist of any other medications being taken. Women who are pregnant or planning to become pregnant should ensure contraception while taking this medication, and breastfeeding women should avoid taking it. Elderly patients may have increased blood drug concentrations due to impaired renal function, though specific dosage adjustment is not required, but the risk of bleeding may increase. The safety and efficacy in children and adolescents have not been established, and use in this population is not recommended. Overdosage may result in side effects such as bleeding, so care must be taken not to exceed the recommended dose, and if overdose is suspected, immediate medical attention should be sought. While taking this medication, drowsiness or dizziness may occur during driving or operating machinery, so caution is advised. Before surgery or invasive procedures, this medication should be stopped for a certain period; after surgery, the timing for resuming medication should be determined according to the physician's instructions. This medication increases the risk of bleeding when used concurrently with neuraxial (epidural or spinal) anesthesia or lumbar puncture, and patients undergoing such procedures need special caution.

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. Additionally, it is recommended to store the medication at room temperature between 1°C and 30°C, away from extremes of heat or cold.

Appearance

Brownish-red circular film-coated tablet

Package unit

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