Azarel 15 mg Tablets (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. Reduction in 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 of this medicine is 20 mg. There is limited experience in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement, receiving rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] in combination with a P2Y12 inhibitor for up to 12 months. 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 for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. The recommended maintenance dose for subsequent treatment and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completion of treatment (at least 6 months), the recommended dose for extended administration to reduce the risk of recurrence is 10mg once daily. The duration of treatment and dose should be determined after an individualized assessment of the risk of recurrence compared with the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, days 1-21: 15mg twice daily, total daily dose 30mg. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence, from day 22: 20mg once daily, total daily dose 20mg. Reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism, after at least 6 months of treatment: 10mg once daily, total daily dose 10mg. The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 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 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. If a dose is missed, patients taking 15 mg twice daily should take it immediately; in this case, two 15 mg tablets may be taken at once. From the following day, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily should take the missed dose immediately. From the following day, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine: 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. For treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrence, discontinue vitamin K antagonist therapy and start taking this medicine when the INR is ≤ 2.5. The INR value will be falsely elevated after taking this medicine, regardless of the dose. INR should not be used because it is not suitable for measuring the anticoagulant activity of this medicine. Switching from this medicine to a vitamin K antagonist: 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, and thereafter administer a dose based on INR testing. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. If this medicine is discontinued, INR testing may be performed 24 hours after the last dose. Switching from a parenteral anticoagulant to this medicine: 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. Switching from this medicine to a parenteral anticoagulant: Discontinue this medicine and start the parenteral anticoagulant at the time of the next scheduled dose of this medicine. No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Use with caution in patients with severe renal impairment (creatinine clearance 15-29 mL/min). Use is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min. Reduction in 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. 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 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). Avoid administration of 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. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, 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 administration 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 clots by preventing blood from clotting. However, during the use of this medication, there is a possibility of bleeding, so it is important to observe carefully for symptoms of bleeding such as easy bruising, nosebleeds, gum bleeding, or blood in urine or stools. If severe bleeding occurs, you should stop taking this medication immediately and consult a physician. This medication should not be taken by those with certain diseases or allergies, by pregnant or breastfeeding women, or by individuals with specific genetic disorders. Patients with a history of gastrointestinal ulcers or cerebral hemorrhages, patients with liver diseases that affect blood clotting, and patients with high-risk malignant tumors should use this medication with caution. If taken with other anticoagulants or certain antifungal medications, the risk of bleeding may increase, so you must inform your doctor or pharmacist. Patients with reduced kidney function or bleeding-prone diseases also require extra caution when using this medication. During the use of this medication, symptoms of bleeding should be monitored, as well as symptoms of anemia such as dizziness, pallor, and fatigue. If bleeding worsens, it is important to locate the area of bleeding and receive appropriate treatment. This medication can interact with other drugs, so it is essential to inform your doctor or pharmacist of any medications you are currently taking. Pregnant or breastfeeding women should not take this medication, and women planning to become pregnant should definitely consult a physician before taking it. Elderly patients may have a higher blood concentration of this medication; although dosage adjustments are generally not necessary, the risk of bleeding may be increased. This medication is not recommended for children or adolescents under 18 years of age as safety and efficacy have not been established. In the case of overdose, caution is needed as the risk of bleeding increases, and appropriate treatment should be received as directed by a physician in emergency situations. Caution is advised when driving or operating machinery since dizziness or drowsiness may occur. While taking this medication, regular medical check-ups should be conducted, and any symptoms of bleeding or adverse reactions should be reported immediately.

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, hepatic impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusion, wound exudate, vascular pseudoaneurysm, increased transaminases, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transferrin, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, pruritus, rash, petechial hemorrhage, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, recurrent VTE, deep vein thrombosis, arthralgia, unspecified bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stool, myocardial infarction, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, severe uterine bleeding, syncope, drowsiness

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is important to maintain a storage temperature between 1 to 30 degrees Celsius. Storing it this way will help to preserve the effectiveness and safety of the medication for a long time.

Appearance

Red circular film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP packaging * 3]