AzaRel 10 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. 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 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. 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, is 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 of treatment and dose should be determined after an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism compared with the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence: Days 1-21: 15mg twice daily, total daily dose 30mg; from day 22: 20mg once daily, total daily dose 20mg. Reduction of 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 during treatment. 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 confirmed. 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. If you forget to take this medicine: Patients taking 15 mg twice daily should take this medicine immediately; in this case, 2 tablets of 15 mg 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 should not be doubled to make up for a missed dose. Switching from a vitamin K antagonist to this medicine: For reduction 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. For 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 treatment 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. The 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: 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 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 a dose based on INR testing. However, in patients receiving this medicine together 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. 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). 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. Patients with renal impairment: No dose adjustment is necessary in patients with mild renal impairment with a creatinine clearance of 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, administer this medicine with caution. Since there is no clinical experience in patients with severe renal impairment with a creatinine clearance below 15 mL/min, use of this medicine is not recommended. 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. 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). 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. For patients unable to 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 administering this medicine through a gastrointestinal tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This drug prevents or treats the formation of clots by inhibiting blood coagulation. However, like other anticoagulants, there is a risk of bleeding, so symptoms of bleeding should be monitored carefully. If severe bleeding occurs, this medication should be discontinued immediately. During treatment, it is important to regularly check for signs of bleeding and anemia. Certain patients should not take this medication. For example, those who are allergic to any component of this drug, those with existing severe bleeding, patients with severely impaired liver function, pregnant or breastfeeding women, and individuals with certain genetic disorders should not take it. Additionally, patients with recent gastrointestinal ulcers, brain hemorrhage, or who have undergone surgery on the brain or spinal cord, as well as those with high bleeding risk cancers, are also prohibited from taking this medication. Care should be taken when combining it with other anticoagulants or certain antifungals, as there may be an increased risk of bleeding. Patients with renal impairment or bleeding risk conditions, and those taking non-steroidal anti-inflammatory drugs or platelet inhibitors should be treated with extra caution. This medication can cause various adverse reactions, the most common being bleeding-related symptoms. Bleeding can manifest as gum bleeding, gastrointestinal bleeding, skin bruising, or nosebleeds, and in severe cases, can be life-threatening. Adverse effects such as anemia, liver dysfunction, allergic reactions, skin rashes, headaches, and dizziness have also been reported. Particularly rare but severe skin reactions such as agranulocytosis and Stevens-Johnson syndrome can occur, so if any unusual symptoms appear, consult a physician immediately. Older adults or those with reduced renal function may experience higher blood levels of this medication, increasing the risk of bleeding, but generally dose adjustments are not necessary. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential must use effective contraception while taking it. Overdosing on this medication greatly increases the risk of bleeding, so in the event of overdose, notify medical personnel immediately for appropriate action. Furthermore, this medication may require caution when driving or operating machinery, so activities should be avoided if symptoms such as drowsiness or dizziness occur. Finally, there may be a risk of drug interactions while taking this medication, so patients should consult with their physician or pharmacist regarding all medications they are taking.

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, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, ecchymosis, wound exudate, pseudoaneurysm, increased transaminases, elevated bilirubin levels, increased alkaline phosphatase, increased LDH, elevated lipase, increased amylase, elevated transaminases, increased conjugated bilirubin, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, genitourinary bleeding, renal impairment, non-hemorrhage, 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, eosinophilia, drug reactions with systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, joint pain reported as a post-review adverse event, unspecified hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, hematochezia, deep vein thrombosis, joint dislocation, 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, severe uterine hemorrhage, syncope, drowsiness

This medication should be stored in a tightly closed container to protect it from exposure to air and moisture, and it is safest to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

Bright red round film-coated tablet

Package unit

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