Rivaflo 20 mg (Rivaroxaban)

Adult dosage

This 10 mg dose may be taken with or without food, while 15 mg and 20 mg doses 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 drug 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 drug 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 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 recurrent deep vein thrombosis and pulmonary embolism The recommended initial dose of this drug 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 of treatment and dose should be determined after an individual assessment of the risk of recurrent deep vein thrombosis and pulmonary embolism relative to the risk of bleeding. Treatment period Dosing 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 of this drug is 30 mg during the first 3 weeks of treatment and 20 mg thereafter during the treatment period. 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 drug 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 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 drug If you miss a dose of this drug, take the missed dose as follows. ①Patients taking 15 mg twice daily: Take this drug 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 between drugs 1) Switching from a vitamin K antagonist to this drug ①Reduction 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 drug when the International Normalized Ratio (INR) is ≤ 3.0. ②Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism Discontinue treatment with the vitamin K antagonist and start taking this drug when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this drug. INR should not be used because it is not suitable for measuring the anticoagulant activity of this drug. 2) Switching from this drug to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this drug to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this drug may affect the elevation of INR. Patients switching from this drug to a vitamin K antagonist should receive both drugs 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. However, in patients receiving this drug and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this drug. Once this drug is discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this drug For patients receiving a parenteral anticoagulant, start this drug 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. 4) Switching from this drug to a parenteral anticoagulant Discontinue this drug and start the parenteral anticoagulant at the time the next dose of this drug would have been taken. 3. Patients with renal impairment No dose adjustment is required 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 drug are significantly increased; therefore, administer this drug with caution. There is no clinical experience in patients with severe renal impairment with creatinine clearance below 15 mL/min; therefore, use of this drug 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 recurrent 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 administering this drug 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 drug and an increased risk of bleeding may occur in these patients. 5. Patients who cannot swallow tablets Immediately before use, this drug may be crushed, mixed with a liquid such as water or applesauce, and taken orally. This drug may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this drug through a gastrointestinal tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This medication is an anticoagulant used to prevent or treat blood clots. During treatment, there is an increased risk of bleeding, so any signs or symptoms of bleeding should be reported to healthcare providers immediately. If severe bleeding occurs, treatment should be stopped, and appropriate measures should be taken. This medication should not be administered to certain patients, such as those with known allergic reactions to this drug or its components, those with active severe bleeding, patients with severe liver dysfunction, pregnant or breastfeeding women, and those with lactose intolerance. Additionally, patients with a recent history of gastrointestinal ulcers or intracranial hemorrhage, or those with abnormalities in the brain or spinal cord, or patients with high bleeding risk cancers should also avoid this medication. Care should be taken if this medication is taken with other anticoagulants as the risk of bleeding may be increased. Patients with renal dysfunction or bleeding-prone conditions should use this medication cautiously, and bleeding risk may increase when used with drugs affecting hemostasis. This medication can cause various side effects such as bleeding, anemia, gastrointestinal discomfort, skin rash; patients experiencing adverse symptoms should inform their healthcare providers. Especially, severe skin reactions or agranulocytosis could occur, so caution is advised. Regular monitoring for bleeding during treatment is essential, and immediate action should be taken if signs of bleeding are observed. Women who are pregnant or breastfeeding should not take this medication, and women who can become pregnant should use contraception during treatment. Elderly patients may have increased blood levels of this medication due to renal impairment, although no dose adjustment is necessary, the bleeding risk may still be higher. This medication is not recommended for children or adolescents under 18, as its safety and efficacy have not been established. In case of overdose, there is no antidote to reverse its effects, so appropriate emergency treatment is required in the event of bleeding. Caution should be exercised when driving or operating machinery due to the possibility of side effects such as drowsiness or fainting. This medication can interact with several other drugs, so patients taking other medications should inform their healthcare providers, especially since the risk of bleeding may increase when used with certain antifungal agents, antiviral agents, antibiotics, other anticoagulants, and platelet inhibitors. If undergoing surgery or invasive procedures, healthcare providers should be consulted to determine when to appropriately discontinue or adjust this medication.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival hemorrhage, gastrointestinal hemorrhage, abdominal pain, digestive discomfort, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized weakness and energy decrease, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudoaneurysm, increased transaminase, increased serum bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transfer enzymes, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, kidney dysfunction, epistaxis, hemoptysis, itching, rash, petechiae, skin and subcutaneous hemorrhage, hives, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, drug reactions accompanied by eosinophilia and systemic symptoms, arthralgia, unspecified hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, myocardial infarction, deep vein thrombosis, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, atrial fibrillation, heart failure, cardiac arrest, cerebral infarction, sputum disorders, laryngitis, dysphagia, gastrointestinal motility disorders, fractures, arthritis, arthropathy, rhabdomyolysis, urinary tract infection, urinary disorders, kidney stones, bladder carcinoma, prostatic hyperplasia, influenza-like illness, drug hypersensitivity

This medication should be stored in a sealed container that protects it from air and moisture, ideally between 1 to 30 degrees Celsius at room temperature. Proper storage helps maintain the drug's effectiveness over time.

Appearance

Brownish red round film-coated tablet

Package unit

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