Rivaroxaban Tablets 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. 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 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 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 is 20 mg once daily. Following 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 relative to the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction in the risk of recurrence: 15mg twice daily on days 1-21, daily dose 30mg. From day 22, 20mg once daily, daily dose 20mg. Reduction in the risk of recurrence of deep vein thrombosis or pulmonary embolism: After treatment for 6 months or longer, 10mg once daily, daily dose 10mg. The maximum daily dose of this medicine is 30 mg during the first 3 weeks of treatment and 20 mg during the subsequent treatment period. 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 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. Missed dose: Patients taking 15 mg twice daily should 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. 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: For reduction in 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, International Normalized Ratio) is ≤ 3.0. For treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism, discontinue vitamin K antagonist therapy and start taking this medicine when INR is ≤ 2.5. 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 INR≥2.0. During 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 testing. In patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours after taking this medicine. If this medicine is discontinued, INR may be tested 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 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 when the next dose of this medicine would have been due. Patients with renal impairment: No dose adjustment is required in patients with mild renal impairment with creatinine clearance 50-80 mL/min. As there is no clinical experience in patients with severe renal impairment with creatinine clearance below 15 mL/min, use of this medicine is not recommended. 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. This medicine should be administered with caution to patients with severe renal impairment (creatinine clearance 15-29 mL/min). Treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism: No dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Administration of this medicine is not recommended in patients with severe renal impairment with creatinine clearance of 15-29 mL/min. Prevention of venous thromboembolism in adult patients undergoing 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). This medicine should be administered with caution to patients with severe renal impairment (creatinine clearance 15-29 mL/min). 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. 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. Confirm that the tube is correctly positioned and flush the tube with water after administration.

This medication is used to prevent or treat clot formation by inhibiting blood coagulation. While taking this medication, one should always carefully monitor for signs of bleeding, as bleeding may occur. In particular, if severe bleeding occurs, the medication should be stopped immediately and a doctor should be consulted. Although regular monitoring of blood concentration is not required, it can be helpful in emergency situations or in cases of overdose. Patients with allergies to this medication, those who already have severe bleeding, patients with severe liver disease, pregnant or breastfeeding women, and those with certain genetic lactase metabolism disorders should not take this medication. Additionally, patients with a history of recent gastrointestinal ulcers or cerebral hemorrhage, vascular anomalies, malignancies, or other conditions that heighten the risk of bleeding should also avoid this medication. Caution is also required when taking this medication with other anticoagulants or certain antifungal agents, as the risk of bleeding may increase. Patients with decreased kidney function or conditions with high bleeding risks should use this medication carefully, and those taking medications that increase bleeding risks in combination with this medication should exercise additional caution. While taking this medication, various side effects such as bleeding, anemia, skin rash, and liver function abnormalities may occur, so one should consult a doctor immediately if any abnormal symptoms occur. Especially, if there is a severe rash or ulceration of mucous membranes, the medication should be stopped immediately. The medication concentration may be higher in elderly patients, but typically dosage adjustments are not needed, though bleeding risk may increase. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant should ensure effective contraception while taking it. If surgery or invasive procedures are necessary, this medication should be discontinued a certain period before the procedure, and resumption of the medication should occur at the appropriate time after the procedure. In cases of overdose, one should carefully observe for the possibility of bleeding, and emergency treatment should be sought if necessary. Caution is advised during driving or operating machinery, as symptoms such as drowsiness or dizziness may occur. This medication can interact with various drugs, so patients must inform their doctor or pharmacist of any other medications they are taking. Particularly, co-administration with strong CYP3A4 and P-gp inhibitors or inducers, other anticoagulants, NSAIDs, and platelet inhibitors may increase the risk of bleeding.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, digestive discomfort, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized reduction in strength and energy, discomfort, localized edema, hepatic impairment, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, contusion, wound exudate, vascular pseudoaneurysm, enzyme elevation, increased bilirubin levels, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and intracerebral hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechial hemorrhage, skin and subcutaneous hemorrhage, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic reaction, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine hemorrhage, postoperative hematoma, hemorrhagic duodenal ulcer, melena, dark stools, myocardial infarction, arthralgia, facial flushing, deep vein thrombosis, joint dislocation, Pseudomonas wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, flu-like syndrome, drug hypersensitivity reaction

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to keep the storage temperature between 1 degree and 30 degrees Celsius to maintain efficacy and safety.

Appearance

Round red film-coated tablets with a brown tint

Package unit

30 tablets/box [(10 tablets/PTP*3)], 100 tablets/box [(10 tablets/PTP*10)]