Rivaroxaban 10 mg Tablets (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 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') 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 are 20 mg once daily. For extended administration to reduce the risk of recurrence after completing treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose 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, 30mg Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence, 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 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 of this medicine 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 the individual 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 those undergoing knee replacement. If you miss a dose of this medicine, take the missed dose as follows. Patients taking 15 mg twice daily: Take this medicine immediately; in this case, two 15 mg tablets may be taken at once. From the next day onward, continue taking 15 mg twice daily. Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. From the next day onward, 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, 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, International Normalized Ratio) is ≤ 3.0. Switching from a vitamin K antagonist to this medicine, 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, the INR value 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. Switching from this medicine to a vitamin K antagonist: Inadequate anticoagulation may occur during the switch 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. 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. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be tested 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 (creatinine clearance 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. Use of this medicine is not recommended in patients with severe renal impairment (creatinine clearance less than 15 mL/min) because there is no clinical experience in these patients. 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 increased risk of bleeding may occur in these patients. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with a liquid such as water or 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 medication is an anticoagulant that prevents blood clotting. During treatment, bleeding may occur; thus, signs of bleeding should be monitored closely. If serious bleeding occurs, discontinue use immediately. This medication should not be used in certain patients, such as those with significant bleeding, liver disease, pregnant or nursing women, and patients with lactose intolerance. Caution is also required in cases of diseases with a high risk of bleeding or when combined with other anticoagulants. Patients with reduced kidney function or those at high risk for bleeding should be carefully administered this drug, and caution is warranted when taken with other medications that increase bleeding risk. This medication can cause various adverse reactions related to bleeding and may infrequently lead to serious skin reactions or blood disorders. It should be avoided during pregnancy due to potential risks to the fetus, and its use is not recommended during breastfeeding. The elderly may have increased bleeding risk due to elevated drug concentrations from kidney dysfunction, though no separate dosage adjustments are necessary. It is not recommended for children or adolescents under 18 years of age, as safety and efficacy are not established. Caution is necessary in case of overdose, as it increases the risk of bleeding, and appropriate treatment should be sought in emergency situations. Additionally, alertness is required when driving or operating machinery, as drowsiness or dizziness may occur. This drug interacts with certain antifungal agents, antiviral agents, and some antibiotics; caution is advised when used together. When undergoing surgery or invasive procedures, this drug should be discontinued for a certain period before the procedure, and the timing for re-administration should be determined based on the patient's condition afterward. Suddenly stopping this medication may increase the risk of thrombosis, so the dosage should be adjusted according to the physician’s instructions. Women requiring anticoagulant therapy should consult their doctor regarding pregnancy planning and be wary of gynecological issues such as uterine bleeding. During the use of this drug, any symptoms of bleeding or adverse reactions should be reported to healthcare personnel immediately for appropriate assessment and treatment.

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, contusions, wound secretion, vascular pseudoaneurysm, increased transaminases, elevated serum bilirubin, increased alkaline phosphatase, increased LDH, elevated lipase, increased amylase, increased transaminases, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle hemorrhage, dizziness, headache, intracranial and cerebral hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal disease, severe uterine bleeding, syncope, drowsiness

This medication should be stored in a tightly sealed container to avoid exposure to air and light. It is important to maintain a storage temperature between 1°C and 30°C. Proper storage ensures the medication's effectiveness is safely maintained.

Appearance

Bright red round film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP×3)]