Javadoxaban 2.5 mg (Rivaroxaban)

Adult dose

This medicine may be administered without regard to meals. The dose is 2.5 mg twice daily. Patients should take aspirin 75-100 mg once daily, or aspirin 75-100 mg once daily plus clopidogrel 75 mg, together with this medicine. Treatment for at least 24 months is recommended. Treatment with this medicine at 2.5 mg should be initiated as soon as possible after stabilization of the acute coronary syndrome event (including revascularization). Treatment may be started as early as 24 hours after hospital admission, once parenteral anticoagulant therapy has been appropriately discontinued. The recommended dose of this medicine is 2.5 mg twice daily, taken together with aspirin 75-100 mg once daily. If a dose of this medicine is missed, continue taking the recommended dose of 2.5 mg at the next scheduled dosing time. The daily dose must not be doubled to make up for a missed dose. Regardless of the dose, INR values will be falsely elevated after taking this medicine. 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 a dose based on INR testing. Conversely, patients receiving this medicine together with a vitamin K antagonist should not have their INR tested until 24 hours have elapsed after taking this medicine. Once this medicine is discontinued, INR testing may be performed 24 hours after the last dose. In patients receiving a parenteral anticoagulant, initiate 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). Discontinue this medicine and initiate the parenteral anticoagulant at the time the next dose of this medicine would have been due. No dose adjustment is necessary in patients with mild renal impairment and creatinine clearance 50-80 mL/min. Administration of this medicine is not recommended in patients with severe renal impairment and creatinine clearance less than 15 mL/min because there is no clinical experience in this population. No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that plasma concentrations of this medicine increased significantly; therefore, administer this medicine with caution. 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. Immediately before use, this medicine may be crushed, mixed with water or a beverage such as applesauce, and administered orally. It may also be crushed and administered with a small amount of water through a gastrointestinal tube.

This medication is used to prevent or treat thrombus formation by inhibiting blood clotting. During the course of treatment with this medication, bleeding may occur, so one should always be vigilant for signs or symptoms of bleeding. If severe bleeding occurs, the use of this medication should be stopped immediately and medical advice should be sought. Patients with hypersensitivity to this medication, those currently experiencing severe bleeding, patients with severe liver dysfunction, pregnant or breastfeeding women, and those with specific hereditary lactose intolerance should not take this medication. Patients with recent gastrointestinal ulcers, a history of intracranial hemorrhage, or other diseases with a high risk of bleeding should also avoid taking this medication. The risk of bleeding may increase when used in combination with other anticoagulants or certain antifungals, so patients should inform healthcare providers about any additional medications taken. Patients with impaired kidney function or those with diseases that increase bleeding risk should be closely monitored for bleeding risks and treatment efficacy. Patients should pay attention not only to bleeding symptoms but also to symptoms of anemia, and if bleeding is suspected, they should alert their healthcare provider immediately. Before undergoing surgery or invasive procedures, the medication should be discontinued for a certain period of time and resumed only after the risk of bleeding is reduced post-procedure. Pregnant women should take contraceptive measures as this medication may affect the fetus, and breastfeeding women are advised to avoid this medication. Elderly patients may have increased plasma drug concentrations due to decreased kidney function; generally, dose adjustments are not necessary but bleeding risk may be increased. The safety and effectiveness of this medication have not been established in children or adolescents under 18 years of age, and it is not recommended for use in this population. In case of overdose, the risk of bleeding may increase, so it is important to take the exact dose as directed by a physician, and consult healthcare providers immediately in case of overdose. This medication may cause drowsiness or dizziness, so it is recommended to avoid driving or operating machinery after taking it. There may be potential interactions with other medications, so all medications being taken should be reported to healthcare providers and managed carefully.

• Hemorrhage
• anemia
• thrombocytosis
• tachycardia
• ocular hemorrhage
• gingival bleeding
• gastrointestinal bleeding
• abdominal pain
• dyspepsia
• nausea

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1°C and 30°C room temperature.

Appearance

Bright yellow round film-coated tablet

Package unit

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