利伐沙班的说明书

Instructions for Rivaroxaban

[drug name]

Generic name: Rivaroxaban tablets

Product name: Rivaroxaban tablets (Xarelto)

Full pinyin code: LiFaShaBanPian(BaiRuiTuo)

[Main Ingredients] The main ingredient of this product is rivaroxaban. 

[Ingredients] Chemical name: 5-chloro-nitrogen-((5S)-2-oxo-3-[-4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}-2-thiophene-carboxamide, molecular weight: C19H18ClN3O5S

[Characteristics] This product is a red film-coated tablet. 

[Indications/Function and Indications] 1. For adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE). 2. Used to treat venous thrombosis (DVT) in adults and reduce the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT. 3. For use in adult patients with nonvalvular atrial fibrillation who have one or more risk factors (e.g., congestive heart failure, hypertension, age ≥75 years, diabetes, history of stroke or transient ischemic attack) to reduce the risk of stroke and systemic embolism. [Specification model] 10mg*5 tablets*1 plate

[Administration of Rivaroxaban]: Orally. 1. Rivaroxaban 10 mg can be taken with food or alone. Rivaroxaban 15 mg or 20 mg tablets should be taken with food. 2. To prevent venous thrombosis in adult patients undergoing elective hip or knee replacement surgery, the recommended dose is oral rivaroxaban 10 mg, once daily. If the wound has stopped bleeding, the first dose of medication should be between 6 and 10 hours after surgery. 3. For patients undergoing major hip surgery, the recommended treatment course is 35 days. 4. For patients undergoing major knee surgery, the recommended treatment course is 12 days. 5. If a missed dose occurs, the patient should take rivaroxaban immediately and continue to take the medicine once a day the next day. 6. Treat DVT and reduce the risk of acute DVT recurrence and PE. The recommended initial treatment dose for acute DVT is 15 mg twice a day for the first three weeks. After that, the dose for maintenance treatment and reducing the risk of DVT recurrence and PE is 20 mg once a day.

[Precautions] 1. Bleeding risk: As detailed below, some subgroups of patients have a higher risk of bleeding. After initiation of treatment, these patients should be monitored closely for signs of bleeding complications. This can be accomplished by regular physical examination of the patient, close observation of surgical wound drainage, and regular determination of hemoglobin. Any unexplained decrease in hemoglobin or blood pressure should prompt a search for the site of bleeding. 2. Renal damage: In patients with severe renal impairment (creatinine clearance <30 mL/min), the plasma concentration of rivaroxaban may be significantly increased, leading to an increased risk of bleeding. Rivaroxaban is not recommended for patients with creatinine clearance <15 mL/min. Rivaroxaban should be used with caution in patients with creatinine clearance 15-29 mL/min. Rivaroxaban should be used with caution in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) when used concomitantly with other drugs that may increase rivaroxaban plasma concentrations. 3. Liver damage: In cirrhotic patients with moderate liver damage (Child Pugh category B), the plasma concentration of rivaroxaban may be significantly increased, leading to an increased risk of bleeding. Rivaroxaban is contraindicated in patients with liver disease associated with coagulation abnormalities and clinically relevant risk of bleeding. Rivaroxaban can be used with caution in patients with cirrhosis who have moderate hepatic impairment (Child Pugh category B) and are not accompanied by coagulation abnormalities. 4. Interactions with other drugs: in azole-antifungal agents (such as ketoconazole, itraconazole, voriconazole and posaconazole). Please read the instructions carefully and use it as directed by your doctor. 

[Pediatric Use] Due to the lack of safety and efficacy data, rivaroxaban is not recommended for use in adolescents or children under 18 years of age.

[Contraindications] 1. Patients who are allergic to rivaroxaban or any excipients in the tablets. 2. Patients with clinically obvious active bleeding. 3. Lesions or conditions with a significant risk of major bleeding, such as current or recent gastrointestinal ulcers, malignant tumors with a high risk of bleeding, recent brain or spinal injury, recent brain, spine or eye surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intravertebral intracranial vascular malformations. 4. Except in the case of switching to or from rivaroxaban from other treatments, or the administration of unfractionated heparin (UFH) doses required to maintain central venous or arterial catheters, concomitant treatment with any other anticoagulants is prohibited, such as UFH, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, apixaban, dabigatran, etc.). 5. Patients with liver disease associated with coagulation abnormalities and clinically relevant bleeding risks, including patients with cirrhosis reaching Child Pugh classes B and C. 6. Pregnant and lactating women.

The above is the content of the instructions for rivaroxaban. I hope it can help you!