利伐沙班的说明书

Instructions for Rivaroxaban

Generic name: Rivaroxaban tablets

Product name: Rivaroxaban tablets (Xarelto)

Full pinyin code: LiFaShaBanPian(BaiRuiTuo)

Main ingredients: The main ingredient of this product is rivaroxaban. 

The indications of rivaroxaban are: 1. Used in 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.

How to administer rivaroxaban:

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. For patients undergoing major knee surgery, the recommended course of treatment is 12 days.

4. If a missed dose occurs, the patient should take rivaroxaban immediately and continue to take the medicine once a day the next day. If a missed dose occurs during 15 mg twice daily treatment (Days 1-21), patients should take rivaroxaban immediately to ensure 30 mg of rivaroxaban is taken daily. In this case, it may be necessary to take two 15 mg tablets at once. Thereafter, regular 15 mg twice daily dosing should be continued as recommended. If a missed dose occurs during 20 mg once-daily treatment (day 22 and beyond), the patient should begin rivaroxaban immediately and continue to receive once-daily dosing at the recommended dose thereafter. The dose should not be doubled in one day to make up for a missed dose.

5. Treat DVT and reduce the risk of acute DVT recurrence and PE. The recommended dose for initial treatment of acute DVT is 15 mg twice a day for the first three weeks. After that, the dosage for maintenance treatment and reducing the risk of DVT recurrence and PE is 20 mg once a day, as shown in Table 1.

Adverse reactions: 1. Risk of bleeding; in the ROCKET AF trial, the most common adverse reaction related to permanent discontinuation was bleeding events, with an incidence rate of 4.3% in the rivaroxaban group and 3.1% in the warfarin group. The incidence of discontinuation due to non-hemorrhagic adverse events was similar in both treatment groups.

2. Spinal/epidural hematoma.

3. In patients with valvular atrial fibrillation, the risk of stroke increases after early discontinuation of medication;

4. Blood and lymphatic system diseases: agranulocytosis, thrombocytopenia;

5. Intestinal diseases: retroperitoneal bleeding;

6. Hepatobiliary diseases: jaundice, cholestasis, hepatitis (including liver cell damage);

7. Immune system diseases: hypersensitivity, allergic reaction, anaphylactic shock, angioedema;

8. Nervous system diseases: cerebral hemorrhage, subdural hematoma, epidural hematoma, hemiparesis;

9. Skin and subcutaneous tissue: Stevens-Johnson syndrome.

Notes: 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. 

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