利伐沙班的详细说明书

Detailed instructions for Rivaroxaban

[Drug name] Rivaroxaban, Xarelto, Rivaroxaban

【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 non-valvular atrial fibrillation who have one or more risk factors (such as congestive heart failure, hypertension, age ≥75 years, diabetes, history of stroke or transient ischemic attack) to reduce the risk of stroke and systemic embolism.

[Usage and Dosage] The recommended dose is 10 mg of oral rivaroxaban, once daily.

If the wound has stopped bleeding, the first medication should be administered between 6-10 hours after surgery. The length of treatment is determined by each patient's risk of VTE, i.e. by the type of orthopedic surgery the patient has undergone.

For patients undergoing major hip surgery, a recommended course of treatment is 5 weeks.

For patients undergoing major knee surgery, a recommended course of treatment is 2 weeks.

If a missed dose occurs, the patient should take rivaroxaban immediately and continue taking the drug once a day the next day. Patients can take rivaroxaban with a meal or on its own.

[Side Effects] 1. The risk of stroke increases after early discontinuation of medication in patients with non-valvular atrial fibrillation. 2. Bleeding risk. 3. Spinal/epidural hematoma.

[Precautions] Renal impairment: 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.

Hepatic Impairment: In cirrhotic patients with moderate hepatic impairment (ChildPugh B category), rivaroxaban plasma concentrations may be significantly elevated, resulting in 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 cirrhotic patients with moderate hepatic impairment (ChildPugh B category) if they are not accompanied by coagulation abnormalities.