Edoxaban Tosylate and Flumazenil Injection

• Generic Name: edoxaban
• Dosage Forms: n.a.
• Other Brand Names: Savaysa

Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Do not use in patients with Clcr >95 mL/minute. (See Boxed Warning.)

Noninferior to well-controlled (mean time in therapeutic INR range: 65%) warfarin therapy in preventing stroke and systemic embolism, and associated with lower rates of bleeding and cardiovascular death.

The American College of Chest Physicians (ACCP), American Stroke Association (ASA), ACC, AHA, and other experts recommend antithrombotic therapy in all patients with nonvalvular atrial fibrillation considered to be at increased risk of stroke, unless contraindicated.

Choice of antithrombotic therapy based on patient's risk for stroke and bleeding; in general, oral anticoagulant therapy recommended in patients who have a moderate to high risk for stroke and acceptably low risk of bleeding; consider aspirin or no antithrombotic therapy in patients at low risk. Patients at increased risk of stroke generally include those with prior ischemic stroke or TIA, advanced age (e.g., ≥75 years), history of hypertension, diabetes mellitus, or CHF. In addition, female sex considered an important risk factor for stroke in patients with atrial fibrillation, particularly in patients ≥75 years of age.

Although warfarin traditionally has been used for oral anticoagulation in patients with atrial fibrillation at increased risk of stroke, non-vitamin K antagonist oral anticoagulants such as edoxaban may be useful alternatives in selected patients at moderate to high risk of stroke who are unable to comply with warfarin monitoring requirements or in whom a consistent therapeutic response to warfarin cannot be achieved; warfarin may still be preferred in patients who are optimally managed and have well-controlled INRs.

Relative efficacy and safety of the non-vitamin K antagonist oral anticoagulants (e.g., apixaban, dabigatran, edoxaban, rivaroxaban) remain to be fully elucidated.

When selecting an appropriate anticoagulant, consider factors such as the absolute and relative risks of stroke and bleeding; costs; patient compliance, preference, tolerance, and comorbidities; and other clinical factors such as renal function and degree of INR control (if the patient has been taking warfarin).

Safety and efficacy of edoxaban not established in patients with mechanical heart valves or moderate to severe mitral stenosis; use not recommended in such patients.

Treatment of DVT and/or PE, following initial treatment with a parenteral anticoagulant for 5–10 days.

Noninferior to warfarin in reducing the risk of recurrent venous thromboembolism; associated with substantially reduced rates of clinically important bleeding.

• Generic Name: flumazenil
• Dosage Forms: injection, solution
• Other Brand Names: Romazicon

Flumazenil reverses the effects of benzodiazepine (BENZ-oh-dye-AYZ-e-peen) sedatives such as Valium, Versed, Xanax, Tranxene, and others. Benzodiazepines are sometimes used as sedatives before surgery or other medical procedures.

Flumazenil is used to reverse benzodiazepine sedation to help you wake up after your medical procedure. Flumazenil is also used to treat benzodiazepine overdose in adults.

Flumazenil may also be used for purposes not listed in this medication guide.