Product Overview
[Drug Name]
Generic Name: Edoxaban Tosylate Tablets
Trade Name: Aixinan Edoxaban Tosylate Tablets 30mg x 7 tablets
[Main Ingredients]
The active ingredient in this product is edoxaban tosylate. Chemical name: N-(5-chloropyridin-2-yl)-N,-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl]oxamide, mono(4-methylbenzenesulfonate) monohydrate. Molecular formula: C24H30CIN7O4S·C7H8O3S·H2O. Molecular weight: 738.27. Excipients: Mannitol, pregelatinized starch, hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, magnesium stearate, film coating premix.
[Properties]
This product is available as orange, round film-coated tablets (15 mg); pink, round film-coated tablets (30 mg); or yellow, round film-coated tablets (60 mg).
[Indications/Main Functions]
1. For the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF) and one or more risk factors (such as congestive heart failure, hypertension, age ≥75 years, diabetes, or a history of stroke or transient ischemic attack (TIA)). 2. For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, as well as for the prevention of recurrence of DVT and PE in adults. (For use in hemodynamically unstable PE patients, see [Precautions]).
[Specifications]
30mg x 7 tablets
[Dosage and Administration]
Oral administration. This product can be taken with or without food. (See [Pharmacokinetics]). Dosage: The recommended dose for the prevention of stroke and systemic embolism is 60 mg once daily. Edoxaban should be used long-term in patients with non-valvular atrial fibrillation (NVAF). The recommended dose of edoxaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE (venous thromboembolism, VTE) is 60 mg once daily, initiated after at least 5 days of initial parenteral anticoagulant therapy. Edoxaban should not be administered concomitantly with parenteral anticoagulants. The duration of treatment for DVT, PE, and recurrent VTE prevention should be determined on an individual basis after careful assessment of treatment benefits and bleeding risks (see Precautions). Short-term treatment (at least 3 months) should be indicated for transient risk factors (e.g., recent surgery, trauma, immobilization), and longer-term treatment should be indicated for permanent risk factors or idiopathic DVT or PE. For patients with nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE) who have one or more of the following clinical factors, the recommended dose of edoxaban is 30 mg once daily: moderate or severe renal impairment (creatinine clearance (CrCl) 15-50 mL/min), low body weight (<60 kg), and concomitant use of a P-glycoprotein (P-gp) inhibitor: cyclosporine, dronedarone, erythromycin, or ketoconazole. (For other details, see the package insert.)
[Adverse Reactions]
See the package insert for details.
