LIXIANA 60MG FILM COATED TABLET 28S
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Edoxaban (Lixiana) is indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Edoxaban (Lixiana) is indicated in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
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"Prevention of stroke and systemic embolism- the recommended dose is 60 mg edoxaban once daily. Therapy with edoxaban in NVAF patients should be continued long term. Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE)- The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see section Pharmacodynamic properties ). Edoxaban and initial parenteral anticoagulant should not be administered simultaneously. For NVAF and VTE the recommended dose is 30 mg edoxaban once daily in patients with one or more of the following clinical factors: • Moderate or severe renal impairment (creatinine clearance (CrCl) 15 50 mL/min) • Low body weight ≤ 60 kg • Concomitant use of the following P glycoprotein (P gp) inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole. "
"FORMULATION: Each film-coated tablet contains: Edoxaban (as tosilate) ………………………….30 mg Edoxaban (as tosilate) ………………………….60 mg Tablet core: Mannitol (E421), Pregelatinised starch, Crospovidone (E1202), Hydroxypropyl cellulose (E463) Magnesium stearate (E470b) Tablet coating: Hypromellose (E464), Macrogol (8000), Titanium dioxide (E171), Talc (E553b) Carnauba wax Edoxaban (Lixiana) 15 mg film-coated tablets: Iron oxide yellow (E172), Iron oxide red (E172) Edoxaban (Lixiana) 30 mg & 60mg film-coated tablets: Iron oxide red (E172) "
"SPECIAL WARNINGS AND PRECAUTIONS Edoxaban (Lixiana) 15 mg is not indicated as monotherapy
Product Code: 50032981