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  • Rivaroxaban Dexcel (2.5 mg, 10 mg, 15 mg, 20 mg)
    / Dexcel


    Active Ingredient
    Rivaroxaban 2.5 mg, 10 mg, 15 mg, 20 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    56 x 2.5 mg

    partial basket chart 16653 18707

    Film Coated Tablets

    30 x 10 mg

    partial basket chart 16667 18708

    Film Coated Tablets

    28 x 15 mg

    partial basket chart 16668 18709

    Film Coated Tablets

    28 x 20 mg

    partial basket chart 16671 18710

    Related information


    Dosage

    Dosage must be adjusted individually according to the patient’s medical condition.
    Please refer to the license holder for further details.


    Indications

    Rivaroxaban 2.5 mg: Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.
    Rivaroxaban 2.5 mg, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
    Rivaroxaban 10 mg: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
    Prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE), adults (following completion of at least 6 months therapy for DVT or PE).
    Rivaroxaban 15, 20 mg: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
    Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
    Paediatric population: Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.


    Contra-Indications

    Rivaroxaban 2.5, 10, 15, 20 mg:
    * Hypersensitivity to the active substance or to any of the excipients.
    * Active clinically significant bleeding.
    * Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
    * Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low  molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter.
    * Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C.
    * Pregnancy and breastfeeding.
    Rivaroxaban 2.5mg:
    * Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA).
    * Concomitant treatment of CAD/PAD with ASA in patients with previous haemorrhagic or lacunar stroke, or any stroke within a month.


    Special Precautions

    Please refer to the license holder for further details


    Side Effects

    Please refer to the license holder for further details


    Drug interactions

    Please refer to the license holder for further details


    Pregnancy and Lactation

    Please refer to the license holder for further details


    Overdose

    Please refer to the license holder for further details


    Manufacturer
    Medichem S.A.,
    Licence holder
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