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Thread: Pradaxa 75 mg capsules

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    Default Pradaxa 75 mg capsules

    Composition: Each hard capsule contains: 86,48 mg dabigatran etexilate mesilate equivalent to 75 mg dabigatran etexilate.

    Mechanism of Action
    Dabigatran etexilate is a low-molecular-weight prodrug that exhibits no pharmacological activity. After oral administration, dabigatran etexilate is converted to its active form, dabigatran, a potent, competitive, and reversible direct inhibitor of the active site of thrombin, the final effector in blood coagulation.

    Thrombin has an active site and secondary binding exosites. Exosite acts as a dock for substrates such as fibrin to promote orientation for active site binding. Exosite is the heparin-binding domain. Dabigatran is a univalent direct thrombin inhibitor that binds to the active site, thereby inactivating both fibrin-bound and unbound (ie, free) thrombin. Indirect thrombin inhibitors such as unfractionated heparin and low-molecular-weight heparin cannot inhibit fibrin-bound thrombin. The ability to inhibit fibrin-bound thrombin is an important theoretical advantage of dabigatran over the heparins because bound thrombin can continue to trigger thrombus expansion. By inhibiting thrombin, dabigatran prevents the conversion of fibrinogen into fibrin, positive feedback amplification of coagulation activation, cross-linking of fibrin monomers, platelet activation, and inhibition of fibrinolysis

    Therapeutic indications
    • Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
    • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.
    • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults


    Pradaxa capsules attachment.php?attachmentid=443&stc=1&d=1436862141
    Contraindications
    • Hypersensitivity to the active substance or to any of the excipients.
    • Patients with severe renal impairment (CrCL < 30 mL/min)
    • Active clinically significant bleeding
    • Lesion or condition, if considered a significant risk factor 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, rivaroxaban, 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 impairment or liver disease expected to have any impact on survival
    • Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole and dronedarone
    • Prosthetic heart valves requiring anticoagulant treatment











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