Pradaxa Contraindications



Boehringer Ingelheim


Full Prescribing Info
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. These are switching anticoagulant therapy (see Dosage & Administration), when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation (see Interactions).
Hepatic impairment or liver disease expected to have any impact on survival.
Concomitant treatment with the following strong P-gp inhibitors: systemic ketoconazole, cyclosporine, itraconazole and dronedarone (see Interactions).
Prosthetic heart valves requiring anticoagulant treatment (see Pharmacology under Actions).
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