All the Active Ingredient Drugs
Direct Thrombin Inhibitor. Dabigatran Etexilate 75, 110, 150 mg. HARD CAPS: 10, 30, 60 x75 mg, 110 mg, 150 mg. Dosage adjust. individ.
75 mg: Prim. prevent. of VTE in adult pts. who have undergone elective total hip replacem. surg. or total knee replac. surg.
100 mg: Prim. prevent. of ven.
thromboembol. events in adult pts. who have undergone elect. total hip replacem. surgery or total knee replac. surg.
150mg: Prevent. of stroke and syst.
embolism in adult pts. with non-valvular atrial fibril. (NVAF). Tmt. of DVT and PE, and prevent. of recur. DVT and PE in adult.
C/I: Hypersens. Pts. with severe renal impair. (CrCL < 30 mL/min). Active clinical. signific. bleed. Lesion or condit., if considered a signific. risk factor for major bleed. This may include current or recent GI ulcerat., presence of malig. neoplasms at high risk of bleed., recent brain or spinal injur., recent brain, spinal or ophthalm. surg., recent intracran. haemorrhage, known or suspect. oesophageal varices, arterioven. malformat., vascular aneurysms or major intraspin. or intracerebr. vascul. abnormalit.
Concom. tmt. with any other anticoag. e.g. unfractionated heparin (UFH), low MW heparins (enoxaparin, dalteparin etc), heparin derivat. (fondaparinux etc), oral anticoag. (warfarin, rivaroxaban, apixaban etc) except under specific circumstances. These are switching anticoag. ther., when UFH is given at doses necessary to maintain an open central venous/arterial catheter or when UFH is given during catheter ablation for atrial fibrillat.
Hepat. impair. or liver dis. expected to have any impact on survival concom. tmt. with the follow. strong P-gp inhibitors: system. ketoconazole, cyclosporine, itraconazole and dronedarone.
Prosthetic heart valves requiring anticoagulant treatment.