Pradaxa

Dabigatran etexilate

Treatment of DVT & pulmonary embolism (PE) & prevention of recurrent DVT & PE in adults. Prevention of stroke & systemic embolism in patients w/ non-valvular atrial fibrillation. Primary prevention of venous thromboembolic events in adults who have undergone elective total hip or knee replacement surgery.

Primary prevention of VTE event in adult patients in elective knee or hip replacement surgery One 110 mg cap w/in 1-4 hr of completed surgery & continued w/ two 110 mg cap once daily thereafter for 10 days (knee replacement surgery) or 28-35 days (hip replacement surgery). Initiate treatment w/ two 110 mg cap once daily if treatment is not started on day of surgery. Treatment of DVT & PE & prevention of recurrent DVT & PE in adults 300 mg taken as one 150 mg cap bd following treatment w/ parenteral anticoagulant for at least 5 days. Prevention of stroke & systemic embolism in non-valvular atrial fibrillation 300 mg taken as one 150 mg cap bd. Elderly ≥80 yr, patients receiving concomitant verapamil for SPAF, DVT/PE 220 mg taken as one 110 mg cap bd. Elderly 75-80 yr, moderate renal impairment, w/ gastritis, esophagitis or gastroesophageal reflux, other patients at increased bleeding for SPAF, DVT/PE 300 mg or 220 mg daily based on individual assessment of the thromboembolic risk & risk of bleeding.

May be taken with or without food. Swallow whole w/ water, do not open. May be taken w/ a meal to avoid gastrointestinal symptoms.

Hypersensitivity. Clinically significant active bleeding; prosthetic heart valve replacement requiring anticoagulant treatment; lesion or condition at significant risk of major bleeding. Concomitant use w/ systemic ketoconazole, cyclosporine, itraconazole & dronedarone; other anticoagulants eg, unfractionated heparin, LMWH (eg, enoxaparin, dalteparin), heparin derivatives (eg, fondaparinux), oral anticoagulants (eg, warfarin, rivaroxaban, apixaban). Severe renal impairment (CrCl <30 mL/min). Hepatic impairment or disease.

Discontinue use if acute renal failure develops. Not recommended in hip fracture surgery. Increased risk of bleeding; spinal & epidural anaesth/lumbar puncture; MI. Patients at high surgical mortality risk & w/ intrinsic risk factors for thromboembolic events; DVT/PE patients w/ active cancer. Assess renal function prior to treatment & when declined renal function during treatment is suspected. Closely monitor patients w/ body wt <50 kg. Temporarily discontinue use at least 12 hr prior to acute surgery/intervention or at least 24 hr prior to invasive or surgical procedures. Not recommended in concomitant use w/ dronedarone. Concomitant use w/ desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, ticlopidine, dextran, sulfinpyrazone, rivaroxaban, prasugrel, vit K antagonists, P-gp inhibitors, itraconazole, tacrolimus, cyclosporine, ritonavir, tipranavir, nelfinavir & saquinavir; ticagrelor; SSRIs or SNRIs; antiplatelet (including ASA & clopidogrel) & NSAID; strong P-gp inducer eg, rifampicin, St. John's wort or carbamazepine. Use of fibrinolytic agents in acute ischemic stroke. False +ve elevations in INR test. Not recommended in patients w/ elevated liver enzymes >2 x ULN. Moderate renal impairment. Women of childbearing potential. Not to be used during pregnancy. Discontinue use during lactation. Not recommended in childn <18 yr. Elderly >75 yr.

Anemia, GI, urogenital, skin & wound haemorrhage, hematoma, hematuria, epistaxis; wound secretion, post-procedural hematoma, haemorrhage & discharge, post-op anemia, traumatic hematoma; ALT ≥3 x ULN, decreased Hb; rectal haemorrhage, dyspepsia, abdominal pain; diarrhoea, nausea; contusion.

Increased bleeding risk w/ anticoagulants & platelet aggregation agents eg, unfractionated heparins & heparin derivatives, LMWH, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, clopidogrel, ticlopidine, dextran, sulfinpyrazone & vit K antagonists; NSAIDs (chronic use). Increased plasma conc w/ P-gp inhibitors eg, amiodarone, verapamil, quinidine, systemic ketoconazole, dronedarone, ticagrelor & clarithromycin. Reduced exposure w/ P-gp inducers eg, rifampicin, St. John's wort, carbamazepine or phenytoin.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AE07 - dabigatran etexilate ; Belongs to the class of direct thrombin inhibitors. Used in the treatment of thrombosis.

POM