Pradaxa

Dabigatran etexilate

75 mg & 110 mg: Primary prevention of venous thromboembolic events in adults who have undergone elective total hip or knee replacement surgery. 110 mg & 150 mg: Prevention of stroke & systemic embolism in patients w/ non-valvular atrial fibrillation. DVT & pulmonary embolism (PE); prevention of recurrent DVT & PE in adults.

Adult Primary prevention of venous thromboembolic (VTE) events in elective knee replacement surgery Initially 220 mg once daily as 2 cap of 110 mg w/in 1-4 hr of completed surgery w/ a single cap & continuing w/ 2 cap once daily thereafter for a total of 10 days. Delay initiation of treatment if haemostasis is not secured. Initiate w/ 2 cap of 110 mg once daily if the treatment is not started on the day of surgery. Primary prevention of VTE events in hip replacement surgery Initially 220 mg once daily as 2 cap of 110 mg w/in 1-4 hr of completed surgery w/ a single cap & continuing w/ 2 cap once daily thereafter for a total of 28-35 days. Delay initiation of treatment if haemostasis is not secured. Initiate w/ 2 cap of 110 mg once daily if the treatment is not started on the day of surgery. DVT & PE, & prevention of recurrent DVT & PE 150 mg bd following treatment w/ parenteral anticoagulant for at least 5 days. Patient w/ non-valvular atrial fibrillation Prevention of stroke & systemic embolism 150 mg bd. Elderly ≥80 yr, patient who receive concomitant verapamil Stroke prevention in atrial fibrillation (SPAF), DVT/PE 110 mg bd. Patient 75-80 yr, moderate renal impairment, w/ gastritis, esophagitis or gastroesophageal reflux, other patient at increased risk of bleeding SPAF, DVT/PE 300 mg or 220 mg daily, based on individual assessment of thromboembolic risk & risk of bleeding. Moderate renal impairment (CrCl 30-50 mL/min) Primary prevention of VTE events in elective total hip or knee replacement surgery 150 mg once daily as 2 cap of 75 mg. After knee or hip replacement surgery, initiate treatment w/in 1-4 hr of completed surgery w/ a single cap & continuing w/ 2 cap of 75 mg once daily thereafter for a total of 10 days (for knee replacement surgery) & 28-35 days (for hip replacement surgery). Delay initiation of treatment if haemostatis is not secured. Initiate w/ 2 cap of 75 mg once daily if the treatment is not started on the day of surgery. Elderly >75 yr Primary prevention of VTE events in elective total hip or knee replacement surgery 150 mg once daily as 2 cap of 75 mg. After knee or hip replacement surgery, initiate treatment w/in 1-4 hr of completed surgery w/ a single cap & continuing w/ 2 cap of 75 mg once daily thereafter for a total of 10 days (for knee replacement surgery) & 28-35 days (for hip replacement surgery). 75-80 yr Prevention of stroke & systemic embolism in non-valvular atrial fibrillation; treatment of DVT & PE, & prevention of recurrent DVT & PE 300 mg daily as 150 mg cap bd. Individually consider 220 mg as 110 mg cap bd, when thromboembolic risk is low & bleeding risk is high. ≥80 yr Prevention of stroke & systemic embolism in non-valvular atrial fibrillation; treatment of DVT & PE, & prevention of recurrent DVT & PE 220 mg daily as 110 mg cap bd.

May be taken with or without food: Take w/ meals if GI discomfort occurs. Swallow whole w/ a glass of water.

Hypersensitivity. Active clinically significant bleeding. Prosthetic heart valve replacement, lesion or condition at risk factor for major bleeding. Concomitant treatment w/ systemic ketoconazole, cyclosporine, itraconazole, dronedarone & any other anticoagulant agent eg, unfractionated heparin (UFH), LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, rivaroxaban, apixaban). CI in patients w/ hepatic impairment or liver disease. Severe renal impairment (CrCl <30 mL/min).

Not recommended in patients w/ elevated liver enzymes >2 x ULN. Increased risk of bleeding. Do not perform INR tests. Closely monitor for diseases that may increase haemorrhagic risk eg, congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, active ulcerative GI disease, recent biopsy or major trauma, recent intracranial haemorrhage or brain, spinal or ophth surgery, bacterial endocarditis. Discontinue use in patients who develop acute renal failure. Risk of bleeding may increase w/ decreased renal function (CrCl 30-50 mL/min), age ≥75 yr, or strong P-gp inhibitor comedication, concomitant use w/ drugs (eg, dronedarone, ticagrelor, SSRIs & selective serotonin norepinephrine re-uptake inhibitors) & coadministration of anti-platelet (including aspirin & clopidogrel) & NSAID therapies. Not recommended for patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Surgery or invasive procedures may be stopped temporarily in advance due to increased risk of bleeding. Temporarily discontinue therapy if an acute intervention is required; delay intervention if possible until at least 12 hr after the last dose. Discontinue therapy at least 24 hr before elective surgery. Consider stopping therapy 2-4 days before surgery for patients at higher risk of bleeding or in major surgery whose complete haemostasis may be required. Patients at high surgical mortality risk & w/ intrinsic risk factors for thromboembolic events. Spinal or epidural haematoma risk may be increased in case of traumatic or repeated puncture & by prolonged use of epidural catheters. Resume or start therapy after complete haemostasis is achieved in post-procedural period. Not recommended in hip fracture surgery. MI, DVT/PE patients w/ active cancer. Not recommended in patients w/ body wt <50 kg. Assess renal function prior to initiation of treatment & for elderly patients or moderate renal impairment patient (CrCl 30-50 mL/min) yrly. Moderate renal impairment. Women of childbearing potential. Pregnancy & lactation. Not recommended in childn <18 yr.

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

Increased risk of bleeding 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); rivaroxaban, prasugrel. Closely observe for signs of bleeding w/ NSAIDs. Increased plasma conc w/ P-gp inhibitors (eg, amiodarone, verapamil, quinidine, systemic ketoconazole (concomitant use is contraindicated), dronedarone, ticagrelor & clarithromycin). Systemic exposure may be reduced by 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