Pradaxa

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

Adult Primary prevention of VTE in elective knee or hip replacement surgery 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 (for knee replacement surgery); 28-35 days (for hip replacement surgery). Delay initiation of treatment if haemostasis is not secured. Initiate w/ 2 cap of 110 mg once daily if 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. Elderly 75-80 yr, patient w/ moderate renal impairment, gastritis, esophagitis or GERD, other patient at increased risk of bleeding SPAF, DVT/PE 300 mg or 220 mg daily, based on individual assessment of thromboembolic & bleeding risks. Moderate renal impairment (CrCl 30-50 mL/min) Primary prevention of VTE 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 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 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 due to increased risk of bleeding.

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 requiring anticoagulant treatment. Lesion or condition, if considered a significant risk factor for major bleeding. Concomitant treatment w/ strong P-gp inhibitors (eg, systemic ketoconazole, cyclosporine, itraconazole & dronedarone); any other anticoagulants. 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. 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 co-medication; concomitant use w/ desirudin, thrombolytics, GPIIb/IIIa receptor antagonists, ticlopidine, dextran, sulfinpyrazone, prasugrel & P-gp inhibitors; glecaprevir/pibrentasvir; ticagrelor; SSRIs & SNRIs; NSAIDs, antiplatelets including ASA & clopidogrel. Not recommended to use w/ dronedarone. Concomitant use w/ strong P-gp inducers. Closely observe for bleeding signs or anaemia in situations where there is increased haemorrhagic risk (eg, recent biopsy, major trauma, bacterial endocarditis). Not recommended for patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Surgery or invasive procedures may be stopped temporarily due to increased bleeding risk. Temporarily discontinue therapy if 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 in patients at higher risk of bleeding or in major surgery where complete haemostasis may be required. Patients at high surgical mortality risk & w/ intrinsic risk factors for thromboembolic events. Risk of spinal or epidural haematoma may be increased in cases 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. Possible MI. DVT/PE patients w/ active cancer. Closely monitor patients w/ body wt <50 kg. Assess renal function prior to initiation of treatment especially in the elderly >75 yr. Moderate renal impairment (CrCl 30-50 mL/min). Women of childbearing potential should avoid pregnancy during treatment. Pregnancy. Discontinue 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/ treatments that act on haemostasis or coagulation including vit K antagonists; unfractionated heparins & heparin derivatives, LMWH, fondaparinux; desirudin, thrombolytics, GPIIb/IIIa receptor antagonists, ticlopidine, dextran, sulfinpyrazone, prasugrel. Closely observe for bleeding signs w/ NSAIDs. Increased plasma conc w/ P-gp inhibitors [eg, amiodarone, verapamil, quinidine, systemic ketoconazole (concomitant use is contraindicated), dronedarone, ticagrelor, clarithromycin & glecaprevir/pibrentasvir]. 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