Pradaxa

Prevention of venous thromboembolic events (VTE) in patients who have undergone major orthopaedic surgery. Prevention of stroke, systemic embolism & reduction of vascular mortality in patients w/ atrial fibrillation. Treatment of acute DVT &/or pulmonary embolism (PE) & prevention of related death. Prevention of recurrent DVT &/or PE & related death.

Adult & elderly Prevention of VTE in patient who have undergone major orthopaedic surgery 220 mg once daily taken as 2 cap of 110 mg. Prevention of stroke, systemic embolism & reduction of vascular mortality in patient w/ atrial fibrillation 300 mg taken as 150 mg bid. Therapy should be continued life-long. Treatment of acute DVT &/or PE & prevention of related death 300 mg taken as 150 mg bid following treatment w/ a parenteral anticoagulant for at least 5 days. Therapy should be continued for up to 6 mth. Prevention of recurrent DVT &/or PE & related death 300 mg taken as 150 mg bid. Therapy could be continued life-long depending on the individual patient risk. Adult Prevention of VTE following knee or hip replacement surgery Initially 110 mg w/in 1-4 hr of completed surgery & continuing w/ 2 cap of 110 mg once daily thereafter for a total of 10 days (following knee replacement surgery) or 28-35 days (following hip replacement surgery). Delay initiation of treatment for both surgeries if haemostasis is not secured. Initiate 2 cap of 110 mg once daily if the treatment is not started on the day of surgery. Elderly ≥80 yr Prevention of stroke, systemic embolism & reduction of vascular mortality in patient w/ atrial fibrillation 220 mg taken as 110 mg bid. Moderate renal impairment (CrCl 30-50 mL/min) or concomitant use w/ strong P-gp inhibitors (eg, amiodarone, quinidine or verapamil) Prevention of VTE in patient who have undergone major orthopaedic surgery 150 mg once daily as 2 cap of 75 mg. Prevention of VTE events following knee or hip replacement surgery Initially 75 mg w/in 1-4 hr of completed surgery & continuing w/ 2 cap of 75 mg once daily thereafter for a total of 10 days (following knee replacement surgery) or 28-35 days (following hip replacement surgery). Delay initiation of treatment for both surgeries if haemostasis is not secured. Initiate 2 cap of 75 mg once daily if the treatment is not started on the day of surgery. Patient at risk of bleeding (eg, ≥75 yr, moderate renal impairment, concomitant use w/ strong P-gp inhibitors) 220 mg taken as 110 mg bid. Catheter ablation for atrial fibrillation 150 mg bid.

May be taken with or without food: Swallow whole w/ a glass of water, do not open the cap. Take w/ meals if GI discomfort occurs.

Hypersensitivity to dabigatran or dabigatran etexilate. Haemorrhagic manifestations, patients w/ bleeding diathesis, or patients w/ spontaneous or pharmacological impairment of haemostasis. Organ lesions at risk of clinically significant bleeding including haemorrhagic stroke w/in the last 6 mth. Concomitant treatment w/ systemic ketoconazole. Prosthetic heart valve replacement. Severe renal impairment (CrCl <30 mL/min).

Haemorrhagic risk. Increased risk for thromboembolic events in patients w/ antiphospholipid syndrome (especially if triple +ve). Discontinue use at least 12 hr for acute surgery or at least 24 hr prior to invasive or surgical procedures or 2-4 days in major surgery where complete hemostasis may be required. Increased risk of spinal or epidural hematoma in case of traumatic or repeated puncture & by prolonged use of epidural catheters; an interval of at least 1 hr after removal of catheter should elapse before the administration of the 1st dose. False +ve INR elevations; do not perform INR tests. Concomitant use w/ unfractionated heparin & heparin derivatives, LMWH, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, ticlopidine, dextran, sulfinpyrazone, rivaroxaban, prasugrel, vit K antagonists, P-gp inhibitors (eg, itraconazole, tacrolimus, cyclosporine, ritonavir, tipranavir, nelfinavir & saquinavir), fixed-dose combination of P-gp inhibitors glecaprevir/pibrentasvir, dronedarone, ticagrelor, SSRIs/SNRIs. Discontinue if acute renal failure develops. Avoid pregnancy in women of childbearing potential. Pregnancy & lactation. Not recommended in childn <18 yr.

Anaemia, thrombocytopenia, neutropenia, agranulocytosis; drug hypersensitivity including pruritus, rash & urticaria, bronchospasm, angioedema, anaphylactic reaction; intracranial haemorrhage; haematoma, haemorrhage; epistaxis, haemoptysis; GI haemorrhage, abdominal pain, diarrhoea, dyspepsia, nausea, GI ulcer including oesophageal ulcer, gastrooesophagitis, GERD, vomiting, dysphagia; abnormal hepatic function; skin haemorrhage, alopecia; haemarthrosis; urogenital hemorrhage; inj & catheter site haemorrhage; traumatic & incision site haemorrhage. Prevention of VTE events in patients who have undergone major orthopaedic surgery: Wound haemorrhage; bloody discharge; post-procedural haematoma, haemorrhage & discharge, anaemia post-op, wound secretion; wound & post-procedural drainage.

Increased risk of bleeding w/ drugs acting on haemostasis or coagulation including vit K antagonists; unfractionated heparin & heparin derivatives, LMWH, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, ticlopidine, dextran, sulfinpyrazone, rivaroxaban, prasugrel, P-gp inhibitors (eg, itraconazole, tacrolimus, cyclosporine, ritonavir, tipranavir, nelfinavir & saquinavir) & fixed-dose combination of P-gp inhibitors glecaprevir/pibrentasvir, SSRIs/SNRIs. Increased plasma conc w/ P-gp inhibitors (eg, amiodarone, verapamil, quinidine, systemic ketoconazole, dronedarone, ticagrelor, clarithromycin & the fixed-dose combination glecaprevir/pibrentasvir). Increased exposure w/ amiodarone, quinidine, clarithromycin, systemic ketoconazole, dronedarone, & ticagrelor. Increased C_max & AUC w/ oral verapamil. Reduced exposure w/ P-gp inducers (eg, rifampicin).

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

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