Pradaxa

Dabigatran etexilate

Acute DVT &/or pulmonary embolism (PE). Prevention of VTE in patients who have undergone orthopaedic surgery for knee or hip replacement; stroke, systemic embolism & reduction of vascular mortality in patients w/ atrial fibrillation; recurrent DVT &/or PE & related death.

Adult including elderly Acute DVT &/or PE & prevention of related death 150 mg bid following treatment w/ parenteral anticoagulant for at least 5 days. Continue therapy for up to 6 mth. Prevention of recurrent DVT &/or PE & related death 150 mg bid, continued life-long depending on individual patient risk. Prevention of VTE following knee replacement surgery Initially single 110-mg cap w/in 1-4 hr of completed surgery, continuing w/ 2 cap once daily thereafter for 10 days. Delay treatment if haemostasis is not secured & initiate w/ 2 cap once daily if treatment is not started on the day of surgery; following hip replacement surgery Initially single 110-mg cap w/in 1-4 hr of completed surgery, continuing w/ 2 cap once daily thereafter for 28-35 days. Delay treatment if haemostasis is not secured & initiate w/ 2 cap once daily if treatment is not started on the day of surgery. Prevention of stroke, systemic embolism & reduction of vascular mortality in patients w/ atrial fibrillation 150 mg bid, continued life-long. Elderly ≥75 yr, moderate renal impairment (CrCl 30-50 mL/min), concomitant treatment w/ strong P-gp inhibitors, antiplatelets or previous GI bleed Reduce dose to 110 mg bid. Catheter ablation for atrial fibrillation 150-mg cap bid, treatment does not need to be interrupted. Moderate renal impairment (CrCl 30-50 mL/min), concomitant use w/ strong P-gp inhibitors eg, amiodarone, quinidine or verapamil Prevention of VTE in patients who have undergone major orthopaedic surgery Reduce dose to 150 mg once daily as two 75-mg cap. Renal impairment/concomitant use w/ strong P-gp inhibitors eg, amiodarone, quinidine or verapamil Prevention of VTE following knee or hip replacement surgery Initially single 75-mg cap, continuing w/ two 75-mg cap once daily thereafter for 10 days following knee replacement or 28-35 days following hip replacement. Delay treatment if haemostasis is not secured & initiate w/ 2 cap once daily if treatment is not started on the day of surgery.

May be taken with or without food: Swallow whole, do not chew/crush.

Known hypersensitivity. Haemorrhagic manifestations, bleeding diathesis, spontaneous or pharmacological impairment of haemostasis; organ lesions at risk of clinically significant bleeding including haemorrhagic stroke w/in the last 6 mth. Prosthetic heart valve replacement. Concomitant use w/ systemic ketoconazole. Severe renal impairment (CrCl <30 mL/min).

Discontinue treatment in patients who develop acute renal failure; at least 5 days before major surgery in patients w/ severe renal dysfunction (CrCl <30 mL/min). Temporarily discontinue in advance of invasive or surgical procedures. Discontinue at least 24 hr before invasive or surgical procedures. Delay acute surgery/intervention at least 12 hr after last dose. Consider discontinuing 2-4 days before surgery in patients at higher risk of bleeding or in major surgery requiring complete hemostasis. Not to perform INR tests due to false +ve INR elevations. Patients w/ antiphospholipid syndrome (especially if triple-+ve for antiphospholipid Ab); GI bleeding. Frequent observation for neurological signs & symptoms of spinal or epidural hematoma. Reversing therapy. Closely observe for signs of bleeding or anaemia in situations w/ increased haemorrhagic risk eg, recent biopsy or major trauma, bacterial endocarditis. Appropriate measure eg, testing for occult blood in stool, or a drop in Hb if bleeding is clinically suspected. Not recommended to use concomitantly w/ dronedarone. Increased bleeding risk w/ unfractionated heparins (except at doses necessary to maintain patency of central venous or arterial catheter or during catheter ablation for atrial fibrillation) & 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; glecaprevir/pibrentasvir; ticagrelor; SSRIs or SNRIs; anti-platelets eg, ASA & clopidogrel & NSAID. Avoid simultaneous treatment initiation of verapamil in patients who have undergone major orthopaedic surgery w/ prior dabigatran treatment. Concomitant use w/ strong P-gp inducers eg, rifampicin; St. John's wort or carbamazepine. Assess renal function at least once a yr in patients w/ moderate renal impairment (CrCl 30-50 mL/min). Women of childbearing potential should avoid pregnancy during treatment. Not to be used during pregnancy. Discontinue breastfeeding while on treatment. Not recommended in paed patients <18 yr. Elderly >75 yr (assess renal function).

Anaemia, thrombocytopenia, neutropenia, agranulocytosis; drug hypersensitivity including pruritus, rash & urticaria, bronchospasm, angioedema, anaphylactic reaction; intracranial haemorrhage; haematoma, haemorrhage; wound 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 haemorrhage; inj & catheter site haemorrhage, bloody discharge; traumatic & incision site haemorrhage, post-procedural haematoma, haemorrhage & discharge, post-op anaemia, wound secretion; wound & post-procedural drainage.

Increased risk of bleeding w/ vit K antagonists. Increased plasma conc w/ P-gp inhibitors eg, amiodarone, verapamil, quinidine, systemic ketoconazole, dronedarone, ticagrelor, clarithromycin, glecaprevir/pibrentasvir. Increased exposure w/ amiodarone; quinidine; clarithromycin; systemic ketoconazole; dronedarone; ticagrelor. Increased C_max & AUC w/ oral verapamil. Reduced AUC_0-∞ & C_max 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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