Pradaxa

Primary prevention of venous thromboembolic events (VTE) in adults who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke & systemic embolism in adults w/ non-valvular atrial fibrillation (NVAF), w/ ≥1 risk factors eg, prior stroke or transient ischemic attack (TIA); age ≥75 yr; heart failure (NYHA class ≥II); DM; HTN. Treatment of DVT & pulmonary embolism (PE) & prevention of recurrent DVT & PE in adults.

Primary prevention of VTE in orthopaedic surgery Patient following elective knee/hip replacement surgery Initiation (on the day of surgery): 110 mg 1-4 hr after completed surgery. Maintenance (on the 1st day after surgery): 220 mg once daily for 10 days (knee replacement surgery) or 28-35 days (hip replacement surgery). Patient w/ moderate renal impairment (CrCl 30-50 mL/min); patient receiving concomitant verapamil, amiodarone or quinidine; elderly ≥75 yr Initiation (on the day of surgery): 75 mg 1-4 hr after completed surgery. Maintenance (on the 1st day after surgery): 150 mg once daily for 10 days (knee replacement surgery) or 28-35 days (hip replacement surgery). Prevention of stroke & systemic embolism in NVAF w/ ≥1 risk factors Recommended dose: 150 mg bd, continued as long-term therapy. Treatment of DVT & PE & prevention of recurrent DVT & PE Recommended dose: 150 mg bd, following treatment w/ parenteral anticoagulant for at least 5 days. Individualised duration of therapy after careful assessment of treatment benefit against bleeding risk. Prevention of stroke & systemic embolism in NVAF w/ ≥1 risk factors; treatment of DVT & PE & prevention of recurrent DVT & PE Patient receiving concomitant verapamil; elderly ≥80 yr Recommended dose: 110 mg bd. Patient w/ moderate renal impairment (CrCl 30-50 mL/min); patient w/ gastritis, esophagitis or GERD; patient at increased risk of bleeding; elderly 75-80 yr Recommended dose: 300 or 220 mg daily, selected based on individual assessment of thromboembolic & bleeding risk.

May be taken with or without food: Swallow whole w/ water. Do not open cap.

Hypersensitivity. Active clinically significant bleeding. Lesion or condition, if considered a significant risk factor for major bleeding eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophth surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Prosthetic heart valves requiring anticoagulant treatment. Concomitant treatment w/ any other anticoagulants eg, unfractionated heparin (UFH), LMWH (eg, enoxaparin, dalteparin), heparin derivatives (eg, fondaparinux), oral anticoagulants (eg, warfarin, rivaroxaban, apixaban) except under specific circumstances when switching anticoagulant therapy, when UFH is given at doses necessary to maintain an open central venous or arterial catheter, or when UFH is given during catheter ablation for atrial fibrillation. Concomitant treatment w/ strong P-gp inhibitors eg, systemic ketoconazole, cyclosporine, itraconazole, dronedarone & fixed-dose combination glecaprevir/pibrentasvir. Severe renal impairment (CrCl <30 mL/min). Hepatic impairment or liver disease expected to have any impact on survival.

Use cautiously in conditions w/ increased risk of bleeding or w/ concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation. Associated w/ higher rates of major GI bleeding. Closely observe for signs of bleeding or anaemia throughout treatment period. Discontinue treatment in case of acute renal failure or severe bleedings. Consider administration of PPI to prevent GI bleeding. Reports of false +ve INR elevations; do not perform INR tests. Consider use of fibrinolytics for the treatment of acute ischemic stroke if patient presents w/ diluted thrombin time (dTT), ecarin clotting time (ECT), or aPTT not exceeding ULN according to local reference range. Temporarily discontinue use in patients undergoing surgery or invasive procedures. Caution in patients at high surgical mortality risk & w/ intrinsic risk factors for thromboembolic events. Not recommended in patients undergoing hip fracture surgery; patients w/ elevated liver enzymes >2 ULN; patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome, particularly triple +ve patients (for lupus anticoagulant, anticardiolipin Abs, & anti-β2-glycoprotein I Abs). Risk of MI. Efficacy & safety have not been established for DVT/PE patients w/ active cancer. Avoid concomitant administration w/ P-gp inducers. Women of childbearing potential should avoid pregnancy during treatment. Should not be used during pregnancy unless clearly necessary. Discontinue breast-feeding during treatment.

Primary prevention of VTE after hip or knee replacement surgery: Decreased Hb; abnormal hepatic function/LFT. Prevention of stroke & systemic embolism in atrial fibrillation: Anaemia; epistaxis; GI haemorrhage, abdominal pain, diarrhoea, dyspepsia, nausea; skin haemorrhage; genitourological haemorrhage, including haematuria. Treatment & prevention of DVT/PE: Epistaxis; GI haemorrhage, dyspepsia, rectal haemorrhage; skin haemorrhage; genitourological haemorrhage, including haematuria.

Increased plasma conc w/ P-gp inhibitors. Decreased plasma conc w/ P-gp inducers. Concomitant treatment w/ PIs is not recommended. Increased bleeding risk w/ thrombolytics, antiplatelets, & other anticoagulants; SSRIs & SNRIs.

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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