Pradaxa百達生

Pradaxa

dabigatran

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Dabigatran etexilate
Indications/Uses
Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke & systemic embolism in adult patients w/ non-valvular atrial fibrillation (NVAF), w/ ≥1 risk factors eg, prior stroke or transient ischemic attack; age ≥75 yr; heart failure (NYHA class ≥II); DM; HTN. Treatment of DVT & pulmonary embolism (PE) & prevention of recurrent DVT & PE in adults.
Dosage/Direction for Use
Primary prevention of venous thromboembolism in orthopaedic surgery Patient following elective knee replacement surgery 110 mg on the day of surgery 1-4 hr after completed surgery. Maintenance dose starting on the 1st day after surgery: 220 mg once daily for 10 days. Patient following elective hip replacement surgery 110 mg on the day of surgery 1-4 hr after completed surgery. Maintenance dose starting on the 1st day after surgery: 220 mg once daily for 28-35 days. Patient w/ moderate renal impairment (CrCl 30-50 mL/min); patient receiving concomitant verapamil, amiodarone or quinidine; elderly ≥75 yr 75 mg on the day of surgery 1-4 hr after completed surgery. Maintenance dose starting 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 adult w/ NVAF w/ ≥1 risk factors Recommended dose: 150 mg bd. Therapy should be continued long term. Elderly ≥80 yr or patients receiving concomitant verapamil Recommended dose: 110 mg bd. Elderly 75-80 yr; patient w/ moderate renal impairment (CrCl 30-50 mL/min); patient w/ gastritis, esophagitis or GERD; patient at increased risk of bleeding 300 or 220 mg daily, selected based on individual assessment of thromboembolic & bleeding risk. Treatment of DVT & PE; prevention of recurrent DVT & PE Recommended dose: 150 mg bd, following treatment w/ a parenteral anticoagulant for at least 5 days. Individualised duration of therapy after careful assessment of treatment benefit against bleeding risk. Elderly ≥80 yr or patients receiving concomitant verapamil Recommended dose: 110 mg bd. Elderly 75-80 yr; patient w/ moderate renal impairment (CrCl 30-50 mL/min); patient w/ gastritis, esophagitis or GERD; patient at increased risk of bleeding 300 or 220 mg daily, selected based on individual assessment of thromboembolic & bleeding risk.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
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 of 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. Hepatic impairment or liver disease expected to have any impact on survival. Severe renal impairment (CrCl <30 mL/min).
Special Precautions
Use cautiously in conditions w/ increased risk of bleeding or w/ concomitant use of medicinal products affecting haemostasis by platelet aggregation inhibition. Associated w/ higher rates of major GI bleeding. Close observation for signs of bleeding or anaemia is recommended throughout treatment period. Discontinue in case of acute renal failure or severe bleedings. Consider use of fibrinolytic medicinal products for treatment of acute ischemic stroke if patient presents w/ a dTT, ECT, or aPTT not exceeding the upper limit of normal (ULN) according to the local reference range. Patients undergoing surgery or invasive procedures; 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 for patients that are triple positive (for lupus anticoagulant, anticardiolipin Ab, & anti-beta 2-glycoprotein I Ab). MI. Avoid concomitant administration of P-gp inducers. DVT/PE patients w/ active cancer. Women of childbearing potential should avoid pregnancy during treatment. Should not be used during pregnancy unless clearly necessary. Discontinue breast-feeding during treatment.
Adverse Reactions
Primary prevention of venous thromboembolism after hip or knee replacement surgery: Decreased Hb, abnormal hepatic function/liver function test. Prevention of stroke & systemic embolism in patients w/ atrial fibrillation: Anaemia, epistaxis, GI haemorrhage, abdominal pain, diarrhoea, dyspepsia, nausea, skin haemorrhage, genitourological haemorrhage including haematuria. DVT/PE treatment & prevention: Epistaxis, GI haemorrhage, dyspepsia, rectal haemorrhage, skin haemorrhage, genitourological haemorrhage including haematuria.
Drug Interactions
Increased plasma conc w/ P-gp inhibitors. Possible increased bleeding risk w/ anticoagulants eg, UFH, LMWH, & heparin derivatives (eg, fondaparinux, desirudin), thrombolytic medicinal products, & vit K antagonists, rivaroxaban or other oral anticoagulants, & antiplatelet aggregation medicinal products eg, GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, & sulfinpyrazone; SSRIs or selective serotonin norepinephrine re-uptake inhibitors (SNRIs). Concomitant administration w/ P-gp inducer is expected to result in decreased dabigatran conc. Concomitant treatment w/ PIs eg, ritonavir is not recommended.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AE07 - dabigatran etexilate ; Belongs to the class of direct thrombin inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
Form
Pradaxa cap 110 mg
Packing/Price
30's
Form
Pradaxa cap 150 mg
Packing/Price
30's
Form
Pradaxa cap 75 mg
Packing/Price
30's
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