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Manufacturer Boehringer Ingelheim 
Distributor Zuellig 
Contents Dabigatran etexilate
Indications Prevention of VTE in patients who have undergone orthopaedic surgery for knee or hip replacement.
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Dosage Adult VTE prevention following knee replacement surgery Initially one 110-mg cap w/in 1-4 hr of completed surgery; continue w/ 2 cap once daily thereafter for 10 days. Initiate w/ 2 cap once daily if not started on the day of surgery. VTE prevention following hip replacement surgery Initially one 110-mg cap w/in 1-4 hr of completed surgery; continue w/ 2 cap once daily thereafter for 28-35 days. Initiate w/ 2 cap once daily if not started on the day of surgery.
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Overdosage View Pradaxa overdosage for action to be taken in the event of an overdose.
Administration May be taken with or without food (Swallow whole, do not chew/crush.).
Contraindications Severe renal impairment (CrCl <30 mL/min), 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, indwelling spinal or epidural catheter & during the 1st hr after removal.
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Special Precautions Hepatic impairment, renal insufficiency, recent biopsy or major trauma, bacterial endocarditis. Spinal/epidural anesth, lumbar puncture. Acute renal failure (discontinue). Pregnancy, lactation. Childn <18 yr.
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Adverse Drug Reactions Anaemia, thrombocytopenia, haematoma, haemorrhage, wound haemorrhage, epistaxis; GI, rectal, haemorrhoidal & skin haemorrhage; abnormal hepatic function; haemarthrosis; haematuria; inj & catheter site haemorrhage, bloody discharge; wound secretion, post-procedural haematoma, haemorrhage & discharge; post-op anaemia, traumatic haematoma, incision site haemorrhage; post-procedural & wound drainage.
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Side Effects View Pradaxa side effects
Drug Interactions Unfractionated heparins & heparin derivatives, LMWH, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, clopidogrel, ticlopidine, dextran, sulfinpyrazone, vit K antagonists, acetylsalicylic acid.
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Pregnancy Category (US FDA)      
     
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. 
Storage View Pradaxa storage conditions for details to ensure optimal shelf-life.
Description View Pradaxa description for details of the chemical structure and excipients (inactive components).
Mechanism of Action View Pradaxa mechanism of action for pharmacodynamics and pharmacokinetics details.

Presentation/Packing
Form Packing Photo
Pradaxa capsule  Pradaxa 75 mg x 3 x 10's 
Pradaxa 110 mg x 3 x 10's 
 

 
Manufacturer: Boehringer Ingelheim
 
Distributor: Zuellig