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Manufacturer Boehringer Ingelheim 
Distributor Hong Kong: Zuellig/Macau: Agencia Lei Va Hong 
Contents Dabigatran etexilate
Indications Prevention of venous thromboembolic events in patients who have undergone elective total hip or knee replacement surgery; stroke & systemic embolism in patients w/ atrial fibrillation in whom coagulation is appropriate.
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Dosage Following elective knee replacement surgery Initially 110 mg w/in 1-4 hr of completed surgery then 220 mg once daily thereafter for 10 days. Following elective hip replacement surgery Initially 110 mg w/in 1-4 hr of completed surgery then 220 mg once daily thereafter for 28-35 days. For both surgeries, if hemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery, the treatment should be initiated 2 cap at once. Prevention of stroke & systemic embolism in patients w/ atrial fibrillation Recommended dose: 150 mg bd. Following orthopedic surgery Elderly >75 yr 75 mg bd. Prevention of stroke & systemic embolism in patients w/ atrial fibrillation 110 mg bd.
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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 or patients w/ spontaneous or pharmacological impairment of haemostasis, lesions at risk of clinically significant bleeding, concomitant treatment w/ strong p-glycoprotein (p-gp) inhibitors eg ketoconazole.
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Special Precautions Patients at high risk of bleeding, peri-op spinal/epidural anaesth, lumbar puncture, surgery, renal impairment, patients <50 kg. Elderly >65 yr. Childn <18 yr. Pregnancy & lactation.
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Adverse Drug Reactions Anemia, GI haemorrhage, haematoma, hematuria, wound haemorrhage; wound secretion, postprocedural haematoma, postprocedural haemorrhage, post-op anemia, traumatic haematoma, postprocedural discharge; ALT ≥3 x ULN, decreased haemoglobin. Epistaxis, urogenital haemorrhage; abdominal pain, diarrhoea, dyspepsia, nausea.
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Drug Interactions Other anticoagulants; antacids, atorvastatin, ketoconazole, pantoprazole, verapamil, quinidine, amiodarone; carbamazepine, St. John's wort; clarithromycin, rifampicin.
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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 30's 
Pradaxa 110 mg x 30's 
Pradaxa 150 mg x 30's 
 
Manufacturer: Boehringer Ingelheim
 
Distributor: Hong Kong: Zuellig
Macau: Agencia Lei Va Hong