Drug interactions-

Dabifatran is not significantly metabolized by the CYP450 pathway and has no effect on human
CYP450 enzymes in vitro .
Consequently CYP450 related drug-drug interaction is  not expected with dabigatran

P-glycoprotein interactions-

Dabigatran is a substrate of P-glycoprotein (P-gp) resulting in possible interactions with other
drugs that influence  P-gp. eg amiadarone( an agent used in the treatment of various types of
tachyarryhmia  )  verapramil ( a calcium -channel used i the treatment of hypotension and
cardiac arrthmias ) and the antibiotic clarithromycin are inhibitors of P-gp transporter

Caution should be excrcised with strong P-gp inhibitors, such as amiodaone , quinidine
or verapramil which are associated with increased dabigartan levels.

Concomittant admin of P-pg inducers( such as rifampicin , St Johns Wort (Hypericum perfortum )
carbamzepine  or phenytoin)  is expected to result in decreased dabigatran plasma concentration
and should be avoided

Prevention of venous thromboembolism

Most adverse events were mild to moderate in severity, and  there was no marked effect
of increasing dose.

Anaemia   4.4%    hematoma  1.4%   wound haemorrhage 1%    traumatic haemotoma 1.5%

skin haemorrhage 2.1%    haematuria  1.4%   decreased haemoglobin  1.3%
 
wound secretion  4.9%      post-procedural haematoma    1.7%   

post-procedural haemorrhage  2%     postoperative anemia   3.2%   

post-procedural discharge  1.3%

Contraindications-

Hypersensitivity to the activesubstanc or any of the excepients
Patients with severe renal impairment ( CrCl< 30mL.min)
Active clinically significant bleeding
Organ lesion at risk of bleeding
Sponataneous or pharmacological impairment of haemostasis
Hepatic impairment or liver disease expected to have an impact on survival
Concomittant treatment with quininidine

Safety precautions-

Initiation of surgery should be delayed if haemostatis is not secured. If treatment is not started
on the day of surgery,  then treatment should be initiated with two capsules OD

There is limited experience in patients with moderate renal impairment CrCl 30 -50mL/min .
These patients should be treated with caution. The recommended dose for these patients
is 150mg  OD, taken as two 75mg capsules.  

Prevention of venous thromboembolism

Dabigratan etexilate is approved in Europe for prevention of VTE events in adult patients
who have undergone elective surgery

Dosage-
Recommended dose is 220mg OD taken as two capsules of 110mg each.
Treatment should be initiated orally with a single capsule taken within 1-4 hours of completing
surgery and continued with two capsules once daily thereafter for 10 days