| Drug Name |
Dabigatran etexilate |
| Drug ID |
BADD_D00564 |
| Description |
Dabigatran etexilate is an oral prodrug that is hydrolyzed to the competitive and reversible direct thrombin inhibitor [dabigatran].[A177463, A6970, L34675, L34680] Dabigatran etexilate may be used to decrease the risk of venous thromboembolic events in patients in whom anticoagulation therapy is indicated.[A177463] In contrast to warfarin, because its anticoagulant effects are predictable, lab monitoring is not necessary.[A177463] Dabigatran etexilate was approved by the FDA in 2010.[L6022] |
| Indications and Usage |
Dabigatran is indicated for the prevention of venous thromboembolic events in patients who have undergone elective hip or knee replacement surgery (based on RE-NOVATE, RE-MODEL, and RE-MOBILIZE trials). In 2010, it was approved in the US and Canada for prevention of stroke and systemic embolism in patients with atrial fibrillation (approval based on the RE-LY trial). Contraindications: severe renal impairment (CrCL < 30 ml/min); haemorrhagic manifestations, bleeding diathesis or spontaneous or pharmacologic impairment of haemostasis; lesions at risk of clinically significant bleeding (e.g. extensive cerebral infarction (haemorrhagic or ischemic) in the last 6 months, active peptic ulcer disease); concomitant treatment with P-glycoprotein inhibitors (e.g. oral ketoconazole, verapamil); and those with known hypersensitivity to dabigatran, dabigatran etexilate or any ingredient used in the formulation or component of the container. As of December 2012, dabigatran is contraindicated in patients with mechanical prosthetic heart valves. |
| Marketing Status |
Prescription |
| ATC Code |
B01AE07 |
| DrugBank ID |
DB06695
|
| KEGG ID |
D07144
|
| MeSH ID |
D000069604
|
| PubChem ID |
135565674
|
| TTD Drug ID |
D0KI5R
|
| NDC Product Code |
31722-621; 0597-0445; 0597-0425; 31722-622; 0597-0435; 0597-0450; 0597-0430; 0597-0440 |
| Synonyms |
Dabigatran | N-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1H-benzimidazol-5-yl)carbonyl)-N-2-pyridinyl-beta-alanine | BIBR 1048 | Pradaxa | Dabigatran Etexilate | Etexilate, Dabigatran | Dabigatran Etexilate Mesylate | Etexilate Mesylate, Dabigatran | Mesylate, Dabigatran Etexilate |
