Dabigatran Etexilate
- Atc Codes:B01AE07
- CAS Codes:211915-06-9
- PHARMGKB ID:211915-06-9
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Pradaxa; Belgium: Pradaxa; Bulgaria: Pradaxa; Cyprus: Pradaxa; Czech Republic: Pradaxa; Denmark: Pradaxa; Estonia: Pradaxa; Finland: Pradaxa; France: Pradaxa; Germany: Pradaxa; Greece: Pradaxa; Hungary: Pradaxa; Ireland: Pradaxa; Italy: Pradaxa; Latvia: Pradaxa; Lithuania: Pradaxa; Luxembourg: Pradaxa; Malta: Pradaxa; Netherlands: Pradaxa; Poland: Pradaxa; Portugal: Pradaxa; Romania: Pradaxa; Slovakia: Pradaxa; Slovenia: Pradaxa; Spain: Pradaxa; Sweden: Pradaxa; UK: Pradaxa.
North America
Canada: Pradax.
Latin America
Argentina: Pradaxa.
Drug combinations
Chemistry
Dabigatran Etexilate: C~34~H~41~N~7~O~5~. Mw: 627.73. Ethyl 3-[[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoate. CAS-211915-06-9.
Pharmacologic Category
Antithrombotic Agents; Anticoagulants; Direct Thrombin Inhibitors. (ATC-Code: B01AE07).
Mechanism of action
Inhibits coagulation by preventing thrombin-mediated effects, including cleavage of fibrinogen to fibrin monomers, activation of factors V, VIII, XI and XIII, and inhibition of thrombin-induced platelet aggregation.
Therapeutic use
Postoperative thromboprophylaxis in total hip or knee replacement procedures.
Pregnancy and lactiation implications
Adverse events observed in some animal reproductive studies. Dabigatran etexilate should be used in pregnant women only if clinical benefit outweighs risks of therapy. Use not recommended during lactation.
Unlabeled use
Investigational: Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation.
Contraindications
Hypersensitivity to dabigatran or any component of the formulation. Severe renal impairment (CrCl <30 mL/minute), and moderate-to-severe hepatic impairment. Hemorrhagic manifestations, bleeding diathesis, spontaneous or pharmacological hemostatic impairment. Lesions at risk of clinically significant bleeding (e.g. hemorrhagic or ischemic cerebral infarction). Concomitant therapy with strong P-glycoprotein inhibitors such as quinidine.
Warnings and precautions
Bleeding is common. Avoid use in severe renal or hepatic impairment. Avoid anticoagulants. Caution in patients >75 years of age, patients <50 kg, or patients <18 years of age.