Generic Name:- Dabigatran Etexilate 110mg
Manufactured By:- National Healthcare Pvt. Ltd.
Dabirom-110 is a brand name of Dabigatran Etexilate 75mg Tablet.Dabigtran belongs to novel oral anticoagulant agents.
Anticoagulant (Direct Thrombin Inhibitor)
Dose and Direction of Use
Dabigatran can be taken with or without food. Capsules should be swallowed as a whole with a glass of water.
Mode of Action
Dabigatran Etexilate is a prodrug that does not exhibit any pharmacological activity. After oral administration, Dabigatran Etexilate is rapidly absorbed and converted to Dabigatran by esterase-catalysed hydrolysis in plasma and in the liver. Dabigatran is a potent, competitive, reversible direct thrombin inhibitor. Since thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus. Dabigatran inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.
- Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
- Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and prevention of recurrent DVT & PE.
- Primary prevention of DVT & PE following elective total hip replacement or knee replacement surgery.
- Hypersensitivity reactions to Dabigatran .
- Active clinically significant bleeding
- Mechanical prosthetic heart valve
- Severe renal impairment (CrCl <15 mL/min) or hemodialysis
- Hepatic impairment or liver disease expected to have any impact on survival
Precautions and Warning
Dabigatran should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation.
- In the absence of adequate alternative anticoagulation, premature discontinuation of any oral anticoagulant, including Dabigatran, increases the risk of thrombotic events.
- Epidural or spinal hematomas may occur in patients treated with Dabigatran who are receiving neuraxial anesthesia or undergoing spinal puncture.
- The concomitant use of Dabigatran with P-gp inducers (e.g., rifampin) reduces exposure to Dabigatran and should generally be avoided.
- P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to Dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of Dabigatran compared to that seen with either factor alone.
- Dabigatran’s anticoagulant activity and half-life are increased in patients with renal impairment.
- Direct-acting oral anticoagulants (DOACs), including Dabigatran, are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS).