Dabigat
Generic Name
Dabigatran Etexilate
Manufacturer
Example Manufacturer Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| dabigat 75 mg capsule | ৳ 75.00 | ৳ 750.00 |
Description
Overview of the medicine
Dabigatran is an oral anticoagulant that directly inhibits thrombin, an enzyme central to the coagulation cascade. It is used to prevent and treat various thromboembolic conditions.
Uses & Indications
Dosage
Adults
For prevention of stroke in NVAF: 150 mg twice daily. For patients with moderate renal impairment (CrCl 30-50 mL/min) or concomitant use of certain P-gp inhibitors, 75 mg twice daily may be considered. For DVT/PE treatment and prevention: Initial dose 150 mg twice daily (after 5-10 days of parenteral anticoagulant).
Elderly
For patients 75-80 years old, 150 mg twice daily should be considered; 75 mg twice daily may be considered depending on renal function. For patients >80 years old or those with moderate renal impairment, 75 mg twice daily is recommended for stroke prevention in NVAF.
Renal_impairment
CrCl 30-50 mL/min: 75 mg twice daily. CrCl 15-30 mL/min: 75 mg twice daily for stroke prevention in NVAF only. Not recommended for CrCl <15 mL/min.
How to Take
Take orally, with or without food. Swallow the capsule whole with a glass of water. Do not open, chew, or break the capsule, as this may increase the bioavailability and bleeding risk.
Mechanism of Action
Dabigatran is a direct, competitive, and reversible inhibitor of thrombin (factor IIa). Thrombin is a key enzyme in the coagulation cascade that enables the conversion of fibrinogen to fibrin, activates factors V, VIII, XI, and XIII, and inhibits platelet aggregation. By inhibiting thrombin, dabigatran prevents clot formation.
Pharmacokinetics
Onset
Anticoagulant effect typically observed within 30 minutes to 2 hours.
Excretion
Primarily excreted renally (approximately 80% of the active dabigatran is excreted unchanged in the urine). The remainder is eliminated via the biliary route.
Half life
Approximately 12-17 hours; prolonged in renal impairment.
Absorption
Rapidly absorbed after oral administration, peak plasma concentration reached within 0.5 to 2 hours. Absolute bioavailability is low (3-7%) due to P-glycoprotein efflux and presystemic hydrolysis of the prodrug.
Metabolism
Dabigatran etexilate is a prodrug that is rapidly and completely converted to its active form, dabigatran, by esterase-catalyzed hydrolysis. It is not metabolized by the cytochrome P450 enzyme system.
Side Effects
Contraindications
- •Active pathological bleeding.
- •Severe renal impairment (CrCl <15 mL/min).
- •Patients with mechanical prosthetic heart valve.
- •Hypersensitivity to dabigatran or any excipients.
- •Concomitant use of other anticoagulants (e.g., heparin, warfarin, other DOACs) except when switching therapy or receiving unfractionated heparin at doses necessary to maintain a patent central venous or arterial catheter.
- •Patients with liver disease associated with coagulopathy and clinically relevant bleeding risk.
Drug Interactions
Systemic Ketoconazole and Dronedarone
Strong P-gp inhibitors, significant increase in dabigatran levels; avoid concomitant use.
P-glycoprotein Inducers (e.g., Rifampin, Phenytoin, Carbamazepine):
Concomitant use can decrease dabigatran plasma concentrations, potentially reducing efficacy. Avoid concomitant use.
Other Anticoagulants/Antiplatelets (e.g., Warfarin, Heparin, Aspirin, NSAIDs):
Increased risk of bleeding. Use with caution or avoid.
P-glycoprotein Inhibitors (e.g., Amiodarone, Verapamil, Quinidine, Clarithromycin):
Concomitant use can increase dabigatran plasma concentrations, potentially increasing bleeding risk. Dose reduction may be necessary.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of dabigatran increases the risk of bleeding. Management involves supportive care and symptomatic treatment. Idarucizumab (Praxbind) is a specific reversal agent for dabigatran, which can rapidly neutralize its anticoagulant effect. Activated charcoal may be considered if taken within 2 hours of overdose. Hemodialysis can remove dabigatran.
Pregnancy & Lactation
Pregnancy Category C. Limited data on dabigatran use in pregnant women; use only if the potential benefit justifies the potential risk to the fetus. It is unknown whether dabigatran is excreted in human milk. Due to potential serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months, depending on manufacturer and storage conditions.
Availability
Available in pharmacies and hospitals
Approval Status
FDA Approved
Patent Status
Patent expired for original formulation in many regions; generics available
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Global Brand Names
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