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Indications & Uses
Dabigatran Etexilate Mesylate is a direct thrombin inhibitor. It's used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It's also used to treat deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with a parenteral anticoagulant for 5 to 10 days. Dabiren is a direct thrombin inhibitor too, and it carries the same uses. It can also be used to reduce the risk of DVT and PE coming back in patients who have been treated for them before. And it's used for the prophylaxis of DVT and PE in patients who have had hip replacement surgery.
Pharmacology
Dabigatran etexilate mesylate works through its active forms, dabigatran and its acyl glucuronides. These are competitive, direct thrombin inhibitors. Thrombin is a serine protease, and during the coagulation cascade it turns fibrinogen into fibrin. When thrombin is blocked, a thrombus can't develop.
The active moieties act on both free thrombin and clot-bound thrombin. They also inhibit platelet aggregation that is induced by thrombin.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Reduction in the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation: for patients with CrCl above 30 mL/min, the dose of Dabigatran Etexilate Mesylate is 150 mg orally, twice daily. For patients with CrCl 15 to 30 mL/min, it is 75 mg orally, twice daily.
Treatment of DVT and PE: for patients with CrCl above 30 mL/min, give 150 mg orally, twice daily, after 5 to 10 days of parenteral anticoagulation.
Reduction in the risk of recurrence of DVT and PE: for patients with CrCl above 30 mL/min, give 150 mg orally, twice daily, after the previous treatment.
Prophylaxis of DVT and PE following hip replacement surgery: for patients with CrCl above 30 mL/min, give 110 mg orally on the first day, then 220 mg once daily. When possible, stop Dabigatran Etexilate Mesylate temporarily before invasive or surgical procedures, and restart it promptly afterwards.
Pediatric use: the safety and effectiveness of Dabigatran Etexilate in pediatric patients have not been established.
Geriatric use: in the RE-LY study, 82% of the patients were 65 and over, and 40% were 75 and over. The risk of stroke and bleeding rises with age, but the risk-benefit profile is favorable in all age groups.
Side Effects
Stopping Dabigatran Etexilate Mesylate too early raises the risk of thrombotic events. It also raises the risk of bleeding, and this bleeding can be serious and sometimes fatal. Common side effects are indigestion, upset stomach, burning and stomach pain. In some people, Dabigatran Etexilate Mesylate can cause symptoms of an allergic reaction.
Cautions & Contraindications
Warnings & Precautions
Stopping Dabigatran Etexilate Mesylate too early raises the risk of thrombotic events. The medicine also raises the risk of bleeding, and this can be significant and sometimes fatal. Epidural or spinal haematomas may occur in patients on Dabigatran Etexilate Mesylate who are receiving neuraxial anaesthesia or having a spinal puncture. These haematomas can lead to long-term or permanent paralysis. The medicine is contraindicated in patients with mechanical prosthetic valves. Using it together with P-gp inducers (for example, rifampin) lowers exposure to dabigatran, so this combination should generally be avoided. In patients with triple-positive antiphospholipid syndrome, treatment with Dabigatran Etexilate Mesylate increases the risk of thrombosis.
Contraindications
Dabigatran Etexilate should not be given to people who have active pathological bleeding, to people who have had a serious hypersensitivity reaction to Dabigatran Etexilate before, or to people with a mechanical prosthetic heart valve.
Pregnancy & Breastfeeding
No one has established that Dabigatran Etexilate is safe to use during pregnancy. If you are breastfeeding, it's not recommended while you are being treated with Dabigatran Etexilate.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Taking too much Dabigatran Etexilate Mesylate by accident can cause bleeding. If bleeding happens, the patient needs proper clinical support straight away, the Dabigatran Etexilate Mesylate Etexilate should be stopped, and the cause of the bleeding should be looked for. There is a specific reversal agent for this, called idarucizumab.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Dabigatran Etexilate Mesylate in a dry place, at a temperature not above 30°C. Protect it from light and moisture.
Drug Interactions
Common questions about Pradaxa 110 mg
What is Pradaxa 110 mg Capsule?
Pradaxa 110 mg Capsule is a medicine that contains Dabigatran Etexilate Mesylate. It is made by Radiant Pharmaceuticals Ltd. It belongs to the Anti-coagulants group of medicines.
What is Pradaxa used for?
Dabigatran Etexilate Mesylate is a direct thrombin inhibitor. It's used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
What are the side effects of Pradaxa?
Stopping Dabigatran Etexilate Mesylate too early raises the risk of thrombotic events. It also raises the risk of bleeding, and this bleeding can be serious and sometimes fatal.
Can I take Pradaxa during pregnancy or while breastfeeding?
No one has established that Dabigatran Etexilate is safe to use during pregnancy. If you are breastfeeding, it's not recommended while you are being treated with Dabigatran Etexilate. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Pradaxa?
Taking too much Dabigatran Etexilate Mesylate by accident can cause bleeding. If bleeding happens, the patient needs proper clinical support straight away, the Dabigatran Etexilate Mesylate Etexilate should be stopped, and the cause of the bleeding should be looked for. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Pradaxa?
Keep Dabigatran Etexilate Mesylate in a dry place, at a temperature not above 30°C. Protect it from light and moisture.
Can I take other medicines with Pradaxa?
Some medicines can interact with Dabigatran Etexilate Mesylate, for example: Rifampicin, Dronedarone, Ketoconazole. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Pradaxa is already among the lowest-priced brands of Dabigatran Etexilate Mesylate at this strength.
Do I need a prescription for Pradaxa?
Pradaxa is a prescription (Rx) medicine. Take it as your doctor advises.