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What is Pradaxa
Dabigatran etexilateThe Generic name of this drug
Treatment SummaryDabigatran etexilate is a medication that helps prevent blood clots by inhibiting thrombin, an enzyme involved in clotting. It is taken orally and is converted to a drug called dabigatran when it is metabolized in the body. It was approved by the FDA in 2010 and is commonly prescribed to prevent venous thromboembolic events. Unlike warfarin, it does not require monitoring with lab tests, making it a convenient treatment option.
Pradaxais the brand name
Pradaxa Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Pradaxa
Dabigatran etexilate
2010
23
Approved as Treatment by the FDA
Dabigatran etexilate, also known as Pradaxa, is approved by the FDA for 8 uses including Disease and Deep Vein Thrombosis .Disease
Deep Vein Thrombosis
Pulmonary Embolism
Pulmonary Embolism
Total Knee Arthroplasty
Deep Vein Thrombosis
Pulmonary Embolism
recurrent Prophylaxis of Deep Vein Thrombosis
Effectiveness
How Pradaxa Affects PatientsDabigatran is a type of medicine that prevents blood clots. Its effects can be seen through longer clotting times in tests like the activated partial thromboplastin time (aPTT), ecarin clotting time (ECT), thrombin time (TT), and dilute thrombin time (dTT). There is an increased risk of bleeding when taking dabigatran, especially if taken with other medicines like antiplatelet agents, fibrinolytic therapy, heparins, or NSAIDs. It should not be used with neuraxial anesthesia or spinal puncture as it
How Pradaxa works in the bodyDabigatran works to balance coagulation in the body. Normally, thrombin, a serine protease, activates prothrombin which then forms fibrin fibres and platelets to form clots. Too much clotting can be bad for your health and so dabigatran is used to reduce thrombin activity. Dabigatran is a reversible direct thrombin inhibitor which means it can be turned on and off, allowing some normal clotting activity to occur. It also inhibits platelet aggregation, though the exact mechanism is unknown.
When to interrupt dosage
The proposed dosage of Pradaxa is contingent upon the diagnosed condition, such as Systemic Embolism, Deep Vein Thrombosis and recurrent Prophylaxis of Deep Vein Thrombosis. The measure of dosage can be found in the subsequent table, depending on the technique of delivery (e.g. Capsule - Oral or Capsule).Condition
Dosage
Administration
Atrial Fibrillation
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Disease
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
recurrent Prophylaxis of Deep Vein Thrombosis
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
following at least 5 days of initial therapy with a parenteral anticoagulant
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Hip structure
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Deep Vein Thrombosis
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Deep Vein Thrombosis (DVT)
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Stroke
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Pulmonary Embolism
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Systemic Embolism
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Pulmonary Embolism
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
previously treated
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Total Knee Arthroplasty
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Pulmonary Embolism
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Deep Vein Thrombosis
, 150.0 mg, 75.0 mg, 110.0 mg, 6.25 mg/mL, 30.0 mg, 50.0 mg, 20.0 mg, 40.0 mg
, Oral, Capsule, Capsule - Oral, Capsule, coated pellets - Oral, Capsule, coated pellets, Pellet, Pellet - Oral
Warnings
Pradaxa has three contraindications which preclude its combination with the conditions given in the below table.Pradaxa ContraindicationsCondition
Risk Level
Notes
mechanical prosthetic heart valve
Do Not Combine
Hemorrhage
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Dabigatran Etexilate may interact with Pulse Frequency
Common Pradaxa Drug Interactions
Drug Name
Risk Level
Description
(R)-warfarin
Major
Dabigatran etexilate may increase the anticoagulant activities of (R)-warfarin.
(S)-Warfarin
Major
Dabigatran etexilate may increase the anticoagulant activities of (S)-Warfarin.
4-hydroxycoumarin
Major
Dabigatran etexilate may increase the anticoagulant activities of 4-hydroxycoumarin.
Abciximab
Major
Dabigatran etexilate may increase the anticoagulant activities of Abciximab.
Acenocoumarol
Major
Dabigatran etexilate may increase the anticoagulant activities of Acenocoumarol.
Pradaxa Toxicity & Overdose RiskThere is not enough data available to know the effects of dabigatran on pregnant women, labor and delivery, nursing mothers, or children. Elderly people may be more likely to experience side effects, but the drug can still be beneficial. People with reduced kidney function should take a lower dose of the drug. Animal studies have shown that dabigatran can lead to dead offspring and bleeding near the time of birth. It is unknown whether the drug is passed through breast milk, so the potential risks must be weighed against the benefits before taking it or breastfeeding.
Pradaxa Novel Uses: Which Conditions Have a Clinical Trial Featuring Pradaxa?
99 active clinical trials are currently investigating the potential of Pradaxa to provide relief from Pulmonary Embolism, Anticoagulant Therapy and Systemic Embolism.Condition
Clinical Trials
Trial Phases
Deep Vein Thrombosis (DVT)
27 Actively Recruiting
Phase 4, Phase 3, Not Applicable, Early Phase 1, Phase 1, Phase 2
Stroke
11 Actively Recruiting
Not Applicable, Phase 1, Phase 2, Phase 3
Pulmonary Embolism
34 Actively Recruiting
Not Applicable, Phase 4, Phase 3, Early Phase 1, Phase 1, Phase 2
Hip structure
1 Actively Recruiting
Not Applicable
Pulmonary Embolism
0 Actively Recruiting
Pulmonary Embolism
0 Actively Recruiting
Systemic Embolism
2 Actively Recruiting
Not Applicable
Disease
0 Actively Recruiting
Deep Vein Thrombosis
0 Actively Recruiting
Total Knee Arthroplasty
15 Actively Recruiting
Phase 3, Not Applicable, Phase 2, Phase 4
Atrial Fibrillation
4 Actively Recruiting
Not Applicable
recurrent Prophylaxis of Deep Vein Thrombosis
0 Actively Recruiting
following at least 5 days of initial therapy with a parenteral anticoagulant
0 Actively Recruiting
Deep Vein Thrombosis
17 Actively Recruiting
Phase 4, Phase 3, Not Applicable, Phase 1, Phase 2
previously treated
0 Actively Recruiting
Pradaxa Reviews: What are patients saying about Pradaxa?
5Patient Review
2/9/2016 I was disappointed when I received my last refill in the form of a blister package instead of a bottle. It's not safe to have to use scissors to remove the pill, and there's no way to see the pill itself through the packaging. This could easily lead to damaging the pill.
4.7Patient Review
12/19/2014 I've been taking this treatment for three years now and it seems to be working well. I don't have excessive bleeding or bruising, which is great.
4.3Patient Review
10/16/2017 I became anemic after seven years on this medication. I would recommend getting your blood checked frequently while taking this drug.
3.7Patient Review
10/16/2014 I had a DVT and PE about 10 years ago. I was initially put on Coumadin/Warfarin for treatment, but then I got another PE. So, my hematologist switched me to Lovenox injections, which are quite expensive. Then Pradaxa came out and I thought it was amazing. But after being on it for a while, I developed severe hemorrhoids. My hematologist denied that the medication was the cause, but after switching to Xarelto, my hemorrhoids cleared up within a week.
3.7Patient Review
9/22/2014 I had another pulmonary embolism while on coumadin, and the only available option at the time was heparin injections. These were quite expensive, so I took them for two years until Pradaxa became available. However, after being on Pradaxa for a month or so, I developed hemorrhoids which grew progressively worse. My hemotologist insisted that this drug wasn't the cause of my hemorrhoids but agreed to switch me to Xarelto instead. I've been happily taking Xarelto for over a year now with no side effects whatsoever.
3.3Patient Review
12/6/2014 I unfortunately developed a really unpleasant body odor while on this drug. Additionally, I had some pain in my right kidney area. However, since discontinuing the drug per my doctor's orders, both the smell and pain have gone away.
3Patient Review
3/19/2017 I was given this prescription by my doctor, but I'm not sure how to use it yet. The pill is difficult to get out of the packaging; my wife and I spent half an hour trying before giving up and just cutting the pill out. Not safe.
3Patient Review
2/3/2019 This drug helped with my DVT, but unfortunately it also caused some really terrible heartburn. I would get it about every ten days or so, and it was just awful. I always felt nauseous, and even though I never got diarrhea, I had to poop a lot more than usual (like, six times a day). And then the final straw was when I started bleeding rectally. That's when I decided to switch insurance companies and ditch this medication.
3Patient Review
5/30/2019 I recently started taking Pradaxa to help with my Afib. The packaging is terrible and very difficult to open without scissors, but I haven't had any negative side effects yet.
2.7Patient Review
6/5/2021 The pill is effective, but hard to swallow. It doesn't slide down your throat easily like it should. I've started coating the pill in butter, which helps a bit. But really, the manufacturer should do something about this issue.
1.3Patient Review
5/23/2021 I took this drug for a couple months before switching back to Eliquis. The reason being that I experienced chronic side effects like mouth sores, bruising, diarrhea, and bleeding.
1Patient Review
9/20/2015 I've been feeling really lousy since I started taking this medication. My stomach is upset, my body aches, and I just don't feel well at all. Plus, I'm not even walking as much as usual according to my Fitbit. When I went to the doctor yesterday, they said I need to keep taking it for six more months and prescribed another pill (gabapentin) for the pain. That's just too many pills for me.
1Patient Review
12/11/2019 This medication is quite strong and has a lot of potential side effects that I unfortunately experienced first-hand. These include body aches, stomach pain, terrible hemorrhoids, insomnia, jitters, and swelling in my legs.
Patient Q&A Section about pradaxa
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.What foods should you avoid while taking Pradaxa?
"There are no dietary restrictions. However, you may need to limit many foods with vitamin K, such as leafy green vegetables and some vegetable oils. This is because vitamin K can affect the way warfarin works in your body."
Answered by AI
What is the drug Pradaxa used for?
"Pradaxa is a medication used to thin the blood and prevent the formation of blood clots. It is commonly used after surgery or in patients with an abnormal heart beat."
Answered by AI
What is the most common side effect of Pradaxa?
"Pradaxa is most commonly associated with bleeding, as it inhibits the body's ability to clot. This can manifest as increased bruising or longer bleeding after cuts or injuries."
Answered by AI