Indications
Pradaxa (active ingredient: dabigatran etexilate) is a prescription medication indicated for:
- Prevention of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation (NVAF): Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
- Treatment and Prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE): Pradaxa is indicated for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated
with parenteral anticoagulants for 5-10 days.
Pradaxa belongs to the drug class known as direct thrombin inhibitors, which work by inhibiting the activity of thrombin, an enzyme involved in the clotting process.
Uses and Dosage
Pradaxa should be taken as directed by your doctor and comes in the form of a Capsule to be taken by mouth, with or without food, usually twice a day. For children, the first dose should be taken in the morning and the second dose in the evening with a gap of about 12 hours. Swallow the capsules whole with a full glass of water. Do not crush, chew, or break open the capsules. Doing so can release all the drug at once, increasing the risk of side effects. If you experience any stomach upset while taking this medication, take it with food as advised by your doctor.
If you have had hip or knee replacement surgery, take Pradaxa once a day as directed by your doctor to prevent clots. However, avoid taking antacids within 24 hours after surgery as this may affect the effectiveness of dabigatran. Do not put this medication in a pill box or medication reminder box. It must be kept tightly closed in the original bottle (or blister package) to protect it from moisture.
The dosage is based on your medical condition, kidney function, response to treatment, and other medications you may be taking.
- Nonvalvular atrial fibrillation: The dose is usually 75 mg or 150 mg by mouth twice daily, depending on how healthy your kidneys are.
- Blood clot prevention after surgery: The dose is usually 110 mg by mouth once daily a few hours after the surgery is finished, then it is raised to 220 mg by mouth once daily.
- Blood clot treatment, pulmonary embolism treatment, and blood clot prevention for those with a history of blood clots: The dose is usually 150 mg by mouth twice daily after finishing the injectable blood thinners given in the hospital.
Side Effects
Common Side Effects of Pradaxa (Dabigatran Etexilate):
- Nausea
- Easy bruising
- Indigestion
- Diarrhea
- Abdominal discomfort
- Heartburn
Serious Side Effects of Pradaxa (Dabigatran Etexilate):
- Severe headache
- Severe heartburn
- Persistent vomiting
- Fainting
- Blood in the urine
- Black or bloody stool
- Unusual swelling
- Prolonged bleeding
Form and Strength
Pradaxa (Dabigatran Etexilate) is available in the following forms and strengths:
Pradaxa: Capsule
- 75 mg
- 110mg
- 150 mg
Dabigatran Etexilate: Capsule
- 110mg
- 150 mg
Caution
- Do not stop taking Pradaxa without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.
- Daily use of alcohol while using dabigatran may indeed increase your risk for stomach bleeding, and limit alcoholic beverages.
- Pradaxa may contain inactive components that have the potential to cause allergic reactions or other complications. Before beginning to take dabigatran, inform your doctor or pharmacist if you have any allergies, including an allergy to this medication.
- If you are no longer taking Pradaxa for reasons other than pathological bleeding or completion of a therapeutic course, another type of anticoagulant to maintain anticoagulation therapy.
- During pregnancy, this medication should be used only when clearly needed. Dabigatran may increase the risk of bleeding in the pregnant woman, the unborn baby, and the newborn.
- If you are taking Pradaxa, you may be more prone to bleeding. Contact your doctor immediately if you experience any of the following symptoms: bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in urine or stool, coughing up blood or vomiting material that resembles coffee grounds.
Frequently Asked Questions (FAQ)
Is this medication safe for children?
Yes, this anticoagulant is safe and effective even for children.
How long should I use this medication?
Your length of time of treatment will depend on your medical condition.
How should I store this medication?
Keep Pradaxa in its blister package. Do not transfer it to a pillbox to protect it from moisture.
Resources
- https://www.medsafe.govt.nz/hot/media/2011/dabigatranqanda.asp
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s028lbl.pdf
- https://www.drugs.com/pradaxa.html
- https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-post-market-reports-serious-bleeding-events
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9
- https://www.webmd.com/drugs/2/drug-154839-1122/pradaxa-oral/dabigatran-oral/details
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