Dabigatran etexilate is the active ingredient in the medication.It is a prodrug, meaning it is converted to the active form, dabigatran, in the body.The medication is available in tablet form, typically as capsules or etexilate mesylate.
Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AFib) with one or more risk factors.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Treatment of venous thromboembolism (VTE) in patients with cancer.
Dabigatran is a direct thrombin inhibitor. It works by blocking the activity of thrombin, a key enzyme in the blood clotting process. This prevents the formation of blood clots and helps to reduce the risk of stroke, DVT, and PE.
Store the medication at room temperature, between 20°C and 25°C (68°F and 77°F).
Protect from light and moisture.
Keep the medication out of reach of children.
Do not flush unused medication down the toilet or pour it into the drain.
Dispose of the medication properly when it is expired or no longer needed.
Ask your pharmacist about safe disposal methods.
The dosage of dabigatran etexilate will vary depending on the condition being treated and the individual patient's needs.
Take the medication exactly as prescribed by your doctor.
Do not change the dose or stop taking the medication without talking to your doctor.
The medication is typically taken twice daily with or without food.
Swallow the capsules whole. Do not crush or chew the capsules.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Do not double the dose to make up for a missed dose.
Bleeding is the most common side effect of dabigatran etexilate. This can occur anywhere in the body, including the stomach, intestines, brain, and joints.
Other possible side effects include:
Nausea
Vomiting
Abdominal pain
Dyspepsia
Anemia
Dizziness
Headache
Rash
Pruritus
Liver enzyme elevations
Increased bleeding time.
Avoid alcohol while taking dabigatran etexilate. Alcohol can increase the risk of bleeding.
Dabigatran etexilate may cause dizziness. Do not drive or operate machinery until you know how the medication affects you.
It is not known if dabigatran etexilate is safe to use during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. It is not known if dabigatran etexilate passes into breast milk. Tell your doctor if you are breastfeeding or plan to breastfeed.
Dabigatran etexilate is not approved for use in children.
Dabigatran etexilate is eliminated from the body by the kidneys. If you have kidney problems, your doctor may need to adjust your dose.
Dabigatran etexilate may be metabolized by the liver. If you have liver problems, your doctor may need to monitor your liver function.
Product information for Pradaxa (dabigatran etexilate) from Boehringer Ingelheim.
National Institutes of Health (NIH) website.
United States Food and Drug Administration (FDA) website.
