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Name of the Generic: Dabigatran [da-BIG-a-tran da-BIG-atran].
Name of the Brand: Pradaxa.
Dosage Forms: Oral capsules (110 mg, 150 mg, and 75 mg); oral granules (110 mg, 150 mg, 20 mg, 30 mg, 40 mg, and 50 mg).
Drug Class: Thrombin inhibitors.

What is Dabigatran?

Dabigatran can be used for treating blood clots that are deep throughout your body (deep vein thrombosis, DVT) as well as in your lungs (pulmonary embolism, PE) in adults who have received injections of blood thinners for 5–10 days. Dabigatran is a treatment for blood clots in infants aged three months to 18 years old who have received treatment with an injection-able blood thinner for a minimum of five days. Dabigatran is used by the adult population as well as children who are 3 months old or under 18 years old. age in order to decrease the chance of a blood clot appearing again following the treatment of blood clots.

Dabigatran can also be used following the hip replacement procedure to stop a blood clot in the body (deep vein thrombosis, also known as DVT) or in the lungs (pulmonary embolism PE). Dabigatran can also be used to decrease the risk of stroke and blood clots in people suffering from atrial fibrillation (a heart rhythm disorder). Dabigatran is employed when atrial fibrillation does not result from a heart valve issue. Dabigatran can also be used for other purposes not covered in this medication guide.

Side effects of Dabigatran

See a doctor immediately. If you are experiencing symptoms that are warning signs of an allergic response, such as hives, difficulty breathing, or swelling of your lips, face, and tongue, You should also seek medical attention immediately in the event that you exhibit signs of a spinal blood clot, such as back pain, numbness or tenderness of muscles within your lower body, or loss of control over your bladder or bowel. Dabigatran may cause serious side effects. Contact your physician immediately. If you suffer from:

  • Bleeding or bruising that does not stop (nosebleeds, bleeding gums, vaginal bleeding, or heavy menstrual flow).
  • Headache, dizziness, weakness, headache, or feeling as if you could pass out.
  • Bloody or tarry stool that coughs up blood or vomit that resembles coffee grounds.
  • Urine that appears pink, red, or brown.
  • Sudden discomfort, joint pain, or swelling.

Common negative side effects of dabigatran could include:

  • Stomach pain or discomfort.
  • Upset stomach, burning.
  • Bleeding.
  • Excessive menstrual bleeding.
  • Nausea, vomiting, and diarrhea.

This isn't a comprehensive list of all the possible adverse reactions. Other side effects could be present. Consult your physician for advice regarding medical adverse effects. You can report any side effects to the FDA at 1-800-FDA-1088.


Don't stop using dabigatran without consulting your physician. If you stop it abruptly, it could increase the chance of developing blood clots and strokes. Certain medications can increase the risk of bleeding when used in conjunction with dabigatran. Discuss with your doctor all the other medications you are taking. Contact your doctor immediately if you are experiencing symptoms of bleeding, such as headaches, joint swelling or pain, feeling weak or dizzy, bleeding gums, or nosebleeds. irregular menstrual cycles or heavy vaginal bleeding, urine that is bloody, bloody or tarry stool, coughing bloody vomiting that resembles coffee grounds, or any bleeding that won't stop.

Dabigatran could cause an extremely grave blood clot in the spinal cord if you have a spinal tap or spinal anesthesia (epidural). Tell your doctor that you're taking dabigatran.

Before you take this drug

You shouldn't consume dabigatran if you have an allergy to the substance or suffer from:

  • A mechanical heart valve.
  • Active bleeding after a surgical procedure or injury, or from any other reason.

Dabigatran could cause a severe blood clot in the event that you take part in a procedure like an MRI, a spinal tap, or spinal anesthesia (epidural). This kind of blood clot may cause permanent or prolonged paralysis. Dabigatran could allow bleeding to occur even after a minor injury. Call your doctor if you're bleeding and it isn't stopping.

Inform your doctor if you are or have ever experienced:

  • A genetic spinal defect.
  • A small tube (catheter) is put into your back to supply you with some medicine.
  • A history of issues in your spine or spine surgery.
  • An occurrence of difficult or frequent spinal taps.
  • Bleeding issues.
  • It could be a stomach ulcer or bleeding from the stomach or intestines of your.
  • Take other medications that could increase the risk of bleeding.
  • Antiphospholipid disorder An illness of the immune system that can increase the chance of blood clots.
  • Procedure, or an emergency medical or tooth procedure.
  • kidney disease.

It is unclear whether dabigatran can cause harm to an unborn baby. The use of dabigatran during pregnancy can cause bleeding within the mother or in the baby who is not yet born. Tell your doctor that you are expecting or are planning to be pregnant. It is not recommended to feed your baby when taking dabigatran.

How to take Dabigatran?

Follow all the instructions on the prescription label and read the medication guide or instructions sheets. Your doctor may alter your dosage. Make sure you take the medicine precisely as prescribed. Doses are determined by weight gain in teenagers and children. The dose for your child could alter if your child weighs more or less. Dabigatran capsule in a full glass of liquid It is possible to consume the capsule with or without food. Consume food. If dabigatran capsules cause stomach upset. Suck and swallow the dabigatran capsule in its entirety, but do not chew, crush, break, crack, or even crack it. Offer dabigatran oral pellets prior to meals to ensure that your child is taking the complete dosage. It is also possible to mix the pellets in applesauce or other soft foods (apple sauce, apple juice, or bananas mashed) at ambient temperature. Don't mix oral pellets in conjunction with any other dairy, food, milk products, or some other fluid. The mixture should be administered as soon as possible or within 30 minutes after mixing. Don't give dabigatran via a syringe or an infusion tube. The medicine may also help you get bleeds even after an injury that is minor, like an accident or scratch on your head. Tell your doctor or seek medical attention immediately if you fall, strike your head, or experience any bleeding that doesn't stop. Your kidney function could require regular monitoring.

Your physician will decide for how long you should be taking dabigatran. Do not alter the dosage or stop taking this drug without consulting your physician. The abrupt stoppage of your medication can increase your chances of having blood clots or a stroke. Inform any physician you see that you're taking dabigatran. If you are in need of dental or surgical work, inform the dentist or surgeon beforehand that you're using this drug. If you require anesthesia to perform surgical or medical procedures, it is possible to discontinue taking dabigatran for some time. If your child fails to consume all of their dabigatran orally-dispersed pellets, don't give a dose later at the same moment and return to the regular dosage. You should not drink more than one bottle of dabigatran capsules at a time. Make sure to open a fresh bottle once all capsules from the previous bottle have been removed. Keep the dabigatran capsule tightly sealed at room temperature and away from heat and moisture. Store the capsules in their packaging or container that you received when they were first opened until the time to consume the medication. Don't put dabigatran capsules inside an empty pill container or organizer. Get rid of any remaining dabigatran capsules if it's been more than four months since the time you first took the capsule out of its bottle. Keep dabigatran oral pellets at ambient temperature, away from heat and moisture. Place the medication in its original silver aluminum bag. Do not open it until the time is right to take the medication. Take the pellets for oral use within 6 months after opening the bag of aluminum.

What happens if I miss a dose?

Use the medicine as quickly as you are able, but do not miss your missed dose in case the next dose falls within less than six hours. Don't take two doses at once. Make sure you refill your prescription before the expiration date of your medication.

What happens if I overdose?

Get medical attention in an emergency or contact the Poison Help line toll-free at 1-800-222-1222. An overdose may cause excessive bleeding.

What should be avoided?

Avoid activities that increase the chances of sustaining injuries or bleeding. Take extra care when cleaning your teeth or shaving.

Interaction with other drugs

Discuss all of your prescriptions with your doctor. Numerous drugs can impact dabigatran, particularly:

  • Rifampin.
  • Dronedarone.
  • Ketoconazole.
  • Medicine that is used to prevent blood clots, including enoxaparin and warfarin, dipyridamole, clopidogrel, or prasugrel.
  • These are NSAIDs (nonsteroidal anti-inflammatory drugs): aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac (also known as indomethacin), diclofe, and many more.

The list below isn't exhaustive, and a variety of other medications could impact dabigatran. This covers prescription and OTC medications, vitamins, and herbal supplements. The interactions of all drugs are included here.



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