What is Pradaxa?
Pradaxa is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots.
Pradaxa is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. This medicine is used when the atrial fibrillation is not caused by a heart valve problem.
Pradaxa is also used to treat DVT or pulmonary embolism (PE), and to lower your risk of having a repeat DVT or PE.
Pradaxa Oral Pellets are used to treat blood clots in children who are age 3 months to less than 12 years of age who have received an injectable medicine to treat their blood clots for at least 5 days.
Pradaxa Oral Pellets are also used to reduce the risk of blood clots happening again in children who are age 3 months to less than 12 years of age who have already been treated for blood clots.
Pradaxa can cause you to bleed more easily. Call your doctor at once if you have: bleeding gums, nosebleeds, heavy menstrual periods or abnormal vaginal bleeding, blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Many other drugs can increase your risk of bleeding when used with dabigatran. Tell your doctor about all medicines you have recently used.
Pradaxa can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis.
Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.
Do not stop taking Pradaxa without first talking to your doctor. Stopping suddenly can increase your risk of blood clot or stroke.
Before taking this medicine
You should not take Pradaxa if you are allergic to dabigatran, or if you have:
an artificial heart valve; or
active bleeding from a surgery, injury, or other cause.
Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:
you have a genetic spinal defect;
you have a spinal catheter in place;
you have a history of spinal surgery or repeated spinal taps;
you have recently had a spinal tap or epidural anesthesia;
you are using other medicines to treat or prevent blood clots.
Pradaxa may cause you to bleed more easily, especially if:
you have a stomach ulcer or bleeding in your stomach or intestines;
you are older than 75.
To make sure Pradaxa is safe for you, tell your doctor if you have:
a bleeding disorder that is inherited or caused by disease;
antiphospholipid syndrome (also called Hughes syndrome or "sticky blood syndrome"), an immune system disorder that increases the risk of blood clots;
a stomach ulcer; or
if you have been taking rifampin.
Tell your doctor if you are pregnant or if you become pregnant. Taking Pradaxa during pregnancy may cause bleeding in the mother or the newborn baby. However, the risk of blood clots is higher during pregnancy. The benefit of preventing a blood clot may outweigh any risks to the baby.
You should not breast-feed while using dabigatran.
How should I take Pradaxa capsules?
Take Pradaxa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Take this medicine with a full glass of water. You may take Pradaxa with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
Because Pradaxa keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Contact your doctor or seek emergency medical attention if you fall or hit your head, or have any bleeding that will not stop.
If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken Pradaxa within the past 12 hours.
Your kidney function may need to be checked before and during treatment with Pradaxa.
Do not stop taking Pradaxa without your doctor's advice. Stopping the medication can increase your risk of stroke.
If you have received more than a 30-day supply of this medication, do not open more than one bottle at a time. Open a new bottle only after all the capsules in the old bottle are gone.
Store at room temperature, away from moisture and heat. Keep each capsule in the bottle or blister pack until you are ready to take the medicine.
Keep the capsules in their original container or blister pack. Do not put Pradaxa capsules into a daily pill box or pill organizer.
Throw away any unused capsules if it has been longer than 4 months since you first opened the bottle. Capsules stored in a blister pack should be thrown away after the expiration date on the label has passed.
How should I give Pradaxa Oral Pellets?
Give Pradaxa Oral Pellets exactly as prescribed by your healthcare provider. See the detailed Instructions for Use that comes with the prescription for information about the right way to prepare and give your child a dose of Pradaxa Oral Pellets.
Your healthcare provider will decide how long your child should take this medicine. Do not stop giving your child Pradaxa Oral Pellets without first talking with your healthcare provider. Stopping Pradaxa Oral Pellets may increase your child’s risk of forming blood clots.
Give Pradaxa Oral Pellets 2 times a day, 1 dose in the morning and 1 dose in the evening. The doses should be given as close as possible to every 12 hours, and at about the same time every day. Giving the Oral Pellets before meals helps ensure that your child takes the full dose.
You can mix Pradaxa Oral Pellets with apple juice or the following soft foods at room temperature: mashed carrots, apple sauce, or mashed bananas. Do not mix the Oral Pellets with any food or liquid other than those listed. Do not mix Pradaxa Oral Pellets with milk or with foods that contain milk.
Give Pradaxa Oral Pellets right away or within 30 minutes after mixing. Do not give the Oral Pellets if they have been in contact with the soft food or apple juice for more than 30 minutes.
Do not give Pradaxa Oral Pellets using a syringe or through a feeding tube.
Do not run out of Pradaxa Oral Pellets. Refill your child’s prescription before you run out.
If you plan for your child to have surgery, or a medical or a dental procedure, tell your healthcare provider and dentist that your child is taking Pradaxa Oral Pellets. Your child may have to stop taking Pradaxa Oral Pellets for a short time.
If your child only takes part of their dose, do not give another dose at that time. Give your child their next dose at the regular scheduled time, about 12 hours later. If your child misses a dose, give it as soon as you remember. If your child’s next dose is less than 6 hours away, skip the missed dose. Do not give your child a double dose to make up for a missed dose.
If your child takes too much or overdoses, go to the nearest hospital emergency room or call your healthcare provider right away.
Call your healthcare provider right away if your child falls or injures himself, especially if your child hits his head. Your healthcare provider may need to check your child.
Pradaxa Oral Pellets come in an aluminum bag that contains packets of the Oral Pellets used to prepare your child’s dose of medicine. After opening the aluminum bag, the packets of Oral Pellets must be used within 6 months.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.
To best prevent a stroke, try not to miss any doses.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
Avoid alcohol. Heavy drinking can increase your risk of stomach bleeding.
Pradaxa side effects
Get emergency medical help if you have signs of an allergic reaction to Pradaxa: hives; pain or tight feeling in your chest, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
any bleeding that will not stop;
easy bruising or bleeding (nosebleeds, bleeding gums);
blood in your urine or stools, black or tarry stools;
cough with bloody mucus or vomit that looks like coffee grounds;
pink or brown urine;
joint pain or swelling; or
Common Pradaxa side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Pradaxa?
Before you take Pradaxa, tell your doctor if you also take rifampin (Rifater, Rifamate, Rimactane, Rifadin), amiodarone, clarithromycin, dronedarone, or ketoconazole.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Pradaxa, especially other medicines used to treat or prevent blood clots, such as:
abciximab, clopidogrel, dipyridamole, eptifibatide, ticlopidine, tirofiban;
alteplase, reteplase, tenecteplase, urokinase;
apixaban, argatroban, bivalirudin, desirudin, lepirudin, rivaroxaban; or
dalteparin, enoxaparin, heparin, tinzaparin.
This list is not complete. Other drugs may interact with dabigatran, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Pradaxa only for the indication prescribed.
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