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Pradaxa

Dabigatran Etexilate Mesylate

What is Pradaxa used for?

This form of dabigatran is given to infants and children to treat blood clots in the veins of the legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. Dabigatran is an anticoagulant that works by blocking certain clotting proteins in the blood. This helps to keep blood flowing smoothly in your child's body. Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If your child had heart valve surgery, talk to the doctor about the best medication for your child.

CHEMICAL NAME

Dabigatran Etexilate Mesylate (DA-bi-GAT-ran)

DRUG TYPE

Anticoagulant

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Pradaxa Frequently Asked Questions

See also Warning section.

Read the Medication Guide and, if available, the Instructions for Use provided by the pharmacist before your child starts dabigatran and each time you get a refill. If you have any questions, ask the doctor or pharmacist.

This medication is taken by mouth with or without food as directed by the doctor, usually twice daily. For the best effect, give this medication about 12 hours apart (first dose in the morning and second dose in the evening). To help you remember, give this medication at the same times every day.

The dosage is based on your child's medical condition, age, weight, response to treatment, and other medications your child may be taking. Be sure to tell the doctor and pharmacist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

To give this medication without food, open the packet and spoon the contents into your child's mouth. Offer apple juice as needed to ensure the entire dose is swallowed. Pellets can also be mixed in a cup with a small amount of apple juice (such as 1 to 2 ounces/30 to 60 milliliters). If any pellets remain in the cup after drinking, add more apple juice to make sure the entire dose is taken.

If you are mixing the pellets with soft food, open the packet and pour its contents into a small bowl with 2 teaspoons (10 milliliters) of certain soft foods (mashed carrots/banana or applesauce). The soft food should be at or below room temperature. Mix well with a spoon and give all of the mixture right away.

Repeat these steps if the dose is for more than one packet. Do not give/mix with milk or milk products. Discard mixture after 30 minutes and do not save for later use. Do not prepare a supply in advance. Do not give using a syringe or feeding tube. If only part of the dose is taken, do not give another dose to catch up. Give the next dose at the regular time. Giving the medication before meals/feedings may help make sure your child will take the entire dose.

It is very important to give it exactly as directed. Do not increase the dose or give this drug more often or for longer than prescribed. Your child's condition will not improve any faster, and the risk of serious side effects will increase.

Do not stop dabigatran unless directed by your child's doctor. If you stop giving this medication early, your child has a higher risk of forming a serious blood clot (such as stroke, blood clot in the legs/lungs). The doctor may direct your child to take a different "blood thinning" or antiplatelet medication to reduce your child's risk. Get medical help right away if your child has weakness on one side of the body, trouble speaking, sudden vision changes, confusion, chest pain, trouble breathing, or pain/warmth/swelling in the legs.

People taking this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Before any spinal procedure, ask the doctor about the benefits and risks. The risk of bleeding may be higher if your child has a deformed spine, or has had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or if your child is taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/enoxaparin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell the doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).

Pradaxa Dosage and Form Information

Pellets In Packet

Capsule