dabigatran etexilate 40 mg oral pellets in packet

Generic name:
Dabigatran pellets - oral

Pronunciation
(DA-bi-GAT-ran)

Brand name(s)
Pradaxa

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).

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.

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.

See also Warning section.

Easy bruising, minor bleeding (such as nosebleed, bleeding from cuts), diarrhea, upset stomach, or heartburn may occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause serious bleeding if it affects the blood clotting proteins too much. Tell the doctor right away if your child has any signs of serious bleeding, including:

• nosebleeds that happen often or don't stop
• unusual tiredness/weakness
• unusual pain/swelling/discomfort
• unusual/easy bruising
• prolonged bleeding from cuts or gums
• unusually heavy/prolonged menstrual flow
• pink/dark urine
• coughing up blood
• vomit that is bloody or looks like coffee grounds
• severe headache
• dizziness/fainting
• bloody/black/tarry stools

Get medical help right away if your child has any signs of very serious bleeding, including:

• vision changes
• confusion
• trouble speaking
• weakness on one side of the body

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US -

Call the doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call the doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before giving dabigatran, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of:

• mechanical heart valve
• kidney disease
• bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain)
• blood disorders (such as anemia, hemophilia, thrombocytopenia)
• liver disease
• recent major injury/surgery
• stroke
• a certain clotting disorder (antiphospholipid syndrome)
• frequent falls/injuries

Before your child has surgery or any medical/dental procedures (especially spinal puncture or spinal/epidural anesthesia), tell the doctor or dentist that your child is taking this medication and about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products). The doctor or dentist may tell you to stop giving dabigatran before your surgery. Ask for specific instructions about stopping or starting this medication.

This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase the risk for stomach bleeding. Avoid alcoholic beverages.

This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Your child should use an electric razor when shaving and a soft toothbrush when brushing their teeth. If your child falls or is injured, especially if your child hits their head, call the doctor right away. The doctor may need to check your child.

This form of dabigatran is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult the doctor if you have any questions about this medication.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• mifepristone
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/apixaban)

Aspirin can increase the risk of bleeding when used with this medication. However, if the doctor has told you to give aspirin, your child should keep taking the aspirin unless the doctor tells you not to. Ask the doctor or pharmacist for more details.

Other medications can affect the removal of dabigatran from the body, which may affect how dabigatran works. Examples include cobicistat, cyclosporine, dronedarone, ketoconazole, rifampin, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, clotting times) may be done while your child is taking this medication. Keep all medical and lab appointments. Consult the doctor for more details.

If your child misses a dose, give it as soon as you remember. If it is less than 6 hours before the next dose, skip the missed dose. Give the next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep the packets in the aluminum bag until you are ready to give the medication. After opening the aluminum bag, discard the desiccant found in the bag. Once the aluminum bag is opened, this medication expires after 6 months. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your child's condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.