Pradaxa

Generic name: dabigatran
Drug class: Thrombin inhibitors

Medically reviewed by A Ras MD.

What is Pradaxa?

Pradaxa Oral Pellets is a prescription medicine that is 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. It reduces 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.

Description

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:

Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol.

PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, hypromellose, potassium chloride, titanium dioxide, black edible ink, and FD&C Blue No. 2 (150 mg and 110 mg capsules only).

Mechanism of Action

Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.

What is the most important information I should know about Pradaxa?

Do not stop giving Pradaxa without talking to the healthcare provider who prescribes it for your child. Stopping Pradaxa increases your child’s risk of a clot forming in their blood.
Pradaxa may need to be stopped, if possible, before surgery or a medical or dental procedure. Ask the healthcare provider who prescribed Pradaxa for your child when your child should stop taking it. Your healthcare provider will tell you when you may start giving Pradaxa to your child again after their surgery or procedure. If your child has to stop taking Pradaxa, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming.

Pradaxa can cause bleeding which can be serious, and sometimes lead to death. This is because Pradaxa is a blood thinner medicine that lowers the chance of blood clots forming in the body.
Your child may have a higher risk of bleeding if your child takes Pradaxa and:
- has kidney problems
- has stomach or intestine bleeding that is recent or keeps coming back, or a stomach ulcer
- takes other medicines that increase the risk of bleeding, including:
  - aspirin or aspirin-containing products
  - long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
  - a medicine that contains warfarin sodium
  - a medicine that contains heparin
  - a medicine that contains clopidogrel bisulfate
  - a medicine that contains prasugrel
- has certain kidney problems and also takes a medicine that contains dronedarone or ketoconazole tablets
Tell your healthcare provider if your child takes any of these medicines. Ask your healthcare provider or pharmacist if you are not sure if your child’s medicine is one listed above.
Pradaxa can increase your child’s risk of bleeding because it lessens the ability of your child’s blood to clot. During treatment with Pradaxa:
- he or she may bruise more easily
- it may take longer for any bleeding to stop
Call your healthcare provider or get medical help right away if your child has any of these signs or symptoms of bleeding:
- unexpected bleeding or bleeding that lasts a long time, such as:
  - unusual bleeding from the gums
  - nose bleeds that happen often
  - menstrual bleeding or vaginal bleeding that is heavier than normal
- bleeding that is severe or you cannot control
- pink or brown urine
- red or black stools (looks like tar)
- bruises that happen without a known cause or get larger
- cough up blood or blood clots
- vomit blood or your vomit looks like “coffee grounds”
- unexpected pain, swelling, or joint pain
- headaches, feeling dizzy or weak
Take Pradaxa Oral Pellets exactly as prescribed. Do not stop giving Pradaxa Oral Pellets to your child without first talking to the healthcare provider who prescribes it for your child. Stopping Pradaxa increases your child’s risk of a clot forming in their blood.
Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like Pradaxa, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your child’s risk of developing a spinal or epidural blood clot is higher if:
- a thin tube called an epidural catheter is placed in your child’s back to give them certain medicine
- your child takes NSAIDs or a medicine to prevent blood from clotting
- your child has a history of difficult or repeated epidural or spinal punctures
- your child has a history of problems with their spine or has had surgery on their spine
If your child takes Pradaxa and receives spinal anesthesia or has a spinal puncture, your healthcare provider should watch your child closely for symptoms of spinal or epidural blood clots. Tell your healthcare provider right away if your child has back pain, tingling, numbness, muscle weakness (especially in the legs and feet), loss of control of the bowels or bladder (incontinence).

See “What are the possible side effects of Pradaxa?” for more information about side effects.

Who should not take Pradaxa?

Do not give Pradaxa if your child:

currently has certain types of abnormal bleeding. Talk to your healthcare provider before giving Pradaxa if your child currently has unusual bleeding.
has had a serious allergic reaction to any of the ingredients in Pradaxa. See below for a complete list of ingredients in Pradaxa. Ask your healthcare provider if you are not sure.
has ever had or if there are plans for your child to have a valve in their heart replaced with a mechanical (artificial) prosthetic heart valve.

What should I tell my healthcare provider before taking Pradaxa?

Before giving Pradaxa to your child, tell your healthcare provider about all of your child’s medical conditions, including if they:

have kidney problems
have ever had bleeding problems
have ever had stomach ulcers
have antiphospholipid syndrome (APS)
are pregnant or plan to become pregnant. It is not known if Pradaxa will harm your child’s unborn baby.
- If your child is able to become pregnant, talk with your healthcare provider about your child’s risk for severe uterine bleeding during treatment with blood thinner medicines, including Pradaxa.
- Tell your healthcare provider right away if your child becomes pregnant during treatment with Pradaxa Oral Pellets.
are breastfeeding or plan to breastfeed. It is not known if Pradaxa passes into your child’s breastmilk. Your child should not breastfeed during treatment with Pradaxa.

Tell all of your healthcare providers and dentists that your child is taking Pradaxa. They should talk to the healthcare provider who prescribed Pradaxa for your child before your child has any surgery or a medical or dental procedure.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some of your child’s other medicines may affect the way Pradaxa works. Certain medicines may increase your child’s risk of bleeding. See “What is the most important information I should know about Pradaxa?”

Especially tell your healthcare provider if your child takes medicine that contains rifampin.

Know the medicines your child takes. Keep a list of them and show it to your healthcare provider and pharmacist when your child gets a new medicine.

How should I take Pradaxa?

See the detailed “Instructions for Use” that comes with Pradaxa Oral Pellets 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 Pradaxa Oral Pellets. 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 exactly as prescribed by your healthcare provider. Check with your healthcare provider if you are not sure.
Your healthcare provider will prescribe the correct dose of Pradaxa Oral Pellets for your child. Your healthcare provider will change your child’s dose as they grow, and as needed during treatment.
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.
Give Pradaxa Oral Pellets before meals to help 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
- Mash bananas

Do not mix Pradaxa Oral Pellets with any food or liquid other than the ones listed above.
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 Pradaxa 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. See “What is the most important information I should know about Pradaxa?”
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 of Pradaxa Oral Pellets, 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 of Pradaxa Oral Pellets to make up for a missed dose.
If your child takes too much Pradaxa Oral Pellets, 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 Pradaxa Oral Pellets must be used within 6 months. See “How should I store Pradaxa?”

What are the possible side effects of Pradaxa?

Pradaxa can cause serious side effects. See “What is the most important information I should know about Pradaxa?”

Allergic Reactions. Some adults taking Pradaxa capsules have developed symptoms of an allergic reaction.
- Call your healthcare provider if your child gets symptoms of an allergic reaction, such as:
  - hives
  - rash
  - itching
- Get medical help right away if your child gets any of the following symptoms of a serious allergic reaction with Pradaxa Oral Pellets:
  - chest pain or chest tightness
  - swelling of the face or tongue
  - trouble breathing or wheezing
  - feeling dizzy or faint

Common side effects of Pradaxa in children include:

indigestion, upset stomach, burning
nausea, vomiting, or diarrhea
stomach-area (abdominal) pain or discomfort

Call your healthcare provider if your child develops any of the signs and symptoms of stomach and intestine problems listed above.

Tell your healthcare provider if your child has any side effect that bothers them or that does not go away.
These are not all of the possible side effects of Pradaxa. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Pradaxa

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Pradaxa for a condition for which it was not prescribed. Do not give Pradaxa to other people, even if they have the same symptoms that your child has. It may harm them.

This Medication Guide summarizes the most important information about Pradaxa. If you would like more information, talk with your child’s healthcare provider. You can ask your child’s pharmacist or healthcare provider for information about Pradaxa that is written for health professionals.

How should I store Pradaxa?

Store Pradaxa Oral Pellets at room temperature 68°F to 77°F (20°C to 25°C).
After opening the silver aluminum bag that contains the packets of Oral Pellets:
- The silver aluminum bag contains a desiccant container. Throw away (dispose of) the desiccant container in your household trash.
- Pradaxa Oral Pellets must be used within 6 months. Safely throw away any unused Pradaxa Oral Pellets after 6 months.
Keep Pradaxa Oral Pellets packets in the original silver aluminum bag to keep them dry (protect the packets from moisture). Do not open packets of Pradaxa Oral Pellets until you are ready to use them.
Throw away any Pradaxa Oral Pellets that have not been given within 30 minutes after the Oral Pellets come into contact with apple juice or soft food.

Keep Pradaxa and all medicines out of the reach of children.

What are the ingredients in Pradaxa?

Active ingredient: dabigatran etexilate mesylate

Inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid.

For more information about Pradaxa Oral Pellets, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Instructions for use for Pradaxa

Read the Medication Guide and this Instructions for Use that come with Pradaxa Oral Pellets for the most important information you need to know before giving Pradaxa Oral Pellets to your child for the first time, and each time you get a refill. The information may have changed. This Instructions for Use does not take the place of talking to your healthcare provider about your child’s medical condition or treatment.

Your healthcare provider should tell you the amount (dose) of Pradaxa Oral Pellets to give your child. Your child’s dose of Pradaxa Oral Pellets will change as they grow.

Important Information

Pradaxa Oral Pellets can be used in children as soon as they are able to swallow soft food
Do not open the packets of Pradaxa Oral Pellets until you are ready to use them
Give Pradaxa Oral Pellets either with soft foods or apple juice
Do not give Pradaxa Oral Pellets using syringes or through feeding tubes
Do not mix Pradaxa Oral Pellets with milk or soft foods containing milk products
Give your child the prepared dose of Pradaxa Oral Pellets before meals to help ensure that your child takes the full dose
Give Pradaxa Oral Pellets to your child right away or within 30 minutes after mixing
Do not give Pradaxa Oral Pellets if they have been in contact with the food or apple juice for more than 30 minutes
If your child does not take all of the mixed Pradaxa Oral Pellets, do not give another dose at that time. Give the next scheduled dose about 12 hours later.
If a dose of Pradaxa Oral Pellets is not taken at the scheduled time, the dose should be taken as soon as possible on the same day; the missed dose should be skipped if it cannot be taken at least 6 hours before the next scheduled dose. The dose of Pradaxa Oral Pellets should not be doubled to make up for a missed dose.

Instructions are provided below for preparing and giving a dose of Pradaxa Oral Pellets with soft foods and preparing and giving a dose of Pradaxa Oral Pellets with apple juice.

How to prepare and give a dose of Pradaxa Oral Pellets with soft foods:

The food should be at room temperature before mixing with the pellets. Use only one of the following soft foods:

Mashed carrots
Apple sauce (for administration with apple juice see below)
Mashed banana

Do not mix with milk, milk products, or soft foods containing milk products.

Step 1 – Prepare cup or bowl

Place 2 teaspoons of the soft food into a small cup or bowl.

Step 2 – Collect Pradaxa Oral Pellets packet(s)

Open the silver aluminum bag by cutting at the top with scissors. The aluminum bag contains 60 silver-colored packets of Pradaxa Oral Pellets and a desiccant container.
Remove desiccant container from silver aluminum bag. Throw away (dispose of) desiccant container in your household trash.
Do not open or eat the desiccant.

Remove the prescribed number of Pradaxa Oral Pellets packets from the silver aluminum bag.
Leave the unused packets of Pradaxa Oral Pellets in the silver aluminum bag.

Step 3 – Open the Pradaxa Oral Pellets packet(s)

Tap the packet of Oral Pellets on a flat surface to ensure that the contents settle to the bottom.

Keep the packet of Oral Pellets in an upright position and open the packet by cutting at the top with scissors.

Step 4 – Add the Pradaxa Oral Pellets to soft food

Empty the entire packet into the small cup or bowl containing the soft food.
Repeat Steps 3 and 4 if more than one packet is needed.
Throw away the empty packets in your household trash.

Step 5 – Stir the soft food to mix with the Pradaxa Oral Pellets

Stir the pellets into the soft food with a spoon to mix well.

Step 6 – Give the soft food and oral pellet mixture

Give the soft food and oral pellet mixture to your child right away.
Make sure that your child eats all of the soft food and oral pellet mixture.

How to prepare and give a dose of Pradaxa Oral Pellets with apple juice:

Step 1 – Pour about 1 to 2 ounces of apple juice into a clean drinking cup.

Step 2 – Collect Pradaxa Oral Pellets packet(s)

Open the silver aluminum bag by cutting at the top with scissors. The silver aluminum bag includes 60 silver-colored packets of pellets and a desiccant container.
Remove desiccant container from silver aluminum bag. Throw away (dispose of) desiccant container in your household trash.
Do not open or eat the desiccant.

Remove the prescribed number of Pradaxa Oral Pellets packets from the silver aluminum bag.
Leave the unused packets of Pradaxa Oral Pellets in the silver aluminum bag.

Step 3 – Open Pradaxa Oral Pellets packet(s)

Tap the packet on a flat surface to make sure that the contents settle to the bottom.

Keep the packet in an upright position and open the packet by cutting at the top with scissors.

Step 4 – Mix the Pradaxa Oral Pellets with apple juice

Spoon the Pradaxa Oral Pellets from the packet into your child’s mouth. Offer your child as much apple juice as needed to swallow the Pradaxa Oral Pellets. Make sure all of the Pradaxa Oral Pellets are swallowed.OR

Mix the Pradaxa Oral Pellets in a small amount of apple juice that your child is likely to drink completely. Make sure all of the Pradaxa Oral Pellets are swallowed. If any of the Pradaxa Oral Pellets stick to the cup, add a little more apple juice and give it to your child. Repeat until no Pradaxa Oral Pellets remain in the cup.

Storing Pradaxa Oral Pellets

Store Pradaxa Oral Pellets at room temperature from 68°F to 77°F (20°C to 25°C).
After opening the silver aluminum bag that contains the packets of Oral Pellets:
- The silver aluminum bag contains a desiccant container. Throw away (dispose of) the desiccant container in your household trash.
- Pradaxa Oral Pellets must be used within 6 months. Safely throw away any unused Pradaxa Oral Pellets after 6 months.
Keep Pradaxa Oral Pellets packets in the original silver aluminum bag to keep them dry (protect the packets from moisture). Do not open packets of Pradaxa Oral Pellets until you are ready to use them.
Throw away any Pradaxa Oral Pellets that have not been given within 30 minutes after the Oral Pellets come into contact with apple juice or food.

Keep Pradaxa Oral Pellets and all medicines out of the reach of children.

Label

PRINCIPAL DISPLAY PANEL – 110 MG CAPSULE BOTTLE LABEL

NDC 0597-0108-54
60 capsules
DISPENSE IN THIS UNIT OF USE CONTAINER
WITH ENCLOSED MEDICATION GUIDE
Pradaxa®
(dabigatran etexilate)
Capsules
110 mg*
Swallow capsule whole. Once opened, the product
must be used within 4 months.
Pradaxa capsules are NOT substitutable on a
mg-to-mg basis with other dabigatran etexilate
dosage forms.

PRINCIPAL DISPLAY PANEL – 75 MG CAPSULE BOTTLE LABEL

NDC 0597-0355-09
60 capsules
DISPENSE IN THIS UNIT OF USE CONTAINER
WITH ENCLOSED MEDICATION GUIDE
Pradaxa®
(dabigatran etexilate)
Capsules
75 mg*
Swallow capsule whole. Once opened, the product
must be used within 4 months.
Pradaxa capsules are NOT substitutable on a
mg-to-mg basis with other dabigatran etexilate
dosage forms.

PRINCIPAL DISPLAY PANEL – 150 MG CAPSULE BOTTLE LABEL

NDC 0597-0360-55
60 capsules
DISPENSE IN THIS UNIT OF USE CONTAINER
WITH ENCLOSED MEDICATION GUIDE
Pradaxa®
(dabigatran etexilate)
Capsules
150 mg*
Swallow capsule whole. Once opened, the product
must be used within 4 months.
Pradaxa capsules are NOT substitutable on a
mg-to-mg basis with other dabigatran etexilate
dosage forms.

SRC: NLM .

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