Pradaxa

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Generic Name: Pradaxa Brand Name(s): Generics only. No brands available.

Uses

What is Pradaxa® (dabigatran) used for?

Pradaxa® is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots.

Pradaxa® is used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation.

Pradaxa® is also used to treat blood clots in the veins of your legs (deep vein thrombosis, or DVT) or lungs (pulmonary embolism, or PE) and reduce the risk of them occurring again.

How should I take Pradaxa® (dabigatran)?

Take Pradaxa® exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water. You may take Pradaxa® with or without food.

Do not crush, chew, break, or open a capsule. Swallow the capsule whole.

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. You may need to stop taking this medicine for a short time before you have surgery or other medical procedures.

Do not stop taking Pradaxa® without your doctor’s advice. Stopping the medication can increase your risk of stroke. Your doctor may recommend another medication to prevent blood clots if you need to stop taking Pradaxa®.

Your kidney function may need to be checked with blood tests before and during treatment with Pradaxa®.

Keep the capsules in their original container or blister pack. Do not put Pradaxa® capsules into a daily pill box or pill organizer.

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.

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 do I store Pradaxa® (dabigatran)?

Pradaxa® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Pradaxa® in the bathroom or the freezer. There may be different brands of Pradaxa® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Pradaxa® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Pradaxa® (dabigatran)?

Before using this drug, tell your doctor if:

  • You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
  • You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
  • You have allergy with any of active or inactive ingredients of Pradaxa® or other medications.
  • You have any other illnesses, disorders, or medical conditions.

You should not take Pradaxa® if you are allergic to dabigatran, or if you have:

  • An artificial heart valve
  • Any active bleeding from a surgery, injury, or other cause

Pradaxa® may cause you to bleed more easily, especially if:

  • You have a stomach ulcer.
  • You have recent or recurring bleeding in your stomach or intestines.
  • You have kidney disease (especially if you also take dronedarone or ketoconazole).
  • You take certain other medicines that can increase bleeding risk, such as aspirin, clopidogrel (Plavix), heparin, prasugrel, warfarin (Coumadin, Jantoven).
  • You take an NSAID (nonsteroidal anti-inflammatory drug) on a regular basis, such as ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others.
  • You are older than 75.

Pradaxa® 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 taking an NSAID–Advil, Aleve, Motrin, and others.
  • You are using other medicines to treat or prevent blood clots.

To make sure Pradaxa® is safe for you, tell your doctor if you have:

  • Kidney disease
  • A history of stomach ulcer or bleeding
  • If you are older than 75.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Pradaxa® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Pradaxa®. Pradaxa® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown

Side effects

What side effects can occur from Pradaxa® (dabigatran)?

Get emergency medical help if you have any of these signs of an allergic reaction to Pradaxa®: hives; pain or tight feeling in your chest, wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

  • Any bleeding that will not stop
  • Headache, weakness, dizziness, feeling like you might pass out
  • Easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin
  • Blood in your urine or stools, black or tarry stools
  • Coughing up blood or vomit that looks like coffee grounds
  • Pink or brown urine
  • Joint pain or swelling
  • Heavy menstrual bleeding

Common side effects may include:

  • Stomach pain or discomfort
  • Indigestion
  • Heartburn

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Pradaxa® (dabigatran)?

Pradaxa® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

  • Abciximab, clopidogrel, dipyridamole, eptifibatide, ticlopidine, tirofiban
  • Alteplase, reteplase, tenecteplase, urokinase
  • Apixaban, argatroban, bivalirudin, desirudin, lepirudin, rivaroxaban
  • Dalteparin, enoxaparin, heparin, tinzaparin

Does food or alcohol interact with Pradaxa® (dabigatran)?

Pradaxa® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Pradaxa® (dabigatran)?

Pradaxa® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Pradaxa® (dabigatran).

What is the dose of Pradaxa® (dabigatran) for an adult?

Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF

CrCl >30 mL/min: 150 mg twice daily.

CrCl 15 to 30 mL/min: 75 mg twice daily.

CrCl <15 mL/min or on dialysis: Dosing recommendations cannot be provided.

CrCl 30 to 50 mL/min with concomitant use of P-gp inhibitors: Reduce dose to 75 mg twice daily if given with P-gp inhibitors dronedarone or systemic ketoconazole.

CrCl <30 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration.

Treatment of DVT and PE

CrCl >30 mL/min: 150 mg twice daily

Reduction in the Risk of Recurrence of DVT and PE

CrCl ≤30 mL/min or on dialysis: Dosing recommendations cannot be provided.

CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration.

Prophylaxis of DVT and PE Following Hip Replacement Surgery

CrCl >30 mL/min: 110 mg for first day, then 220 mg once daily.

CrCl ≤30 mL/min or on dialysis: Dosing recommendations cannot be provided.

CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid co-administration.

What is the dose of Pradaxa® (dabigatran) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Pradaxa® (dabigatran) available?

Pradaxa® is available in the following dosage forms and strengths:

  • Capsule: dabigatran etexilate mesylate 75mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Pradaxa®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 8, 2017 | Last Modified: August 14, 2017

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