* Generic Name: dabigatran etexilate mesylate
* Brand Name: Pradaxa
* What is dabigatran (Pradaxa)?
* What are the possible side effects of dabigatran (Pradaxa)?
* What is the most important information I should know about
dabigatran (Pradaxa)?
* What should I discuss with my healthcare provider before taking
dabigatran (Pradaxa)?
* How should I take dabigatran (Pradaxa)?
* What happens if I miss a dose (Pradaxa)?
* What happens if I overdose (Pradaxa)?
* What should I avoid while taking dabigatran (Pradaxa)?
* What other drugs will affect dabigatran (Pradaxa)?
* Where can I get more information (Pradaxa)?
What is dabigatran (Pradaxa)?
Dabigatran is an anticoagulant (thrombin inhibitor) that
helps prevent the formation of blood clots.
Dabigatran is used to prevent blood clots and to reduce the risk of
stroke in people with a certain type of heart rhythm disorder.
Dabigatran is also used to treat or prevent blood clots in the veins of
your legs (deep vein thrombosis, or DVT), or the veins in your
lungs (pulmonary embolism, or PE).
Dabigatran may also be used for purposes not listed in this medication
guide.
What are the possible side effects of dabigatran (Pradaxa)?
Get emergency medical help if you have any of these signs of an
allergic reaction: hives; pain or tight feeling in your chest,
wheezing, difficult 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; or
* heavy menstrual bleeding.
Common side effects may include:
* stomach pain or discomfort;
* indigestion; or
* heartburn.
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 is the most important information I should know about dabigatran
(Pradaxa)?
You should not take dabigatran if you have an artificial heart
valve, or if you have any active bleeding from a surgery, injury, or
other cause.
Because dabigatran 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. Avoid activities that may increase your risk of bleeding or
injury. Contact your doctor or seek emergency medical attention if you
have bleeding that will not stop.
Dabigatran 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 dabigatran without your doctor's advice. Stopping
the medication can increase your risk of stroke.
Pradaxa Patient Information including How Should I Take
Atrial Fibrillation:Visual Guidelines to Causes, Tests and
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What should I discuss with my healthcare provider before taking dabigatran
(Pradaxa)?
You should not take dabigatran if you are allergic to it, or if you
have:
* an artificial heart valve; or
* any active bleeding from a surgery, injury, or other cause.
Dabigatran 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;
or
* you are older than 75.
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 taking an NSAID--Advil, Aleve, Motrin, and others; or
* you are using other medicines to treat or prevent blood clots.
To make sure dabigatran is safe for you, tell your doctor if you have:
* kidney disease;
* a history of stomach ulcer or bleeding; or
* if you are older than 75.
It is not known whether this medicine will harm an unborn baby. Tell
your doctor if you are pregnant or plan to become pregnant.
It is not known whether dabigatran passes into breast milk or if it
could harm a nursing baby. Tell your doctor if you are breast-feeding a
baby.
How should I take dabigatran (Pradaxa)?
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 dabigatran
with or without food.
Do not crush, chew, break, or open a dabigatran capsule. Swallow the
pill whole.
Because dabigatran 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
dabigatran within the past 12 hours. You may need to stop taking
dabigatran for a short time before you have surgery or other medical
procedures.
Do not stop taking dabigatran 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 dabigatran.
Your kidney function may need to be checked with blood tests before and
during treatment with dabigatran.
Keep the capsules in their original container or blister pack. Do not
put dabigatran 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.
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 bottle tightly closed when not in use.
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.
Pradaxa Patient Information including If I Miss a Dose
Atrial Fibrillation:Visual Guidelines to Causes, Tests and
Treatment
Atrial Fibrillation Slideshow: Causes, Tests and Treatment
RxList
Take the Atrial Fibrillation Quiz!
Heart Disease: Causes of a Heart Attack
Heart Disease Slideshow Pictures
What happens if I miss a dose (Pradaxa)?
If you are less than 6 hours late in taking your medicine, take the
missed dose as soon as you remember. Skip the missed dose if it is
almost time for your next scheduled dose. Do not take extra medicine to
make up the missed dose.
Try not to miss any doses of dabigatran to best prevent a stroke.
What happens if I overdose (Pradaxa)?
Seek emergency medical attention or call the Poison Help line at
1-800-222-1222.
What should I avoid while taking dabigatran (Pradaxa)?
Avoid activities that may increase your risk of bleeding or injury. Use
extra care to prevent bleeding while shaving or brushing your teeth.
Avoid drinking alcohol. It may increase your risk of bleeding in your
stomach or intestines.
What other drugs will affect dabigatran (Pradaxa)?
Before you take dabigatran, tell your doctor if you also take
rifampin (Rifater, Rifamate, Rimactane, Rifadin).
Tell your doctor about all your current medicines and any you start or
stop using, 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 (Pradaxa)?
Your pharmacist can provide more information about dabigatran.
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