Pradaxa

Pradaxa is a prescription medication used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation. It is also used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in some patients as well as prevent blood clots that travel throughout the body in patients who have been treated for these type of blood clots.

Pradaxa is also used to prevent DVT and PE in patients who have undergone hip replacement surgery. 

Pradaxa is in a class of medicines called direct thrombin inhibitors. Pradaxa helps prevent the formation of blood clots by inhibiting a naturally occurring protein called thrombin.

This medication comes in capsule form and is usually taken twice daily, with or without food. Swallow capsules whole.

Common side effects of Pradaxa include upset stomach or stomach pain.

Pradaxa is a prescription medicine used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation (irregular heart rate or rhythm).

It is used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in some patients. Pradaxa is also used to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) from happening again in those patients who have been treated for a (DVT) or (PE). 

Pradaxa is also used to prevent DVT and PE in patients who have undergone hip replacement surgery. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Boehringer Ingelheim Pharmaceuticals, Inc.

Pradaxa can cause serious side effects. See the "Pradaxa Precautions" section.

Common side effects of Pradaxa include:

• indigestion, upset stomach, or burning
• stomach pain

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Pradaxa. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way Pradaxa  works. Certain medicines may increase your risk of bleeding. See "Pradaxa Precautions".

Especially tell your doctor if you take:

• rifampin (Rifater, Rifamate, Rimactane, Rifadin)
• aspirin or aspirin containing products
• non-steroidal anti-inflammatory drugs (NSAIDs)
• warfarin sodium (Coumadin, Jantoven)
• a medicine that contains heparin
• clopidogrel (Plavix)
• prasugrel (Effient)
• Multaq
• ketoconazole (Nizoral)

This is not a complete list of Pradaxa drug interactions. Ask your doctor or pharmacist for more information.

• 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 your body.
• You may have a higher risk of bleeding if you take Pradaxa and:
  • are over 75 years old
  • have kidney problems
  • have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer
  • take other medicines that increase your risk of bleeding, including:
    • aspirin or aspirin containing products
    • long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
    • warfarin sodium (Coumadin, Jantoven)
    • a medicine that contains heparin
    • clopidogrel (Plavix)
    • prasugrel (Effient)
  • have certain kidney problems and also take the medicines dronedarone (Multaq) or ketoconazole tablets (Nizoral). 
  • Pradaxa can increase your risk of bleeding because it lessens the ability of your blood to clot. While you take Pradaxa:
    • you may bruise more easily
    • it may take longer for any bleeding to stop
  • Call your doctor or get medical help right away if you have 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
• Allergic Reactions. In some people, Pradaxa can cause symptoms of an allergic reaction, including hives, rash, and itching. Tell your doctor or get medical help right away if you get any of the following symptoms of a serious allergic reaction with Pradaxa:
  • chest pain or chest tightness
  • swelling of your face or tongue
  • trouble breathing or wheezing
  • feeling dizzy or faint

Take Pradaxa exactly as prescribed. Do not stop taking Pradaxa without first talking to the doctor who prescribes it for you. Stopping Pradaxa may increase your risk of a stroke.

Pradaxa may need to be stopped, if possible, for one or more days before any surgery, or medical or dental procedure. If you need to stop taking Pradaxa for any reason, talk to the doctor who prescribed Pradaxa for you to find out when you should stop taking it. Your doctor will tell you when to start taking Pradaxa again after your surgery or procedure.

Do not take Pradaxa if you:

• currently have certain types of abnormal bleeding. Talk to your doctor, before taking Pradaxa if you currently have unusual bleeding.
• if you have a mechanical heart valve, also known as a mechanical prosthetic heart valve.
• have had a serious allergic reaction to Pradaxa.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Pradaxa there are no specific foods that you must exclude from your diet when receiving Pradaxa.

Before you take Pradaxa, tell your doctor if you:

• have a mechanical heart valve (also known as a mechanical prosthetic heart valve)
• have kidney problems
• have ever had bleeding problems
• have ever had stomach ulcers
• have any other medical condition
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell all of your doctors and dentists that you are taking Pradaxa. They should talk to the doctor who prescribed Pradaxa for you, before you have any surgery, or medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Pradaxa is excreted in human breast milk or if it will harm your nursing baby.

Take Pradaxa exactly as prescribed by your doctor.

• Do not take Pradaxa more often than your doctor tells you to.
• You can take Pradaxa with or without food.
• Pradaxa comes in a bottle or in a blister package.
• Only open 1 bottle of Pradaxa at a time. Finish your opened bottle of Pradaxa before opening a new bottle.
• After opening a bottle of Pradaxa, use within 4 months. 
• When it is time for you to take a dose of Pradaxa, only remove your prescribed dose of Pradaxa from your open bottle or blister package.
• Tightly close your bottle of Pradaxa right away after you take your dose.
• Swallow Pradaxa capsules whole. Do not break, chew, or empty the pellets from the capsule.
• If you miss a dose of Pradaxa, take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose. Do not take two doses of Pradaxa at the same time.
• Your doctor will decide how long you should take Pradaxa. Do not stop taking Pradaxa without first talking with your doctor. Stopping Pradaxa may increase your risk of stroke.
• Do not run out of Pradaxa. Refill your prescription before you run out. If you plan to have surgery, or a medical or a dental procedure, tell your doctor and dentist that you are taking Pradaxa. You may have to stop taking Pradaxa for a short time.
• If you take too much Pradaxa, go to the nearest hospital emergency room or call your doctor.
• Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you.

Take Pradaxa exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Non-valvular Atrial Fibrillation:

• For patients with CrCl >30 mL/min: 150 mg orally, twice daily 
• For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily

Treatment of DVT and PE:

For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5-10 days of parenteral anticoagulation

Reduction in the Risk of Recurrence of DVT and PE:

For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment

Prophylaxis of DVT and PE Following Hip Replacement Surgery:

For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily

If you take too much Pradaxa call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Pradaxa is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Pradaxa at room temperature between 59°F to 86°F (15°C to 30°C). After opening the bottle, use Pradaxa within 4 months. Safely throw away any unused Pradaxa after 4 months.
• Keep Pradaxa in the original bottle or blister package to keep it dry (protect the capsules from moisture). Do not put Pradaxa in pill boxes or pill organizers.
• Tightly close your bottle of Pradaxa right away after you take your dose.
• Keep Pradaxa and all medicines out of the reach of children.