Visit www. Then use the Doctor Discussion Guide for an easy way to get the conversation started during your next office visit. If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your healthcare provider should watch you closely for symptoms of spinal or epidural blood clots.
Tell your healthcare provider right away if you have back pain, tingling, numbness, muscle weakness especially in your legs and feet , loss of control of the bowels or bladder incontinence. Tell your healthcare provider about all your medical conditions, including if you have kidney problems, bleeding problems, stomach ulcers, or have antiphospholipid syndrome APS. Tell your healthcare provider if you are pregnant or plan to become pregnant.
Tell your healthcare provider if you are a female who is able to become pregnant. Talk with your healthcare provider about your risk for severe bleeding from the uterus if you are treated with blood thinner medicines, including PRADAXA. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
It is important to tell your healthcare provider about all medicines prescription and over-the-counter , vitamins, and supplements you take. Some important considerations you'll want to discuss with your doctor There are different treatment options for your condition. Important safety and side effects information Because PRADAXA is available only by prescription, the decision to prescribe it is made by a healthcare professional after discussing a range of important considerations with the individual adult patient.
Pradaxa is a type of anticoagulant. Clinical studies looked at how well Pradaxa works to help prevent blood clots in people with nonvalvular A-fib. In one study , Pradaxa was compared with the drug warfarin Coumadin. The rate of death from any cause was 3.
The rate of death due to vascular causes was also lower in the Pradaxa group: 2. Pradaxa may also be used off-label for other conditions. Pradaxa is approved to reduce the risk of stroke and blood clots in people with nonvalvular atrial fibrillation A-fib.
A-fib is a condition in which your heartbeat is irregular and can be faster than usual. Symptoms of A-fib include sweating, heart palpitations, feeling tired, and trouble breathing. A-fib causes your heart to not pump blood properly, which can make blood gather and form a clot more easily. Strokes can be caused by blood clots that move to your brain. A blood clot in your lungs is called a pulmonary embolism PE.
And a blood clot that typically develops in your legs is known as a deep vein thrombosis DVT. A blood clot that develops in your lower legs is typically known as a DVT. And a blood clot in your lungs is called a PE.
These conditions are sometimes grouped together and called VTEs. For this use, adults must have taken an injectable form of a type of drug called an anticoagulant for 5 to 10 days. Anticoagulants are sometimes called blood thinners. And children must have taken an anticoagulant for at least 5 days. In these studies , people took either warfarin or Pradaxa after being treated for 5 to 10 days with a blood thinner in injection form.
The results showed that 2. In comparison, 2. In studies, Pradaxa was also effective at treating VTEs in children. These people had the clotting event 3 to 12 months ago and were treated for it. In this study, 1. In comparison, 1. In another study , Pradaxa was compared with a placebo treatment with no active drug to help prevent DVT or PE in people who had one in the past.
These people were treated with a different anticoagulant drug for 6 to 18 months and then started taking Pradaxa or a placebo to prevent another DVT or PE. Researchers found that 0. In comparison, 5.
In studies, Pradaxa was also effective at preventing VTEs in children. Pradaxa was studied to help prevent blood clots in people who had just had hip replacement surgery. Researchers compared Pradaxa with enoxaparin Lovenox , which is an anticoagulant in injection form. DVTs occurred in 7. In comparison, DVTs occurred in 8. PEs occurred in 0. In addition to the uses listed above, Pradaxa may be used off-label. Heparin-induced thrombocytopenia HIT is a condition that can occur after you take an anticoagulant called heparin.
HIT causes thrombocytopenia , which is a decrease in the level of platelets in your blood. HIT is dangerous because it can lead to an increased risk of developing a blood clot.
Some studies show that Pradaxa may decrease the risk of clotting in people with HIT and may be safe to take when you have a low platelet count. This means that platelet counts were normal in 38 of 40 people. The other two people had other conditions that may have caused a decrease in platelet counts. Pradaxa is available only as a brand-name medication. A generic drug is an exact copy of the active drug in a brand-name medication.
The generic is considered to be just as safe and effective as the original drug. Generics also tend to cost less than brand-name drugs. Pradaxa contains the active drug dabigatran. As the active drug, dabigatran is the ingredient that makes Pradaxa work.
Pradaxa can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Pradaxa. For more information on the possible side effects of Pradaxa, talk with your doctor or pharmacist.
They can give you tips on how to deal with any side effects that may be bothersome. Most of these side effects may go away within a few days or a couple of weeks. Call your doctor right away if you have serious side effects. You may wonder how often certain side effects occur with this drug.
As with most drugs, some people can have an allergic reaction after taking Pradaxa. A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:.
Call your doctor right away if you have a severe allergic reaction to Pradaxa. Older adults may have more side effects from Pradaxa than younger people. This group may bruise more easily than usual or have nosebleeds or bleeding gums. As you get older, the risk of bleeding or stroke occurring while taking Pradaxa increases.
However, even with the additional risk of bleeding or stroke, sometimes this medication is the best choice for you. They may switch you to a different medication or decrease the dose.
Pradaxa may increase your risk for bleeding. This is because the drug works by preventing your body from making clots. Pradaxa was compared with warfarin Coumadin in studies. People took either drug to treat a blood clot in their legs called a deep vein thrombosis DVT or a blood clot in their lungs known as a pulmonary embolism PE. About 1. Bleeding was considered a major bleeding event if it resulted in death, occurred in an organ, caused symptoms such as dizziness, or caused a decrease in the level of hemoglobin.
Hemoglobin is a protein found in red blood cells. Bleeding that was fatal occurred in 0. Tell your doctor if you have any of the following:. If left untreated, serious bleeding can be fatal.
So if you have any of the above symptoms while taking Pradaxa, see your doctor right away. Heartburn is a side effect that may occur with Pradaxa. Heartburn can cause you to feel pain or burning in your chest.
This is due to acid from your stomach moving into your esophagus , a tube that runs from your mouth to your stomach. In four studies , 7. This was compared with 5. They may be able to recommend some ways to reduce the acid buildup and help ease your symptoms. Pradaxa is a type of drug called an anticoagulant. Stopping the use of an anticoagulant such as Pradaxa sooner than advised may increase your risk for a blood clot. Pradaxa has a boxed warning for this risk.
A boxed warning is the most serious warning that the FDA requires. Pradaxa works by stopping blood clots from forming. This helps prevent blood clots that can lead to heart attacks , strokes , and death. This type of blood clot is possible only with spinal procedures such as spinal taps or if medication is injected into the spine column.
Symptoms of a spinal or epidural blood clot may include back pain, tingling, weakness, and incontinence loss of control of your bladder or bowels. Typically, your doctor will start you on a low dosage. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs. The dose of Pradaxa to decrease the risk of stroke or a blood clot in people with nonvalvular atrial fibrillation A-fib is usually mg twice a day. However, your doctor may give you a different dose depending on factors such as whether you have kidney disease.
If you have any questions about what dose is right for you, talk with your doctor. The dose of Pradaxa for adults to treat a current deep vein thrombosis DVT or pulmonary embolism PE is also mg twice a day. A DVT is a blood clot that typically develops in your leg, and a PE is a blood clot that occurs in your lung. To prevent a deep vein thrombosis DVT or pulmonary embolism PE from occurring again in adults, the dose of Pradaxa is mg twice a day. Then the dose would increase to mg once a day.
Your dose may need to be adjusted or you may need to stop taking Pradaxa for a few days before you have surgery. Talk with your doctor about any surgeries that you plan to have and how to prevent bleeding. For these uses, Pradaxa should be taken twice daily. Pradaxa dosages for children are based on body weight in kilograms kg , as follows:.
This includes how many capsules the child will need to take to reach their full dose. For children with kidney disease, doctors may prescribe a different dosage than those listed above. If you have any questions about what dosage is right for your child, talk with your doctor.
If you miss your scheduled dose of Pradaxa, be sure to take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose and continue on your schedule with the next dose. If you have any questions about when to take your next dose after missing a dose, talk with your doctor or pharmacist.
A medication timer may be useful, too. Usually, Pradaxa is meant to be used as a long-term treatment. However, in some cases, such as after a hip replacement, you may take Pradaxa for only a short period of time.
Treatment continues with two mg capsules taken once a day for 28 to 35 days after hip replacement and for 10 days after knee replacement. Treatment is delayed in patients who are still bleeding from the site of surgery. A lower dose is used in patients with moderate kidney problems. If you are taking Pradaxa to prevent strokes due to an abnormal heart beat One mg capsule is taken twice a day long term.
A lower dose one mg twice a day is used in patients over 80 years of age or with moderate kidney problems, or who are at high risk of bleeding. It is important to take Pradaxa regularly to prevent strokes and blood clots. There is no requirement for regular blood tests but patients should still look out for any signs of bleeding such as: exceptional weakness, tiredness, paleness, dizziness, headache, unexplained bruising or unexplained swelling.
If you are taking Pradaxa after surgery to prevent blood clots Your doctor may reduce the dose you take if you:. If you are taking Pradaxa to prevent strokes due to an abnormal heart beat Your doctor may reduce the dose you take if you are:.
Your doctor will weigh your risk of bleeding against your risk of having a blood clot before deciding if the reduced dose is right for you. All medicines have risks as well as benefits. The most serious risk associated with Pradaxa is bleeding. Bleeding is a risk for all medicines that thin the blood including warfarin and aspirin. Patients should contact their doctor immediately if they experience any of the following: long or excessive bleeding, exceptional weakness, tiredness, paleness, dizziness, headache, unexplained bruising or unexplained swelling.
Medsafe generally does not place prescribing restrictions on medicines; historically this has only occurred in very rare cases where the potential for very serious harm had been identified. The patient's physician is best placed to decide on the choice of appropriate medicine and dose based on:.
The overall risks and benefits of the medicine are outlined in the data sheet and in other material that has been published about Pradaxa see links in Question 8 below. Since this medicine is used as a fixed dose for all patients Medsafe saw no reason to impose prescribing restrictions. In addition other anticoagulants have similar risks and are not restricted.
Pradaxa dabigatran consumer medicine information CMI. The company who makes Pradaxa is continuing to investigate the safety of this medicine in clinical studies.
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