Pradaxa – Uses, Side Effects, Warnings, and More

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Uses

If you have a specific type of irregular heartbeat, your doctor may prescribe dabigatran to reduce your risk of having a stroke or developing dangerous blood clots (for example, in your legs or lungs) (atrial fibrillation). In addition to this, dabigatran can be used to treat blood clots that have formed in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), and it can also be used to lower the likelihood that these conditions will recur. Following hip replacement surgery, this medicine may also be prescribed to patients in order to reduce the risk of developing blood clots. Anticoagulant dabigatran functions by inhibiting the activity of a specific component (a blood clotting protein known as thrombin) in the body’s bloodstream.

This helps to maintain a steady flow of blood throughout your body, which is beneficial. It is not recommended to take dabigatran to reduce the risk of developing blood clots after having a mechanical heart valve replaced. If you have had surgery on your heart valves, you should consult your physician about the medicine that is most appropriate for you. It is imperative that you see your physician before discontinuing the use of any drug, including dabigatran.

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How to use Pradaxa

Please also see the section labeled Warning.

Before beginning treatment with dabigatran and whenever you get a refill, make sure you have read the information contained in the Medication Guide and, if it is available, the Patient Information Leaflet that your pharmacist has supplied you with. If you have any questions, you should consult with either your physician or your pharmacist.

You should take this medication by mouth as advised by your doctor, often twice daily. It can be used with or without food. The first dose of medication should be given to children in the morning, and the second dose should be given in the evening (about 12 hours apart). You should take it exactly as advised by your doctor, which is typically once per day, to reduce the risk of blood clots developing following knee or hip replacement surgery. If you take antacids in the first twenty-four hours following surgery, your dabigatran treatment may not be as effective. Take this medication with meals if you find that it causes stomach distress for you while you are taking it.

Take the capsules as directed with a full glass of water (8 ounces/240 milliliters). Swallow the pills in their whole. Do not chew the capsules, smash them, or open them in any other way. This can cause the medicine to be released all at once, which raises the likelihood of experiencing adverse effects. Do not place this medication in a pill box or another container designed to remind you to take medication. In order to prevent it from becoming ruined by moisture, the bottle it came in (or the blister pack it came in) should be kept tightly closed at all times. Please refer to the Storage section for other essential details.

Your medical condition, renal function, reaction to treatment, and the potential presence of other medications all play a role in determining the appropriate dosage for you. Make sure to inform both your primary care physician and your pharmacist about all of the products you use (including prescription drugs, nonprescription drugs, and herbal products). When it comes to youngsters, the dosage is determined by the child’s age as well as their weight.

Make sure you take this medication as directed for it to have the desired effect. Take it at the same time(s) every day so that you won’t forget when to take it.

It is very crucial to take it in the manner that has been specifically directed. Take this medication exactly as prescribed, and under no circumstances should the recommended dose be increased or altered. It is important that you speak with your healthcare provider before discontinuing the use of this medicine.

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Side Effects

There is a possibility that you will experience stomach discomfort, heartburn, easy bruising, mild bleeding (such as bleeding from cuts or nosebleeds), or easy bruising. Notify your doctor or pharmacist as soon as possible if any of these side effects continue or become worse.

Keep in mind that the reason your doctor has recommended that you take this medication is that he or she believes that the potential benefits to you outweigh the potential risks of doing so. The majority of persons who take this medicine do not report experiencing any severe adverse effects.

If this drug has too much of an effect on the blood clotting proteins in your body, you could experience significant bleeding. Notify your physician as soon as possible if you experience any of the following symptoms: severe pain, swelling, or discomfort; unusual or easy bruising; prolonged bleeding from cuts or gums; persistent or frequent nosebleeds; unusually heavy or prolonged menstrual flow; pink or dark urine; coughing up blood; vomiting that is bloody or looks like coffee grounds; severe headache; dizziness or fainting; unusual or persistent tiredness or weakness; bloody, black, or tarry stools.

Notify your physician as soon as possible if you experience any major adverse effects, such as discomfort in the stomach or the abdomen, severe heartburn, nausea, or vomiting, unusual exhaustion, dark urine, or yellowing of the eyes or skin.

It is quite unusual for this medicine to cause an extremely severe allergic reaction. However, you should seek immediate medical attention if you observe any symptoms of a major allergic response, such as a rash, itching/swelling (particularly of the face/tongue/throat), severe dizziness, or difficulty breathing. These symptoms include:

This list of potential adverse effects is not exhaustive in any way. Please consult your physician or pharmacist if you have any side effects that are not listed above.

In the United States, if you are experiencing any adverse effects, please consult your primary care physician. You can call the FDA at 1-800-FDA-1088 or visit their website at www.fda.gov/medwatch to report any adverse effects.

In Canada, if you are experiencing any adverse effects, please consult your primary care physician. You can call Health Canada at 1-866-234-2345 to report any adverse effects you experience.

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Precautions

Inform your doctor or pharmacist that you are allergic to dabigatran, as well as if you have any additional allergies, before beginning treatment with dabigatran. There is a possibility that this product contains inactive substances, which, if present, could result in allergic responses or other complications. Discuss the matter further with your pharmacist for further information.

Before beginning treatment with this medication, it is important to discuss your medical history with your doctor or pharmacist, particularly if you have a mechanical heart valve, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), liver disease, a recent major injury or surgery, stroke, a particular clotting disorder (antiphospholipid syndrome), or a history of frequent falls or injuries.

It is essential that all of your medical professionals, including your dentist, are aware that you take dabigatran. Tell your surgeon or dentist that you are currently taking this medication, and provide them a complete list of all the products that you use, before undergoing any kind of medical or dental operation (including prescription drugs, nonprescription drugs, and herbal products). Before undergoing surgery, your physician may instruct you to cease using this drug. Always give great attention to the directions that your doctor gives you.

Steer clear of receiving injections into the muscles at all costs. In the event that you are required to receive an injection into the muscle (for instance, a flu shot), ask that it be administered in the arm. It will be less of a hassle to check for bleeding and/or apply pressure bandages if you do it this way.

This medicine could potentially cause bleeding in the stomach. Consuming alcohol on a regular basis while you are on this medication may raise the risk of gastrointestinal bleeding. Reduce your intake of alcoholic beverages. Inquire with your healthcare provider or pharmacist about the maximum amount of alcohol that you can safely consume.

This medicine has the potential to induce significant bleeding. Be careful when using sharp devices such as razors and nail cutters, and stay away from activities such as contact sports if you want to reduce your risk of becoming cut, bruised, or otherwise harmed. When you shave, use an electronic razor, and when you clean your teeth, use a toothbrush with a gentle bristle. In the event that you trip and injure yourself, particularly if you strike your head, you should contact your physician as soon as possible. It’s possible that your doctor wants to check you out.

When using this medication, people of advanced age may be at a greater risk of bleeding.

During pregnancy, it is important to only use this drug when it is absolutely necessary. A pregnant woman, her unborn child, and her newborn child may all have an increased risk of bleeding if dabigatran is used during pregnancy. Talk to your healthcare provider about the potential drawbacks and advantages. During your pregnancy, your doctor can recommend a different kind of medication for you to take.

There is no evidence to suggest that this medicine makes its way into breast milk. Before you start nursing, you should talk to your primary care provider.

Interactions

Drug interactions can alter the way in which your prescriptions work or raise the likelihood that you will have major adverse effects. This document does not contain all possible medication interactions. Maintain a list of all the goods you use, including prescription and over-the-counter medications, as well as herbal remedies, and give it to both your primary care physician and your pharmacist. Without first consulting your physician, you should never alter the dosage of any medication, stop taking any medication, or start taking any new medication.

Mifepristone is an example of a drug that has the potential to interact negatively with this medication.

The elimination of dabigatran from your body can be impacted by the use of other medications, which may have an effect on how well dabigatran works. Several examples of this would include the medications cobicistat, cyclosporine, dronedarone, ketoconazole, rifampin, and St. John’s wort.

There is a possibility that aspirin, aspirin-like medications (salicylates), and nonsteroidal anti-inflammatory drugs (NSAIDs including ibuprofen, naproxen, and celecoxib) have effects that are comparable to those of dabigatran. If taken at the same time as dabigatran treatment, these medications might make the risk of bleeding complications higher. Because some prescription and over-the-counter treatments, as well as topical medications that are applied to the skin, such as pain-relieving creams, may contain NSAIDs or salicylates, it is important to thoroughly examine the labels of all such items. Talk to your primary care provider about the possibility of switching to a different pain reliever or fever reducer, such as acetaminophen. Ask your physician if you should continue taking the low-dose aspirin and related drugs (such as clopidogrel, and ticlopidine) that have been prescribed to you for specific medical reasons, such as the prevention of heart attack or stroke. Your doctor will be able to tell you whether or not you should continue taking these medications. For further information, please speak with either your physician or pharmacist.

Overdose

 

You should call 911 if you or someone you know has overdosed and is experiencing dangerous symptoms such as passing out or having difficulties breathing. In any other case, you should immediately contact a poison control center. To reach the poison control center for your area in the United States, dial 1-800-222-1222. Canadian residents can call a provincial poison control center. There is a possibility that an overdose will cause symptoms such as bloody, black, or tarry stools, pink or dark urine, and unusual or persistent bleeding.

Warnings

This drug should not be given to anyone else.

It is possible that you will be subjected to periodic laboratory and/or medical tests (including evaluations of your kidney and liver function, as well as your clotting times), in order to track your progress and identify any potential adverse reactions. Consult your doctor for additional details.

Neglected Dose

If you forget to take a dose, you should take it as soon as you realize you forgot. Do not take the missed dose if it will be less than six hours until the next scheduled dose. Your next dose should be taken at the typical time. It is not necessary to double the dose in order to catch up.

Storage

Please also see the section titled “How to Use.”

Keep at room temperature and away from light and moisture. Store at room temperature. Keep away from the bathroom at all costs. Always store this medication in the container it came in. Do not place this medication in a pill box or another container designed to remind you to take medication. Never open more than one bottle at a time, and any medication that has been taken from an opened bottle must be discarded after a period of four months. If your capsules come in blister packaging, you should leave them there until you are ready to take the medication. Do not remove the capsules from the blister package. Always make sure that children and animals are kept well away from any medications.

Unless you have been specifically told to do so, you should not flush drugs down the toilet or pour them down a drain. When it is no longer needed or has passed its expiration date, dispose of this product in the appropriate manner. Talk to your neighborhood pharmacy or the firm that handles garbage disposal in your area.