Pradaxa

Pradaxa is part of the drug class known as direct thrombin inhibitors. It is considered an anticoagulant and is also known as a blood thinner. It works by stopping blood clots from forming in your body, which will make it less likely for you to have a stroke.

Follow all directions and drug information given by your doctor and read the Full Prescribing Information and FDA-approved product labeling, patient information, instructions for use, and Medication Guide before using Pradaxa. In addition, follow your doctor's instructions about any restrictions on food, beverages, or activities.

Pradaxa is typically taken once or twice daily. You can take it with or without food, but you must swallow the capsules whole with a full glass of water. Your dose may change depending on which condition you are treating it for, your kidney function, and your response to treatment. If a dose is missed, take the missed dose as soon as you remember unless it is closer to the time of your next dose, in which case skip this dose, and then you can take the next dose at your normal time.

Call your doctor if you hit your head; they may want to check for a brain bleed. Do not stop taking Pradaxa without your doctor’s approval as you have an increased risk of developing a blood clot.

The most common side effects of Pradaxa seen in clinical trials as compared to placebo include:

• Upset stomach
• Stomach pain
• Acid reflux (heartburn)
• Increased bleeding
• Gastrointestinal bleeding

Some individuals may experience serious side effects while using Pradaxa. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Major bleeding. Call your healthcare provider immediately if you believe you may have major bleeding, which could include:
• Unexpected or a lot of bleeding, such as
• Unusual bleeding from the gums
• Nose bleeds
• Heavy menstrual bleeding
• Pink or brown urine
• Red or black stools (looks like tar)
• Cough up blood or blood clots
• Vomiting blood or your vomit looks like “coffee grounds.”
• Brain bleeding
• Allergic reactions

Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Pradaxa. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before starting Pradaxa, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Other blood thinners such as heparin, clopidogrel, enoxaparin, and prasugrel.
• Dronedarone
• Ketoconazole
• Rifampin
• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen

Boxed warnings

Do not discontinue Pradaxa before it is indicated to do so. Early discontinuation will make stroke and blood clots more likely.

Epidural or spinal hematomas may occur if you are undergoing neuraxial anesthesia or spinal puncture. These types of hematomas have a probability of resulting in permanent or long-term paralysis. Treat immediately if any neurological impairment is observed.

You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Kidney problems
• Ever had bleeding problems
• You are allergic to or have had an allergic reaction to any ingredient in Pradaxa
• Ever had stomach ulcers
• Antiphospholipid syndrome (APS)
• A pregnancy, plan to become pregnant, or are breastfeeding
• If you can become pregnant, you should talk to your doctor about pregnancy planning.
• Or plan on breastfeediing.
• An epidural catheter. Your bleeding risk might be higher.

Pradaxa (dabigatran), an oral anticoagulant, typically begins working within 1 to 3 hours after taking the first dose. This timeframe is when the medication reaches its peak blood concentration and starts effectively inhibiting thrombin, which is key to preventing blood clots.

When Pradaxa is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other blood thinners such as heparin, clopidogrel, enoxaparin, and prasugrel.
• Dronedarone
• Ketoconazole
• Rifampin
• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen

Pradaxa comes in capsules with the following strengths:

• 75 mg
• 110 mg
• 150 mg

Store Pradaxa at room temperature. After the bottle has been opened, use Pradaxa capsules within four months. After they have expired, throw them away.

Pradaxa (dabigatran etexilate) is an oral capsule that is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc

Yes, there are generics available for Pradaxa in the United States.

Don't stop taking Pradaxa unless a healthcare professional specifically tells you it's safe to do so. Stopping the medication too early can cause blood clots to form in your body.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Breastfeeding is not recommended if you are taking Pradaxa. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend the best way to feed your infant.