Dabigatran 

Pradaxa

Pradaxa, or Dabigatran, is a medicine approved by the FDA. It is a prescription medication used to treat blood clots deep in the body and lungs for adults who get injections of blood thinners for 5 to 10 days. Dabigatran, the active ingredient, comes in a group of medicines called direct thrombin inhibitors. It is especially effective for those with atrial fibrillation, as it reduces the risk of stroke and blood clots. Pradaxa comes in capsule form and is taken orally, with dosages varying based on age, weight, and specific medical conditions. Common side effects include bruising, abdominal pain, and mild bleeding. It’s important to follow your healthcare provider’s instructions carefully when taking Pradaxa, as it can increase the risk of bleeding and interact with other medications.

Product Overview

Pradaxa, also known as Dabigatran, is a medicine approved by the FDA that stops blood clots from forming. It is a prescription medication used primarily to prevent and treat blood clots in individuals ranging from children as young as 3 months to adults. It is particularly useful for patients with atrial fibrillation, a heart rhythm issue not related to heart valve problems, as it significantly lowers the risk of stroke and blood clot formation. The medication comes in capsule form and is available in various strengths, including 75 mg, 110 mg, and 150 mg. The recommended dosage of Pradaxa varies based on the patient’s age, weight, and specific medical conditions. 

For adults with nonvalvular atrial fibrillation, the usual dosage is 75-150 mg taken two times a day. In the case of preventing blood clots after hip replacement surgery, adults typically take 110 mg shortly after surgery, followed by 220 mg once daily for 28-35 days. Children’s dosages are determined by their healthcare provider and are based on their weight. Common side effects of Pradaxa include bruising more easily, upper abdominal pain, mild bleeding, upset stomach, and heartburn. More serious side effects can occur, such as significant bleeding, blood clots after stopping treatment, and severe allergic reactions. 

It’s crucial to follow the prescribed dosage and schedule and consult your healthcare provider if you experience any unusual or severe side effects. Pradaxa can interact with other medications, so it’s important to inform your healthcare provider about all medicines, supplements, and herbal products you are taking. Regular check-ups are necessary to monitor your progress and adjust the treatment plan if needed. Pradaxa is a vital medication for many patients, but it requires careful management to ensure its effectiveness and safety.

Uses of Pradaxa

• Pradaxa helps children (3 months to less than 18 years old) with blood clots, especially if they’ve been treated with another blood thinner for at least 5 days. 
• It’s also used in adults and kids to prevent blood clots from coming back after earlier treatment. 
• After hip replacement surgery, Pradaxa is used to avoid deep vein thrombosis (DVT) or pulmonary embolism (PE). 
• In adults with atrial fibrillation (a heart rhythm issue not caused by a heart valve problem), Pradaxa lowers the risk of stroke and blood clots.

How to Use Pradaxa?

Dosage

Pradaxa capsules can be taken orally and available in the following strengths:

• Pradaxa 75 mg capsules
• Pradaxa 110 mg capsules
• Pradaxa 150 mg capsules

Recommended Dosage for Different Patients

For Capsules

Preventing Stroke and Blood Clots in Nonvalvular Atrial Fibrillation:

• Adults: Take 75-150 mg two times a day.
• Children: Follow your doctor’s instructions.

Preventing Blood Clots After Hip Replacement Surgery:

• Adults: Take 110 mg 1-4 hours after surgery, followed by 220 mg once daily for 28-35 days.
• Children: Follow your doctor’s instructions.

Treatment and Prevention of Blood Clots:

• Adults: Take 150 mg two times a day.
• For children 8 years and older, the dose depends on weight, so follow your doctor’s guidance.

Weight-based Dosage for Children:

• Over 81 kg: 260 mg two times a day.
• 61-80 kg: 220 mg two times a day.
• 41-60 kg: 185 mg two times a day.
• 26-40 kg: 150 mg two times a day.
• 16-25 kg: 110 mg two times a day.
• 11-15 kg: 75 mg two times a day.

For Pellets

Treatment and Prevention of Blood Clots:

• Children 2-12 years: Dosage based on weight; follow your doctor’s guidance.

Weight-based Dosage for Children:

• Over 41 kg: 260 mg two times a day.
• 21-40 kg: 220 mg two times a day.
• 16-20 kg: 170 mg two times a day.
• 13-15 kg: 140 mg two times a day.
• 11-12 kg: 110 mg two times a day.
• 9-11 kg: 90 mg two times a day.
• 7-9 kg: 70 mg two times a day.

Specific Dosages for Age and Weight:

• 18-24 months, 21-25 kg: 180 mg two times a day.
• 12-24 months, 16-20 kg: 140 mg two times a day.
• 11-24 months, 13-15 kg: 140 mg two times a day.
• 10-11 months, 11-13 kg: 100 mg two times a day.
• 18-24 months, 11-12 kg: 110 mg two times a day.
• 8-18 months, 9-11 kg: 100 mg two times a day.
• 11-24 months, 9-11 kg: 90 mg two times a day.
• 6-11 months, 8-11 kg: 80 mg two times a day.
• 5-6 months, 7-9 kg: 60 mg two times a day.
• 9-24 months, 7-9 kg: 70 mg two times a day.
• 4-9 months, 7-9 kg: 60 mg two times a day.
• 3-4 months, 5-7 kg: 50 mg two times a day.
• 5-24 months, 5-7 kg: 50 mg two times a day.
• 3-5 months, 3-4 kg: 40 mg two times a day.
• 3-10 months, 4-5 kg: 40 mg two times a day.
• 3-6 months, 3-4 kg: 30 mg two times a day.

[Note: Remember, these recommended doses may vary from person to person. Discuss it with your doctor or pharmacist, and they’ll customize your Pradaxa dosage accordingly.]

How to Take It?

• Follow the prescribed dosage and schedule for Pradaxa Capsules as instructed by your healthcare provider.
• Swallow Pradaxa capsules whole with a full glass of water; do not break, chew, or empty the pellets from the capsule.
• Take Pradaxa Capsules with or without food, as directed by your healthcare professional.
• If you miss a dose of Pradaxa Capsules, take it as soon as you remember unless it’s close to the next scheduled dose. In such cases, skip the missed dose and resume your regular dosing schedule.
• Do not alter your Pradaxa Capsules dosage without consulting your healthcare provider.
• Keep track of your Pradaxa capsule supply and refill your prescription in a timely manner to avoid interruptions in treatment.
• If you experience any unusual or severe side effects from Pradaxa Capsules, contact your healthcare provider promptly.
• Inform your healthcare provider about any other medications, supplements, or herbal products you are taking with Pradaxa Capsules, as they may interact with the prescribed medication.
• Attend regular check-ups with your healthcare provider to monitor your progress on Pradaxa Capsules and adjust the treatment plan if necessary.
• Ensure you take Pradaxa Capsules with a full glass of water to facilitate proper absorption.
• Avoid running out of Pradaxa Capsules; remember to refill your prescription before running out to maintain consistent and effective treatment.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Pradaxa Work?

Pradaxa works by sticking to thrombin, which is a key part of how blood clots form. This helps to slow down thrombin’s ability to create clots in the blood. So, using Pradaxa helps prevent clots from forming inside the blood vessels.

Important Safety Information

Side Effects

Common side effects of Pradaxa may include:

• Bruising More Easily
• Upper Abdominal Pain
• Mild Bleeding
• Upset Stomach
• Heartburn

Mild side effects of Pradaxa may include:

• Nausea
• Diarrhea
• Gastroesophageal Reflux Disease (GERD)
• Esophagus Mild Bleeding
• Mild Allergic Reaction

Serious side effects of Pradaxa may include:

• Serious Bleeding
• Blood Clot After Stopping Pradaxa Treatment
• Blood Clot in or near Your Spinal Column
• Severe Allergic Reaction

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

• Pradaxa can increase your risk of bleeding more frequently and easily. Call your doctor immediately if you experience abnormal bleeding from gums, nose, vagina, blood in urine and stool. 
• It can increase the risk of the formation of blood clots in and around your spinal column, especially if you underwent a spinal tap or received an epidural. This kind of blood clot may result in long-term or permanent paralysis. 
• Do not stop taking Pradaxa without consulting your doctor, as it may lead to adverse, life-threatening side effects such as blood clots and stroke.

Boxed Warning for Pradaxa 

• A boxed warning is the most severe warning given by the FDA. Pradaxa has a boxed warning for blood clots coming back if the medication is stopped abruptly and also for blood clots forming in and around your spinal column.

Precautions

• You should not take Pradaxa if you are allergic to any of its ingredients. 
• Do not take the medication if you have a prosthetic heart valve or active bleeding from an injury, surgery or due to some other cause. 
• Pradaxa may cause you to bleed even due to a minor injury. Call your doctor immediately if you are experiencing abnormal or severe bleeding. 
• Tell your doctor about your medical history, especially if you had or currently have any of the following conditions: a genetic spinal defect;
  • a thin tube (catheter) placed in your back to give you certain medicine
  • a history of problems with your spine or a spinal surgery
  • a history of difficult or repeated spinal taps
  • bleeding problems
  • a stomach ulcer or bleeding in your stomach or intestines
  • Take certain other medicines that can increase bleeding risk.
  • Antiphospholipid syndrome is an immune system disorder that increases the risk of blood clots.
  • plan for surgery, a medical or dental procedure, or kidney disease
• If you think you are pregnant or planning to get pregnant, let your doctor know, as taking Pradaxa during pregnancy may cause bleeding in the mother or baby. You should not breastfeed a baby while taking Pradaxa.

Missed Dose

• If you forget to take your medicine, take it as soon as you remember.
• But if it’s almost time for your next dose, don’t take the missed one; just continue with your regular schedule. Don’t take two doses together.
• If you have less than 6 hours before your next dose, skip the missed one and stick to your usual schedule.
• If you’ve only taken part of your oral pellet dose, wait at least 12 hours before taking the next dose. Don’t take another dose right away.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

If you take Pradaxa more than recommended, it can lead to excessive bleeding. If you think you may have overdosed on the Pradaxa medication, seek immediate medical assistance by calling 911 or heading to the nearest emergency room.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Storage

• Store Pradaxa at room temperature (68° F to 77° F or 20° C to 25° C).
• Use Pradaxa Capsules within 4 months after opening the bottle.
• Dispose of any Pradaxa Capsules you haven’t used after 4 months.
• Keep Pradaxa Capsules in the original bottle or blister package to prevent moisture exposure.
• Do not store Pradaxa Capsules in pill boxes or organizers.
• Immediately close the bottle tightly after taking your dose.
• Ensure Pradaxa Capsules and all medicines are kept out of the reach of children.
• Check expiration dates regularly and discard expired medication.
• Avoid exposure to extreme temperatures and direct sunlight.
• Store Pradaxa away from sources of humidity.
• Do not transfer Pradaxa Capsules to other containers without consulting your healthcare provider.
• Keep out of the reach of pets and children.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Pradaxa Interactions

• Enoxaparin
• Warfarin
• Apixaban
• Rifampin
• Clopidogrel
• Heparin
• Prasugrel
• Dronedarone
• Ibuprofen
• Dalteparin
• Naproxen
• Defibrotide
• Aspirin
• Ketoconazole
• Rivaroxaban

[Note: This isn’t a complete list, and there could be other drugs that interact with (drug name). Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Pradaxa Alternatives

• Eliquis (apixaban) 
• Xarelto (rivaroxaban) 
• Plavix (clopidogrel) 
• Warfarin (warfarin sodium) 
• Coumadin (warfarin sodium) 
• Apixaban (apixaban) 
• Dabigatran (dabigatran etexilate) 
• Rivaroxaban (rivaroxaban)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

Is Eliquis the same as Pradaxa?

Pradaxa and Eliquis are both brand-name medications used for similar purposes, but they contain different active ingredients. The active ingredient in Pradaxa is dabigatran, while Eliquis contains apixaban. The prices of Pradaxa and Eliquis are generally comparable.

Is Pradaxa used long-term?

Pradaxa is typically used as a long-term medication. If your doctor finds it suitable for you, you’ll probably use it for an extended period. However, there are exceptions, like after hip surgery, where you might only need Pradaxa for a short while. It’s important to follow your doctor’s advice on how long to take Pradaxa, as it can vary depending on your individual health needs.

How does Pradaxa make you feel?

Pradaxa is a medication that helps reduce the risk of harmful blood clots forming in your body. People taking Pradaxa might experience some common side effects, such as discomfort in the stomach, a burning feeling in the chest, or loose stools. It’s important to note that Pradaxa can also increase the risk of bleeding, which can be serious in certain cases. If you notice any unusual bleeding or have concerns about your symptoms, it’s crucial to speak with your healthcare provider for advice.

When is the best time to take Pradaxa?

Take Pradaxa consistently at the same time every day to achieve the most effective results. This routine helps you remember your dosage schedule. You can take this medication with or without food, as it does not affect its efficacy. Maintaining a consistent schedule ensures that the medication works optimally in your body.

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