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Dabigatran Etexilate Mesilate

Dabigatran

Dabigatran is an anticoagulant that is only available with your doctor’s prescription. This drug is used to prevent stroke and fatal blood clots in your legs and lungs, especially if your heart rhythm is irregular (atrial fibrillation). Dabigatran also reduces the risk of these blood clots from recurring again. While the medication is suitable for both adults and children, its dosage may vary from patient to patient, according to their body needs and the severity of the condition. Therefore, you are advised to adhere to your doctor’s instructions to prevent future complications. The wrong use of this drug may result in severe side effects, so be cautious while taking this medication.

Product Overview

Dabigatran is widely used to prevent blood clots and reduce the risk of stroke in patients with atrial fibrillation or irregular heartbeats. This drug is widely recognized under the brand name Pradaxa. This newer drug is only available with your healthcare provider’s prescription. Dabigatran can also be used to reduce the risk of stroke in patients due to its anticoagulant properties.

Available in strengths of 75 mg, 110 mg, and 150 mg, the medication should be taken orally, typically twice daily with a full glass of water, with or without food. It is important to swallow the capsules whole without crushing or chewing. This medication is suitable for adults & children but should be used with caution in patients with certain medical conditions, such as kidney problems. Dabigatran works by blocking thrombin activity, thus preventing the formation of blood clots and ensuring smooth blood flow.

Besides its benefits, the drug also has some side effects, which include digestive issues such as nausea, indigestion, and stomach pain. Patients may also experience bleeding or bruising more easily. It is crucial to inform your healthcare provider if you notice any unusual bleeding or other severe reactions. Additionally, there are certain things that people need to follow while taking this medication, such as avoiding activities that may increase the risk of injury or bleeding. Do not share your medicine with any patient. If a dose is missed, take it as soon as possible unless it is almost time for the next dose. In case of overdose, seek immediate medical attention. Store Dabigatran at room temperature, away from moisture and heat, and keep it out of reach of children.

Uses of Dabigatran 

It is used for:

  • Treating & preventing blood clots after a hip replacement surgery.
  • Preventing stroke in patients with atrial fibrillation without a heart valve issue.
  • Preventing blood clots from occurring again.

How to Use Dabigatran?

Dosage

Strengths and Forms

Dabigatran is available in the following strengths:

  • 75mg
  • 110mg
  • 150mg

Recommended Dosage for Different Patients

For Prevention of Stroke & Blood Clots in Patients with Nonvalvular Fibrillation

  • Adults: 75 to 150 mg twice daily.
  • Children: As determined by a doctor.

For the Prevention of Blood Clots, Post Hip Replacement Surgery

  • Adults: Take 110 mg 1 to 4 hours after your surgery. Then, 220 mg for 28 to 35 days once daily.
  • Children: As recommended by a medical professional

For Treatment & Prevention of Blood Clots from Occurring Again

  • Adults: Take 150 mg twice a day.
  • Children (8 Years & Above): The dose depends on the body weight, which is as follows:
    • More Than 81 Kg: 260 mg twice daily.
    • 61 Kg to Less Than 81 Kg: 220 mg twice daily.
    • 41 Kg to Less Than 61 Kg: 185 mg twice daily.
    • 26 Kg to Less Than 41 Kg: 150 mg twice daily
    • 16 Kg to Less Than 26 Kg: 110 mg twice daily.
    • 11 Kg to Less Than 16 Kg: 75 mg twice daily.

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

How to Take It?

  • Take the medication by mouth, with or without food, as instructed by your healthcare provider.
  • For children, take the first dose in the morning and the second in the evening, keeping a 12-hour interval.
  • If you are experiencing an upset stomach while taking this medication, take it with any food.
  • Swallow the capsules as a whole with a glass of water to let them absorb easily.
  • Do not crush, chew, or break them, as it can release the drug all at once, causing severe side effects.
  • Read the Patient’s Information Leaflet before taking this medicine for detailed information.
  • Follow the guidelines as advised by your medical professional.
  • Take the medicines at the same time daily for effective results.
  • Do not skip your doses.
  • If you are facing any problems while swallowing the medication, inform your doctor.

[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 Dabigatran Work?

Dabigatran works by directly restricting thrombin, an enzyme crucial for blood clot formation. By blocking this enzyme, Dabigatran prevents the conversion of fibrinogen to fibrin, a key component in blood clots. This action helps reduce the risk of clot-related conditions such as stroke and deep vein thrombosis. As an anticoagulant, this drug ensures smoother blood flow and reduces the chances of fatal clot formation, making it effective in managing and preventing various thromboembolic disorders.

Important Safety Information

Side Effects

Common side effects of Dabigatran may include:

  • Indigestion
  • Heartburn
  • Stomach pain
  • Diarrhea
  • Bruises
  • Minor nose bleeding
  • Intracranial hemorrhage
  • Hypersensitivity
  • Nausea
  • Vomiting
  • Difficulty in breathing
  • Dizziness
  • Rash 
  • Itching
  • Belching

Serious side effects of Dabigatran may include:

  • Skin swelling
  • Esophageal ulcers
  • Low blood platelets
  • Chest pain
  • Vision changes
  • Trouble in speaking
  • Numbness of the face, arm, and leg
  • Brown or pink urine
  • Tarry stools
  • Blood cough
  • Heavy menstrual bleeding
  • Gum bleeding
  • Joint pain

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

Warnings

  • Bleeding Problem: If you have an active bleeding problem, consult with your doctor once. They probably won’t prescribe this drug in such conditions as it can make it harder for the drug to treat a bleed that is already happening. Inform your doctor if you have issues like hemophilia. 
  • Antiphospholipid Syndrome: Doctors usually don’t prescribe this medication if a patient is suffering from a rare condition called triple-positive antiphospholipid syndrome, as it can increase the risk of blood clots in the patient’s body. Talk with your medical professional before taking this medication. They will suggest safer alternative treatments. 
  • Kidney Problems: Avoid using Dabigatran if you are a patient with Chronic Kidney Disease (CKD). This condition can cause the accumulation of drug levels in your body, increasing the risk of bleeding and severe side effects.
  • Mechanical Heart Valve: According to various studies, Pradaxa is likely to cause blood clots in people with mechanical heart valves. To avoid any future complications, discuss the risks with your doctor and ask them for better and safer options.
  • Stomach Ulcer: If you have a stomach ulcer, let your doctor know before you start Pradaxa, as it can cause your ulcer to bleed excessively. 

Boxed Warning

Pradaxa has boxed warnings as the drug has a high chance of forming blood clots, named hematomas, in or around your spine. Such conditions may occur if you receive an epidural injection into or around your spine. Patients using this drug should remain cautious as it can even lead to paralysis in rare cases. If you are undergoing surgery, doctors might make you stop taking this drug temporarily. So, you are advised to seek medical assistance before starting your treatment with Dabigatran. These experts can tell you when to stop or continue the drug after your surgery.

Precautions

  • Before starting Dabigatran treatment, inform your doctor about any allergies you have or if you are allergic to any of the medication’s ingredients. The product may contain certain inactive ingredients that can cause severe allergic reactions.
  • If you are undergoing any medical surgery or procedure, talk to your healthcare provider about every product you are using, including prescription or nonprescription drugs and herbal products.
  • Do not forget to inform your doctor about any medical history you may have, especially kidney problems, active bleeding, mechanical heart valve, liver problems, any injury, stroke, or a clotting disorder (antiphospholipid syndrome).
  • Do not consume alcohol, as the drug can cause stomach bleeding, which can exacerbate with daily consumption of such substances. 
  • Use caution while using sharp objects such as razors, nail cutters, knives, and activities like contact sports such as Dabigatran, which can cause excessive bleeding. Avoid getting cut, bruised, or injured with such objects.
  • Consult with a medical provider if you are using this drug while pregnant or planning to become one. Discuss every risk and benefit before beginning the treatment.
  • Avoid breastfeeding while using this drug as it passes into the breast milk. Consult with an expert before making any decision.
  • Do not alter or stop taking the medication without discussing it with your doctor. Failing to do so can result in an increased risk of blood clots. Your healthcare provider will prescribe you a different blood thinning medication to reduce this risk.
  • Contact your medical practitioner if you are experiencing weakness or numbness in one of your bodies, difficulty speaking or breathing, chest pain, vision changes, or swelling in the legs. 

Contraindications

Dabigatran is contraindicated in patients with:

  • Severe renal issues, with CrCl below 15 mL/minute.
  • Hypersensitivity
  • Active pathologic bleeding
  • Hemostasis problems
  • Mechanical prosthetic heart valves

Missed Dose

  • If you forget a dose, take it whenever you remember.
  • If it is almost time for the next one, avoid taking the missed dose and continue with your regular dosing schedule.
  • Do not take double doses at once.
  • If there is less than 6 hours before your next dose, do not take the missed one.
  • Take your doses at the same time each day for better results.
  • Install medication apps or set reminders to avoid skipping your medicines.

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

Overdose

When taking Pradaxa, it is essential to stick to the dosage as instructed by your healthcare practitioner. Do not overdose on any medications. If you have mistakenly taken too much of your prescribed doses and are experiencing symptoms, call a medical emergency or 911 immediately. Symptoms of an overdose may include:

  • Unusual bleeding or bruising
  • Pink/brown urine
  • Red or black, tarry stools
  • Vomiting
  • Blood cough

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

Storage

  • Store the medication at room temperature.
  • Do not keep the medicines in a pill box or any other box; keep it in the original container.
  • Use the medicines within 4 months as soon as you open the bottle. Do not use it after 4 months.
  • Discard the product once it has passed its expiration date.
  • Do not flush it down the toilet.
  • Avoid the medication from freezing.
  • Keep it out of reach from children and pets.
  • Ask your doctor/pharmacist how you should dispose of the product properly.
  • Keep it away from the direct light and heat.
  • Do not keep the medication in moist areas like the bathroom or near the sinks.

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

Dabigatran Interactions

Inform your healthcare practitioner about your current medications if you are using Dabigatran, as you don’t know which drugs might interact with each other and cause adverse reactions. Some of these drugs are:

  • Acetylsalicylic acid 
  • Ardeparin
  • Argatroban
  • Asciminib
  • Aspirin
  • Atorvastatin
  • Bosutinib
  • Brigatinib
  • Bromfenac
  • Cyclosporine
  • Carbamazepine
  • Carvedilol
  • Celecoxib
  • Dronedarone
  • Dexamethasone
  • Deoxycholic Acid
  • Dexfenfluramine
  • Dexlansoprazole
  • Flurbiprofen
  • Fluoxetine
  • Hemin
  • Heparin
  • Ibrutinib
  • Ibuprofen
  • Ketoconazole
  • Ketoprofen
  • Lomitapide
  • Lonafarnib
  • Magnesium oxide
  • Magnesium salicylate
  • Nepafenac ophthalmic
  • Neratinib
  • Omacetaxine
  • Omega-3 polyunsaturated fatty acids
  • Phenytoin
  • Piroxicam
  • Quinidine
  • Ritonavir
  • Rivaroxaban
  • Rifampin
  • Salsalate 
  • Tolvaptan
  • Tositumomab
  • Treprostinil
  • Ulipristal
  • Venetoclax
  • Venlafaxine
  • Warfarin

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

Dabigatran Alternatives

[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 there any difference between Dabigatran & Warfarin?

Yes, there is a difference between Dabigatran and Warfarin. Dabigatran is a direct thrombin inhibitor. It works by directly blocking thrombin to prevent blood clot formation. In contrast, Warfarin is a vitamin K antagonist, which reduces the production of clotting factors. Dabigatran has fewer dietary restrictions and does not require regular blood monitoring, unlike Warfarin, which requires frequent International Normalised Ratio (INR) blood checks and dietary management to ensure safe and effective dosing.

Can I use Dabigatran for the long term?

Using Dabigatran for a longer duration may depend on the type of blood clot a patient has, but the minimum duration doctors prescribe this medication is 3 months. Additionally, if you have atrial fibrillation, this drug is recommended for extended use to prevent stroke and other clot-related issues. Long-term use requires regular follow-ups with your healthcare provider to monitor your health and ensure the medication’s effectiveness and safety. 

Which foods are restricted while taking Dabigatran?

Unlike other anticoagulants, Dabigatran does not have any specific dietary restrictions. However, it is still important to maintain a balanced diet and avoid excessive alcohol intake, as this can increase the risk of bleeding. Also, inform your doctor about any supplements or herbal products you are taking, as some may interact with your medication. 

I have a BP issue. Can I take Dabigatran?

There is no scientific reason that advises against taking this medication with BP issues. So, if you have high blood pressure, you can generally take Dabigatran, but it is essential to manage your BP effectively. Uncontrolled high BP can increase the risk of bleeding, a potential side effect of this product. However, consult with an expert first before making any decision.

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