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Pradaxa

Pradaxa

(dabigatran-etexilate)

Dabigatran belongs to the family of medications called anticoagulants. Anticoagulants prevent harmful Blood Clots from forming in the blood vessels by reducing the ability of the blood to clot.

Available form

Dosage

Capsule

75MG, 110MG, 150MG

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Pradaxa information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

For knee replacement surgery, the usual dose of dabigatran is 110 mg (one capsule) taken by mouth between 1 and 4 hours after the surgery, followed by 220 mg (2 capsules) once daily for a total of 10 days. If treatment is not started on the day of surgery, then treatment should be started with a dose of 220 mg once daily. For people over the age of 75, the doctor may recommend a lower dose of 150 mg taken once daily.

For hip replacement surgery, the usual dose of dabigatran is 110 mg (one capsule) taken by mouth between 1 and 4 hours after the surgery, followed by 220 mg (2 capsules) once daily for a total of 28 to 35 days. If treatment is not started on the day of surgery, then treatment should be started with a dose of 220 mg once daily.

To treat or prevent blood clots in the lungs or veins of your legs the usual dose is 300 mg taken as one 150 mg capsule twice daily following 5-10 days of treatment with an injectable blood thinner. For people over the age of 80, or those with a high risk of bleeding, the doctor may recommend a lower dose of 220 mg taken as one 110 mg capsule twice daily.

For stroke and clot prevention in people with atrial fibrillation, the usual dose is 300 mg taken as one 150 mg capsule twice daily. For people over the age of 80, or those with a high risk of bleeding, the doctor may recommend a lower dose of 220 mg taken as one 110 mg capsule twice daily.

Dabigatran may be taken with food or on an empty stomach, with a full glass of water. If you experience heartburn or upset stomach, take dabigatran with food. Swallow the capsules whole. Do not open, break, or chew the capsules.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Pradaxa (Dabigatran-etexilate) be taken exactly as prescribed by your doctor. If you stop Pradaxa (Dabigatran-etexilate) before your doctor advises you to, your risk of developing blood clots may increase.

For hip or knee replacement surgery: if you miss a dose, skip the missed dose and continue with your regular dosing schedule.
For treatment or prevention of blood clots in the lungs or veins of your legs: if you miss a dose, and there are more than 6 hours before your next dose, take the missed dose and continue with your regular dosing schedule. If there are less than 6 hours before your next dose, skip the missed dose and continue with your regular dosing schedule.
For treatment of atrial fibrillation: if you miss a dose, and there are more than 6 hours before your next dose, take the missed dose and continue with your regular dosing schedule. If there are less than 6 hours before your next dose, skip the missed dose and continue with your regular dosing schedule.

Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Pradaxa (Dabigatran-etexilate) at room temperature in its original package, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Pradaxa (Dabigatran-etexilate). If you are concerned about side effects, discuss the risks and benefits of Pradaxa (Dabigatran-etexilate) with your doctor.

The following side effects have been reported by at least 1% of people taking Pradaxa (Dabigatran-etexilate). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

bruising (mild)
Diarrhea
difficulty swallowing
hair loss
heartburn/reflux
nausea
stomach pain
upset stomach
vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

oozing from the surgical wound
joint pain or swelling
signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding, bleeding in the rectum or from hemorrhoids, bleeding from where a catheter enters a vein)
signs of infection (e.g., Fever, chills, cough, difficulty breathing, unusual fatigue)
skin rash
symptoms of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, itching)
symptoms of unidentified bleeding (e.g., weakness, paleness, dizziness, headache, unexplained swelling)

Stop taking the medication and seek immediate medical attention if any of the following occur:

bleeding (severe) from a surgical wound
signs of a serious allergic reaction (i.e., Hives, difficulty breathing, or swelling of the face and throat)
signs of bleeding in the stomach or digestive system (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Pradaxa (Dabigatran-etexilate).

There may be an interaction between dabigatran and any of the following:

acetylsalicylic acid (Asa)
alteplase
Amiodarone
antacids (e.g., aluminum hydroxide, sodium bicarbonate, calcium or magnesium compounds)
Apalutamide
Apixaban
argatroban
"azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole)
Carbamazepine
Carvedilol
Clopidogrel
Cobicistat
Cyclosporine
Deferasirox
Dipyridamole
Dronedarone
Edoxaban
Eliglustat
estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
Flibanserin
garlic
ginger
ginkgo biloba
ginseng
heparin
Hepatitis C antivirals (e.g., daclatasvir, glecaprevir and pibrentasvir, ledipasvir, velpatasvir)
HIV protease inhibitors (e.g., nelfinavir, ritonavir, saquinavir)
Ivacaftor
low molecular weight heparins (e.g., Dalteparin, enoxaparin, Tinzaparin)
lumacaftor and ivacaftor
macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
mifepristone
nonsteroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
Obinutuzumab
omega-3 fatty acids
Phenobarbital
Phenytoin
Prasugrel
primidone
progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
protein kinase inhibitors (e.g., Dasatinib, Crizotinib, Lapatinib, Nilotinib)
proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
quinidine
quinine
rifampin
Rivaroxaban
St. John's wort
selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
serotonin-norepinephrine reuptake inhibitors (SNRIs; Desvenlafaxine, Duloxetine, Venlafaxine)
"statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
Tacrolimus
Ticagrelor
Ticlopidine
Verapamil
vitamin E
vorapaxar
warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Pradaxa (Dabigatran-etexilate). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Pradaxa (Dabigatran-etexilate).

Heart valves: Bleeding events, such as strokes, have been reported to occur when dabigatran is used by someone who has a replacement heart valve. If you have had surgery to replace or repair a heart valve, discuss with your doctor how Pradaxa (Dabigatran-etexilate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pradaxa (Dabigatran-etexilate), and whether any special monitoring is needed.

Increased bleeding risk: If you have an increased risk of bleeding (e.g., recent biopsy; major trauma; brain, spinal, or eye surgery; taking medications that increase the risk of bleeding; bleeding disorders; stomach or intestinal ulcers; stroke; or inflammation of certain parts of the heart), discuss with your doctor how Pradaxa (Dabigatran-etexilate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pradaxa (Dabigatran-etexilate), and whether any special monitoring is needed. Pradaxa (Dabigatran-etexilate) is not recommended for people who are at a high risk of bleeding.

Kidney function: Kidney Disease or reduced kidney function may cause Pradaxa (Dabigatran-etexilate) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Pradaxa (Dabigatran-etexilate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pradaxa (Dabigatran-etexilate), and whether any special monitoring is needed. Pradaxa (Dabigatran-etexilate) is not recommended for people with severely decreased kidney function.

Liver function: Dabigatran may cause liver problems. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately. If you have liver disease, discuss with your doctor how Pradaxa (Dabigatran-etexilate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pradaxa (Dabigatran-etexilate), and whether any special monitoring is needed.

Spinal or epidural catheters: Pradaxa (Dabigatran-etexilate) should not be taken by people who have spinal or epidural catheters in place (or for 2 hours after their removal) or by people receiving pain medications through an epidural catheter.

Surgery: Your doctor may want to stop dabigatran for a few days prior to any planned surgery to prevent any unnecessary bleeding, so it is important to tell all of your doctors that you are taking dabigatran.

Pregnancy: Pradaxa (Dabigatran-etexilate) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Pradaxa (Dabigatran-etexilate), contact your doctor immediately.

Breast-feeding: It is not known if dabigatran passes into breast milk. If you are a breast-feeding mother and are taking Pradaxa (Dabigatran-etexilate), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Pradaxa (Dabigatran-etexilate) have not been established for children less than 18 years of age.

Seniors: Seniors are more likely to have age-related reductions in kidney function. Your doctor may adjust your dose based on your kidney function.

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