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Pradaxa

Generic Name: Dabigatran etexilate
Product Name: Pradaxa

Indication of Pradaxa

Pradaxa may be prescribed to individuals who have a high risk of stroke (a blood clot in the brain) or systemic embolism (a blood clot in any arteries which disrupts blood flow). People are only prescribed Pradaxa to prevent stroke if they have a condition called atrial fibrillation (an irregular heartbeat) and at least one additional risk factor for having a stroke.

Pradaxa is also an anticoagulant or blood-thinning medication. It is used to prevent thromboembolic events (that is, the formation of blood clots which can block the veins or arteries and impair blood flow). Individuals who have a high risk of developing blood clots may be prescribed Pradaxa.

These individuals include people ≥ 18 years of age who have undergone major surgery involving their legs (e.g. a knee or hip replacement). Because mobility is impaired after major leg surgery, the risk of blood clots forming increases, placing these individuals at risk of thromboembolic events.

Action of Pradaxa

Pradaxa is an anticoagulant, that is, a medicine that thins the blood. The active ingredient in Pradaxa, dabigatran etexilate, is called a prodrug, which means that it does not have an effect on the body. Rather, once it enters the body it must be broken down into other substances which affect the body.

Dabigatran etexilate is broken down to form dabigatran. Dabigatran interacts with a component of the blood called thrombin, which is responsible for forming clots in the blood. Dabigatran impairs thrombin’s blood clotting function. In doing so, it thins the blood and reduces the likelihood of blood clots forming which can block the veins and arteries.

Dose advice of Pradaxa

Dose information

Pradaxa capsules should be swallowed with a full glass of water. They may be taken with or without food. Always swallow the capsules whole. They should not be chewed, broken or opened, as this may increase your risk of bleeding.

Take care when removing the capsules from their packaging. If the capsules are blister-packed, do not push them through the foil. Peel back the foil before attempting to remove the capsules.

The correct dose depends on the reason for taking Pradaxa therapy. Always take the dose prescribed by your doctor.


Post-operative indications

Initiating treatment

If you are prescribed Pradaxa because you have had major leg surgery, you should usually start taking the capsules 1–4 hours after the surgery finishes. The doctor will advise you exactly when to take the first capsule. You will usually begin by taking a single capsule containing 110 mg Pradaxa. However, sometimes the doctor will prescribe two 110 mg tablets to start the treatment.


Recommended dose and duration

Thereafter most people will need to take two 110 mg capsules every day for the duration of their treatment. Take both capsules at the same time and always swallow them whole.

If you have had knee replacement surgery, the doctor will typically prescribe medicine for 10 days. Following hip replacement surgery, you will usually receive a prescription to take Pradaxa for 28–35 days.


Impaired kidney function

If you have impaired kidney function, you are more likely to experience dangerous bleeding whilst taking Pradaxa. The doctor will therefore usually prescribe a lower dose of two 75 mg capsules.


If you are using medications which affect Pradaxa

If you are using other medicines which affect the function of Pradaxa, you may also be prescribed a lower dose of two 75 mg capsules.


Missed doses

If you miss a dose of Pradaxa, do not to take a double dose to make up for the missed dose. You should continue taking your remaining medicine as prescribed by the doctor.


Prevention of stroke and systemic embolism

The recommended dose for the prevention of stroke and systemic embolism is 300 mg daily, taken as two 150 mg capsules each day (one in the morning and one in the evening). The treatment should be continued indefinitely unless your doctor specifically tells you to stop, even if you feel well.


Special groups

Impaired kidney function

If you have impaired kidney function you are at increased risk of bleeding whilst taking Pradaxa and may require a lower dose. The doctor will assess your kidney function and may prescribe a dose of 220 mg daily. In this case you should take one 110 mg capsule, twice a day.


Older persons

Older persons (> 75 years of age) also have an increased risk of bleeding. The doctor will probably prescribe you a lower dose of 220 mg daily, taken as one 110 mg capsule, twice a day.


Individuals with risk factors for bleeding

Individuals who are at high risk of bleeding may require a lower dose of 220 mg daily. In this case you will need to take a 110 mg Pradaxa capsule, twice a day.


Missed doses

If you miss taking a dose of Pradaxa when it is scheduled, you can take it up to 6 hours before the next dose is due. Thereafter the dose should be skipped. Never take a double dose of Pradaxa to make up for a skipped dose.


If you have any queries about the correct way to use Pradaxa, please ask your doctor.
 


Contraindications

Pradaxa should not be used under certain conditions. Tell your doctor if you have:

  • Hip fracture surgery: Pradaxa should not be used in hip fracture surgery;
  • Allergies: You may be allergic to one of the ingredients in Pradaxa;
  • A kidney disorder: Individuals with severely impaired kidney function should not take Pradaxa. Your doctor will need to test your kidney function before prescribing Pradaxa;
  • Predisposition to bleed which may be because of a genetic condition, acquired or caused by other medicines you take;
  • History of bleeding:Particularly if you have experienced bleeding in any of the following places:
    • Head or brain;
    • Stomach;
    • Eyes;
    • Joints; or
    • Spine;
  • Recent history of bleeding in the brain: Including bleeding cause by haemorrhagic stroke. You should not take Pradaxa;
  • Stomach ulcers: Which cause stomach bleeding. You should not take Pradaxa;
  • Catheter: Indwelling spinal or epidural catheter. Pradaxa should not be used while your catheter is in place or within 2 hours of its removal;
  • Liver disorder or disease: Pradaxa should not be taken by individuals who have a severe liver disorder. Your doctor will need to perform a liver function test before prescribing Pradaxa;
  • Using ketoconazole: Ketoconazole is a medicine used to treat fungal infections. You should not use ketoconazole and Pradaxa at the same time;
  • Using or intending to use verapamil: Pradaxa and oral verapamil should not be started at the same time. If you are already taking Pradaxa, you should not start taking oral verapamil.


Precautions

Special care needs to be taken when using Pradaxa under certain conditions. Tell your doctor if you:

  • Have an increased risk of bleeding: Your doctor may need to perform additional monitoring while you take Pradaxa. Conditions and medical procedures which may increase your risk of bleeding include:
    • Blood clotting disorders;
    • Bleeding in the stomach;
    • Recent biopsy (removal of a tissue sample);
    • Recent bleeding in the brain;
    • Recent surgery affecting the brain, spine or eye;
    • Endocarditis, a conditions characterised by inflammation of the heart;
  • Have impaired kidney function: Including impaired kidney function caused by age-related decline (usually in people > 75 years old). Pradaxa is cleared from the body by the kidneys. If the kidneys are not functioning properly, too much Pradaxa can build up in your system and increase your risk of bleeding. The doctor may need to test your kidney function and prescribe a lower dose of Pradaxa; 
  • Have impaired liver function: The doctor may wish to perform a liver function test before prescribing Pradaxa;
  • Have an increased risk of trauma: For example because you play a contact sport that carries a high risk of injury;
  • Plan to have surgery: Pradaxa should not be taken whilst you have surgery. You will need to stop taking Pradaxa several days before the surgery is planned;
  • Take other medications:Some medications interfere with the way Pradaxa works. These include:
    • Other anti-coagulant (blood thinning) medicines: Including warfarin, heparin, fondaparinux, desirudin, clopidogrel, tirofiban, bivalirudin, prasugrel, eptifibatide, ticlopidine, dextran, sulfinpyrazone and rivaroxaban;
    • Medicines used to treat irregular heartbeat: Including amiodarone and dronedarone;
    • Verapamil: A medicine used to treat high blood pressure;
    • Medicines used to treat infections: Including clarithromycin and rifampicin;
    • Medicines used to treat HIV: Including lopinavir, nelfinavir, ritonavir, tipranavir and saquinavir;
    • Medicines which affect your immune system: Including cyclosporin and tacrolimus;
    • Medicines containing a herbal remedy called St John’s wort;
    • Medicines used to treat gastrointestinal reflux disorder (heartburn) and stomach ulcers: Including pantoprazole and ranitidine.


Pregnancy

Pradaxa is a Pregnancy Category C medication. It should not be used by pregnant women as it may affect the development of their foetus. Tell your doctor if you are pregnant or plan on becoming pregnant whilst using Pradaxa.


Breastfeeding

Pradaxa should not be used by breastfeeding women. Tell your doctor if you are breastfeeding.


Children

Pradaxa should not be used by children or adolescents. Tests have not been conducted to assess the safety and effectiveness of Pradaxa in people < 18 years of age.

Schedule of Pradaxa

Pradaxa is a Schedule 4 medication.1

Common side effects of Pradaxa

All medicines have side effects. Most commonly the side effects are minor; however, some can be more serious. Usually the benefits of taking a medication outweigh the associated side effects. Your doctor would have considered these side effects before starting you on Pradaxa.

The adverse effects of Pradaxa vary depending on the reason for use, which determines whether therapy is used in the short term (when used following major surgery) or long term (when used for the prevention of embolism). 


Following surgery

Very common side effects

Very common side effects are those that occur in more than 10% of people given Pradaxa following surgery. These include:

  • Bleeding.


Common side effects

Common side effects are those that occur in 1–10% of people given Pradaxa. These include:

  • Major bleeding;
  • Anaemia, usually as a result of bleeding;
  • Haematoma (formation of pockets of blood in the tissues);
  • Bleeding from the wound;
  • Decreased haemoglobin (a component of blood responsible for transporting oxygen);
  • Secretion or discharge from the surgical wound;
  • Haematuria (blood in urine).


Prevention of stroke and systemic embolism

If you are taking Pradaxa for the prevention of stroke and/or systemic embolism, the treatment is lifelong. Over the course of treatment you may or may not experience side effects.

Very common side effects

Very common side effects are those that occur in more than 10% of people given Pradaxa. These include:

  • Bleeding.


Common side effects

Common side effects are those that occur in 1–10% of people given Pradaxa. These include:

Uncommon side effects of Pradaxa

Following surgery

Side effects that occur in less than 1% of people given Pradaxa are considered uncommon. People do not necessarily experience any of these side effects, so do not become alarmed by this list:

  • Bleeding in general;
  • Bleeding in the joints;
  • Changes to your blood which may be apparent in blood tests;
  • Nose bleed;
  • Stomach or intestinal bleeding;
  • Drainage of non-blood fluids from a wound or after a surgical procedure;
  • Rectal bleeding;
  • Blood or discharge from catheter insertion site or other areas of ruptured skin;
  • Blood in urine;
  • Blood in faeces;
  • Bruising;
  • Changes in liver function.

Rare side effects are those that occur in 0.01–0.1% of people given Pradaxa for the prevention of blood clots. These include:

  • Bleeding in your joints;
  • Swelling somewhere on the body which contains blood; or
  • Bleeding in places where you have recently punctured the skin, for example an injection site or cut.


Prevention of stroke and systemic embolism

Side effects that occur in less than 1% of people given Pradaxa are considered uncommon. People do not necessarily experience any of these side effects, so do not become alarmed by this list:

  • Changes to liver function which may be reflected in liver function tests;
  • Heart attack;
  • Life-threatening bleeding in the stomach or intestine;
  • Bleeding in the brain;
  • Abnormal blood test characteristics;
  • Hypersensitivity reaction, which may cause a skin rash, facial swelling and difficulty breathing. Seek urgent medical attention if you experience these symptoms;
  • Inflammation of the stomach and oesophagus;
  • Haematoma (formation of pockets of blood in the tissues);
  • Haemoptysis (coughing up blood);
  • Difficulty swallowing;
  • Abnormal liver function;
  • Gastrointestinal ulcer;
  • Bleeding beneath the skin or bruising; or
  • Haematuria (blood in urine).


If you experience any of the listed side effects, or any other symptoms that appear abnormal or unusual, please tell your doctor.

What to do if you take too much Pradaxa

Taking more than the prescribed dose of Pradaxa can be dangerous. It is called an overdose. It can also be dangerous for someone else to take your Pradaxa, even if they have the same condition as you. In the event of an overdose, even if you have no signs of discomfort or poisoning, contact the Poisons Information Centre or go to Accident and Emergency at the nearest hospital.

References:

  1. Product Information: Pradaxa Capsules. North Ryde, NSW: Boehringer Ingelheim Pty limited; 29 April 2011.
  2. Consumer Medical Information: Pradaxa Capsules. North Ryde, NSW: Boehringer Ingelheim Pty Limited; February 2011.

 

For further information talk to your doctor.

Dates

Posted On: 16 May, 2011
Modified On: 14 March, 2014


Created by: myVMC