Pradaxa

Indications

Dabigatran Etexilate is an oral blood thinner (anticoagulant). It is used to prevent stroke and blood clots in adults with atrial fibrillation (an irregular heart rhythm) not caused by heart valve disease, to treat deep vein thrombosis (a clot in a leg vein) and pulmonary embolism (a clot in the lungs), to prevent these clots from coming back, and to prevent clots after hip or knee replacement surgery.

How It Works

After it is absorbed, Dabigatran Etexilate is changed into Dabigatran, which directly blocks thrombin. Thrombin is a key protein that turns liquid blood into a clot. By blocking it, the medicine makes it harder for harmful clots to form or grow.

Dosage and Administration

The dose depends on the reason for use, your age, kidney function and bleeding risk, so take it exactly as prescribed. For atrial fibrillation, adults commonly take 150 mg twice a day, or 110 mg twice a day in older people or those at higher bleeding risk. Swallow the capsules whole with a glass of water; do not open, chew or empty them, as this greatly increases the amount absorbed. It can be taken with or without food. Do not stop taking it without speaking to your doctor, as this raises the risk of stroke or clots.

Interactions

• Other blood thinners such as Warfarin, Heparin, Rivaroxaban or Apixaban should not be used together, except when switching under medical advice.
• Aspirin, Clopidogrel, NSAIDs (such as Ibuprofen and Diclofenac) and SSRI antidepressants increase bleeding risk.
• Ketoconazole, Itraconazole, Ciclosporin and Dronedarone must not be used with it; Verapamil, Amiodarone and Quinidine may need a dose change.
• Rifampicin, Carbamazepine, Phenytoin and St John's Wort reduce its effect and should be avoided.

Contraindications

• Severe kidney impairment.
• Active significant bleeding, or conditions with a high bleeding risk such as a recent brain bleed or active stomach ulcer.
• Mechanical (artificial) heart valves.
• Severe liver disease.
• Use with the interacting medicines listed above as not allowed.
• Allergy to Dabigatran.

Side Effects

Bleeding is the main side effect: nosebleeds, bleeding gums, easy bruising, blood in urine or stools and heavier periods. Indigestion, heartburn, stomach pain and nausea are also common; taking it with food may help.

Get urgent medical help if you have heavy or uncontrolled bleeding, vomit blood or material that looks like coffee grounds, pass black or bloody stools, have a severe headache, sudden weakness, confusion or trouble speaking, or have a fall or head injury while on this medicine.

Pregnancy and Lactation

Dabigatran should not be used during pregnancy unless clearly necessary; women who could become pregnant should avoid pregnancy during treatment. Breastfeeding should be stopped during treatment.

Precautions and Warnings

• Kidney function should be checked before starting and at least once a year, more often in older people.
• Tell every doctor and dentist that you take a blood thinner before any surgery or procedure; it may need to be stopped beforehand.
• A specific reversal agent exists for emergencies in hospital.
• Keep capsules in the original pack to protect them from moisture.
• Use a soft toothbrush and an electric razor to reduce bleeding.

Overdose

Overdose increases the risk of serious bleeding. Seek emergency medical help immediately. Hospitals can give a specific antidote and other treatments to stop bleeding.

Therapeutic Class

Oral anticoagulant; direct thrombin inhibitor.

Storage

Store below 30°C in the original pack to protect from moisture, away from light and out of the reach of children.