Dabigatran – Anticoagulant Drug

What is Dabigatran?

Dabigatran (Pradaxa) is an anticoagulant that works by blocking the clotting protein thrombin. It is used to prevent blood clots from forming because of a certain irregular heart rhythm (atrial fibrillation). Preventing these blood clots helps to reduce the risk of a stroke.

Properties and Characteristics of Dabigatran

Drug class	Anticoagulant
Brand Names	Pradaxa
Synonyms	Dabigatran, 211914-51-1, BIBR 953, BIBR-953, Pradaxa (dabigatran), Dabigatran-13C6, CHEBI:70752, I0VM4M70GC
Molecular Formula	C₂₅H₂₅N₇O₃
Molecular Weight	471.5 g/mol
IUPAC Names	3-[[2-[(4-carbamimidoylanilino)methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoic acid
Structural formula of main components
Pure active ingredient	Dabigatran etexilate
Appearance	White crystals
Melting Point	276-277 °C
Solubility	A saturated solution in pure water has a solubility of 1.8 mg/L
Excretion	Excreted unchanged in urine
Available as	Capsules, oral granule
Storage	Store at 25 °C (77 °F)
Prescription	Prescription is required

What is Pradaxa (dabigatran) used for?

Lowering the risk of a stroke or blood clots due to nonvalvular atrial fibrillation (an irregular heartbeat that isn’t caused by the valves in your heart)
Blood clot prevention for people who have a history of blood clots
Blood clot prevention following hip replacement surgery
Blood clot treatment
Pulmonary embolism treatment (a blood clot in the lungs)

What are Side Effects of Pradaxa?

Side effects of Pradaxa include:

Bruising and minor bleeding (such as nosebleeds and bleeding from cuts),
Nausea,
Abdominal or stomach pain,
Stomach upset,
Indigestion,
Heartburn,
Diarrhea,
Skin rash, or
Itching

Tell your doctor if you have serious side effects of Pradaxa including:

Severe heartburn,
Nausea, or
Vomiting

Mechanism of Action

Dabigatran contains dabigatran etexilate that works by inhibiting the production of clotting factor Xa, also called thrombin. This prevents the conversion of fibrinogen (soluble protein) to fibrin (insoluble protein), thereby preventing blood clots formation. It makes the blood flow easily through the veins making it less likely to form a serious blood clot. Thus, dabigatran etexilate helps prevent blood clots thereby reducing the risk of heart attack/stroke.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Defibrotide
Itraconazole
Levoketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab
Aceclofenac
Aspirin
Bemiparin
Betrixaban
Dalteparin
Danaparoid
Edoxaban
Enoxaparin
Felbinac
Fenoprofen

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

How and when to take dabigatran

It’s important to take dabigatran as your doctor advises.

Dosage and strength

Dabigatran comes as 75mg, 110mg and 150mg capsules.

Your dose of dabigatran depends on why you’re taking it.

For a heart problem called atrial fibrillation or a blood clot (DVT or pulmonary embolism), the usual dose is 150mg twice a day.

For a hip or knee joint replacement the usual dose is 110mg twice a day.

Your doctor may give you a lower dose if you’re at increased risk of bleeding. This includes if you:

Are aged 75 years or older
Take verapamil (a medicine for high blood pressure)
Have problems with your kidneys, stomach or throat

If you’re unsure what dose you need to take, check with your pharmacist or doctor.

How to take it

You can take dabigatran with or without food, but try to take it at the same time every day.

Swallow the capsules whole with a drink of water. Do not open dabigatran capsules before taking them as this increases the risk of side effects.

If you have trouble swallowing pills, speak to your doctor or pharmacist.

How long to take it for

How long you need to take dabigatran for will depend on why you’re taking it.

If you’re taking it for:

A knee joint replacement – you’ll usually take dabigatran for 10 days
A hip joint replacement – you’ll usually take dabigatran for 4 to 5 weeks
A blood clot – depending on what caused the blood clot, you’ll usually take dabigatran for at least 3 months
Atrial fibrillation – you might need to take dabigatran long term or even for the rest of your life

What happens if I overdose?

In case of overdose, seek emergency medical attention or call the Poison Help line if you experience following symptoms.

Bleeding more easily than usual
Being unable to stop a cut or wound from bleeding
Bruising
Nosebleeds
Bleeding gums

Safety considerations

You can help further manage your bleeding risk while on dabigatran by:

Taking your medicine as directed. You should never stop your medication or change your dosage without talking to your healthcare provider first.
Telling your healthcare providers about all medicines or supplements that you take—including over-the-counter medications, natural products, and vitamins—to avoid drug interactions.
Avoiding certain anti-infectives (antibiotics and/or antiviral/antifungal medications), other blood thinners (heparin, warfarin), aspirin, ibuprofen, and some seizure medications or antidepressants, unless recommended by your healthcare provider.
Limiting or avoiding alcohol use.
Making sure to talk to your healthcare provider before having any type of surgical procedure.

Pregnancy, breastfeeding and fertility while taking dabigatran

Dabigatran and pregnancy

Dabigatran should not be taken during pregnancy.

If you take dabigatran and are planning a pregnancy or you become pregnant while taking it, speak to your doctor or specialist. They will change you to a different medicine.

Dabigatran and breastfeeding

It may be OK to take dabigatran while breastfeeding, but talk to your doctor or pharmacist first.

Dabigatran gets into breast milk in tiny amounts, and it is unlikely to cause side effects in your baby. However, we do not have very much information about dabigatran and breastfeeding, so your doctor may recommend a different medicine we know more about.

If your doctor says it’s OK to take dabigatran while breastfeeding, then monitor your baby for any possible side effects.

Talk to your health visitor, midwife, pharmacist or doctor as soon as possible if:

Your baby is not feeding as well as usual
Your baby seems to bleed or bruise easily
You have any other concerns about your baby

Dabigatran and fertility

There’s no evidence to suggest that taking dabigatran reduces fertility in either men or women.

Speak to a pharmacist or your doctor before taking it if you’re trying to get pregnant.

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