Pradaxa

DRUG DESCRIPTION

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is ?-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 • CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:

PRADAXA® (dabigatran etexilate mesylate) Structural Formula Illustration

Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol.

The 150 mg capsule for oral administration contains 172.95 mg dabigatran etexilate mesylate, which is equivalent to 150 mg of dabigatran etexilate, and the following inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, FD&C Blue No. 2 (150 mg only), FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink. The 75 mg capsule contains 86.48 mg dabigatran etexilate mesylate, equivalent to 75 mg dabigatran etexilate, and is otherwise similar to the 150 mg capsule.

What are the precautions when taking dabigatran etexilate mesylate (Pradaxa)?

Before taking dabigatran, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), liver disease, recent major injury/surgery, infection in the heart (bacterial endocarditis), stroke, frequent falls/injuries.

It is important that all your doctors and dentists know that you take dabigatran. Before having surgery or any medical/dental...

Read All Potential Precautions of Pradaxa »


Pradaxa Consumer (continued)

SIDE EFFECTS: Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual/easy bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools.

Tell your doctor right away if you have any of these serious side effects: stomach/abdominal pain, severe heartburn/nausea/vomiting.

Get medical help right away if any of these rare but very serious signs of bleeding occur: vision changes, confusion, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dabigatran, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), liver disease, recent major injury/surgery, infection in the heart (bacterial endocarditis), stroke, frequent falls/injuries.

It is important that all your doctors and dentists know that you take dabigatran. Before having surgery or any medical/dental procedures, tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may direct you to stop this medication before surgery. Follow your doctor's directions carefully.

Avoid getting injections into the muscles. If you must have an injection into the muscle (for example, a flu shot), it should be given in the arm. This way, it will be easier to check for bleeding and/or apply pressure bandages.

This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit or avoid alcoholic beverages.

This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use great caution with sharp objects like safety razors and nail cutters. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. Avoid activities such as contact sports. If you fall or injure yourself, especially if you hit your head, call your doctor immediately. Your doctor may need to check you.

Older adults may be at greater risk for bleeding while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.



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