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Pradaxa

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Pradaxa

PRADAXA®
(dabigatran etexilate mesylate) Capsules

Pradaxa

WARNING

DISCONTINUING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE

Discontinuing PRADAXA places patients at an increased risk of thrombotic events. If anticoagulation with PRADAXA must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-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 possible side effects of dabigatran (Pradaxa)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dabigatran and call your doctor at once if you have a serious side effect such as:

  • any bleeding that will not stop;
  • weakness, feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your urine or stools, black or tarry stools;
  • coughing up blood or vomit that looks like...

Read All Potential Side Effects and See Pictures of Pradaxa »

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 »

Last reviewed on RxList: 12/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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Pradaxa - User Reviews

Pradaxa User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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