Pradaxa (Dabigatran Etexilate Mesylate) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Pradaxa

Stroke Prevention »

Introduction

If you're like most Americans, you plan for your future. When you take a job, you examine its benefit plan. When you buy a home, you consider its location and condition so that your investment is safe. Today, more and more Americans are protecting their most important asset--their health. Are you?

Stroke ranks as the third leading killer in the United States. A stroke can be devastating to individuals and their families, robbing them of their independence. It is the most common cause of adult disability. Each year more than 700,000 Americans have a stroke, with about 160,000 dying from stroke-related causes. Officials at the National Institute of Neurological Disorders and Stroke (NINDS) are committed to reducing that burden through biomedical research.

What is a Stroke?

A stroke, or "brain attack," occurs when blood circulation to the brain fails. Brain cells can die from decreased blood flow and th...

Read the Stroke Prevention article »

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Pradaxa

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PRADAXA®
(dabigatran etexilate mesylate)

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 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: 2/6/2012
This monograph has been modified to include the generic and brand name in many instances.