Custom Search

Friday, October 22, 2010

Pradaxa capsules dabigatran etexilate to prevent stroke in people with atrial fibrillation

US FDA approves Pradaxa capsules (dabigatran etexilate) to prevent stroke in people with atrial fibrillation
The US FDA has approved drug Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients suffering from atrial fibrillation a condition with abnormal heart rhythm.

Peoples suffering from Atrial fibrillation are more susceptible to formation of blood clot and brain stroke and formation of a block in heart , congestive heart failure , these conditions are life threatening .Atrial fibrillation is a condition where in the contraction of cardiac muscles do not occur in peculiar rhythm , instead they form a irregular contractions particularly in both atria so is the name “atrial fibrillation”.Atrial fibrillation as such is not life threatening but the aliments and conditions such as congestive heart failure, and brain stroke that it leads to are serious and life threatening,
In atrial fibrillation patients electrocardiogram ECG shows absence of P waves as the origin of impulse for contraction of heart muscles (Atria) is not from sinoatrial node rather the impulse for contraction is derived from other pulmonary veins.

Pradaxa capsules (dabigatran etexilate) is a anticoagulant drug which is a direct thrombin inhibitors (DTIs) which delay blood clotting by directly inhibiting the enzyme thrombin coagulation factor II (F2) which converts soluble fibrinogen into insoluble fibrin that forms a blood clot.

Clinical trial:
It was found in safety and efficacy study clinical trials of Pradaxa (dabigatran etexilate) compared to warfarin , that patients taking Pradaxa capsules (dabigatran etexilate) had fewer strokes than patients taking warfarin.

Adverse reactions:
Sever bleeding, uncomfortable feeling in the stomach (dyspepsia), stomach pain, nausea, heartburn, and bloating.

US FDA has approved Pradaxa with a medication guide that provides prompt information about risk of serious bleeding to patients. The guide is required to be distributed each time a patient buys this drug.
Pradaxa (dabigatran etexilate) is manufactured by pharmaceutical company, Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., it is made available in 75 mg and 150 mg capsules.

=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.

=====================================================================================================
You may also like following articles

Whar is Referance Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents


Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions


Antibiotic Definition and classification


Antibiotic resitance and Antibiotic resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production

TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry

Find a Job in Pharmaceutical Company
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company

1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org