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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 18 of 18. This is the beginning of the thread.
Posted by Golf4 on August 12, 2008, at 10:07:15
can anyone share experience with Plexxo(Disentis)as an alternative to the original Lamictal(Glaxo)?
Posted by Phillipa on August 12, 2008, at 13:29:48
In reply to Plexxo versus Lamictal, posted by Golf4 on August 12, 2008, at 10:07:15
From what I read it sounded like the reason you take it impacts on the results. May I ask what you're taking it for? Phillipa
Posted by Golf4 on August 13, 2008, at 1:48:35
In reply to Re: Plexxo versus Lamictal » Golf4, posted by Phillipa on August 12, 2008, at 13:29:48
> From what I read it sounded like the reason you take it impacts on the results. May I ask what you're taking it for? Phillipa
========================================
as a part of my regime treating BP2 since many years ; (150mg/day Lamitrogine as Lamictal until now);again,can Plexxo be a good replacement for Lamictal or not? THIS IS THE QUESTION!Golf4
Posted by Phillipa on August 13, 2008, at 20:36:03
In reply to Re: Plexxo versus Lamictal, posted by Golf4 on August 13, 2008, at 1:48:35
I realize that but there was data I found concerning seizures. Google the source your answer may be there. But remember our miles vary. Love Phillipa ps I'll do another google since it's new to me.
Posted by Phillipa on August 13, 2008, at 20:42:36
In reply to Re: Plexxo versus Lamictal, posted by Golf4 on August 13, 2008, at 1:48:35
According to this study sounds like it can. Phillipa hope this helps.
Titre du document / Document title
In vivo biopharmaceutical characterisation of a new formulation containing the antiepileptic drug lamotrigine in comparison to plain and dispersible/chewable lamotrigine tablets
Auteur(s) / Author(s)
WANGEMANN Martina (1) ; RETZOW Angelika (2) ; POHLMANN-EDEN Bernd (3) ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
(1) esitin Arzneimittel GmbH, Hamburg, ALLEMAGNE
(2) Biopharmaceutical Consulting, Reinfeld, ALLEMAGNE
(3) Epilepsiezentrum Bethel, Bethel, ALLEMAGNERésumé / Abstract
Aim: Two studies in healthy male volunteers were carried out to evaluate the pharmacokinetic profile of a new divisible formulation of lamotrigine (CAS 84057-84-1, Plexxo®, Lamotrigin Desitin®) in plasma in comparison to plain or dispersible lamotrigine tablets. Methods: The plasma pharmacokinetics of lamotrigine were analysed after administration of single doses of 100 mg lamotrigine given as one tablet of the new formulation and either the plain or the dispersible reference formulation in two separate studies. In each study the data of 24 subjects were analysed according to the study protocol. Venous blood samples were taken at appropriate intervals up to 120 h after dosing. Concentrations of lamotrigine were determined in plasma by a validated HPLC method using UV detection. Results and conclusion: In both studies, mean plasma concentration-time profiles of the new lamotrigine formulation and both reference formulations ran nearly in parallel. The pharmacokinetic mean data calculated from different subject groups of the two studies were very similar. The mean ratios of the main pharmacokinetic parameters and the corresponding 90 % confidence intervals of AUC0-t, AUC0-inf and Cmax were 103 % (99.7-105.7), 103 % (99.6-107.3) and 101 % (95.2-106.6) for the comparison with the plain lamotrigine tablet and 100 % (98.0-102.8), 100 % (96.5-102.8) and 102 % (99.1-105.3) for the comparison with the dispersible/chewable tablet, respectively. The most frequently reported adverse events possibly related to the administration of lamotrigine were headache and dizziness in both studies. It is concluded that the new divisible lamotrigine formulation is bioequivalent with regard to rate and extent of absorption to both the plain reference lamotrigine product and to the dispersible/chewable reference product.
Posted by Golf4 on August 14, 2008, at 0:07:53
In reply to Re: Plexxo versus Lamictal » Golf4, posted by Phillipa on August 13, 2008, at 20:42:36
thanks a lot for this article ; it IS important and relevant.Hugs,
Posted by Phillipa on August 14, 2008, at 0:18:10
In reply to Re: Plexxo versus Lamictal, posted by Golf4 on August 14, 2008, at 0:07:53
Let me know how you do so happy I could help my babblemail is always open for talking. Wishing you the best. Phillipa
Posted by Phillipa on August 14, 2008, at 1:07:25
In reply to Re: Plexxo versus Lamictal, posted by Golf4 on August 14, 2008, at 0:07:53
Oh by the way want a surprise? google plexxo page 2 your post is out there. Phillipa
Posted by Golf4 on August 14, 2008, at 8:19:49
In reply to Re: Plexxo versus Lamictal, posted by Phillipa on August 14, 2008, at 1:07:25
Oh,yes it seems that we are becoming now"important people" for Google,too...these are good&encouraging news..
Posted by Marty on August 14, 2008, at 9:44:17
In reply to Re: Plexxo versus Lamictal, posted by Golf4 on August 14, 2008, at 8:19:49
Actually you're post is now the SECOND result on goggle for the term "Plexxo" ! .. not the 2nd page but the 2nd ITEM.
/\/\arty
Posted by Phillipa on August 14, 2008, at 19:33:25
In reply to Re: Plexxo versus Lamictal, posted by Marty on August 14, 2008, at 9:44:17
Well now you're famous. Phillipa
Posted by Golf4 on August 15, 2008, at 0:44:18
In reply to Re: Plexxo versus Lamictal » Marty, posted by Phillipa on August 14, 2008, at 19:33:25
well,coming back to some more serious talking,are you and what for taking Lamictal? at which dose?
Posted by Golf4 on August 15, 2008, at 0:47:11
In reply to Re: Plexxo versus Lamictal » Marty, posted by Phillipa on August 14, 2008, at 19:33:25
Phillipa,
talking more seriously,are you and what for taking Lamictal,too? at which dose?
Posted by yxibow on August 15, 2008, at 1:35:28
In reply to Re: Plexxo versus Lamictal, posted by Golf4 on August 15, 2008, at 0:47:11
http://www.desitin.cz/index.php/file/download/3179?PHPSESSID=9c5cb76862a3f21a103d718681550917
Describes the gist of it but basically it really comes down to only watching the most susceptible of epileptic patients and not what it is being used off label for in places where that is allowed, namely as an AED mood adjunct. In the US, Teva has an exclusive 180 days at the moment.
Posted by Golf4 on August 15, 2008, at 3:22:54
In reply to Re: Plexxo versus Lamictal, posted by yxibow on August 15, 2008, at 1:35:28
many thanks for the sent site ; it is very comprehensive ; it is also true that commercially talking the article has been written by a German scientist ;Plexxo (Desitin) is manufactured in Hamburg, so lets hope that he is "fair"
P.S. what are you meaning by saying:... "In the US, Teva has an exclusive 180 days at the moment".. ?
Posted by Phillipa on August 15, 2008, at 19:39:36
In reply to Re: Plexxo versus Lamictal, posted by yxibow on August 15, 2008, at 1:35:28
Same as synthroid always told never switch. Phillipa
Posted by Phillipa on August 15, 2008, at 19:40:59
In reply to Re: Plexxo versus Lamictal, posted by Golf4 on August 15, 2008, at 0:44:18
Golf took it for what the doc thought might boost an ad. Phillipa
Posted by yxibow on August 16, 2008, at 0:59:58
In reply to Re: Plexxo versus Lamictal, posted by Golf4 on August 15, 2008, at 3:22:54
> many thanks for the sent site ; it is very comprehensive ; it is also true that commercially talking the article has been written by a German scientist ;Plexxo (Desitin) is manufactured in Hamburg, so lets hope that he is "fair"
> P.S. what are you meaning by saying:... "In the US, Teva has an exclusive 180 days at the moment".. ?When a patent expires -- all arcane and complex legal laws, 17 years typically in the US, but there are challenges, and sometimes a company comes out with "XR" or "CR", etc....
anyhow long story short, generic drug companies submit what are called NDAs and ANDAs (new drug, amended new drug applications -- which also have to be submitted by new drugs as well) and usually through the system one company ends up with the first pick.
And that usually means a 180 day distribution through pharmacies before other companies can compete generically. I'm not a legal expert so that's just a layman's response I guess.
-- Jay
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