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Re: Are brand name and generic celexa the same?

Posted by yxibow on May 23, 2005, at 22:25:18

In reply to Are brand name and generic celexa the same?, posted by tampagirl70 on May 23, 2005, at 10:55:44

> Are brand name and generic drugs EXACTLY the same? I was thinking about how I've been on a downhill spiral since late last year and then I remembered that my pharmacy started filling my celexa prescription with the generic when it became available. Is it possible that the generic is different than the brand name and that's what has added to my deteriorating condition?


I quote a summary of the FDA:

"The FDA requires bioequivalency studies to demonstrate that there is no difference between brand and generic products for the mean maximal drug concentration (Cmax) and the drug concentration time curve (AUC). Further, the 90% confidence interval around this difference in mean values must be within 80% and 125% of the mean measured Cmax and AUC for the brand product."

Basically this means that the maximum plasma blood level and the time that it is in your body (AUC) must be the same, and any difference between the average of the generic and the brand name must meet a 90% standard... my college statistics becomes fuzzy around there but basically generics must be the same product. I'm sure ed_uk could tell you more.

The only difference from what I remember that possibly could make a difference between generics and the original product (and remember the original product can also vary in this standard) is with anticonvulsants /in vivo/ (in the body) in epileptic patients, those who take lithium combinations and a few other esoterica can experience enough of a significant difference if they are on the borderline of things.

But just plain Valium or Klonopin at levels for anxiolytic purposes or for those who arent epileptics, is not really likely to make any difference and the cost difference between generic benzos and the originals (if they are still being produced) is orders of magnitude not terribly worth it. However, as stated, if one feels more comfortable, they can pay out of pocket. (I speak not for the HMOs, who by the way state the same thing). Its a pleasure only paying $7 for generic Klonopin when I have to pay a high copay for Seroquel.

Anyhow, my 2c.
Tidings.

 

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