View Full Version : Dexedrne brand by catalent pharma


Quiet-eyes
02-01-16, 08:20 PM
My Pharmacist just told me he had ordered me Dexedrine Spansules by Catalent Pharma Solutions He says they make both Brand and Generic

My NYC insurance has refused to cover the Brand Dexedrine Ive been on since 1995. Im on 70mgs a day. The cost was insane.. my last copay was 1500.00!I didn't pay it obviously.

BUT today he ordered the Dex Spansules from this company and my insurance approved it...
The Core Pharma generic I tried previously didn't work. Isomer issue.

So fingers crossed this one actually works!

http://www.drugbank.ca/drugs/DB01576
is a great website for Dexadrine info and manufacturers... but I couldn't find Catalent Pharma.

Anyone heard of this manufacturer ?
Thanks T

aeon
02-01-16, 09:09 PM
The Core Pharma generic I tried previously didn't work. Isomer issue.

Please explain what you mean via the known science of the isomers of amphetamine and how that relates to the med and your experience.

Based on what you said, with no other information, it makes no sense whatsoever.


Thanks,
Ian

Quiet-eyes
02-09-16, 07:54 AM
Please explain what you mean via the known science of the isomers of amphetamine and how that relates to the med and your experience.

Based on what you said, with no other information, it makes no sense whatsoever.
Thanks,
Ian

http://www.ama-assn.org/ama/pub/physician-resources/medical-science/united-states-adopted-names-council/naming-guidelines/geometric-isomerism-chirality-the-usan-perspective.page?

Basically What my shrink said is that the Isomers in the Generic versions of Dex Spansules are not the same as the brand.. and thats why they don't work on some people. IE ME.
The CorePharma Generic Dexedrine didn't work like the brand. It gave me anxiety and didn't absorb and kick in the same way.
Generics are supposed to work the same way and have the same effects as the name-brand drug. Its called “bioequivalence”. Even though the Dexedrine generic has the same "active ingredient", it was not bioequivalent.
My shrink said that it had to do with the Isomers not being the same. And here it gets very complicated.

I am not a chemist but I think the following links explain how a "copy" is made of a drug and but its not a bioequivalent.

https://en.wikipedia.org/wiki/Enantiopure_drug
https://en.wikipedia.org/wiki/Racemic_mixture
https://en.wikipedia.org/wiki/Enantiomeric_excess


https://en.wikipedia.org/wiki/Dextroamphetamine
The amphetamine molecule exists as two enantiomers (i.e., two different molecules that are mirror images of one another), levoamphetamine and dextroamphetamine. Dextroamphetamine is the more active dextrorotatory, or "right-handed", enantiomer of the amphetamine molecule.

Dextroamphetamine is the dextrorotary stereoisomer of the amphetamine molecule
Hard to understand what this study means.. but
http://www.ncbi.nlm.nih.gov/pubmed/10774542

Quiet-eyes
02-09-16, 08:01 AM
Please explain what you mean via the known science of the isomers of amphetamine and how that relates to the med and your experience.

Here is the isomer thing explained,.. (I think)
http://toxsci.oxfordjournals.org/content/110/1/4.full

But to sum up my point - every generic Dexedrine Spansule I try, doesn't work the same as the original brand.. even though the pharmacist tells me its " THE SAME ACTIVE INGREDIENT".

Houston we have a problem.

namazu
02-09-16, 08:12 AM
Dexedrine (dextroamphetamine) is specifically the dextro- (or "right-handed") version of the amphetamine molecule, so unless they're giving you the wrong drug altogether (say, giving you generic Adderall instead of Dexedrine), the problem with the generic is not an isomer issue.

The generics may contain slightly different *fillers* or inactive ingredients, though, and some people feel that they notice a difference.

For some medications (e.g. generic Wellbutrin and generic Concerta), there have been problems where the generics didn't perform like they were supposed to in terms of the amount or timing of medication release. I haven't heard of that being an issue with Dexedrine, but I wouldn't be the first to hear...

Another possibility is that for some reason, the current dose just isn't cutting it for you any more, or something else is out of whack. How's your sleep? Any new stresses in your life (besides the meds not working well?!)?

Whatever the issue ends up being, I hope you're able to get it sorted soon. And I'm sorry your insurance won't cover the stuff that you know works!

namazu
02-09-16, 08:44 AM
P.S. From the label you posted, it looks like it's the brand-name Dexedrine Spansules, "manufactured by Catalent for Amedra".

Per FDA, Amedra has approval for the brand-name stuff:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Set_Current_Drug&ApplNo=017078&DrugName=DEXEDRINE&ActiveIngred=DEXTROAMPHETAMINE%20SULFATE&SponsorApplicant=AMEDRA%20PHARMS&ProductMktStatus=1&goto=Search.Label_ApprovalHistory

I don't see Catalent listed as a manufacturer of generic -- unless they did so under another name, or were bought out by another company, or something like that. Regardless, if your insurance is willing to cover it like a generic, and it works like the brand-name stuff did for you, it's a win!

Quiet-eyes
02-09-16, 01:15 PM
P.S. From the label you posted, it looks like it's the brand-name Dexedrine Spansules, "manufactured by Catalent for Amedra".

Per FDA, Amedra has approval for the brand-name stuff:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Set_Current_Drug&ApplNo=017078&DrugName=DEXEDRINE&ActiveIngred=DEXTROAMPHETAMINE%20SULFATE&SponsorApplicant=AMEDRA%20PHARMS&ProductMktStatus=1&goto=Search.Label_ApprovalHistory

I don't see Catalent listed as a manufacturer of generic -- unless they did so under another name, or were bought out by another company, or something like that. Regardless, if your insurance is willing to cover it like a generic, and it works like the brand-name stuff did for you, it's a win!

Well not exactly! He was mistaken. Even a pharmacist cant figure out who the packager is and who the actual manufacturer is!

Anyway, my Pharmacist sent me the same ones I had before! OMG!!!
The ones that didn't work, Corepharma.

Catalent is a packager maybe? They are on each of these Packaging labels:

namazu
02-09-16, 02:28 PM
Huh! That's interesting!

Catalent's website suggests that they do a lot of stuff on the "delivery" end, like making soft capsules and extended-release mechanisms. I wonder if they turn the raw dextroamphetmatine sulfate into "spansules", then? Hmmm... I did a search for the name on the FDA website, and it seems that Catalent may be a kind of subcontractor for drug manufacture for a lot of other companies -- as those labels suggest. They did have a couple of recalls of Dex Spansules in 2013-2014.

Anyway, I'm sorry you're stuck with a generic you don't like (again). How frustrating for the pharmacist to tell you one thing, and then to give you another! Argh.

Quiet-eyes
02-09-16, 08:10 PM
Huh! That's interesting!

Catalent's website suggests that they do a lot of stuff on the "delivery" end, like making soft capsules and extended-release mechanisms. I wonder if they turn the raw dextroamphetmatine sulfate into "spansules", then? Hmmm... I did a search for the name on the FDA website, and it seems that Catalent may be a kind of subcontractor for drug manufacture for a lot of other companies -- as those labels suggest. They did have a couple of recalls of Dex Spansules in 2013-2014.

Anyway, I'm sorry you're stuck with a generic you don't like (again). How frustrating for the pharmacist to tell you one thing, and then to give you another! Argh.

Thanks for your support.

Recalls? Really? Maybe it was the batch that I was sent that was off?
Do you have the link to that? Id love to find an explanation for this generic being so ****.

But isn't it just insane that we have to go to these lengths to find out what is going on.. and why things are either too expensive for anyone ever to afford or we find ourselves taking a lesser quality drug. Thats crazy! This situation would never happen in the UK where I live. Only in the US does greed and medication go together this way... ! And these awful companies and their shareholders who are allowed to go on, and on, getting richer and richer off of people who need to take their medicine in order to live a life.. What horrid opportunistic ******** these CEO's are!

Im just so angry that I have to go thru this again at 59 years of age.. Ive been on Dexadrine Spansules brand since 1995. Taking between 50 and 70mgs a day. A Long time and a high dose. My life changed and I could function. I have a career as a film editor. Im techy. I feel so lucky to have found something that helped my mind work properly. But I never dreamed I'd have to put my mind through this again..its been terrifying.. this situation totally destabilised my life as I ran out of meds more than once because I couldn't get my usual script filled as the price was thru the roof ! To literally lose my mind.. couldn't drive or work. This has been going on and off for about 6 months.

This should be illegal. There has to be a limit to how much Big Pharma can raise the prices as we are addicted to their meds. We are at their mercy. These companies control us. I mean, that is just so wrong.

End of rant.

Quiet-eyes
02-09-16, 08:31 PM
Dexedrine (dextroamphetamine) is specifically the dextro- (or "right-handed") version of the amphetamine molecule, so unless they're giving you the wrong drug altogether (say, giving you generic Adderall instead of Dexedrine), the problem with the generic is not an isomer issue.The generics may contain slightly different *fillers* or inactive ingredients, though, and some people feel that they notice a difference.

It may be an isomer issue or a filler issue. A generic can match its equivalent 80 % to be be approved by the FDA. (wtf?) I read that somewhere and was shocked. But the point is some generics are not the same thing as the brand and they don't work the same way or they don't work near as well.

For some medications (e.g. generic Wellbutrin and generic Concerta), there have been problems where the generics didn't perform like they were supposed to in terms of the amount or timing of medication release. I haven't heard of that being an issue with Dexedrine, but I wouldn't be the first to hear...

I experienced it first hand. CorePharma Dexedrine spansules were awful. So may side effects I didn't have with brand.

Another possibility is that for some reason, the current dose just isn't cutting it for you any more, or something else is out of whack. How's your sleep? Any new stresses in your life (besides the meds not working well?!)?

Sleep has never been great. but more to do with late computer typing bright screen. But the brand was working perfectly.. as it always had. Then I get a replacement generic without warning from my pharmacist. And everything got very difficult.

Whatever the issue ends up being, I hope you're able to get it sorted soon. And I'm sorry your insurance won't cover the stuff that you know works!

I'll let you know how it goes.. and what solves it.
I really want to try the Malincroft generic.

namazu
02-09-16, 09:44 PM
Recalls? Really? Maybe it was the batch that I was sent that was off?
Do you have the link to that? Id love to find an explanation for this generic being so ****.
Fortunately or unfortunately, the recalls are a year or more old. By now that stock of medicine (if not returned to the manufacturer) is probably used up/expired, so it's unlikely to be the batch you got. (Also, at least one of the recalls is for the brand-name product, not the generic.)

Here are links, though:
January 2014 (http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-385-2014&w=01012014&lang=eng)
March 2013a (http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-171-2013&w=03062013&lang=eng)
March 2013b (http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-172-2013&w=03062013&lang=eng)
March 2013c (http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-173-2013&w=03062013&lang=eng)

By the way, you can report adverse effects to the FDA directly: http://www.fda.gov/Safety/MedWatch/default.htm

Im just so angry that I have to go thru this again at 59 years of age.. Ive been on Dexadrine Spansules brand since 1995. Taking between 50 and 70mgs a day. A Long time and a high dose. My life changed and I could function. I have a career as a film editor. Im techy. I feel so lucky to have found something that helped my mind work properly. But I never dreamed I'd have to put my mind through this again..its been terrifying.. this situation totally destabilised my life as I ran out of meds more than once because I couldn't get my usual script filled as the price was thru the roof ! To literally lose my mind.. couldn't drive or work. This has been going on and off for about 6 months.

Yeah, I hear you. My experience with medications hasn't quite been "happily ever after", either, so I know the rollercoaster of being able to function ... and not.