Psycho-Babble Medication Thread 613836

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Re: FDA approves EMSAM

Posted by cecilia on February 28, 2006, at 20:45:18

In reply to Re: FDA approves EMSAM » Psyc 1, posted by RobertDavid on February 28, 2006, at 15:24:08

Re food restrictions on higher doses but not lower-this still doesn't make a lot of sense to me because one person can have higher blood levels on a low dose than another person on a high dose. I think they're just covering their you know what and cheese etc are probably safe at any dose, though it probably makes sense to avoid the really high tyramine foods like very aged cheeses even on the low doses. I'll definitely give Emsam a try, but I'm not holding my breath, from what I've read it sounds like its likely to be one of those anxiety increasing, insomnia increasing type drugs. Cecilia

 

Re: FDA Approves EMSAM » RetiredYoung

Posted by Phillipa on February 28, 2006, at 20:52:49

In reply to Re: FDA Approves EMSAM » ed_uk, posted by RetiredYoung on February 28, 2006, at 18:33:05

The question is do they work? I know this is a change of subject. But during menopause couldn't take oral hormones but had no problem with the creams you appled to your skin. Maybe Ensam is the same? Fondly, Phillipa

 

Re: FDA approves EMSAM

Posted by FredPotter on February 28, 2006, at 21:34:25

In reply to Re: FDA approves EMSAM, posted by cecilia on February 28, 2006, at 20:45:18

The killer blow is having to give up broad-bean pods (just kidding)

 

Re: FDA Approves EMSAM... dosage? » gibber

Posted by jrbecker on February 28, 2006, at 21:39:13

In reply to Re: FDA Approves EMSAM... dosage?, posted by gibber on February 28, 2006, at 18:18:33

> I thought the dosages were 20,40,60 mg/day. It seems that they are 6,9, and 12mg/day...I'm sure this is not a last minute change. I suppose 6mg of transdermal is like 20mg of oral tabs. Am I right?


Actually there's really no difference than those dosages done in the clinical trials (20, 30, 40). I guess they're now measuring transdermal dose absorption [time] rate versus before they spoke of it in terms of dosage by patch area... ...see link above for the product's prescription information/product insert. The following quote from it might explain the discrepancy...

"EMSAM systems are transdermal patches that contain 1mg of selegiline per cm2 and deliver
approximately 0.3mg of selegiline per cm2 over 24 hours. EMSAM systems are available in three sizes: 20mg/20cm2, 30mg/30cm2, and 40mg/40cm2 that deliver, on average, doses of 6mg, 9mg or 12mg, respectively, of selegiline over 24 hours."


 

Re: FDA Approves EMSAM... dosage?

Posted by aabag on March 1, 2006, at 0:58:46

In reply to Re: FDA Approves EMSAM... dosage? » gibber, posted by jrbecker on February 28, 2006, at 21:39:13

I know I'll certainly be read to try it when April rolls around. The reduction in side effects, and the different mechanism of action over largely "lateral move" antidepressants are two reasons to consider EMSAM.

 

Re: MAOI-A and MAOI-B at 6mg?

Posted by blueberry on March 1, 2006, at 5:40:17

In reply to FDA Approves EMSAM, posted by jrbecker on February 28, 2006, at 8:11:40

I couldn't quite get it exactly, I was wondering if anyone knew if 6mg ensam is both MAOI-A and MAOI-B. I know at 6mg regular deprenyl would be just MAOI-B. ???

 

Re: FDA approves EMSAM

Posted by Last Chance on March 1, 2006, at 10:45:08

In reply to Re: FDA approves EMSAM, posted by FredPotter on February 28, 2006, at 21:34:25

> The killer blow is having to give up broad-bean pods (just kidding)

Yeah, Fava Beans and a Nice Chianti. I am still putting some faith in Emsam, and am waiting for it to be available. I tried oral Selegeline for awhile with no good results - also moclobomide, which within a week gave me negative sexual side effects which it is not supposed to do. Richard

 

Re: MAOI-A and MAOI-B at 6mg? » blueberry

Posted by Chairman_MAO on March 1, 2006, at 11:49:24

In reply to Re: MAOI-A and MAOI-B at 6mg?, posted by blueberry on March 1, 2006, at 5:40:17

The bioavailability of oral selegiline is poor. Much of it is eliminated by first-pass metabolism in the liver. Some of it binds to MAO-A in the gut.

With the patch, a majority of what gets into the bloodstream makes it to the CNS. The brain:gut ratio of MAO-A inhibition by selegiline patch in guinea pig is 7.5:1.

 

Re: FDA approves EMSAM » cecilia

Posted by Larry Hoover on March 1, 2006, at 12:05:20

In reply to Re: FDA approves EMSAM, posted by cecilia on February 28, 2006, at 20:45:18

> Re food restrictions on higher doses but not lower-this still doesn't make a lot of sense to me because one person can have higher blood levels on a low dose than another person on a high dose. I think they're just covering their you know what and cheese etc are probably safe at any dose, though it probably makes sense to avoid the really high tyramine foods like very aged cheeses even on the low doses. I'll definitely give Emsam a try, but I'm not holding my breath, from what I've read it sounds like its likely to be one of those anxiety increasing, insomnia increasing type drugs. Cecilia

The recommendations about tyramine restriction are statistical concepts. Individuals would be foolish to pay no regard to tyramine, even if on lower doses of Emsam. It is important to determine one's own tyramine sensitivity, whenever overt manipulation of MAO activity is considered, whatever the dose.

Lar

 

Re: FDA Approves EMSAM » Phillipa

Posted by RetiredYoung on March 1, 2006, at 12:45:52

In reply to Re: FDA Approves EMSAM » RetiredYoung, posted by Phillipa on February 28, 2006, at 20:52:49

>> The question is do they work?

I assume you mean my Zyprexa/SSRI combo? To a degree. They keep me from feeling rock bottom/suicidal, but I never come close to feeling well.

 

Re: FDA approves EMSAM

Posted by cecilia on March 1, 2006, at 17:30:07

In reply to Re: FDA approves EMSAM » cecilia, posted by Larry Hoover on March 1, 2006, at 12:05:20

You're probably right Larry. I suspect there will be some big time lawsuits with people who happen to be unusually sensitive to tyramine and it will end up being taken off the market like so many new drugs. I'll be cautious at 1st. Cecilia

 

Re: FDA approves EMSAM

Posted by cecilia on March 1, 2006, at 17:31:42

In reply to Re: FDA approves EMSAM, posted by Last Chance on March 1, 2006, at 10:45:08

Don't forget the banana peels-such deprivation. Cecilia

 

Re: FDA Approves EMSAM » RetiredYoung

Posted by Phillipa on March 1, 2006, at 18:19:46

In reply to Re: FDA Approves EMSAM » Phillipa, posted by RetiredYoung on March 1, 2006, at 12:45:52

Yes that's what I meant. thank, Phillipa

 

Re: FDA's decision on EMSAM tomorrowthanks Jake (nm) » RobertDavid

Posted by Jakeman on March 1, 2006, at 21:03:04

In reply to Re: FDA's decision on EMSAM tomorrow » Jakeman, posted by RobertDavid on February 27, 2006, at 23:15:31

 

Re: FDA approves EMSAM » Last Chance

Posted by Iansf on March 2, 2006, at 14:58:59

In reply to Re: FDA approves EMSAM, posted by Last Chance on March 1, 2006, at 10:45:08

<I tried oral Selegeline for awhile with no good results - also moclobomide, which within a week gave me negative sexual side effects which it is not supposed to do. Richard >

Same for me with sexual side effects. I'd heard it could even boost sexual performance, but no such luck. That's my big concern with the patch - will it TRULY not have negative sexual side effects?

 

Re: FDA's decision on EMSAM tomorrow

Posted by rvanson on March 4, 2006, at 21:16:53

In reply to Re: FDA's decision on EMSAM tomorrow » RobertDavid, posted by Jakeman on February 27, 2006, at 20:48:17

> Can someone summarize what the benefits will be from taking selegline transdermally rather than orally?
>
> thank, Jake

It avoids first pass liver problems, unlike nardil, ect leading to less problems/SE's.

 

Re: FDA's decision on EMSAM tomorrow

Posted by RobertDavid on March 4, 2006, at 21:21:01

In reply to Re: FDA's decision on EMSAM tomorrow, posted by rvanson on March 4, 2006, at 21:16:53

Getting my perscription for EMSAM Thursday. I'm told it should be available in a few weeks. I'll post how I do.

 

Re: FDA's decision on EMSAM tomorrow

Posted by Last Chance on March 5, 2006, at 1:44:03

In reply to Re: FDA's decision on EMSAM tomorrow, posted by RobertDavid on March 4, 2006, at 21:21:01

> Getting my perscription for EMSAM Thursday. I'm told it should be available in a few weeks. I'll post how I do.

Got my script and now just waiting - I will also post how it is working. Richard

 

Re: FDA's decision on EMSAM tomorrow

Posted by RobertDavid on March 5, 2006, at 13:34:02

In reply to Re: FDA's decision on EMSAM tomorrow, posted by Last Chance on March 5, 2006, at 1:44:03

Has anyone else noticed how much attention EMSAM's approval is getting? I've seen it several times on the news, read it in the newspaper, others that I've mentioned it to through the years have called me and said "I heard your patch got approved."

Even last night on the news segment of Saturday Night Life they did a spoof on the approval of "the first of its kind patch for depression", but they of course made a joke of it by saying it was to be used to put on your mothers mouth to keep her from talking. (LOL)

Anyway, I'd heard originally that there weren't big sales expectations by the drug companies as is would primarily be psychiatrists that would feel comfortable to perscribe it, but with this much publicity, who knows.

 

EMSAM price

Posted by Iansf on March 5, 2006, at 13:49:02

In reply to Re: FDA's decision on EMSAM tomorrow, posted by RobertDavid on March 5, 2006, at 13:34:02

Does anyone by chance know what EMSAM will cost?

 

Re: EMSAM price

Posted by cecilia on March 5, 2006, at 22:19:27

In reply to EMSAM price, posted by Iansf on March 5, 2006, at 13:49:02

Does anyone by chance know what Emsam will cost?

A lot!

 

Re: FDA's decision on EMSAM tomorrow

Posted by rvanson on March 6, 2006, at 4:08:00

In reply to Re: FDA's decision on EMSAM tomorrow, posted by RobertDavid on March 4, 2006, at 21:21:01

> Getting my perscription for EMSAM Thursday. I'm told it should be available in a few weeks. I'll post how I do.


Good luck! I will be asking my Pdoc about an Rx on my next visit. If he says "no", its the last time he will see me in his waiting room, period.

Finally, the FDA got its head out of its collective $%# and I think lots of people might be helped greatly by this non-SSRI, pro-dopamine AD medication.

 

Re: FDA's decision on EMSAM tomorrow

Posted by Last Chance on March 6, 2006, at 10:16:33

In reply to Re: FDA's decision on EMSAM tomorrow, posted by rvanson on March 6, 2006, at 4:08:00

> > Getting my perscription for EMSAM Thursday. I'm told it should be available in a few weeks. I'll post how I do.
>
>
> Good luck! I will be asking my Pdoc about an Rx on my next visit. If he says "no", its the last time he will see me in his waiting room, period.
>
> Finally, the FDA got its head out of its collective $%# and I think lots of people might be helped greatly by this non-SSRI, pro-dopamine AD medication.
>
> Man, do I hope it will help - my doc hasn't wanted me to wait, but take Lex instead - I am holding out - I am afraid that it will be too expensive, I don't have any insurance. Doubt if they will be dumping samples at my local clinic? Hopefully your doc will let you give it a trial. Richard

 

Re: FDA's decision on EMSAM tomorrow » RobertDavid

Posted by noordhoff on March 16, 2006, at 9:41:43

In reply to Re: FDA's decision on EMSAM tomorrow, posted by RobertDavid on March 4, 2006, at 21:21:01

I don't see how you can get a script for a med which has only just been approved but not yet manufactured or marketed. In fact, I spoke to BMS & they've informed me that there is as of today still no launch date on the books for EmSam, but that'll it'll probably take a couple of months to become available. From my research, I'd say it should be available withing the next 6 weeks, so I guess the pharma rep I spoke to was erring on the side of caution. Still, don't expect any script to be filled any time this month!
BTW, PLEASE inform me if I'm wrong, RobertDavid! I've been waiting for this bloody approval for months. Don't feel I can wait much more (but I guess I will if I have to...)
Good luck to us all.

 

Re: FDA's decision on EMSAM tomorrow » noordhoff

Posted by RobertDavid on March 16, 2006, at 10:13:35

In reply to Re: FDA's decision on EMSAM tomorrow » RobertDavid, posted by noordhoff on March 16, 2006, at 9:41:43

> I don't see how you can get a script for a med which has only just been approved but not yet manufactured or marketed. In fact, I spoke to BMS & they've informed me that there is as of today still no launch date on the books for EmSam, but that'll it'll probably take a couple of months to become available. From my research, I'd say it should be available withing the next 6 weeks, so I guess the pharma rep I spoke to was erring on the side of caution. Still, don't expect any script to be filled any time this month!
> BTW, PLEASE inform me if I'm wrong, RobertDavid! I've been waiting for this bloody approval for months. Don't feel I can wait much more (but I guess I will if I have to...)
> Good luck to us all.


I can totally relate to being frustrated about the wait. I have been watching this med in the process for about 5 years now, I feel the same way and am counting the days.

Yesterday I contacted BM and after going though various departments got through to someone that gave me more info than the general "it will be a few months". He said it will launched in April. Wouldn't commit to what part of April. I got the impression from him it's finally getting close to being released. We'll see.

As for my getting a script, when I got to my psychiatrists appointment we reviewed EMSAM, drug interations (an issue for certain drugs), food restrictions (which he said shouldn't be an issue), possible side effects (which he thought would be less than most SSRI's I've tried) and an overal game plan for continued treatnent for my social anxiety/depression. And though perscribing information is posted on the BM website, I did not leave the office with a script in hand. Once released he will call the perscription into my pharmacy, no additional appointment with him will be necessary. I'm good to go. Just need product.

I understand not wanting to wait any longer. I check every other day. I'm sure I'll be one of the first "guinea pigs" and will post how I do. I am realistic that it may not work, but this is my first crack at an MAOI so I'm very anxious to give it a try. My doc thinks it will work, but again, we'll see. Good luck to everyone.


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