[lurkingforacure]

We just refilled our name brand sinemet Rx late yesterday, and noticed the pills are larger (bad-why?) and now have a line for breaking in half (good, yea!). We don't know yet what, if any, effect the size difference will make, but are watching. Anyone taking name brand should be on the alert for changes in pill size, coloration, etc., and note any change in effect.

I can't imagine that adding a line to a pill for scoring would require an increase in diameter of the pill, and it also looks thicker. I'm going to call our pharmacy tomorrow, they're closed today, and see what's up.

[paula_w]

Originally Posted by lurkingforacure

We just refilled our name brand sinemet Rx late yesterday, and noticed the pills are larger (bad-why?) and now have a line for breaking in half (good, yea!). We don't know yet what, if any, effect the size difference will make, but are watching. Anyone taking name brand should be on the alert for changes in pill size, coloration, etc., and note any change in effect.

I can't imagine that adding a line to a pill for scoring would require an increase in diameter of the pill, and it also looks thicker. I'm going to call our pharmacy tomorrow, they're closed today, and see what's up.

is it still from the same company? merck?

[lurkingforacure]

Nope, the last bottle was from Merck, and it was different from the ones we used to take as well (all are 25/100 name brand). here's the history:

first pills: oval and yellow with a line for scoring, made by Merck but not sure where

second batch (first change for us-this was after the international "shortage"): these pills were round, light yellow, and no line for scoring, still made by Merck but not sure where

third batch: (second change for us, updated script from doc, but still 25/100): larger diameter pills, they also seem thicker, still light yellow, and they now have a line for scoring, NOT made by Merck, and the script lable is so doggone small I can't read who the manufacturer is, but will update when I find my magnifying glass!

Seems like Merck moved its operations to another country resulting in change #1, then either some company took over those operations or bought them out, or there is another company acutally making name brand sinemet now and it's cheaper so our insurance company only covers that manufacturer. There could be other possiblities, of course, and as long as the med has no adverse effects (less effective, worse side effects) it's not a big deal. But is they do....

Originally Posted by lurkingforacure

Nope, the last bottle was from Merck, and it was different from the ones we used to take as well (all are 25/100 name brand). here's the history:

first pills: oval and yellow with a line for scoring, made by Merck but not sure where

second batch (first change for us-this was after the international "shortage"): these pills were round, light yellow, and no line for scoring, still made by Merck but not sure where

third batch: (second change for us, updated script from doc, but still 25/100): larger diameter pills, they also seem thicker, still light yellow, and they now have a line for scoring, NOT made by Merck, and the script lable is so doggone small I can't read who the manufacturer is, but will update when I find my magnifying glass!

Seems like Merck moved its operations to another country resulting in change #1, then either some company took over those operations or bought them out, or there is another company acutally making name brand sinemet now and it's cheaper so our insurance company only covers that manufacturer. There could be other possiblities, of course, and as long as the med has no adverse effects (less effective, worse side effects) it's not a big deal. But is they do....

Let me know if the inside of your mouth, your tongue, and throat start burning. I'm still having this adverse effect. Don't know if anyone else is. But, I'm taking generic.

Originally Posted by TonyaV

Let me know if the inside of your mouth, your tongue, and throat start burning. I'm still having this adverse effect. Don't know if anyone else is. But, I'm taking generic.

I get mixed up with the different manufacturers of Sinemet I've tried.

Actually, Mylan was the pharmaceutical co. making Sinemet per my phone conversation with a rep. at Merck. Merk was in partnership with Mylan in the production of Sinemet. The rep. told me all production of Sinemet was on hold. It was either in May or June when I made that call.

That was the only brand I could tolerate. Since you are getting it now, I have to conclude they are producing Sinemet again.

So, THANK YOU for posting this. I'll be calling my pharmacist tomorrow morning.

Well, come to think of it, Merck could be in partnership with another pharmaceutical co. now. Oh, jeepers. I'll call Merck again tomorrow morning.

Thanks lurkingforacure!

ok i'm editing this.

re-read and realized it is not Merck. This is what I get for posting when not feeling well and thinking is slow.
Sorry

[lurkingforacure]

OK, should have done this research first, but my point is still that everyone needs to watch their drugs for different effects....

The patent expired on name brand sinement (isn't it always about the money?) and so now there are THREE companies making generic sinemet, ALL of them are rated AB by the FDA which I think stinks, you know there are major differences in formulations but they hide behind the "AB" rating which to me, means diddly.

The three companies I found are:

Teva
Avartis Elizabeth (this is the company making the one we just got)
Sandov

Mylan makes the name brand sinemet for Merck. I think it's so cheesy how when our doc had to renew our script because they expire every year, the default by the insurer was back to generic which they know we cannot tolerate! This is documented from our attempt to try generic before and yet they are still trying to pass the generic stuff off on us, it makes me really mad. If we could take the generic, we would, it's cheaper and who cares? But it doesn't work for us, and now since the doc didn't actually read our file before renewing the script, we have a bottle of pills we will not be able to use, and have to get another bottle of name brand. Had he just read our file, he'd have seen the "name brand required" notation and would have specified that to the pharmacy. So annoying.

A lesson for us all: if you need name brand, don't assume the doc will remember that, remind him when it's time for script renewal. And keep watch on your drugs, read who is making your levodopa and keep a record of any changes in your response to it.

[paula_w]

are both on my bottle so no change yet. they are small and have no dividing line.

even with medicare and cigna , i have a $70 copay every month. they can't be worth all that money. they create shortages ....oh i'll just stop and not ruin my night with thoughts of greedy scoundrels.

did that last night...

[tremorgrrrl]

Originally Posted by lurkingforacure

OK, should have done this research first, but my point is still that everyone needs to watch their drugs for different effects....

The patent expired on name brand sinement (isn't it always about the money?) and so now there are THREE companies making generic sinemet, ALL of them are rated AB by the FDA which I think stinks, you know there are major differences in formulations but they hide behind the "AB" rating which to me, means diddly.

The three companies I found are:

Teva
Avartis Elizabeth (this is the company making the one we just got)
Sandov

Mylan makes the name brand sinemet for Merck. I think it's so cheesy how when our doc had to renew our script because they expire every year, the default by the insurer was back to generic which they know we cannot tolerate! This is documented from our attempt to try generic before and yet they are still trying to pass the generic stuff off on us, it makes me really mad. If we could take the generic, we would, it's cheaper and who cares? But it doesn't work for us, and now since the doc didn't actually read our file before renewing the script, we have a bottle of pills we will not be able to use, and have to get another bottle of name brand. Had he just read our file, he'd have seen the "name brand required" notation and would have specified that to the pharmacy. So annoying.

A lesson for us all: if you need name brand, don't assume the doc will remember that, remind him when it's time for script renewal. And keep watch on your drugs, read who is making your levodopa and keep a record of any changes in your response to it.

I've posted on this topic previously and NPF recently released on article on the differing efficacy of generics for PWP. In short, generics can be up to 20% less effective than the name brand and still be considered equivalents. So we need to be vigilant about our medications. (If we aren't, no one esle will be.)

My advice is not only to alert your physician to your need for the name brand (or a particular manufacturer's version of the generic) but even more importantly, to tell your pharmacist. When I get a refill, if the medication is not exactly the same as it was the previous time, the pharmacist will tell me. Then I have a choice. I can either take the entire dose home and hope for the best; reject the entire dose and ask the pharmacist to work with my physician and insurance complany to obtain the preferred drug; or take home a partial prescription as a "tester" to see how it works. I've found I can tell right away when there is a problem -- either because the drug is less effective or because it causes unwanted side effects. And if the drug is a problem, I ask the pharmacist and my physician to include documentation of the problem(s) in my file. This way, it is more likely I will get the *proper* drug next time because I will be identified as having a "need" versus a "want" for a particular drug.

That all said, good luck to us all. It is hard enough trying to find the right balance of medications and then when the balance is tipped even a little, it is almost like starting over again.

[lindylanka]

I believe that there is quite a wide % +/- allowable for generics that makes them less great for us to use, with different binders and amounts of active ingredient this means that the variables are likely to be noticeable. Paula is right, they do not cost that much to produce, it is health system overheads in the US that make them cost so much. It looks like the issue of generics is one that is not going to go away.

On a more optimistic note, if you can ensure that you get the same generic each time you refill, the variables will be less noticeable.

[tremorgrrrl]

Originally Posted by lindylanka

I believe that there is quite a wide % +/- allowable for generics that makes them less great for us to use, with different binders and amounts of active ingredient this means that the variables are likely to be noticeable. Paula is right, they do not cost that much to produce, it is health system overheads in the US that make them cost so much. It looks like the issue of generics is one that is not going to go away.

On a more optimistic note, if you can ensure that you get the same generic each time you refill, the variables will be less noticeable.

Here is what we are dealing with in the U.S.:

The FDA allows generics to have a range of bioavailability from 4/5 to 5/4 (i.e. 80–125%) that of the comparator brand-name drug.

The FDA permits manufacturers to have tolerances of up to 20% in the manufacturing process. This means that one batch of pills may contain 100% of the active ingredient, one may contain less, and one may contain more. Just as long as the overall rate for the manufacturer is at or near 100%.

There is very little research comparing one generic to the next. In studies of anti-depressant medications, for example, generics were found to vary in bioavailability up to 45%.

Clearly we need more information about the bioavailability of the generics to make the best choices about our medications.