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Bad bottle of sinemet?

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Old 07-13-2019, 01:14 AM   #1
toyL
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Default Bad bottle of sinemet?

Hello everyone. Has anyone here ever received what they believed to be a "bad" bottle of sinemet from their pharmacy/supplier? I get my sinemet from the VA pharmacy, and until recently I always got the carbidopa 25mg/levodopa 100mg made by Mylan Pharmaceuticals Inc. Not too long ago I got a bottle of 360 tabs, and I swear they're "no good". I say this because they wear off hard and fast right at about 2 hours, and I mean it is "ugly". I've been having the worst dyskinesia that I've ever experienced. At first, I thought the pills were old/out-dated, because the color wasn't quite right. They're "yellow", but it's a slightly darker shade. They're "texture" isn't "correct" either--they seem "harder" than usual. Then I noticed they're larger. So, I took a look at the imprint (m/721), and sure enough they sent me a bottle of 360 tabs made by Mayne Pharma US. For some reason, my brain dose not like this med. So, before I actually figured out I simply had a different manufacturer, I called my VA neurologist and told her I had a "bad" bottle. Her remedy was to write me a prescription to be filled at a regular pharmacy. Well, "News Flash"--I can't really afford another prescription at SAMs Club or anywhere else. Oh well, I'm screwed AGAIN. This is madness. I take 3 tabs, four times daily. When this bottle runs out, whose to say the next prescription won't be from Mayne Pharma US again. I guess it's time to write my senator again, although he's already working on something else for me right now.
Question: My symptoms began around June 1996, so I'm 23 yrs into this. Could this length of time make me more sensitive to whatever subtle difference(s) there may be between makers of sinemet? I mean, I always thought "regular" sinemet was "regular sinemet."
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Old 07-13-2019, 03:32 AM   #2
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toyl,

I'm sorry to hear of your problems.

The fact that you are having the "worst dyskinesia" suggests that the new pills are stronger (a higher CMAX than usual). And, the fact that you have shorter "on"/"off" transitions suggests that THALF is less.

The regulatory system demands bioequivalence, but this is interpreted rather loosely. Very roughly speaking this allows about a 5% difference.

See the thread:
Sun Pharmaceuticals new supplier

Last year I measured the weight of my pills (Stalevo in my case) and found inter-batch differences and intra-batch differences of 4%. Note that's the total weight of the pill, not the weight of the active ingredients.

Weighing tablets

After what dose are you having dyskinesia? You may find benefit spreading out your doses. Similarly, with the strong transition, perhaps eating a little fat with the dose may extend the half-life.

John
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Old 07-13-2019, 11:45 AM   #3
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Won't the VA let you trade in this questionable batch & try a new batch?
Or give you a few days worth from another batch to test them?

I'm sure is possible for batches to have slightly different mix , but not recall worthy..
Just like food or anything.. if you get something that seems off ask about a return or exchange...
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Old 07-13-2019, 05:44 PM   #4
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Thanks, johnt, for your reply. Don't know what CMAX is, and don't know what THALF is. I did have a look at the "Sun Pharmaceuticals" link, and was surprised to see so many different makers.
For about 4 years now, I've been taking 3 tabs, four times daily of the carbidopa 25mg/levodopa 100mg formulae. Except for a few years beginning around the year 2000, I have always taken the Mylan carbidopa 25mg/levodopa 100mg (Imprint Code: M;CL2).
Your idea of "weighing" individual tabs and then trying to objectively decide if the heavier tabs worked "better" or caused worse "off" crashes or whatever, if that's where you were headed, sounds interesting. Of course, you realize that drug makers, as well as 8th grade chemistry and home-economics students, are quite adept at ensuring that each individual pill (or cupcake) in the batch contains the correct dose of ingredients. It's really quite simple, save some catastrophic mechanical failure in the "process". It's achieved by "extensive" mixing of ingredients. This is why I don't understand how a Mayne Pharma carbi/levodopa can have such a profoundly different affect than the Mylan made pill of the same ingredients.
Yes, "spreading out" my doses is always critical. After all, sinemet is essentially "poison".
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Old 07-13-2019, 05:45 PM   #5
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Thanks for your reply, Jo*mar. Well, everything you've just said is exactly what I was thinking. I think if my VA neurologist had received maybe 5 or 6 complaints similar to my own, she would have actually done something to look into it. Maybe she would have asked the maker and or distributor for documents that would certify the date of manufacture (to verify the "use by" date).
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Old 07-13-2019, 07:51 PM   #6
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Our regular pharmacies here, we got all the paperwork about the med and the labels had the maker and some code number or identification..
Yours didn't have that info with it?

My dad got the generic C/L often the shape & color changed between 2 or 3 makers. But we didn't notice any issues..

There were posts many years ago about generics having more filler or lesser active percentages.. I think by soccerteses?? I probably misspelled the username..but it is close to that.. you can search for those posts with a name or keyword..

Oh taking any other meds?
After some years we had to drop the add on meds due to the accumulated side effects.. plus they weren't doing any positives by then.
Mirapex (pramipexole) was one those dropped

I think as we age we lose nutrient absorption. ..
That is written about on many website for ageing & nutrition.....
So I assume medication absorption changes too for better or worse..

When pot became legal in Oregon, we asked dad if he wanted to try it or CBD oil
, we had asked his neuro too but she claimed no knowledge on it and PD, so my parents did not want to give it a try.. Anxiety and hallucinations/delusions were a main symptoms by then.. and fatigue..
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Old 07-14-2019, 05:28 PM   #7
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Same experience with the exact same pill manufactured and distributed by Mayne Pharma, only add in too nauseous to eat which made the hyperness it made me feel and dyskinesias worse. My MDS ordered the one that was working for me previously which is made by ACTAVIS but is now distributed by Mayne. There is no extra charge since both are generics but I have to double check with CVS every month to make sure I get the right one because as the pharmacist explained, there is no way to enter a request for a specific generic into their system. The company just stocks the stores with whatever generic is cheapest. I open the package and look at the pills with the pharmacy clerk standing there to avoid paying for and getting home with the wrong ones. Maybe you can take the bottle back and tell the pharmacy that you aren't tolerating it and it needs to be replaced with another generic?

Don't assume you are imagining anything where generics are concerned. These drugs are manufactured overseas, mainly in India, with very little FDA oversight. (NPR's Fresh Air had a harrowing show on the topic a few weeks ago.) A few years ago, TEVA had to recall a batch of super potent carbidopa/levodopa.

Last edited by Canna; 07-14-2019 at 05:48 PM.
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Old 07-15-2019, 05:59 PM   #8
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Quote:
Originally Posted by Jo*mar View Post
Our regular pharmacies here, we got all the paperwork about the med and the labels had the maker and some code number or identification..
Yours didn't have that info with it?

My dad got the generic C/L often the shape & color changed between 2 or 3 makers. But we didn't notice any issues..

There were posts many years ago about generics having more filler or lesser active percentages.. I think by soccerteses?? I probably misspelled the username..but it is close to that.. you can search for those posts with a name or keyword..

Oh taking any other meds?
After some years we had to drop the add on meds due to the accumulated side effects.. plus they weren't doing any positives by then.
Mirapex (pramipexole) was one those dropped

I think as we age we lose nutrient absorption. ..
That is written about on many website for ageing & nutrition.....
So I assume medication absorption changes too for better or worse..

When pot became legal in Oregon, we asked dad if he wanted to try it or CBD oil
, we had asked his neuro too but she claimed no knowledge on it and PD, so my parents did not want to give it a try.. Anxiety and hallucinations/delusions were a main symptoms by then.. and fatigue..
Thanks, Jo*mar. Yes, thee is always plenty of paperwork that arrives with my meds in the mail from the VA. It's the "government", and they love "paperwork". It's more than I care to ever to peruse or skim over. I have a problem with "paperwork", having worked for government for several years. So, I called my VA neurologist directly with my complaint.
yes, I take several other meds, but none are agonists or PD-related at this late stage. I've been through the lot of them already.
Sorry about your dad. Yeah, it does kind of make sense that pot might not be good for someone who is already delusional and having hallucinations, but it could have a "paradoxical effect". Stranger things have happened.
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Old 07-15-2019, 06:02 PM   #9
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Quote:
Originally Posted by Canna View Post
Same experience with the exact same pill manufactured and distributed by Mayne Pharma, only add in too nauseous to eat which made the hyperness it made me feel and dyskinesias worse. My MDS ordered the one that was working for me previously which is made by ACTAVIS but is now distributed by Mayne. There is no extra charge since both are generics but I have to double check with CVS every month to make sure I get the right one because as the pharmacist explained, there is no way to enter a request for a specific generic into their system. The company just stocks the stores with whatever generic is cheapest. I open the package and look at the pills with the pharmacy clerk standing there to avoid paying for and getting home with the wrong ones. Maybe you can take the bottle back and tell the pharmacy that you aren't tolerating it and it needs to be replaced with another generic?

Don't assume you are imagining anything where generics are concerned. These drugs are manufactured overseas, mainly in India, with very little FDA oversight. (NPR's Fresh Air had a harrowing show on the topic a few weeks ago.) A few years ago, TEVA had to recall a batch of super potent carbidopa/levodopa.
Thanks for your reply, Canna. I can't take it back, because it's from the VA pharmacy.
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Old 07-17-2019, 10:05 AM   #10
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I have noticed major differences between generics and i turn into a space case when taking the activis generic and always get the mylan brand. mylan makes some or all of merck's sinemet, it's on the bottle label.

teva used to make a great C/L but sold their C/L and their ACTIVIS C/L (TEVA BOUGHT ACTIVIS

teva Completes Acquisition of Actavis Generics. JERUSALEM --(BUSINESS WIRE)--Aug. 2, 2016-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Allergan plc (NYSE: AGN) today announced that Teva has completed its acquisition of Allergan's generics business (“Actavis Generics”).Aug 2, 20

and then they sold it to MAYNE
GREENVILLE, N.C. — Mayne Pharma recently announced that it had closed its $652 million acquisition of 42 products from Teva and Allergan. The portfolio includes 37 approved products and five products currently awaiting approval. The acquisition makes Mayne Pharma one of the 25 largest retail generic pharmaceutical companies in the United States and the second-largest generic oral contraceptive provider, the company said.

“We are extremely pleased to complete this transaction that establishes Mayne Pharma as a key player in the U.S. generic market,” president Stefan Cross said. “This portfolio is highly profitable and will significantly extend our size, scale and reach in the United States. Recent investments in people, systems and facilities will readily support the rapidly growing organization and ensure we continue to deliver exceptional service and high-quality products to our customers.”

The company has recently invested in a new manufacturing facility in Greenville, N.C., that will increase its manufacturing capacity by a factor of more than four. It has also grown its workforce by more than 700 employees globally.

The products acquired include the following in different dosage strengths.
Carbidopa/Levodopa

so i assume that MAYNE just repackages the ACTIVIS product. the teva C/L is defunct.

so what can you do to get the MYLAN generic? can't help you with the V.A. but you should call independent pharmacies and ask what they would charge you for 25/100 mylan C/L, you might find a pharmacy that will give you a break on the price. GOODRX quotes $11-$17 for 90tablets of what looks like the activis brand so maybe you can get the MYLAN for a little more. 90 pills is only 7.5 days for you.

you can also see if your doctor will write you an RX for 25/250 C/L, you might get a better price. it has less than 1/2 of the carbidopa/100mg than the 25/100 so you will have to probably take more, maybe not.

this is just to try to get you by until you hopefully find a way to get the V.A. to pay for the mylan brand. i'm very fortunate that i have a friend who owns an independent pharmacy and thus i have few problems getting a certain generic.

this is just going to get worse unless congress forces generic manufacturers to actually test their generics on people with pd and measure the relief one gets and side affects. right now they just have to measure the blood levels of the active ingredients on healthy volunteers.

here's a very critical story on chinese and indian generic mfg's.
NPR Choice page

i'm not saying i believe everything in the article but food for thought.
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