Impact of new generic formulation of Clonazepam

[[Cy...]]

My clonazepam script was refilled with a different generic formulation than I've been using. If I understand correctly, there could be some differences between brands that could effect my taper.  The brand I was on was Teva; the new brand is Aurobindo.  Anyone know if there is a difference between the two?  They weigh the same.  What kind of impact should I expect?

Thank you.

[[...]]

I was on teva. I remember years ago I was given another brand. I noticed the difference I had to specifically requested the teva at the pharmacy.

I've seen a thread talking about teva and another brand. That  person was on the other brand and when it changed to teva they didn't like the teva and wanted to get back on the other brand.

Different brands can feel different.

Long story short if you feel a worse  difference don't hesitate to make an issue of it and get what you need.

Edited March 15 by [...]

[[Li...]]

Hello @[Cy...].  I’m sorry your generic manufacturer was changed.  This seems to be happening more frequently here in the US.  Fortunately, there are steps you can take to decrease the likelihood of this happening moving forward.

Like everything else related to benzodiazepine withdrawal, some individuals have no issues with manufacturer changes whereas others do.  Let’s hope you fall into the first category! 

Re: your question about the differences between tablets made by different generic manufacturers … 

Three of them are:

1. The amount of active ingredient can be different.  My understanding is that in the US, most generics are allowed to vary +/- 10% from the reference standard (I.e. the brand).  So, in the most extreme case, a 1mg tablet from Manufacturer A could actually contain 0.9mg of the active ingredient, whereas a 1mg tablet from Manufacturer B could contain 1.10mg of the active ingredient.  Let me emphasize — this would be an extreme case.
2. The other ‘inactive’ (see note)  ingredients in tablets from different manufacturers can also vary.  I’ve included the inactive ingredients for 0.5mg tablets from Aurobindo vs Teva below.
3. The weight of the tablets can be different. 

To minimize the impact of a manufacturer change, strategies you can use include:

1. Hold your dose constant while switching from one manufacturer to another!  Do not continue to make reductions in dose if you have been actively tapering.
2. If you have extra tablets from the previous manufacturer, alternate between using them and the tablets from the new manufacturer.  Gradually phase out your use of the tablets from the previous manufacturer.
3. Wait 7-10 days after you have completed the switch to make sure you have fully adjusted to the change.

Note:  Inactive ingredients are not really ‘inactive’ in the sense that they have no effect on the active ingredient (AI). For example, ‘inactive’ ingredients may protect the AI from degradation and/or affect its bioavailability. In other words, inactive ingredients are not just ‘binders and fillers that don’t matter’ as is often incorrectly claimed.

Aurobindo 0.5mg clonazepam
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)

Teva 0.5mg clonazepam
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)

 

[[Cy...]]

Update....so I have gone from pretty bad wd sxs, to severe sxs while transitioning to the Aurobindo brand (not complete yet).  I am the opposite of stable, and predominantly non-functional at this point. I believe that this brand does have a significant reduction of active medication. I am additionally very susceptible to reactions from excipient fillers, so that my also play a part.

I've read that the Teva brand currently has a shortage, and expected availability is not until July!  Has anyone been successful getting them? Will be calling pharmacy tomorrow.

What brand do the compounding pharmacies use?  Brand name, or does it vary?  Would I still be dealing with brand changes/shortages?

Thanks all!

[[...]]

Sorry, I have no answers to your questions. wanted to let you know I have been facing the same thing, pharmacy changed my prescription from Teva to auribindo. I have phased the transition and it feels like I’ve taken a bigger cut than I’m used to.There is definitely less active ingredient in the auribindo brand! So I am riding it out just like every other cut I’ve made. 
Hope it passes for you soon!

Edited April 7 by [...]

[[Li...]]

12 hours ago, [[C...] said:

I've read that the Teva brand currently has a shortage, and expected My availability is not until July!

Might I add a clarification to the above @[Cy...]?  

Per the ASHP drug shortage database, there is a shortage of the 100 count bottles of 0.5mg Teva clonazepam tablets.  The company estimates a release in mid- to late July 2024.

500 count bottles of 0.5mg tablets are being released as they become available. So availability of the 500 count bottles will vary by distributor/supplier/pharmacy.  

You might ask your pharmacist if they would be willing to order a 500 count bottle of Teva and keep it in reserve to fill your prescriptions, at least until the shortage of the 100 count bottles is resolved in July.  My experience is that smaller, independent pharmacies are more open to doing this than the large chain pharmacies. 

It also helps if your prescriber writes a DAW (Dispense As Written) script for Teva.

 

[[Cy...]]

[[Cy...]]

2 hours ago, [[L...] said:

Might I add a clarification to the above @[Cy...]?  

Per the ASHP drug shortage database, there is a shortage of the 100 count bottles of 0.5mg Teva clonazepam tablets.  The company estimates a release in mid- to late July 2024.

500 count bottles of 0.5mg tablets are being released as they become available. So availability of the 500 count bottles will vary by distributor/supplier/pharmacy.  

You might ask your pharmacist if they would be willing to order a 500 count bottle of Teva and keep it in reserve to fill your prescriptions, at least until the shortage of the 100 count bottles is resolved in July.

Hi @[Li...],

Thanks for the clarification!  Unfortunately, CVS is my pharmacy, however, I'm in a very small town, so maybe they'll work with me.  Hoping so.

Thank you!

[[Li...]]

You’re most welcome @[Cy...]!

 

In case your pharmacist needs it, the NDC (National Drug Code) for the 500 count bottle of 0.5mg clonazepam tablets from TEVA is:

NDC 0093-0832-05

Another option to consider would be to try brand Klonopin tablets (see link to its FDA drug label below).  Brand manufacturers typically hold themselves to higher quality control standards than generics.   This means the amount of active ingredient in the tablets is more accurate (i.e. closer to the true value) and precise (i.e. more consistent).

For example, my compounding pharmacist and I agreed that she would use brand Klonopin tablets to make my stability-tested 0.1mg/mL oral clonazepam suspension.  The formulation only requires 7.5 of the 2mg Klonopin tablets per month so the cost is reasonable.

Please do let us know how your pharmacist responds to your request. 

Link:
DailyMed - KLONOPIN- clonazepam tablet
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1

 

 

[[Cy...]]

@[Li...]

My CVS can't get Teva brand, their distributor doesn't have it.  I may be able to get it thru mail away, however, being on Medicare, I have to have the doctor apply for a prior authorization because it is not a preferred brand. They may not approve.  WTH.

Of course, I'm now running in crisis mode, as I'm flooded with panic over this.  If I have to use the Aurobindo, would you suggest adding back the 5% I last cut?  Would that help mitigate the difference in strength?  Of course, it could be more than that.  Or, it could, as you pointed out, also be related to the excipients, but I can't be non-functional.

I realize that the majority do not have these issues, however, they shouldn't be allowed to do this.

[[Li...]]

Are there other pharmacies in your area?  Different pharmacies use different suppliers so you might be able to find one that stocks Teva.

Am I understanding correctly that you made a 5% reduction in dose at the same time that you were transitioning from Teva to Aurobindo?  If so, in your shoes, I would try a 5% updose.

Please keep in mind that it can take a few days for the concentration of the drug in your blood serum to ‘level out’ after a change. 

Re: excipients being a factor …

The Aurobindo tablets only have two different excipients compared to the Teva tablets — silicon dioxide and sodium lauryl sulfate.  Both are used in food, cosmetic, and pharmaceutical products. Have you had a reaction to either of these in the past? 

[[Cy...]]

8 hours ago, [[L...] said:

Are there other pharmacies in your area?  Different pharmacies use different suppliers so you might be able to find one that stocks Teva.

Am I understanding correctly that you made a 5% reduction in dose at the same time that you were transitioning from Teva to Aurobindo?  If so, in your shoes, I would try a 5% updose.

Please keep in mind that it can take a few days for the concentration of the drug in your blood serum to ‘level out’ after a change. 

Re: excipients being a factor …

The Aurobindo tablets only have two different excipients compared to the Teva tablets — silicon dioxide and sodium lauryl sulfate.  Both are used in food, cosmetic, and pharmaceutical products. Have you had a reaction to either of these in the past? 

@[Li...]

There are two additional local pharmacies I can call.  Express Scripts stocks it.  However, I will have to get the prior authorization approved from my Medicare drug plan before I can have a script filled anywhere.  Hopefully that won't be an issue. 

No, I didn't cut and transition simultaneously.  I cut 5% a little over a month ago now.  I started a slow transition about 2 weeks later.  I thought going slowly would make the transition smoother.  Not so much.  As the Aurobindo has increased, I have felt far worse mentally and physically.  I had planned to finish the Teva  (6/7 tablets left).  I took only the Teva today and felt a bit better. I was thinking that the updose of 5% might close the gap in the variance between the two medications.  Do you think that is a potential strategy?

I haven not had an issue with silicon dioxide that I am aware of.  However, I am sulfate/sulfite sensitive.  It is a histamine trigger.  I am histamine and salicylate sensitive and have MCAS issues, among other gastro issues, since going thru tolerance wd for two years on this poison. I've also had an uptick in salicylate symptoms since starting the Aurobindo.

This makes me wonder if it's time to consider switching to compounded meds.  I've only been on the Teva brand, so assuming if I wanted the smoothest of transitions, I should stick with Teva, which would potentially mean still dealing with availability issues.  Did you have symptoms from switching to the brand name Klonopin?

Thanks for your help with this!

[[Li...]]

6 hours ago, [[C...] said:

I was thinking that the updose of 5% might close the gap in the variance between the two medications.  Do you think that is a potential strategy?

This is your decision to make, @[Cy...].  The only way to know if it will help in your individual case is for you to try it.   Troubleshooting a taper (actually tapering in general) is an experiment in which you are both the principal investigator and the subject.

Given that it’s been a month since you made the 5% reduction …

In your shoes, I’d be inclined to try a smaller updose (e.g. one-quarter to one-half of 5%) first to see if that helps.  If I did not see an improvement after 5 days or so, I would try a slightly larger updose.

[[Cy...]]

@[Li...]

I did up dose today by approximately 3%, and it did help a bit.

I spoke today to a compounding pharmacy that I have used in the past. One of the pharmacists told me that even within the same brand of tablets, the variance between batches could run a 10% variance!  They do not use a manufactured medication to create a compounded solution. They use, in this case, a pure clonazepam powder, with no fillers or excipients, and make the solution from that, adding excipients if necessary or requested.  He did say that it also could swing in variance by 10% or so, from what I've been using.  No way to tell if it will be a problem until you try.   They can additionally use a water based solution to ensure no allergy issues, however, it expires in 30 days. 

You seem happy with the pharmacy you use.....would you mind sharing who it is?  I understand if you don't.

Thank you!

[[Li...]]

 

Hello @[Cy...].  Thank you for letting us know the updose helped a bit.  That’s an encouraging sign!

Tip of the hat for talking to your compounding pharmacist.  He is correct that the amount of active ingredient can vary from the labeled amount from batch to batch produced by the same manufacturer as well as from one manufacturer to another.  (This is why I personally prefer to use either brand or a generic from an established manufacturer that does not have a history of quality issues.)

I am not comfortable disclosing the name of my compounding pharmacy because doing so would disclose where I live.  However, what I can do is share the formulation my pharmacist uses to prepare my compound.   See link below.  As I mentioned in a previous post, she uses brand Klonopin tablets as the source of the active ingredient. 

Multiple members have worked with pharmacists who use the pure active drug substance instead of regular tablets as the drug source in compounds.  In terms of water-based solutions, please be aware that clonazepam is insoluble in water and only slightly soluble in ethanol so another solvent will likely be necessary (e.g. propylene glycol). 

I hope you are able to find a fix sooner rather than later.  Please keep us posted!

Link:
0.1mg/mL Clonazepam Oral Suspension
https://www.nationwidechildrens.org/-/media/nch/specialties/pharmacy/compounding-formulas/clonazepam-oral.ashx

 

 

[[...]]

I had staggered my change from Teva to auribindo which took a couple of weeks, there was definitely an uptick in symptoms.
had a couple good days and thought I was over the change, should’ve waited another week! Stupid me I did a 3% cut and now I’m really paying for it.

I was having a hard time tapering and was just starting to get my feet back under me when my pharmacy changed manufacturers

How did you make out @[Cy...] with the change, how are you feeling better?

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Edited April 28 by [...]

[[Cy...]]