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Trouble getting PAR orally disintegrating tablets


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[An...]

Hi everyone, I have been taking par clonazepam orally disintegrating tablets during my taper. Last week all of the CVS pharmacies in my area told me they can no longer get par tablets. I tried the Teva yesterday and had a very bad reaction.

My doctor recommended that I call some private pharmacies in the area, which I did do today. None of them can get the par tablets.

I could not get through to par Pharmaceutical in order to find out what is going on but will try again tomorrow during their business hours.

Is anyone else having trouble with this? I'm not sure what to do since the Teva was so bad for me. I do have about 2 weeks left to figure this out. Thank you so much for any information.

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[Li...]

Hello @[An...].  I’m sorry CVS switched generics on you and you are now having issues with the change.  I’ve used the ODTs from both Teva and Par in the past and didn’t notice a difference (other than I didn’t much care for the ‘too sweet for me’ taste of the Tevas). 

Below are the excipients for the Teva and Par ODTs.  As you can see, five of the excipients are the same but three are different.  Have you had issues with microcrystalline cellulose, sodium stearyl fumarate or xylitol in the past?

Teva
ASPARTAME (UNII: Z0H242BBR1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
XYLITOL (UNII: VCQ006KQ1E)

Par
ASPARTAME (UNII: Z0H242BBR1)  
CROSPOVIDONE (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)

 

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[An...]

Thank you @[Li...]. I don't know if I've had trouble with those in the past. Things affect me so differently now. 

I tried to switch yesterday morning and was brutally nauseous within 45 minutes. Also woke up last night feeling really rough. Slept just a few hours.

I'm really hoping to find a pharmacy that can help. I think I'm just too sensitive to switch things around just now. My doctor thought maybe there is a slight difference in the active ingredient? When tapering I do feel my 0.003mg decreases...

So appreciate your feedback on this one.

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[Li...]

I hear you about things affecting you differently @[An...].  It’s amazing how sensitive we can be during withdrawal.  Your doctor is correct — it’s possible the amount of active ingredient (i.e. the clonazepam) in the Teva ODTs is slightly different than that in the Par ODTs.  The US FDA allows a certain amount of variability from manufacturer to manufacturer. 

I hope you are able to find the Par ODTs.  Back when I was using them, my pharmacy was unable to fill my prescription because its distributor ran out of stock.  My pharmacy immediately got on the phone with the distributor to ask them to find a supply ASAP.  The ODTs arrived within a day or so.

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[An...]

Ok. @[Li...], thank you so much. I really hope we can get this straightened out. Really good to hear that it only took a few days. Was this a privately owned pharmacy?

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[Li...]
45 minutes ago, [[A...] said:

Was this a privately owned pharmacy?

It’s an independent. The lead pharmacist/owner and his staff are always willing to go the extra mile to help when needed.

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[Re...]
5 hours ago, [[L...] said:

Hello @[An...].  I’m sorry CVS switched generics on you and you are now having issues with the change.  I’ve used the ODTs from both Teva and Par in the past and didn’t notice a difference (other than I didn’t much care for the ‘too sweet for me’ taste of the Tevas). 

Below are the excipients for the Teva and Par ODTs.  As you can see, five of the excipients are the same but three are different.  Have you had issues with microcrystalline cellulose, sodium stearyl fumarate or xylitol in the past?

Teva
ASPARTAME (UNII: Z0H242BBR1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
XYLITOL (UNII: VCQ006KQ1E)

Par
ASPARTAME (UNII: Z0H242BBR1)  
CROSPOVIDONE (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)

WOW @[Li...], Where did you find this information? This is fascinating to see how different the formulations can be. It shouldn't even be legal for pharmacies to change manufacturers -- especially of benzos. @[An...] Will you please update us on what happens when you call PAR?

Edited by [Re...]
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[An...]

Thank you @[Li...] and @[Re...] . It seems that my compounding pharmacist will be able to get the par orally disintegrating tablets. He said he will order them and they should be in within a couple of days. I hope this works out and will keep you updated. thank you both so much.

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[Li...]

Thank you for the encouraging news, @[An...].  Compounding pharmacists can be valuable allies when tapering psychotropic medications. 

Do you know how your compounding pharmacist plans to use the ODTs?  Are they going to make an oral suspension for you?  If so, what formulation and ingredients will they use?

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[Li...]

@[Re...] My apologies I was so focused on supporting @[An...] I did not see your question until now.

Ingredients can be found in the official US FDA drug labels.  Here are links to the labels for Teva and Par ODTs:

DailyMed - CLONAZEPAM tablet, orally disintegrating - Teva
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cb2e209e-e69b-422b-8abb-34df2bc92caa

DailyMed - CLONAZEPAM tablet, orally disintegrating - Par
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1aef0069-80ea-483d-ac70-c8d485462c5b

 

 

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[An...]

Thanks so much @[Li...]. I'm so grateful for your help. 

Right now, my pharmacist compounds my afternoon dose using a powder. I take the generic morning and evening.

I did try to switch over completely to the compound since the switch in the afternoon went okay. But when I tried to make the switch in the morning to the compound, I had a really bad reaction including hallucinations. Scary.

We're really not sure why that happened, but my doctor made the decision at that point to stick with the generic for the morning and evening dose and just taper the compound in the afternoon for now.

I'm so interested to see if my pharmacist can somehow work with the orally disintegrating tablets and make some kind of a compound out of them. Have you ever heard of this?

I never even thought about it until you mentioned it in the post above. This would be amazing as I could stick with the formulation that I have been using and possibly avoid a bad reaction to the switch. 

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[Li...]

You’re most welcome @[An...].

You’re the first person I’ve encountered who tolerated a dosage form (i.e. the powder) at one time of day (the afternoon) but not another (the morning). I absolutely believe you but this one’s a real head scratcher.  Did you take other medications, supplements, food or drink at the same time as the morning dose that might have interacted with the powder?  Was your stomach empty or full?  

I haven’t read or heard about compounding pharmacists using ODTs so I’ll be interested in what your compounding pharmacist proposes as well.

What I have heard and read about both here and elsewhere is individuals who have used the ‘shave-and-weigh’ technique with ODTs as well as individuals who have used ODTs to make do-it-yourself liquids with whole fat, homogenized milk.  Per the Maudsley Deprescribing Guidelines:

“Benzodiazepines are more soluble in oil or fat than in water.  When mixed with milk, all or some of the drug will dissolve in the milk fat. This should form an evenly dispersed emulsion when shaken vigorously” (p. 389). 

Compounding pharmacists are all about devising solutions to meet individual needs so I’m confident yours will find a solution for you.  Please do keep us posted so we all can learn from your experience!

 

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[An...]

Thank you @[Li...], and sorry for the long delay.

Yes, I was quite surprised that I had trouble switching over my morning dose to the compound since the afternoon dose was rocky but tolerable. I have no idea what caused it to be so difficult, and I had not made any other changes during that time.

I'm going to have to do it again at some point because after I taper off of the afternoon dose I would like to taper the morning and evening dose simultaneously.

My compounding pharmacist was able to get the PAR orally disintegrating tablets and thinks he can do so as long as I need it.

He would like to use the powder that he is using for my capsules if we switch to liquid at some point. The other option I am considering is using the orally disintegrating tablets and full fat milk to make my own solution. I don't feel quite strong enough to do that yet as my days are so unpredictable, so I may rely on the compounding pharmacy to make the liquid compound. We'll  see. I'm so grateful for your help and guidance with this tapering process. Whew. What a time.

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