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erer

Tapering Valdoxan / Agomelatine

25 posts in this topic

As I am taking a medication not many people have experience with, there is no topic about tapering it. I am not at a stage to start tapering Valdoxan, but I constantly worry, that once I wish to start, there is no information or support available for me to take guidance from.

 

So I started this topic here and I am asking if anyone has any piece of information on how one would go about tapering Valdoxan, please be so kind and post here. Or if you know of anybody who has already done it or if you have stumbled upon any information anywhere else in the Web. Perhaps by the time I am ready to taper these pieces of information will have formed a good plan.

 

Background:

  • The Valdoxan pill has a coating so I am worried what will happen, if I break it. It has no line for breaking either. 
  • Also I have no idea if it would be ok to make it into a liquid. I would like to do a liquid taper, if possible, because I see no other way to do it accurately.
  • It is said to have an effect on the melatonin system and the pharmaceutical company claims it has no WD. I know better not to believe that but could it still be a bit of a good sign that they have not had acute WD problems in their short term studies? Or am I too naive to hope that?

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Also, does anyone have any information (I could not find) what the polymer coating on Valdoxan pills is used for. I know the coating can serve many purpouses (easier to swallow, protect from acidity in the stomach, be recognizable etc).

 

"Most enteric coatings work by presenting a surface that is stable at the highly acidic pH found in the stomach, but breaks down rapidly at a less acidic (relatively more basic) pH. For example, they will not dissolve in the gastric acids of the stomach (pH ~3), but they will in the alkaline (pH 7-9) environment present in the small intestine."

 

Could it be Valdoxan also has a coating that is supposed to make it dissolve in small intestine?! How to taper then?

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Is 25mg the lowest available dose?  Perhaps the manufacturer makes smaller pills?

 

I honestly don't know if the low pH of the stomach will alter the chemical structure of the drug - the aldehyde in the chemical structure may become reduced in the stomach, but then oxidized in the small intestine, making no difference at all. 

 

Here's my hunch:  I would assume that there's no problem with taking the coating off - because these classes of drugs all tend to look relatively similar, and yet there are a number of them that are very likely exposed to the low pH of the stomach during digestion that still retain their effectiveness (e.g., any of the drugs that don't have a seal or a cap).   A drug like prozac has a cap, and then direct powder - no beads, and there are other drugs like this as well.  Instead, the cap may be to extend the release of the drug into the bloodstream, rather than protect it from the low pH of the stomach - in which case it's not going to alter the drugs effectiveness.

 

If you look at the chemical structures of a drug like prozac, and Valdoxan, you will see the same general arrangement:  a couple aromatic rings (the six sided carbon rings with double bonds), and then some side chains of carbons with functional groups (the Oxygen molecules, and nitrogen molecules are parts of functional groups). 

 

Here's the structures of some common drugs for comparison:

 

https://en.wikipedia.org/wiki/Fluoxetine

 

https://en.wikipedia.org/wiki/Agomelatine

 

https://en.wikipedia.org/wiki/Duloxetine

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osk, please do not speculate about the coating on these tablets when, with a little effort, you can find the factual answer, which would be of great help. On the other hand, speculative answers may confuse and mislead people.
 
For example, http://www.medicines.ie/medicine/14490/SPC/Valdoxan+25mg+Film-coated+Tablets/gives information from the manufacturer, Servier.
 
 

6.1 List of excipient(s)

Tablet core:
− Lactose monohydrate
− Maize starch
− Povidone K 30
− Sodium starch glycolate type A
− Stearic acid
− Magnesium stearate
− Silica, colloidal anhydrous
Film-coating:
− Hypromellose
− Yellow iron oxide (E172)
− Glycerol
− Macrogol 6000
− Magnesium stearate
− Titanium dioxide (E171)
Printing ink containing shellac, propylene glycol and indigotine (E132) aluminium lake.

 

 

There is no indication the coating is a time-release coating. It is just an ordinary coating. The tablet could be split.

 

I would be skeptical of the claims from short-term clinical trials that there is no difficulty in withdrawing from agomelatine. See this discussion http://survivingantidepressants.org/index.php?/topic/965-agomelatine-melatonin-as-an-ad/

 

Use of search on this site or on the Web can answer many questions.

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Is 25mg the lowest available dose?  Perhaps the manufacturer makes smaller pills?

 

Yes, it is the smallest available.

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There is no indication the coating is a time-release coating. It is just an ordinary coating. The tablet could be split.

I also found the ingredients' list of the coating but I did not know what to make of it. I am not that knowledgeable in chemistry to know if that makes it an extended release one or not. I also found no reference to it being extended release but then I thought that you'll never know. Perhaps someone in the industry just didn't think a "commoner" like me needed to know their pill had this or that quality (for example where it was meant to be absorbed).  

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Hi Erer, I think you might be the first person to join with Valdoxan as the problem. Congratulations for getting off Cymbalta, Xanax, and Ativan, and the others.

 

I am interested in Valdoxan because it is not available in the US and it so different from other antidepressants, and have read many users' descriptions of side effects. Not much is said about getting off the drug. (I just realized that.) Maybe because it's usually painless, or maybe because so many people only take it for a few weeks before quitting.

 

The two quitters I found are on the same web page. They are faste99 and petg57. They both report difficulty but do not describe symptoms. That's only two people, though.

http://www.drugs.com/answers/hi-friends-hope-all-is-well-with-you-all-435468.html

I wouldn't have known what all those chemicals in the coating meant, either  :o 


 

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Just bumping the topic, wondering if maybe someone has joined who has experience with Valdoxan.

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have you found out if valdoxan dissolves in water and can be made to liquid? I have people who ask for advice from me, and I can't answer this particular case about valdoxan. as I understand, it can be cut, but what about liquid?

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Most drugs can be made into a liquid. There are compounding recipes for this. Please ask a pharmacist and let us know what you find out.

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there are no compounding pharmacies in Estonia. 

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http://www.caymaneurope.com/pdfs/13203.pdfProduct information

Agomelatine is soluble in organic solvents such as ethanol, DMSO, and dimethyl formamide. The solubility of agomelatine in these solvents is approximately 30 mg/ml.
 
Agomelatine is sparingly soluble in aqueous buffers. For maximum solubility in aqueous buffers, agomelatine should first be dissolved in ethanol and then diluted with the aqueous buffer of choice. Agomelatine has a solubility of approximately 0.5 mg/ml in a 1:1 solution of ethanol:PBS (pH 7.2) using this method. We do not recommend storing the aqueous solution for more than one day.

 
This means agomelantine is soluble in drinking alcohol, such as vodka or other clear spirits. Taking a milliliter or two of vodka mixed with agomelantine probably would not cause problems.
 
DMSO is non-alcoholic but tastes terrible; if you use DMSO as a solvent, be sure to get medical-grade DMSO liquid that is safe for ingestion.
 
You can crush a tablet and mix the powder with water (aqueous buffer) to make a suspension. There will be little particles floating around. You will need to do this every day. Also see
 
How to make a liquid from tablets or capsules
 
Using a digital scale to measure doses
 
Compounding pharmacies (US, UK, and elsewhere)

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Just wondering if anybody has any new information regarding Valdoxan or experiences tapering it.

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Bump. I'm also tapering Valdoxan and am wondering if it may be causing the akathisia I'm experiencing.

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I switched from Cymbalta to Valdoxan on my GP's advice.  I told him what I had learned from this site about tapering and buying empty capsules to make up smaller and smaller doses.  He agreed that it made sense.  By that stage I think I had already reduced to about 75% of my prescribed dose.  He put me straight on Valdoxan, and told me to continue to taper off the Cymbalta.  I had no cymbalta withdrawals and the Valdoxan was noticeably better. On Valdoxan my sex life and orgasms returned to normal and I generally felt better.  It's more subtle than Cymbalta.  It allowed me to feel whereas Cymbalta was flattening and deadening.

 

I am now looking to go off Valdoxan after a year on it.  The main reasons are expense, liver health and readiness.  It is expensive.  In Australia it is not on our pharmaceutical benefit scheme so it costs a lot more than other ADs.  My liver function tests (you must have 3 in the first 6 months) were fine but I drink a bit and it's better to not combine alcohol with Valdoxan.  And also I am ready.  I have been getting good help from a psychologist and know what I must physically actually do with my life and habits to improve my depression.  

 

My GP suggested waiting a little longer; he said another year.  I've been on it for about a year.  But I think I am ready.  He said that Valdoxan is unusual amongst ADs in that there are no withdrawal symptoms other than the potential for relapse.  I found this at medicines.org: 

 

Withdrawal / Discontinuation

The abrupt discontinuation of VALDOXAN (agomelatine) was evaluated in a specific active control study (CL3-030) using the Discontinuation Emergent Signs and Symptoms (DESS) check-list. Patients with major depression were treated under double-blind conditions with VALDOXAN (agomelatine) 25 mg or paroxetine 20 mg over a 12 week period. Only those who remitted at week eight and sustained that remission until week 12 were randomised to placebo or the initial active treatment for a two-week double-blind period. Patients discontinued from VALDOXAN (agomelatine) to placebo were compared to those who continued treatment on VALDOXAN (agomelatine) and, likewise for the active control paroxetine.

The abrupt discontinuation of VALDOXAN (agomelatine) was not associated with discontinuation symptoms [p=0.250 for difference between the VALDOXAN (agomelatine) and placebo groups]. The sensitivity of the study was demonstrated by the presence of significant emergent discontinuation symptoms following the abrupt discontinuation of treatment with the active control paroxetine [p<0.001 for difference between the paroxetine and placebo groups]. 

 

I'm sure this has come from the manufacturer, but nevertheless it describes double blind testing where there were no discontinuation symptoms.  Like others here, I have found it hard to find anything about Valdoxan withdrawal symptoms.  So maybe people are not having the same problems with Valdoxan as with other drugs?

 

I am going to stop taking Valdoxan, without tapering, in association with meditation and exercise.  I will try to remember to report back here.  

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The 12-week period on Valdoxan used in this study to evaluate the risk of Valdoxan withdrawal is shamefully inadequate. A year is truly long-term exposure.
 
A comparison of 12 weeks of Valdoxan with (presumably) 12 weeks of paroxetine (Paxil), which has a vicious withdrawal syndrome, is not only dishonest but cruel to the experimental subjects who were put on paroxetine and then ripped off it.
 
Googling around, I see there are reports of Valdoxan withdrawal syndrome, even though Valdoxan is very infrequently prescribed, probably because it has a reputation for being expensive but not particularly effective, see https://www.thelocal.fr/20170127/french-told-to-avoid-82-drugs-that-do-more-harm-than-good
 
https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0061425/
 

Agomelatine versus other antidepressant medication for depression
This version published: 2014; Review content assessed as up-to-date: July 01, 2013.
.... 
The reviewers conclude that agomelatine is not more effective than other antidepressants currently on the market. It did seem to be more tolerable to patients in terms of lower rates of some side‐effects, however, the quality of trials was low and there were only a few trials that compared agomelatine with each medication. No firm conclusion on agomelatine can be made because of problems with reporting of data in the trials included. The authors recommend that further trials of agomelatine versus placebo (dummy pill), particularly in primary care settings (where the majority of patient/practitioner contact take place, e.g. GP surgeries), should be carried out to improve the quality of evidence.

 

I'm sure Valdoxan is being marketed as having minimal withdrawal problems -- exactly like all the other newer antidepressants, including paroxetine.
 
If you want to go off Valdoxan, if I were you, I'd try a 10% reduction and see what happens. Please let us know how you do.

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In my googling, I could not find any reports of Valdoxan withdrawal syndrome.  If you can point to any, altostrata , I would be very grateful.

 

Not too worried about the poor subjects pulled off Paroxetine in this test; more interested in the lack of discontinuation symptoms suffered by those pulled off Valdoxan.  I spoke to my GP at length about this.  Although he wants me to stay on for longer, he said that when i stop, I should just stop and not taper as with the Cymbalta.

 

I've always been one for testing the orthodoxy.  So I'm going to just drop off Valdoxan, keep a small stash in case it goes to crap, and see what happens.  Will report back.  

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How are you doing? Did you experience any insomnia or other problems? I'm tapering Valdoxan too and made a big jump a few days ago. Can't sleep properly and had stomach cramps for the first few days.

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It's strange but two of my posts have been removed.  In those I described that I had no discontinuation symptoms other than obviously noticing a difference in my general mood.  I still have no symptoms and am feeling well.  A few days ago, I spoke to a close friend who is a psychiatrist and she said to keep watching, especially after a few months, and be aware that things can happen after a few months.  She also agreed that Valdoxan is said to be free of withdrawal symptoms. But so far I'm fine after about 3 weeks.  

 

Perhaps a moderator might answer this question about why my posts were taken down?

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Glad to hear that you're doing good! I hope my symptoms subside, too. If not, I'll probably have to go back up again to 5 or 6 mg.

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Posted (edited)

Hi Marx, I am going to move your post to start an introduction for you. All members must have an introduction with a signature to enable them to reply to other topics. 

I will reply to your valdoxen withdrawal over there. 

 

Here is your new topic Marx 

 

Edited by mammaP

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On 2017-5-15 at 11:33 AM, RipVanWinkle said:

It's strange but two of my posts have been removed.  In those I described that I had no discontinuation symptoms other than obviously noticing a difference in my general mood.  I still have no symptoms and am feeling well.  A few days ago, I spoke to a close friend who is a psychiatrist and she said to keep watching, especially after a few months, and be aware that things can happen after a few months.  She also agreed that Valdoxan is said to be free of withdrawal symptoms. But so far I'm fine after about 3 weeks.  

 

Perhaps a moderator might answer this question about why my posts were taken down?

Sometimes we move posts to a members introduction topic. You might find the missing posts there. When a post is specifically about a member's situation it is best ion their introduction for continuity. We can't delete posts, we can hide inappropriate ones but they are still on the site. I am sorry this has confused you. 

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Anyone?..

 

On 26/06/2016 at 1:43 PM, rapunzel2 said:

have you found out if valdoxan dissolves in water and can be made to liquid? I have people who ask for advice from me, and I can't answer this particular case about valdoxan. as I understand, it can be cut, but what about liquid?

 

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Posted (edited)

On 2016-06-26 at 6:43 AM, rapunzel2 said:

have you found out if valdoxan dissolves in water and can be made to liquid? I have people who ask for advice from me, and I can't answer this particular case about valdoxan. as I understand, it can be cut, but what about liquid?

 

19 hours ago, marx said:

Anyone?..

 

marx: Please go to the top of this page and read ALL the posts. You'll find the answer to your question.

Edited by scallywag

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Thanks to fuerza. :)

 

11 hours ago, fuerza said:

I make a liquid and measure it out with a syringe. Basically 25mg tablet + 25ml of water. I use hot water, break the pill into little pieces, stir and it's ready in about 5 minutes. There's still a bit residue, but I think it's from the fillers. I've been successful with a liquid taper so far. :)

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