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The Corroboree
irabionist

Modafinil queries

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Heyo,

So back at the end of last year, had some police over at the ol' household and they saw a packet with 50x Modafinil pills that I had in my room.

They couldn't determine whether it was naughty or not but confiscated it until they could figure out what to do.

I believed at the time that it was alright to have Modafinil, you needed a prescription to buy it within Australia, however you could purchase up to 3 months worth of it from overseas without needing a prescription.

Now at the time I wasn't 100% sure but I did mention it to them. Now, a friend recently received a letter from TGA stating pretty much what I thought was true, that if you purchase from overseas you don't need a prescription.

So, my question is, how should I go about it? Should I call up and ask for it back? Would I need proof? Kind of just don't really know how to start, so any advice will be appreciated.

Cheers

Letter my friend received attached below

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So this is directly from the TGA website

Personal Importation Scheme
Under the Personal Importation Scheme you may import a 3 month supply at the one time (at the maximum dose recommended by the manufacturer) of unapproved therapeutic goods into Australia without any approval required by the TGA provided that:

  • the goods are for your own treatment or the treatment of your immediate family; and
  • you do not supply (sell or give) the medicine to any other person; and
  • where possible, you keep the medicines or medical devices in their original packaging with any dispensing labels intact; and
  • the goods are not restricted under Australian Customs controls or quarantine rules and the goods do not contain a controlled substance; and
  • the goods are not injections that contain material of human or animal origin (except insulin); and
  • the total quantity of the goods imported within a 12 month period does not exceed 15 months supply of the goods (for medicines, at the maximum dose recommended by the manufacturer); and
  • if the goods are medicines in Schedule 4 or 8 of the Poisons Standard a prescription from an Australian-registered medical practitioner is held for the medicines.
You cannot import more than a 3 month supply at the one time under the personal importation scheme. If you wish to bring more than 3 months supply at the one time into Australia, an Australian-registered doctor will first need to apply to the TGA for Special Access Scheme approval.

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An interesting point to note with modafinil and its analogues is that they shouldn't be taken by people who take medications/drugs that rely on steady metabolism by cyp liver enzymes such as opiates/opioids etc.

(So its bad news for people with an opiate dependency like those on methadone etc.)

They are a CYP liver enzyme inducer and will put a person into withdrawal or reduce the effectiveness of the medication by speeding up it's metabolism rate.

Edited by AndyAmine.
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if the goods are medicines in Schedule 4 or 8 of the Poisons Standard a prescription from an Australian-registered medical practitioner is held for the medicines.

someone may be able to confirm this, but my understanding is you are looking at Schedule 4.

Sill need a prescription to be legit.

I would stay in duck and cover mode :wink:

EDIT - opened poisons schedule pdf, yep its 4

unless that attachment I cant see...lol...is contradictory

Edited by waterboy 2.0
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See a doctor and try and get it off script or if you're working shift you may be able to do a sleep evaluation and get it on the PBS.

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On 4/7/2016 at 5:16 PM, AndyAmine. said:

An interesting point to note with modafinil and its analogues is that they shouldn't be taken by people who take medications/drugs that rely on steady metabolism by cyp liver enzymes such as opiates/opioids etc.

(So its bad news for people with an opiate dependency like those on methadone etc.)

They are a CYP liver enzyme inducer and will put a person into withdrawal or reduce the effectiveness of the medication by speeding up it's metabolism rate.


The million dollar question though is "to what extent will modafinil make use of the CYP liver enzymes compared to other medications?"

There's heaps of substances that also make use of the CYP liver enzymes that aren't contraindicated. Just because a substances utilises CYP enzymes doesn't mean it utilises their total completely.

This is where references are handy :)

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In Vitro Inhibition and Induction of Human Hepatic Cytochrome P450 Enzymes by Modafinil

 

By the way, P450 is a synonym for CYP liver enzyme.

As is often overlooked when it comes to drugs, dosage is key. The study in the paper showed only a minimal effect on CYP by modafinil, specifically CYP2C19, at an equivalent human dosage of 400mg/day. Anecdotal evidences shows 100mg to be effective for a good 8-10 hours. However 400mg per day isn't unheard of in patients suffering from narcolepsy.

Here are the juicy bits from the paper's abstract:

  • Modafinil exhibited minimal capacity to inhibit any CYP enzyme, except CYP2C19.
  • No irreversible inhibition of any CYP enzyme was observed, and there was no evidence of metabolism-dependent inhibition.
  • At high concentrations of modafinil (≥100 μM), the mean activity of CYP2C9 was decreased (up to 60%) relative to that in the solvent controls.
  • Although effects obtained in vitro are not always predictive of effects in vivo, such results provide a rational basis for understanding drug-drug interactions that are observed clinically and for planning subsequent investigations.

 

Bold emphasis mine.

While modafinil did have an effect on CYP2C19 this was only at higher than normal doses.

 

Here are the takeaways:

  • The enzymes utilised by your liver to metabolise the drugs you've taken are complex. 
  • It can be inaccurate to say that a whole class of enzymes is affected by a particular drug.
  • The metabolism of drugs is dependent/predicated on certain enzymes.
  • In the case of modafinil, at a standard dosage of 400mg/day, it has minimal affect on your liver's ability to break it down. Therefore, co-action on P450/CYP by other drugs shouldn't present too much of an issue in this regard. See "Homework" below.
  • "sola dosis facit venenum/the dose makes the poison" - dosage is important! This couldn't be repeated enough :) Make a poster of it and stick it in the dunny so you can read it next time you go overboard on the chilli on your next curry.
     

Homework for modafinil users: pick a drug you'd take along with modafinil and find out if it is metabolised by CYP2C19, as this was the only liver enzyme reported to be significantly inhibited by modafinil.

 

@Anodyne Just in case this is taken the wrong way, this isn't a personal attack. I'm only taking issue with the apparent misinterpretation of research, which is all too easy to do if the light of reason isn't shone on the details - hence this post.

 

All in all it's a pretty interesting read. The P450 enzymes are responsible for metabolising all manner of substances, and knowing how they are affected (by things as varied as grapefruit!) is important in knowing how your drug experience will pan out. 

Edited by mu!
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4 hours ago, mu! said:

@Anodyne Just in case this is taken the wrong way, this isn't a personal attack. I'm only taking issue with the apparent misinterpretation of research, which is all too easy to do if the light of reason isn't shone on the details - hence this post.

 

Um... ok? I'm going to guess you're talking to Andy though.

 

On 07/04/2016 at 5:16 PM, AndyAmine. said:

They are a CYP liver enzyme inducer and will put a person into withdrawal or reduce the effectiveness of the medication by speeding up it's metabolism rate.

 

I will add one thing to mu's post, which is that just because you induce an enzyme that is important in the metabolism of particular drug, does NOT mean that all of the effects from that drug will necessarily be weaker. Sometimes a drug's effect (or part of it) comes from the action of one of its metabolites, rather than the drug itself, and in those cases inducing the enzyme responsible for this conversion will actually increase the effect.

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Im on Methadone and have a rapid metabolism so my life is ruled by CYP2D6/CYP2* and CYP3A4 which are effected by a great number of things, so I need to be very careful with what I consume and be aware of intetactions which usually involve liver enzymes.

 

It was some time ago and I dont have a lot of time right now but this was the first article that I read on the subject and I was able to find supporting peer reviewed data.

The linked anecdotal report is enough for someone in my situation to say no to it, haha.

https://erowid.org/smarts/modafinil/modafinil_interactions.shtml

s Methadone is metabolized by several liver enzymes in the CYP2* cluster, with CYP3A4 being an important metabolizer. Because modafinil up-regulates CYP1A2, CYP2B6, and CYP3A4/5, the action of methadone may be substantially shortened. Erowid also received one experience report from a reported methadone user who found that they had to redose with methadone every few hours to avoid opiate-withdrawal after taking large doses (> 1000 mg) of modafinil.

So many things mess with my dose like too much alcohol and Im in withdrawal, caffine - bam - withdrawal, some strains of pot - withdrawal (or potentiation for other strains) amphetamines and most stimulants - withdrawal.

But it works in reverse too, lots of commonly used things induce those enzymes like Proton Pump Inhibitors, white grapefruit juice, classic antihistamines, antidepressants etc.

When I first started the program I became pretty good at finding out what potentiated my dose ;)

.

Im also really sensitive to the pH of my g.i tract, if I drink or eat acid things my dose doesnt work as well and vice versa with alkaline substances. 

Edited by AndyAmine.
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What is interesting is that the overseas vendors do in fact *at times* write doctors prescriptions when they send modafinil over this way.

Edited by manu
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