Nizoral Tablet (not Shampoo) Becomes Illegal in France

cyberprimate

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I've just heard the news tonight on French national radio. Nizoral is now forbidden here. It was shown to cause hepatitis, but i think it's oral Nizoral not the topical shampoo. But that makes me wonder whether I should I keep using Nizoral shampoo or not… :dunno:
 

Rawtashk

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Re: Nizoral becomes illegal in France

Here's what I found about Nizoral the tablet (which you DONT use to control dandruff)

"WARNINGS
NIZORAL tablet (not shampoo) has a potential for clinically important drug interactions. (See the section on “Interactionsâ€￾).
Decreased gastric acidity: Absorption is impaired when the gastric acidity is decreased. In patients also receiving acid neutralizing medicines (e.g. aluminium hydroxide) these should be administered at least 2 hours after the intake of NIZORAL. In patients with achlorhydria such as certain AIDS patients and patients on acid secretion suppressors (H2-antagonists, proton pump inhibitors) it is advisable to administer NIZORAL with a cola beverage.
The concomitant administration of terfenadine and astemizole with NIZORAL is contra-indicated. For combinations with other drugs see Interactions.
During NIZORAL treatment hepatitis has been reported. If symptoms or signs suggestive of hepatic dysfunction are detected, medication should be stopped at once. Patients on NIZORAL should be instructed to report any of the prodromal symptoms of hepatitis, such as fatigue associated with nausea or vomiting, jaundice, dark urine or pale stools, immediately and stop treatment.
A risk/benefit evaluation should be made before ketoconazole in cases of non-life threatening diseases requiring long treatment periods.
Factors increasing the risk of hepatitis are: females over 50 years of age, previous long-term treatment with griseofulvin, history of liver disease, known drug intolerance, long lasting treatment and concomitant use of liver compromising medication.
A mild transient asymptomatic increase in transaminases or alkaline phosphatase sometimes occurs. This asymptomatic reaction is harmless and does not necessarily require a discontinuation of the therapy but these patients should be monitored.
Patients on prolonged therapy (longer than 2 weeks) should have regular monitoring of liver function (before treatment, after 2 weeks and later on, monthly), particularly those patients with a known history of prior liver disease or an idiosyncrasy to other medicines. Should liver disease be confirmed, the therapy is to be discontinued.
After long-term griseofulvin treatment, it is advisable to wait for one month before starting NIZORAL treatment.

DOSAGE AND DIRECTIONS FOR USE
NIZORAL should be taken with meals for maximal absorption.
Chronic and recurrent vaginal candidiasis not responding to topical treatment:
Two tablets (400 mg) once daily with a meal for 5 days.
All other indications: One tablet (200 mg) once daily with a meal until at least one week after the symptoms have disappeared and until all cultures have become negative.
The dose of ketoconazole may be doubled to 400 mg if the clinical response is insufficient after a reasonable period of treatment.
The usual duration of treatment is as follows:
- Serious chronic mycoses of the skin and hair: 1 to 2 months;
- Systemic candidiasis: 1 to 2 months;
- Serious chronic mucocutaneous candidiasis: 6 to 12 months;
- Paracoccidioidomycosis and histoplasmosis: 2 to 6 months;
- Dermatophytes: 4 weeks."

It sounds like it's talking about something other than shampoo. I don't know about you, but I don't take shampoo internally :)
 

Bryan

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Re: Nizoral becomes illegal in France

cyberprimate said:
I've just heard the news tonight on French national radio. Nizoral is now forbidden here. It was shown to cause hepatitis, but i think it's oral Nizoral not the topical shampoo.

I suggest that from now on, you should be very careful to state explicitly what it is you're referring to; for example: "Nizoral shampoo" or "Nizoral cream" or "ketoconazole capsules". This nonsense of not knowing exactly which product you're referring to is for the birds.
 

Bryan

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Re: Nizoral becomes illegal in France

finfighter said:
Yeah that's freaky! And look at this, apparently nizoral shampoo has been implicated in some cases as well, damn, I wish we had access to this study! http://www.ncbi.nlm.nih.gov/pubmed/6300702

Why do you assume that that's the shampoo that they're referring to? Ketoconazole is very very poorly absorbed from the use of Nizoral Shampoo.
 

Bryan

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Re: Nizoral becomes illegal in France

I repeat the question I asked before: why do you assume that they're referring to the shampoo? Ketoconazole is very poorly absorbed from the shampoo. The author of that blurb you posted needs to be given the same advice I gave to the original poster: SPECIFY EXACTLY WHAT YOU MEAN BY "NIZORAL"!! :dunno:
 

Shma

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Re: Nizoral becomes illegal in France

Bryan said:
I repeat the question I asked before: why do you assume that they're referring to the shampoo? Ketoconazole is very poorly absorbed from the shampoo. The author of that blurb you posted needs to be given the same advice I gave to the original poster: SPECIFY EXACTLY WHAT YOU MEAN BY "NIZORAL"!! :dunno:

nizoral is the shampoo brian. Don't act stupid.

Otherwise there would be "Ketoconazole"
 

cyberprimate

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Re: Nizoral becomes illegal in France

Nizoral as shampoo has always been available as prescription medicine only in France, and as a 2-3 weeks treatment, not a regular one. Which is why i had to buy it from abroad. It will become illegal as well here. The ban on nizoral comes because cases of severe hepatitis happened statiscally more often with oral nizoral than other anti-fongal medicine. Bear in mine it happened only 5 times since 1982 but each time causing the death of the patient after an extremely brief period of time. This severe side effect has been known for years but since the scandal regarding the Mediator (Benfluorex) which killed 500 people in 35 years in France, the AFSSAPS (the French FDA) is becoming more cautious these days, hence this new ban, and others will follow.

Still I can't stop wonder whether I want to use Nizoral as shampoo for decades…
 

UunoTurhapuro

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Re: Nizoral becomes illegal in France

Nizoral is a trademark name and it comes in cream, shampoo and tablet form. Ketoconazole is the chemical name and Nizoral is a trademark for certain company to name its ketoconazole products. Topical Ketoconazole is very poorly absorped and there are studies to show that. Thanks to the Internet I have found out that indeed French medical authorities have banned the 200mg ketoconazole in tablet form.

http://www.afssaps.fr/var/afssaps_site/ ... adda74.pdf
 

cyberprimate

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Re: Nizoral becomes illegal in France

Thanks for that link. The information I got was partially wrong.

"Considering the existence of therapeutic alternatives covering all needs, the AFSSAPS reckons that ketoconazole as absorbed orally should no longer being used against fongal infections. This conclusion doesn't apply to the local use of ketoconazole, considering the poor systemic absorption and the absence of reported hepatic toxicity with this mode of use."
 

Rawtashk

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Re: Nizoral becomes illegal in France

Shma said:
Bryan said:
I repeat the question I asked before: why do you assume that they're referring to the shampoo? Ketoconazole is very poorly absorbed from the shampoo. The author of that blurb you posted needs to be given the same advice I gave to the original poster: SPECIFY EXACTLY WHAT YOU MEAN BY "NIZORAL"!! :dunno:

nizoral is the shampoo brian. Don't act stupid.

Otherwise there would be "Ketoconazole"

I would reiterate your "don't act stupid" comment to you, but in a very nice way :). Jesus invented the internet, and google, so that we can always make sure we're saying the right thing. If nizoral was only shampoo...then we wouldn't see this
http://www.netdoctor.co.uk/infections/m ... 01862.html

:)
 

Rawtashk

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Re: Nizoral becomes illegal in France

cyberprimate said:
Nizoral as shampoo has always been available as prescription medicine only in France, and as a 2-3 weeks treatment, not a regular one. Which is why i had to buy it from abroad. It will become illegal as well here. The ban on nizoral comes because cases of severe hepatitis happened statiscally more often with oral nizoral than other anti-fongal medicine. Bear in mine it happened only 5 times since 1982 but each time causing the death of the patient after an extremely brief period of time. This severe side effect has been known for years but since the scandal regarding the Mediator (Benfluorex) which killed 500 people in 35 years in France, the AFSSAPS (the French FDA) is becoming more cautious these days, hence this new ban, and others will follow.

Still I can't stop wonder whether I want to use Nizoral as shampoo for decades…

Wait...."5 people have died since 1982", so....in 29 years 5 people have died? That's less than have died in allergic reactions to Tylenol or penicillin. And MUCH less than have died in car wrecks. That's not going to keep me from popping pills when I have a headache, taking drugs to fight an infection, or driving my car to work everyday.
 

Ende

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Re: Nizoral becomes illegal in France

They're talking about oral medication. You shouldn't get any systemic absorption from the shampoo - as long as you don't expose the scalp for longer than 3 - 5 minutes, and don't get the shampoo in your eyes, mouth or nose. The cream is likely to cause some systemic absorption, but the amount is insignificant compared to several hundred mg's of oral ketoconazole. Nizoral shampoo only contains 10 or 20 mg's ketoconazole per ml! The cream contains 20 mg ketoconazole per gram too, but it's more likely to cause systemic absorption because the scalp is exposed for several hours, and it's possible that it contains a small amount of alcohol to aid absorption as well - I don't know.
 

cyberprimate

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Re: Nizoral becomes illegal in France

Rawtashk said:
Wait...."5 people have died since 1982", so....in 29 years 5 people have died? That's less than have died in allergic reactions to Tylenol or penicillin.

I didn't mention the several thousands of people that had a sever liver illness but didn't die of it…
 

cristi2011

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Re: Nizoral becomes illegal in France

Well, it's no surprise,if you read the list of ingredients. That shampoo contains aprox 10 very bad chemicals. I don't get how that may help hair, but personally i know some stories of people who in fact LOST hair due to nizoral. They simply had no major problems, washed with nizoral for eliminating dandruff, but guess what? Nizoral eliminated their hair.
 

John979

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Re: Nizoral becomes illegal in France

One 30 gram tube contains 600 mg of Ketoconazole. The tube lasts me at least 2 months so I am applying about 10 mg per day, plus shampoo at night.

Can't find the study but there are several out there documenting the fact that topical keto is very, very poorly absorbed. Even 1% absorption would be just 0.1 mg per day

A couple of glasses of wine per day are far worse on your liver.
 

Nene

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Re: Nizoral becomes illegal in France

Does this explain why it's now impossible to find in the US? I guess I'll just stick with T Gel.
 

Nene

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Re: Nizoral becomes illegal in France

monty1978 said:
finfighter said:
Yeah you're right, it's molecular weight is 531.431 so it shouldn't be easily absorbed through the epidermis.....

And at what mass should molecules begin to slip through the epidermis?

I have used nizoral on and off for nearly a decade cos it's cheap, everyone says it should do something and it is apparantly safe. Personally I have observed no benefit from it, it doesn't stop scalp itch if I come off of other treatments at all either.

I'm stopping nizoral!

Yeah I don't think it helped my hair one bit. It was just good at stopping the minoxidil itch.
 

vauxall

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Re: Nizoral becomes illegal in France

Rawtashk said:
Jesus invented the internet

I thought that the Internet was created by DARPA (Defense Advanced Research Projects Agency).

So DARPA was Jesus under cover?
 

Rawtashk

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Re: Nizoral Tablets (not Shampoo) Becomes Illegal in France

I don't know that nizoral by itself will stop your balding. But, it does give the hairs a better/healthier place to start growing again. Don't think of it as a wonder cure, think of it like a protein shake. A protein shake by itself isn't going to give you more muscles...but a protein shake in conjunction with a workout will give you bigger muscles than a workout w/o the shake.

Just my 2 cents.
 
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