List of excipients (fillers) and shelf life for Naltima Brand Naltrexone 50mg tablets
List of excipients (fillers) and shelf life for
Naltima Brand Naltrexone 50mg tablets
Hi All,
I get asked what the excipients (fillers) are in Nodict and Naltima brand Naltrexone tablets. Here is what I found...
Naltrexone Hydrochloride 50 mg Film-coated Tablets
6.1 List of excipients
Tablet core
Lactose monohydrate
Cellulose Microcrystalline
Crospovidone
Colloidal anhydrous silica
Magnesium stearate
Film Coating:
Hypromellose (E464)
Macrogol 400
Polysorbate 80 (E 433)
Iron Oxide Yellow (E172)
Iron oxide red (E172)
Titanium Dioxide (E171)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions
6.5 Nature and contents of container
Naltrexone Hydrochloride 50 mg film-coated tablets are packed in White opaque PVC/PE/Aclar – Alu Blister and Alu-Alu blister packs containing 7, 14, 28, 30, 50 and 56 tablets.
Not all pack sizes may be marketed.
Here is what The Mayo Clinic says about Naltrexone: “Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.” and the link:
http://www.mayoclinic.org/drugs-supplements/naltrexone-oral-route/proper-use/drg-20068408
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LACTOSE: Lactose is a naturally-occurring simple
carbohydrate, or sugar, found only in the milk of mammals. For
this reason, it is also commonly referred to as “milk sugar.”
Lactose has long been used as a soluble filler in the manufacture
of orally administered pharmaceuticals. It is safe, stable,
inexpensive, and has a fast dissolution rate. Pharmaceutical-
grade lactose powder is highly pure, and specifically produced
to meet government standards of safety and purity.
Lactose is easily tolerated by most patients. However, if you
are lactose-intolerant (that is, if milk products give you nausea,
diarrhea, abdominal cramping, bloating, or flatulence), you
might want to try another filler.
Note: Dr Bihari asks his patients to use lactose, unless they
have an adverse reaction… not because he believes lactose is
better than other fillers, but because he began his study of LDN
with lactose, and he wants his records to be consistent.
from
http://www.lowdosenaltrexone.org/gazorpa/LDNFillers.html
I could not find any information for the Naltima brand, and this following may be why..
Naltima & Nodict
"susan MercuryTrouble" susan_mercury
River pharmacy has two type Naltrexone: Naltima & Nodict.
I wonder which one i need to order?
Thanks,
--Susan
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They are identical, or very close to it. There's a page at River Pharmacy that explains different names are used for different coutries/areas. In India it's call Naltima. If in the US you would order Nodict. Or at least that's what I've been using.
Swede
http://www.SwedesDock.com/LDN << Why> http://www.Swedesdock.com/LDN/Sources << Sources> http://www.Swedesdock.com/LDN/Study_Summary/ << Summary>
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About Fillers and Aditives in Nodict Brand Naltrexone.
This is basically the thread of our forum discussions about fillers,
and additives etc. Some people Very very few) are simply
"ultra-sensitive and have tried changing the filler but still cannot tolerate LDN"
In the end, we each only have our own experiences. I have used Naltrexone from overseas since May 1, 2009. It not only stopped the progression of my Multiple Sclerosis, but promoted healing to the point that, if I did not know that I have MS, there would be no evidence of it (as long as I stay on the liquid, dissolved LDN).
I addition, I am in total remission from very nearly fatal cancer as well. If my homemade LDN is ineffective, I am loving this 5 year placebo effect. I have never taken a single compounded capsule, but feel that I might have done as well, just far, far more expensive and regimented, especially as to dose.
I will believe my experiences that whatever is in the Naltrexone tablets that I buy on the internet, it certainly works for me, my family and pets.
I also hope that newcomer commercial interests don't hijack, what thousands of people have found to save their very lives.
-- Francie
*****************
It seems the excipients do not effect the efficacy of Naltrexone, and especially with a Low Dose Naltrexone solution, I only notice a tiny bit of sediment, and by all accounts, there is no need for concern.
We must remember it has been approved by the FDA as non-toxic, and that is at 100mg per day.
We are taking only about 4% of that dose, so you can imagine how little filler we ingest.
This was sent to the LDN forum by a respected LDN proponant .....
I believe that only the Naltrexone dissolves into the water. Any residue can simply be discarded and take the essentially clear liquid. That would be the best test of whether you are sensitive to those other fillers. Lots of people take the 50 mg tablet for addictions, without dissolving it. If you dissolve it, and then take 1/20 of that tablet, without the dregs, you could not be getting enough to sense. The titration would be so very miniscule.
Best of luck,
--Francie
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I don't know that it's possible to avoid the filler altogether
compounding your own LDN from 50 mg Naltrexone pills. I suspect at
least some (if not most) filler is dissolved along with the Nx. The
only way to avoid filler altogether is buy from a pharmacist who uses
only pure Nx and will use a filler of your choice.
Keep in mind how little volume of Nx is in 3 mg:
454 grams to a lb. --
.0022 lb = 1 gram --
1,000 mg to a gram --
.0000022 lb = 1 milligram --
.0000066 lb = typical 3 mg dose of Nx (LDN)
That's a nearly infinitesimal amount by volume, which would make an
awfully small pill if no filler is added. I'd bet the pill would be
no bigger than the head of a pin if only pure Nx.
While I certainly wouldn't argue with anyone who claimed to be
affected by a particular (or any) filler I tend to think (nearly) all
this "filler" worry is just unnecessary anxiety brought on by
starting an "unapproved by a medical professional" prescription med
and getting spooked by internet hyperbole. If (most) people just took
a deep breath and let themselves adjust to whatever benefits (if any)
LDN will bring for a month or two they would find something else to
worry about as it almost certainly isn't the LDN causing their
problems. After all, it's less dangerous than taking an aspirin a day.
Of course there's always that 1 person in 10,000 who actually is
affected by a particular filler who
will be heard and (unintentionally) plant seeds of doubt in the minds
of the 5,000 who are nervous about "self prescribing" for themselves.
One thing to keep in mind is that fillers have been in use for more
than 100 years and the medical community has inert pretty well
harmless (inert inactive) fillers down pat.
Swede
http://www.SwedesDock.com/LDN << Why>
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Q)
A chemist I know tells me that naltrexone is totally water soluble and after initial mix should not be mixed again as it picks up the settled sediment. Do you have any opinion on this?
A)
The tiny amount of settled sediment is not harmful.Can be consumed or discarded.
-- Dudley Delany, RN, MA, DC
** Dudley's Low Dose Naltrexone Sites **
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Cheers,
Ian