| Tina Found Shoreline's info on methadose
Re: Is there a difference: Methadose and Methadone
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Methadose is Mallinkrodts crappy generic, Roxanne is also generic for name brand Dolophine. I took meth for 2&1/2 years and the two time I was given methadose at the pharmacy it caused withdrawal.
My brother was the Quality control and FDA liason for another International pharma maufacturer and I sent 1 10mg tablet to him and he tested the amount of methadone HCL in a 10 mg Meth Tab, It came back at 8.3, 17% less than what is supposed to be in it but that still falls within the FDA guidelines for generic equivelance. If you start and stick with it because you can't find roxanne, you won't know what your missing, but if you start with Roxanne, don't give the mallincrap a try.
This is the article that explains what equivalent actually means and how important it is to be truly equivalent. It discuses how the generics must fall within ranges that are expectable parameters that don't create a large enough change to be clinically significant in the FDA's mind.
[url]http://www.americanheart.org/presenter.jhtml?identifier=3015266[/url]
Approval of a generic version of a proprietary drug by the FDA requires demonstration of “chemical equivalence” (similar quantities and availability of the active ingredient in proprietary and generic formulations), and “bioequivalence” (defined by absorption parameters generally falling between 80% and 125% of those obtained with the proprietary agent under the same testing conditions) (2) The use of the –20%/+25% rule is based on a regulatory decision that for most drugs that difference in concentration of the active ingredient in blood will not be clinically significant.
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There are parameters for generic testing against the proprietary drug "name brand". The scary thing is, there are no clinical testing or comparison from one generic to the other, just comparison to the proprietary drug. So if one generic company is at the top of the parameter and using +25% and the other is at the bottom using -20% then your talking about a 45% variation.
Only 17% of the polled docs knew what the parameters where to obtain bio equivelance. Pharmacist are no better and they are paid a bonus to push generics due to the GPM.
It's not that all generics are inferior, you just never know when you move from one manufacturer to another. Stick with one and don't make exceptions when it comes to meth and some other meds out there. JMO.
Take care, Dave
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Last edited by Shoreline : 10-24-2005 at 01:32 PM.
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