Mallinkrodt is the only bulk manufacturer of methadone in the country, so even Roxanne buys their bulk Meth HCL from mallinkrodt, It's just a matter of how much meth they put into each tablet.If they can make 12 tablets for the price of 10, you can bet they are going to do it. It was my brother that tested Methadose for me, He was the quality control and the FDA liason for another major pharma company. The 10 mg Methadose tablet I sent him contained 8.2 mgs of meth HCL. I didn't have a Roxane tab to send him at the time.
The FDA allows a -20% or +25% allowable variance in the genric drugs. This keeps it close in qualities and strength to the name brand but if one generic manufacturer is using +25% and the other is using -20% your talking about a significant difference between generics. Both times I was given methadose brand I experienced withdrawal. Fortunately the second time the pharmacist swapped it fout for the Roxanne the following week when his order came in. The pharmacist must know something if he's willing to bend the rules that much.
If you start with methadose and stick with it, you would never know the dfference, but changing from one generic to the other you could have as much as a 45% difference.
This is the FDA definition of equivalent.
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.
They have never had their meth dose dropped 40-45% to know if one generic was equivalent to another, they are comparing generic to Name brand, not comparing generic to other generics.
The profit margin is so much higher on generics, pharmacist are paid a bonus based on their percenatge of generics dispensed each month. This is why they continually tell us there is no difference.
Here is an article from the American Heart association about generics.
[url]http://www.americanheart.org/presenter.jhtml?identifier=3015266[/url]
Excerpt:
Only 17 percent of physicians could correctly identify the FDA standards for bioequivalency.
Good luck, Dave
! Hope and pray you are all pain-free!
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