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#693059 - 05/03/08 04:33 PM
Re: FM, Upcoming Surgery, and Oxy Question!
[Re: Tiades]
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GRAND Pooh-Bah
Registered: 09/04/06
Posts: 10641
Loc: UK
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The 20% difference is a fallacy. Doctors would be unable to practise properly if that were the case: # What are generic drugs? A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. # Are generic drugs as safe as brand-name drugs? Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts. # Are generic drugs as strong as brand-name drugs? Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs. # Do generic drugs take longer to work in the body? No. Generic drugs work in the same way and in the same amount of time as brand-name drugs. Now there are variations in individual human responses, but these cannot be predicted. http://www.fda.gov/cder/consumerinfo/generics_q&a.htm#whatare
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#693092 - 05/03/08 06:17 PM
Re: FM, Upcoming Surgery, and Oxy Question!
[Re: Tiades]
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GRAND Pooh-Bah
Registered: 09/04/06
Posts: 10641
Loc: UK
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Please do post the website where you saw this 20% rule. I don't know much about the USA; I'm assuming the FDA does, hence the link. But how is a doctor supposed to prescribe, say, an increase in hydrocodone from 7.5mg to 10mg, and the patient only receives 8mg? Similarly, if a patient performs a slow taper using a benzodiazepine and the dose actually goes up and down sharply, it will fail. The reasons why people feel that some medications are weak are many, and nobody really understands why. Inactive ingredients may affect individuals differently, and some people may not absorb a particular tablet as quickly as another. A slow onset of a drug certainly seems weaker than a quick onset. 100mg pethidine IV will leave many people gasping for breath, while the same dose IM will have the same total analgesic effect, but appear 'weaker' because it takes several minutes to take effect, rather than 7 seconds. Orally, stomach contents make a big difference in many cases, and some people don't realise that food may remain in the stomach a lot longer than they think sometimes. In the IOP world, things are more complicated due to pills from questionable sources. But the small amount of meds I have used from overseas have been fine. Tolerance is sometimes to blame as well, as it doesn't always increase steadily with time. It can remain steady for a while, then one day the meds just don't work. I have taken doses of liquid from the same bottle, and it has had different effects at different times. That cannot be blamed on anything I can understand.
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#705959 - 05/28/08 09:10 PM
Re: FM, Upcoming Surgery, and Oxy Question!
[Re: nephro]
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Journeyman
Registered: 02/25/06
Posts: 63
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I think I know where the misunderstanding is about the "20% rule". The generic drug itself must contain the same amount of active ingredient as the brand, however, the mechanism of the way the generic works in the body, specifically as relates to it's bio-availability, is allowed to have a 20% +/- variation. So, theoretically the pain-killing effect of the drug could vary in a person as much as 20% less or 20% more. Here is a link to and an excerpt from an explanation of the Hatch-Waxman Act of 1999 in the USA. ... A number of assumptions were made in enacting Hatch-Waxman. One major assumption underlying the Hatch-Waxman Act was that duplicates of pioneer drugs would be the same as the innovator’s drug. FDA still uses the plus-or-minus-twenty percent test to determine blood serum bioavailability (i.e., the amount of active ingredient in the blood over a period of time has to come within plus-or-minus twenty percent of that which is observed when the innovator’s drug is ingested). Twenty percent is a fairly good margin, and many medical professionals believe that for drugs that have a wide index of tolerance, twenty percent is not important at all; in such instances, twice as much or half as much of the active ingredient in a generic product will still work. For drugs where there is a very narrow therapeutic band, for example, where a patient gets antiseizure medication, plus-or-minus twenty percent may not be appropriate. This is true particularly if a drug is at that higher end of bioavailability and a patient is titrated on the higher end (plus twenty percent) and then a second generic is dispensed where the active ingredient was at the lower end (minus twenty percent); mathematically, that is a fifty percent swing and may not be safe or effective. It is a curious thing that FDA has not altered its regulatory approach to this situation. With the advances in modern pharmaceutics, those standards could be tightened. Although such tightening might not be to the advantage of the brand name companies, it could be to the advantage of patients... Leesee
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#708186 - 06/02/08 11:42 AM
Re: FM, Upcoming Surgery, and Oxy Question!
[Re: leesee]
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Pooh-Bah
Registered: 10/30/02
Posts: 1436
Loc: Southern, US
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I think I know where the misunderstanding is about the "20% rule". The generic drug itself must contain the same amount of active ingredient as the brand, however, the mechanism of the way the generic works in the body, specifically as relates to it's bio-availability, is allowed to have a 20% +/- variation. So, theoretically the pain-killing effect of the drug could vary in a person as much as 20% less or 20% more. Excellent -- This is on par. The 20% rule apply's to Generics and Differing NAME brands. It is all relative to the person, the unique individual's biochemistry (and environmental endogenous factors ((as pointed out by nephro)) ). I find that Vintage and Mallinckrodt to be the most complained about (for weakness) variations of opiate synthetic pills. Generally, generic wise, Watson comes to the fore-front for preference. I would simply recommend, given your concern, to pay for the name brand of the Oxycodone (tell the pharmacy you want name brand, and if they don't have it go to another) -- it will be substantially more expensive, but it should give you comfort. Not all name brands are equal as well. ..and as was said above the amount of active ingredient , in this case oxycodone, is nearly identical in name brand vs. generic (by law).
_________________________
-/\/eofate
"Efforts and courage are not enough, without purpose and direction."
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