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Thread: The 4-AP List

  1. #111
    Senior Member NW-Will's Avatar
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    Quote Originally Posted by PN View Post
    Cory, I have never heard anyone say that the dosage is based on or off your body weight.
    One of the reasons 4-AP is still going through clinical trials is to find out more about the optimal dose, including whether the dose should be related to body weight and if it needs to be different for men and women.
    source


    In this trial the 4-AP was administered in a dosage relating to weight.
    The total daily dose of 4-AP during the four weeks of treatment was systematically increased to a maximum of 0.5 mg/kg body weight.
    Last edited by NW-Will; 02-02-2010 at 08:14 PM. Reason: edit

  2. #112
    Senior Member Tim C.'s Avatar
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    Time to move onto 5-ap

    Isn't it time we move on from this stuff?

  3. #113
    Weight was measured, but as long as you could handle the medication the milligrams would get ramped up. This was my experience in three separate clinical trials.

    I think this is as good of time as any to discuss 4-AP.

    Good luck.
    The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
    --General George Patton

    Complex problems need to be solved collectively.
    ––Paul Nussbaum
    usc87.blogspot.com

  4. #114
    Quote Originally Posted by PN View Post
    Weight was measured, but as long as you could handle the medication the milligrams would get ramped up. This was my experience in three separate clinical trials.

    I think this is as good of time as any to discuss 4-AP.

    Good luck.
    The following article describes the pharmacokinetics of Fampridine SR
    http://www.sciencedirect.com/science...4fc6591d2e0254

    Archives of Physical Medicine and Rehabilitation
    Volume 85, Issue 1, January 2004, Pages 29-34
    doi:10.1016/S0003-9993(03)00651-8 | How to Cite or Link Using DOI
    Copyright © 2004 American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Science (USA). Cited By in Scopus (14)
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    Article

    Pharmacokinetics and safety of multiple oral doses of sustained-release 4-aminopyridine (fampridine-sr) in subjects with chronic, incomplete spinal cord injury 1 , , *1

    Keith C. Hayes PhDa, , , Patrick J. Potter MDa, Jane T. Hsieh MScb, Mitchell A. Katz PhDb, Andrew R. Blight PhDb and Ron Cohen MDb
    a University of Western Ontario and Parkwood Hospital, London, ON, Canada
    b Acorda Therapeutics Inc, Hawthorne, NY, USA

    Available online 29 December 2003.

    Abstract
    Hayes KC, Potter PJ, Hsieh JT, Katz MA, Blight AR, Cohen R. Pharmacokinetics and safety of multiple oral doses of sustained-release 4-aminopyridine (Fampridine-SR) in subjects with chronic, incomplete spinal cord injury. Arch Phys Med Rehabil 2004;85:29–34.

    Objective
    To examine the pharmacokinetics and safety of sustained-release 4-aminopyridine (Fampridine-SR), a potassium channel blocker, in subjects with chronic, incomplete spinal cord injury (SCI).

    Design
    Open-label.

    Setting
    Clinical research unit in Ontario.

    Participants
    Sixteen neurologically stable subjects with chronic, incomplete SCI (American Spinal Injury Association Impairment Scale grade B, C, or D).
    Intervention

    Oral administration of Fampridine-SR (25, 30, 35, 40, 50, 60mg twice daily, each for 1wk).

    Main outcome measures
    Steady-state pharmacokinetic parameters: maximum observed plasma concentration (Cmax), minimum observed plasma concentration (Cmin), average observed plasma concentration (Cav), area under the plasma concentration-time curve from 0 to 12 hours (AUC0–12), time to Cmax (tmax), plasma half-life (t1/2), apparent volume of distribution (Vd/F), and apparent total clearance (Cl/F). Safety assessments: physical examinations, vital sign measurements, clinical laboratory tests, electrocardiogram recordings, and adverse events.

    Results
    Mean steady-state Cmax, Cmin, Cav, and AUC0–12 increased over the entire Fampridine-SR dosage range and were dosage dependent up to 50mg twice daily. Fampridine-SR had a mean tmax of 2.2 to 3.0 hours and a mean t1/2 of 5.7 to 6.9 hours. Mean Vd/F (415.4–528.0L) and Cl/F (51.4–57.7L/h) were independent of dosage, as were mean tmax and t1/2 across dosages. Adverse events were mild or moderate and were not dosage related. During the entire study period (17wk), dizziness was the most frequently reported adverse event, followed by urinary tract infection, paresthesia, ataxia, and insomnia.

    Conclusion
    In subjects with chronic, incomplete SCI, Fampridine-SR was slowly absorbed and eliminated, which will allow Fampridine-SR to be administered in a convenient twice-daily manner. Fampridine-SR was well tolerated at dosages from 25 to 60mg twice daily.
    Author Keywords: 4-Aminopyridine; Pharmacokinetics; Rehabilitation; Safety; Spinal cord injuries
    Like many drugs intended to affect the central nervous system (as opposed to the body), Fampridine dose is not usually considered in mg/kg terms but usually simply in milligram x number of times per day. This is usually done for four reasons.

    1. Oral doses of drug are too crude to be amenable to mg/kg or mg per body surface calculations. For example, in the case of immediate release 4-aminopyridine, one really only has 5 mg and 10 mg capsules.

    2. The timing of doses is the most important determinant of serum levels. When one takes a oral dose, one gets a rapid peak serum concentration followed by clearance of the drug from the body. The dose of the capsule determines the peak serum level but the steady state level depends on how often one takes the drug.

    3. Bioavailability of the drug varies enormously for orally administered drugs. The serum levels achieved may vary by several fold from person to person and depends on many factors including the presence of food in the stomach at the time of dosing.

    4. The formulation of the drug determines how long it takes the drug to be absorbed. An immediate release formulation may be mostly absorbed within 10-20 minutes while a sustained release formulation continues to be absorbed over several hours or longer.

    Given all these variables, most orally administered drugs are prescribed by the number of available dose capsules/tablets given how many times a day. Is drug effect is dose-sensitive, a physician may start with a lower dose and increase the dose until the therapeutic effects appear while minimizing unpleasant side-effects.

    If the drug is potentially toxic and toxicity levels are close to therapeutic levels, the physician may titrate the dose using serum levels. This is what we do for lithium, for example. We give a certain dose of lithium, wait three days and then test the serum lithium levels to determine whether the dose should be increased, maintained, or reduced.

    Drug absorption depends on gut transit time. People with spinal cord injury tend to have slower gut transit times than able-bodied people. Dosing regimens should be directly tested in the patient population for whom the drug is intended.

    Wise.

  5. #115
    Wise, I didn't know about the transit time. I can't afford the monthly prescription for AMPYRA. I don't think my insurance will cover the cost. That means many individuals with an SCI will get this medication from an independent compounding pharmacy. My advice to others was to wait for Acorda to get FDA approval.

    Looking back I realize that I never had a major issue tolerating this medication. Below is from the long term clinical trials at the Long Beach VA Hospital. This is for the quick release version of 4-AP. The trials started in 1997 and ended in 2001.
    The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
    --General George Patton

    Complex problems need to be solved collectively.
    ––Paul Nussbaum
    usc87.blogspot.com

  6. #116
    Senior Member mr_coffee's Avatar
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    Interesting my doc for some reason thought it was based on body weight. Either way 20mg was too much for me.
    Injured:10-16-04
    C7/C8, T1 incomplete;


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  7. #117
    Senior Member NW-Will's Avatar
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    Quote Originally Posted by Sue Pendleton View Post
    It will be cheaper when you get to 10mg capsules as they charge for each capsule more than the strength. There is very little difference in compounded "sustained release" and regular old 4-AP. Unlike Fampridine that is formulated to maintain the same blood levels of the drug over 12 hours the compounders normally just add cellulose to slow or cut the amount of the drug released from as soon as the gel capsule dissolves to maybe an added half hour to hour to your blood stream.
    Quote Originally Posted by NW-Will View Post
    I managed to get a prescription and took my first 5mg 4-AP today,
    fingers crossed.

    186 5mg capsules = $ 115

    This is not sustained release.
    I was figuring sustained release would be better, I don't mind taking it
    4 times a day, even 4 times a day sustained release. For some
    reason the pharmacist talked the doctor into changing the prescription
    to non sustained release, even though they have the capability to
    compound sustained release. !!!!

    Anyone reading this taking more than 40mg of 4-AP??
    Just received my 10mg capsule prescription.

    120 10mg capsules $150

    186 * 5mg = 930mg - ($115 / 930 = $0.123 per mg)

    120 * 10mg = 1200mg - ($150 / 1200 = $0.125 per mg)

  8. #118
    Guys and Gals, we're talking about 4ap and dosages. What benefits are any of you seeing? This is important ;as I understand it; the elctrical circuit is supposed to be increased in efficency, and for one I am interested in trying it. About 8 months ago, I approcahed it with my neuro and he said it was somewhat dangerous, but would revisit it with me this next vist. Hey any improvement woudl be welcome.

    T.J.

  9. #119
    Junior Member Pluto64's Avatar
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    Ok, I’m ready to try 4-AP. Getting together info for my doctor. Next questions is if I’m given a prescription, what compounding pharmacy has the experience to fill it for me?

    Any compounding pharmacy’s located in IL?

    Next question, just to be a little lazy, can some one post a link of the information of what you gave to your doctor with information on what dose to start out with.

  10. #120
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    Pluto St. Joseph Apothacary in St. Joseph, IL is a compounding pharmacy. If you need there phone number pm and I will get it to you.

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