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Thread: Intravesical gentamicin is a winner

  1. #21
    Several of the research studies/journal articles available seem to point to the 480 mg/1 liter saline as the typical titration. However, it wasn't so clear as to the frequency of treatment, whether once or twice a day.

    According to my calculations for what my insurance company would pay for, I could get 100 days of twice per day treatment if the amount use is 30 mL.

    Do the unopened vials need to be refrigerated?

    I would imagine that for any indwelling, whether suprapubic or Foley that it would have to be clamped off for a time frame to get allow for absorption and action, yet not enough to cause distention and either reflux up the ureters or leakage around the stoma or out the urethra.

    I don't recall but were there any issues with developing antibiotic resistance to the class of antibiotic that gentamicin belongs due to the long term exposure? Would instillation avoid this rather than oral consumption?

    I have my semiannual urological visit next month and will bring this information to him and see if he agrees to try the protocol. I don't think he will have a problem and will probably be interested into its efficacy.

  2. #22
    i dont refrigerate. doesnt say to on box. keep mine in a drawer.
    Quote Originally Posted by crags View Post
    Several of the research studies/journal articles available seem to point to the 480 mg/1 liter saline as the typical titration. However, it wasn't so clear as to the frequency of treatment, whether once or twice a day.


    According to my calculations for what my insurance company would pay for, I could get 100 days of twice per day treatment if the amount use is 30 mL.

    Do the unopened vials need to be refrigerated?

    I would imagine that for any indwelling, whether suprapubic or Foley that it would have to be clamped off for a time frame to get allow for absorption and action, yet not enough to cause distention and either reflux up the ureters or leakage around the stoma or out the urethra.

    I don't recall but were there any issues with developing antibiotic resistance to the class of antibiotic that gentamicin belongs due to the long term exposure? Would instillation avoid this rather than oral consumption?

    I have my semiannual urological visit next month and will bring this information to him and see if he agrees to try the protocol. I don't think he will have a problem and will probably be interested into its efficacy.
    Bike-on.com rep
    John@bike-on.com
    c4/5 inc funtioning c6. 28 yrs post.
    sponsored handcycle racer

  3. #23
    Storage of Gentamicin 10mg/ml and 40mg/ml solution: https://www.hpra.ie/img/uploaded/swe...ved.160628.pdf

    25 degrees C = 77 degrees F. (See image for storage instructions)
    Attached Images Attached Images  

  4. #24
    I don't how wise it is to mix up a whole liter at a time which I would prefer as the instructions posted above says it is only stable for 24 hours once mixed with .9% saline.

  5. #25

  6. #26
    The bogey in this protocol is how those of us with indwelling catheters can use it.

    Very glad that those of you who use intermittent catheterization to manage your bladders have found a protocol that works...but this method may not be the panacea for the rest of us who manage our bladders in other ways.

    We must always remember in this life of spinal cord injury...one size does not fit all.

  7. #27
    agreed, i only do week at a time.
    Quote Originally Posted by crags View Post
    I don't how wise it is to mix up a whole liter at a time which I would prefer as the instructions posted above says it is only stable for 24 hours once mixed with .9% saline.
    Bike-on.com rep
    John@bike-on.com
    c4/5 inc funtioning c6. 28 yrs post.
    sponsored handcycle racer

  8. #28
    FYI, I emailed one of the investigators in one of the gentamicin instillation research studies available (University of Michigan Medical Center) on the Internet to get their idea about how much they mix at one time and how they store it. Below is the response I got.

    "Thank you for taking the time to share your story with me as well as your interest in our study. We actually had to get FDA approval prior to IRB approval, as use of gentamicin in this manner for bladder instillation is considered off-label. So we addressed many of your questions directly with the FDA division of Anti-Infective Products. Per the USP, the diluted gentamicin is good for 48 hours at room temperature and 14 days refrigerated, but the FDA recommended we adjust the protocol to state: "For home instillations, the participant will be instructed and provided with written instructions indicating that the solution is to be stored in the refrigerator no more than 10 days and stored at room temperature for no more than 48 hours.

    The formulation is prepared by the pharmacy in a laminar flow hood using USP 797 regulations just prior to the scheduled assessment (within 20-30 minutes) and stored in the refrigerator at a temperature range of 2-8?C until use in the
    outpatient setting. However, we found that if we instill the cold solution directly in the bladder from the fridge, it will trigger a reflex contraction and the participant will leak urethrally. We typically warm the solution in our hands prior to instillation so that it is closer to body temperature.

    Our current protocol is 60ml instillation/2x day (once in am and once in pm).

    Hope this helps and let me know if you have any additional questions."

    So it looks like one wanted to mix up a batch for convenience sake it should be no more than 10 days worth and then take out the amount needed every two days (48 hours). Their protocol was outlined above, yours will obviously differ if the amounts and schedule differ. I don't know what a laminar flow hood is but if it is one of those enclosed chambers you reach into to mix things while the vents draw out the vapors I don't know what the reason would be nor do I think most of us have one. Saline isn't awful and gentamicin is hardly like sulfuric acid in terms of harmful vapors.

  9. #29
    A laminar flow hood or cabinet is used for mixing solutions to avoid introduction of microrganisms into the solution, as well as preventing contact with fumes or microparticulates by the person preparing the drug. This really should be done for any sterile solutions (IVs, irrigation solutions, etc.).

    (KLD)
    The SCI-Nurses are advanced practice nurses specializing in SCI/D care. They are available to answer questions, provide education, and make suggestions which you should always discuss with your physician/primary health care provider before implementing. Medical diagnosis is not provided, nor do the SCI-Nurses provide nursing or medical care through their responses on the CareCure forums.

  10. #30
    Quote Originally Posted by crags View Post
    I don't know what a laminar flow hood is but if it is one of those enclosed chambers you reach into to mix things while the vents draw out the vapors I don't know what the reason would be nor do I think most of us have one. Saline isn't awful and gentamicin is hardly like sulfuric acid in terms of harmful vapors.
    And it is unlikely that any of us will buy one. These pictures show the least expensive one ($280) I found and the most expensive one (floor model at $2250) I found in my short search. I'd bet that they can get much more expensive.
    Attached Images Attached Images   

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