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Unread 07-02-2010, 11:57 AM   #1
TIM
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Default New buprenorphine medication for PAIN

The FDA just approved a transdermal buprenorphine patch that lasts for 7 days. Although it is not approved for opioid addiction it is approved for pain. To prescribe this for pain doctors DO NOT need the DATA-2000 waiver.

http://www.purduepharma.com/pressroom/news/20100701.htm
http://www.purduepharma.com/PI/presc.../ButransPI.pdf

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Unread 07-02-2010, 04:01 PM   #2
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That is interesting, Tim. Do you have any idea why buprenorphine in an oral form for pain treatment has never made it to the States? I think it is fairly widely used elsewhere, though at 0.2mg/tablet, it would take 40 pills to equal the dosage of one 8mg suboxone tab. I believe it is also used in veterinary medicine, too.
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Unread 07-02-2010, 04:11 PM   #3
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Quote:
Originally Posted by toms View Post
..Do you have any idea why buprenorphine in an oral form for pain treatment has never made it to the States? ...
Yes it's due to the fact that there is no marketing protection for a buprenorphine tablet for pain. Without patents, orphan drug status, or a proprietary delivery system, manufacturers have no way to protect themselves from generics and make a profit or even break even with the huge expense required to get a new drug FDA approved. Despite that the drug is used in other countries the FDA requires new US studies to prove efficacy regardless of how effective it has been for years in the field. This along with the cost of filing makes it very expensive. So without any way for a manufacturer to justify the expense I doubt we’ll see a buprenorphine tablet for pain, unless it has some kind of patentable delivery method or another ingredient that both adds to the efficacy and is protected by patents.


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Unread 07-03-2010, 06:53 AM   #4
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All of which has nothing to do with coming up with an effective medical solution for those suffering from chronic moderate->severe pain. How unfortunate.

IMO, this new transdermal delivery system, however, could be a real boon for those who have chronic pain and have fallen victim to the full agonist opiod tolerance problem that so often sends people spiraling into the world of high-dose dependence and even addiction.

I wonder if it makes sense to consider transdermal as an alternate delivery system for opiate addiction if only because of the bioavailability problem of sublingual administration. Does naloxone have a higher bioavailability transdermally than orally/sublingually? Could a formulation like Suboxone be a feasible solution in the near future? If RB were to take such a medication to the FDA, do you think it could be more widely adopted than Suboxone once a patient is stabilized? Could it mean better control over non-compliant patients? Could such a medication be a replacement (in some cases) for those using Duragesic (fentanyl transdermal) patches?

Interesting subject and great article, Tim, thanks

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Unread 07-03-2010, 08:48 AM   #5
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I think this is a step in the right direction, as other non addictive medications are developed. Given the tolerance issue, a pain medication like this would have saved me a great deal of pain and life problems.

For me today, I am better off using Suboxone for pain, as I only take it on the days when I really need it and have been using OTC and non narcotic prescription medications for daily use. As well as life style changes and therapy.

This is good news!

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Unread 07-03-2010, 12:21 PM   #6
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I dont understand the abuse part of it. isnt it the same as sbutex and has a cieling affect? I mean it may make you feel beeter than normal in the begining but i think weve seen enough and experienced enough to know it aint nothin to write home about.
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Unread 07-07-2010, 05:07 AM   #7
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I do know that it's used in veterinary medicine in a shot, and the vet called it by the generic name buprenorphine. This was at least 10 years aago.

You're right that the companies only care about getting something new out there to help people if they can patent it and be the exclusive vendor. Which, IMO, is one of the things wrong with our current healthcare system, but that's a separate issue.

I remember reading that, although buprenorphine was already generic, that the company managed to get patent protection on Suboxone and Subutex mainly because of the new delivery system (sublingual) and the new use of opiate dependency.

I've heard that it either is or is soon going to generic, so I expect that Reckitt-Ben. is looking for another tweak so they can get it re-patented. Going to a patch and prescribing for pain would definitely do that for them. I just hope that if that happens, my insurance company doesn't stop covering it. They hate brand names and sub is one of the few brand-names they cover.

I find the machinations of the pharmacy industry really fascinating and have been following such things for a long time. You can really learn a lot about corporate culture!

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Unread 07-07-2010, 08:14 PM   #8
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So what dose would the 20mcg/hr patch be equivalent to compared to suboxone? I'm not sure how to transfer 20mcg/hr into mgm/24hrs.
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Unread 07-08-2010, 11:27 AM   #9
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It comes out to less than 1mg/day. The studies that show buprenorphine is effective for pain are all done at very low doses. The injectable buprenorphine (approved for pain, not approved for addiction) come in 0.3mgs doses. This patch probably wouldn't be very effective to treat addiction even if it was approved for it, except maybe at the very end of a long slow taper.
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Unread 11-20-2010, 10:20 PM   #10
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It will be available in January. Would it be .48mg/24hrs? so, about comparable to 1/4 of a 2mg tablet?
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Unread 11-21-2010, 04:05 AM   #11
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Though I no longer need Sub for daily pain, we have a fair amount here locally who this could benefit. At that mg delivery each day it could be effective in helping those with more acute daily pain, as it would build up in their system and refresh it's self at the proper dose for pain management.

Per the manufactures making money, it isn't cheap to develop a new medications and if they don't turn a profit they are no longer able to justify producing new breakthroughs. Yes, medication costs are too high, I know as I don't have any insurance for them, but, more productive ways need to be found to bring cost down, which doesn't stifle R & D or cost jobs. I can't totally accept that the only motivation is money, but yes, it certainly is the everlasting devil, the necessary evil.

If anything for me personally not having insurance and trying to manage the high cost of medication has helped me find alternative, yet effective ways to manage my needs.

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Unread 11-21-2010, 12:08 PM   #12
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It makes no sense that the active ingredient is the same and the only difference is the method of delivery. Either bupe is good for pain or it isn't. This is where Methadone trumps bupe.

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Unread 11-21-2010, 04:01 PM   #13
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Wayne, from my experience taking it for pain, I can see where a delivery system which is more consistent could be a benefit. We know that for those who it does help, that it works best at the lowest dose range and cutting to get that dose is more inconsistent. So for me, one who has and still does use it for pain, I can see where if I took it daily, I feel it would be a benefit to me. The down side to me about bupe is that it doesn't help enough people with pain and it doesn't help with all types of pain.
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Unread 11-21-2010, 09:47 PM   #14
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Mike I see what you are saying. It just frustrates me that the impetus behind the delivery system seems to be money driven rather than pain relief driven.

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Unread 01-20-2011, 01:08 PM   #15
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Default Butrans™ (buprenorphine patch) Now Available

Butrans™ (buprenorphine) Transdermal System CIII Now Available

PR Newswire | STAMFORD, Conn., Jan. 20, 2011

STAMFORD, Conn., Jan. 20, 2011 /PRNewswire/ -- Butrans™ (buprenorphine) Transdermal System CIII from Purdue Pharma L.P. is now available by prescription and indicated for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans Transdermal System is the first opioid analgesic that delivers continuous release of buprenorphine for seven days.

Read more: http://www.digitaljournal.com/pr/204482
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Unread 01-20-2011, 01:44 PM   #16
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That's great, thanks for the update! I spoke with my Sub doctor about it coming out this year and me possibly being able to try it depending on the dose they come in. Excited to be able to print the info and talk with her about it next month! Thanks!
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Unread 01-29-2011, 10:18 AM   #17
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I have been on sub for close to 2 yrs now...As most on here I have a cronic pain condition and addiction to pain meds. My Dr has just changed my sub from the 2mg subutex pills to this patch. He told me that Dr are going to stop using the pills all together and will either go with this patch or the strips...( I don't know if this is fact or not) I will be filling my patches later this week, and will update everyone on how they work. I am very nervous about the switch b/c I have done well with the pills and Im afraid the patch isn't going to keep away cravings, w/d's ect...
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Unread 02-01-2011, 03:52 PM   #18
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Hi Tim. I looked up that link, and it said that the patch comes in up to 20 mcg per hour patches. How much does that equal as far as milligrams, do you know? I couldnt find it anywhere. Question is...what doses will the patches be? thanks, Deanna
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Unread 02-02-2011, 01:20 PM   #19
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Hi Deanna,
20mcg is 20 micrograms which is .000020 grams. but that is per hour. So .000020 X 24 hours = .00048g or 0.48mgs. (about 1/2 of miligram/day) but that is at 100% absorption so its probably close to 0.75-2mgs/ a day of sublingual buprenorphine, depending on the individual's absorption efficiency.
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Unread 02-07-2011, 06:32 PM   #20
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Imagine how this could be used to combat 'Dr shopping'/pain med abuse. If you were to hit your local health clinic 'cause you've run out of your doc (say Hydros) with the excuse that you are in pain due to 'xy' injury and the Dr. writes an Rx for the patch... instant w.ds !! And the patient can't complain: "Excuse me, whats this ? I'm in PAIN'. Dr: 'Yes I realize you're in pain, thats why I wrote this Rx for a narcotic pain med.". Check mate !
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Unread 03-25-2011, 11:03 AM   #21
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Press Release about Butrans:
http://www.prnewswire.com/news-relea...118640179.html

The Efficacy and Safety of Butrans (buprenorphine) Transdermal System in Opioid-Naive Patients with Moderate to Severe Low Back Pain: A Double-Blind Study

NATIONAL HARBOR, Md., March 25, 2011 /PRNewswire-USNewswire/ -- Physicians from Purdue Pharma LP, Stamford, CT, showcased study results that demonstrate the analgesic efficacy and safety of Butrans for the relief of moderate to severe chronic low back pain in opioid-naive patients. Butrans is a transdermal delivery system that provides systemic delivery of buprenorphine, a Schedule III medication, continuously over a 7-day period.

"Butrans is a new treatment for chronic pain that was approved [by the Food and Drug Administration] on June 30, 2010, and is available in the market today," said Deborah Steiner, MD, MS, medical director at Purdue Pharma. "We were able to demonstrate that Butrans was superior to placebo in treating opioid-naive patients with moderate to severe chronic low back pain and that the safety profile of Butrans is consistent with that associated with opioid analgesics and transdermal patches."

The randomized, double-blind, 12-week study employed an enriched design. A total of 1,024 patients were treated with Butrans during the open-label run-in period and were randomized to Butrans 10 and Butrans 20, or matching placebos. Age, gender, and weight were equally distributed across the two treatment groups.

"In the open-label run-in period, if Butrans 10 was tolerated but adequate analgesia was not reached, the dose was increased to Butrans 20 for an additional 10 to 12 days," Dr. Steiner said. "Patients who achieved adequate analgesia and tolerated Butrans were then randomized to remain on the titrated dose of Butrans (10 or 20) or a matching placebo. To demonstrate adequate analgesia in the open-label run-in period, patients had to have pain scores of less than or equal to 4 on an 11-point scale for 3 consecutive days and at least a 2-point reduction from their screening pain scores."

The primary efficacy outcome, the "average pain over the last 24 hours" at Week 12, resulted in a statistically significant treatment difference of -0.58 in favor of Butrans over placebo (P=.0104). The proportions of patients with at least 30% and at least 50% pain score improvements were larger for Butrans-treated patients.

The treatment adverse events occurring in at least 5% of Butrans-treated patients included nausea, application-site rash, and headache. In the double-blind phase of the study, serious adverse events occurred in 1.2% of Butrans-treated patients and .7% of placebo-treated patients.

"Healthcare professionals require a range of therapeutic options to manage chronic pain conditions that affect many Americans," Dr Steiner said. "Appropriate adult patients suffering from moderate to severe chronic pain now have a new option when an around-the-clock opioid may be needed to manage their pain."

The full prescribing information for Butrans is available at http://www.purduepharma.com/PI/presc.../ButransPI.pdf. Additional information, including a medication guide, is available at www.Butrans.com. Working with the FDA, Purdue has also developed a Risk Evaluation and Mitigation Strategy (REMS) for Butrans. The Butrans REMS includes a medication guide; elements to assure safe use, such as healthcare providers training; and a timetable for submitting assessments of the REMS. This information is available at www.butransrems.com

For more information: www.painmed.org/press

For more than 27 years, the American Academy of Pain Medicine (AAPM) has been the medical specialty society representing more than 2,500 physicians practicing in the field of comprehensive pain medicine. The Academy is involved in education, training, advocacy and research in the specialty of pain medicine. Information is available on the practice of pain medicine at www.painmed.org.

SOURCE American Academy of Pain Medicine
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Unread 04-14-2011, 04:58 AM   #22
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Question I'm possibly switching to Butrans from Suboxone...questions?

Quote:
Originally Posted by TIM View Post
It comes out to less than 1mg/day. The studies that show buprenorphine is effective for pain are all done at very low doses. The injectable buprenorphine (approved for pain, not approved for addiction) come in 0.3mgs doses. This patch probably wouldn't be very effective to treat addiction even if it was approved for it, except maybe at the very end of a long slow taper.
Tim
Hi Tim, I haven't been to this forum for a while as I have been doing great on Suboxzone...slowly tapered from 12mgs to 2 mgs/day over the course of a year and a half. My Doctor originally prescribed Suboxone for me to treat opiate dependence and pain. I was becoming tolerant to Norco and needed more and more to help with the pain. Anyway, to make a long story short...my doctor just suggested I switch to Butrans for the pain (and because my insurance co is creating a major issue regarding how long one should be on Suboxone...and making it harder and harder for me to get the meds because they do not recognize it as a pain med...only for addiction support and withdrawal). After speaking with my Dr, Butrans sounded like the ideal solution...finally a pain med that does not make me feel high...yet helps with the pain...yay! Well, after doing some research (talked to some pharmacists and they were no help), searching the web, trying to figure out a accurate conversion (as Butrans is mcg and Suboxone is mg) etc...I remembered to come here for info. I searched Butrans and came across your thread. I was worried at first when I got my RX that I was going to be on too high of a dose of Bupe (I don't want to go higher than the 2mgs/day). After reading your conversion information, it looks like I will be on a very low dose of Bupe...not a concern if it helps with my pain...but now I am worried that I will go into withdrawl as I am lowering my daily intake significantly. My Dr prescribed the 5 mcg/hour dose and according to your post, you said a 20mcg/hour patch is like taking less that 1 mg/day. Now I am worried that the level of meds will not help my pain and that I am going to go through w/drawls switching from 2mgs/day to ??? Way less than that. Any helpful advise would be much appreciated. It kills me that Suboxone works so well at a low dose for me for the pain...and I have no desire to take any other pain meds, however, due to insurance BS, this is the option for me...AND my Dr said that if I have bouts of severe pain, he would prescribe Norco to take with Butrans????? I thought that was a no-no to mix narcotics with Bupe. I am trying to do as much research as I can before I actually make the step and do the patch...does it seem to you that I should start on the 20mcg/hour and slowly work my way down as that seems to be the closes dose to 2mgs/day sub film.

SOOOOO Confused. Thanks for your help. Frances
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Unread 04-14-2011, 10:02 AM   #23
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Quote:
Originally Posted by frances View Post
Hi Tim, I haven't been to this forum for a while as I have been doing great on Suboxzone...slowly tapered from 12mgs to 2 mgs/day over the course of a year and a half. My Doctor originally prescribed Suboxone for me to treat opiate dependence and pain. I was becoming tolerant to Norco and needed more and more to help with the pain. Anyway, to make a long story short...my doctor just suggested I switch to Butrans for the pain (and because my insurance co is creating a major issue regarding how long one should be on Suboxone...and making it harder and harder for me to get the meds because they do not recognize it as a pain med...only for addiction support and withdrawal). After speaking with my Dr, Butrans sounded like the ideal solution...finally a pain med that does not make me feel high...yet helps with the pain...yay! Well, after doing some research (talked to some pharmacists and they were no help), searching the web, trying to figure out a accurate conversion (as Butrans is mcg and Suboxone is mg) etc...I remembered to come here for info. I searched Butrans and came across your thread. I was worried at first when I got my RX that I was going to be on too high of a dose of Bupe (I don't want to go higher than the 2mgs/day). After reading your conversion information, it looks like I will be on a very low dose of Bupe...not a concern if it helps with my pain...but now I am worried that I will go into withdrawl as I am lowering my daily intake significantly. My Dr prescribed the 5 mcg/hour dose and according to your post, you said a 20mcg/hour patch is like taking less that 1 mg/day. Now I am worried that the level of meds will not help my pain and that I am going to go through w/drawls switching from 2mgs/day to ??? Way less than that. Any helpful advise would be much appreciated. It kills me that Suboxone works so well at a low dose for me for the pain...and I have no desire to take any other pain meds, however, due to insurance BS, this is the option for me...AND my Dr said that if I have bouts of severe pain, he would prescribe Norco to take with Butrans????? I thought that was a no-no to mix narcotics with Bupe. I am trying to do as much research as I can before I actually make the step and do the patch...does it seem to you that I should start on the 20mcg/hour and slowly work my way down as that seems to be the closes dose to 2mgs/day sub film.

SOOOOO Confused. Thanks for your help. Frances
Hi Frances,
Congratulations on your sustained addiction remission!!! I’m sorry to hear that the bureaucracies of the insurance companies are forcing you off a successful treatment.

Absorption efficiency through the skin varies from person to person so your doctor might be starting you low to see how that goes and be sure he isn’t giving you too much. With a steady delivery of bupe, you won’t need as high of a dose as equivalent to the tablet dose. With the tablet, blood levels rise when you take it and slowly decline throughout the day until your next dose. If the level drops below your threshold for withdrawal symptoms could occur, so the dose has to be high enough that even as it dissipates blood levels never drop below that threshold. With a constant delivery system like the patch, you need less of a total dose because you don’t have the peak in the beginning. In short, a patch that delivers a lower total daily dose (maybe as much as 50% less) would still provide blood levels that stay above the threshold of withdrawal- your current tolerance level. It will take a few days on the patch before you know and you should use the COWS to rate symptoms to avoid mistaking anxiety about the switch for symptoms. If its not enough I would imagine most doctors would prefer increasing the patch dose, either with a stronger patch or additional one, rather than introducing full agonist opioids. At that low of a dose of bupe the blocking isn’t total, so opioids would have some effect, but if the same can be achieved with an increase in the bupe I think that would be better because it eliminates the ritual of taking an opioid which could be a trigger for some.

I hope this info is helpful, good to hear from you again!
Tim
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Unread 04-14-2011, 10:20 AM   #24
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Thumbs up Thank you!!!!

Thanks Tim,
That does help a lot. I've talked to 2 pharmacists and my Docter and nobody explained it that simply to me so THANK YOU! I don't mind being on a lower dose...in fact, that's great if it handles my pain and does not put me into withdrawal. I certainly do not want to take opioids as that is what got me into trouble in the first place

When I first start, if I feel like I'm having w/drawls and I have a couple sub films left (2) would it be okay to take a small slice of the film to help with that...or would that just be confusing things? I'm a girl who hates & is afraid of wdrawls. Also, when going off the patch, do people usually have a harder time stopping it since there is no way to taper it?

Thanks for all your info and support. I knew I should have come here first with my questions . I'll definitely keep you updated on the progress, success with the patch or lack there of.

Frances
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Unread 04-14-2011, 11:42 AM   #25
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Hi Frances,
I don't think your doctor will object to you taking some of the film if you have withdrawal, but be very sure it is withdrawal because anxiety and stress can seem very much like withdrawal. Fearing withdrawal can sometimes cause some of the symptoms. If you use the COWS you can rate the symptoms to know for sure particularly pupil size. Also, even if you do have some withdrawal, if its tolerable try and stick with it for a few days and see if your body adjusts to the lower dose.

As far as going off the patch, I don't know anyone who did it or read any clinical data on it, but the patch doesn't go directly to zero at the end of the prescribed period, it might deliver a diminishing dose for a period of time which might work as a taper itself. If that isn't sufficient using the bupe film in very low doses can extend the taper. Please keep us informed if you go on the patch, I'm sure others would like to know how it works out for you.


Tim

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http://www.naabt.org/documents/NAABT_PrecipWD.pdf (page 2)
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Unread 04-14-2011, 03:37 PM   #26
frances
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Question Thank you & a couple more questions...

Thanks Tim...I went my pharmacist and told her what you told me...because she couldn't explain it to me yesterday clearly. She kept mentioning that all over the brochure and information that she has on the Medication it mention's "possibility of fatal overdose in the first two days of applying the patch"... I am assuming that would be for someone with no tolerance to opiods or Bupe...I'm I correct on that? She said she didn't feel comfortable giving advise on how to use the patch, any dosing questions or how to switch to Butrans from another medication. However, the way I understand it from you is that I will be on an overall lower dose...even though I am getting it hourly. Why is there so many scary warnings on Butrans when Suboxone is a much stronger form of Bupe and I don't recall being freaked out to try it. I take anxiety medication occasionally as needed and also take Ambien CR at night to sleep. The brochure says not to mix Butrans with those type of medications or possible overdose. my Doctor knows exactly what I am on and never mentioned a concern. Is the Drug Co. being overly causious as it is a new med or do I need to be concerned because it is released into my system hourly???

Thanks again for all your great information and support!

Frances
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Unread 04-14-2011, 04:07 PM   #27
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I think you hit the nail on the head with your suspicion that the drug company is over stating to cover their butt. A fatal overdose from buprenorphine alone is extremely unlikely, even among opioid naive people. Even when irresponsible parents let their kids get a hold of buprenorphine, they didn't die. The ceiling effect prevents fatal overdoses. However when mixed with other drugs it can have an adding effect on respiratory depression. Alcohol and Xanax can both add to the limited respiratory depression from the bupe. So a near fatal dose of alcohol, Xanax or another drug that causes respiratory depression, combined with buprenorphine could be enough to put someone over the edge, but normal doses of those medications combined with the small dose in the patch are not dangerous in an otherwise healthy person.
Tim

FYI- Here's the official prescribing info for Butrans
http://www.purduepharma.com/PI/presc.../ButransPI.pdf
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Unread 04-14-2011, 07:20 PM   #28
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Hi Frances, just wanted to stop by and say! Please do keep us posted with how the BuTrans works for you. Nice to see you!

Nancy
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Unread 04-15-2011, 12:16 AM   #29
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The warnings on the patch are stronger because it is harder to reverse if you do have an adverse reaction. like was said above, they have to cover their butts. Yes, the warnings are more for people who aren't tolerant. also like if you have kids or something and they get hold of a patch. It sounds wonderful to me, the idea of a patch for this, but thats just my humble opinion
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Unread 04-15-2011, 03:27 PM   #30
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hey how about mixing it with acetamenophen? It would be a new med right?

I have chronic pain and want the option of bupe without the hassle of getting it. My insurance will most likely pay but it is such a waste when the pill works fine

oh well cross that bridge if and when pain gets too bad

Glen
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Unread 08-11-2011, 09:11 PM   #31
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bump
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Unread 08-23-2011, 09:20 AM   #32
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Hey all I haven't posted alot but wanted to let everyone know my experience on the patch. My Dr. put me on the patch a few months back and I had the hope that they would work the same as the pill or films... Within about a week I started having w/d's, leg kicks, shaking, hot and cold sweats you name it I had it. I called my Dr and he told me to wear 2 if them at once and insisted there was no way I could be in w/d because I was still getting the medicine. I went the entire month in w/d... I don't know if he put me on the wrong dose or what but it was not fun! As soon as I walked into his office I told him I did not want to be on the patch it didn't help my pain and I was sick the whole time. Thank the lord he put me back on the films. Now he is trying to force the vivitrol injection on me.... I know I'm not ready for that yet. Anyways just wanted to share my experience with everyone here... I hope that others have a better experience with them then I did.
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Unread 08-23-2011, 01:23 PM   #33
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Started the patch last week Took two days but worked decent. On 5mcg I have no symptoms or effects save for one night I went to bed early due to being tired.

So wish this was around years ago when I first needed medication

Glen
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