Guest guest Posted April 26, 2005 Report Share Posted April 26, 2005 Lee I recently switched from generic to brand name URSO as the generic produced untolerable side effects. As it turns out for me I can tolerate neither.(My Hep hasn't heard this one yet!) My hep said the drug makers use different " binders " that deliver the med to the body in somewhat different ways. He has worked with a few PSC types that can tolerate one but not the other, usually more tolerant of the brand name URSO 250. I think I have , as I understand it, creating for him the first in a third category, someone who can take neither. Some of us get ALL the breaks! Anyone else out there have side effects so sever that you had to D/C an Actigal/URSO product, or am I alone on this one? All the Best jd, 44 UC 1973, Jpouch 2000, Chronic Pouchitis 2001, PSC 2004, Stage 3 ston City, IL krmpotich@... Re: Lee - URSO Forte > > I'm just wondering why people are making such a distinction between > them if they are from the same pharmaceutical and basically the same > thing. Thanks for sending this. > I will ask the reps there about any advantage for one over the other. > Lee > > > > > > > > Dear Lee; > > > > URSO from Axcan Pharma normally comes in a 250 mg tablet (URSO 250). > > URSO Forte is a 500 mg tablet of ursodiol made by our Axcan Pharma. > > This is from their website: > > > > ______________________ > > > > http://www.axcan.com/ > > > > Attention Business/Financial Editors: > > > > Axcan Launches URSO Forte in the U.S. > > TSX SYMBOL (Toronto Stock Exchange): AXP > > Nasdaq SYMBOL (Nasdaq National Market): AXCA > > > > MONT SAINT-HILAIRE, Quebec, Nov. 2 /CNW Telbec/ - Axcan Pharma > > Inc. ( " Axcan " or the " Company " ) announced today the launch of new > > URSO Forte. This unique, 500 mg ursodiol tablet was recently > > approved by the U.S. Food and Drug Administration ( " FDA " ) for the > > treatment of Primary Biliary Cirrhosis(PBC). > > " URSO Forte will help improve compliance, simplify dosing > > for many patients and may lower cost for this drug, which is the > > only approved product for patients with Primary Biliary Cirrhosis > > ( " PBC " ), " said Lindor, MD, Vice Chair, Medical Affairs for the > > American Liver Foundation ( " ALF " ), and Professor of Medicine at the > > Mayo Clinic. " URSO also improves survival while reducing the need > > for liver transplantation in these patients. " > > URSO Forte, and its lower dose equivalent, URSO 250®, are > > the only FDA-approved ursodiol products for the treatment of PBC. > > Also, they are the only ursodiol products proven to delay the > > progression of PBC, normalize liver function tests, and > > significantly improve transplant-free survival to the point that non- > > cirrhotic PBC patients will have a survival rate similar to > > that of the general population. > > In North America the ursodiol market exceeds U.S.$100 million > > annually. During the twelve-month period ended August 31, 2004, > > 38.2% of all gastrointestinal prescriptions for ursodiol in the > > United States were for URSO 250, making URSO 250 the most > > prescribed " branded " ursodiol in the U.S. > > URSO Forte will be distributed to major independent and > > retail pharmacies. > > ______________________ > > > > I don't want to come across as promoting any one formulation, but > > while we are talking about different formulations, I thought I would > > also post this article about a new liquid formulation specifically > > for young children: > > > > Aliment Pharmacol Ther. 2005 Mar 15;21(6):709-21. > > > > Bioequivalence of a new liquid formulation of ursodeoxycholic acid > > (Ursofalk suspension) and Ursofalk capsules measured by plasma > > pharmacokinetics and biliary enrichment. > > > > Setchell KD, Galzigna L, O'Connell N, Brunetti G, Tauschel HD. > > > > Department of Pathology, Cincinnati Children's Hospital Medical > > Center, Cincinnati, OH 45229, USA. kenneth.setchell@... > > > > BACKGROUND: Ursodeoxycholic acid is an approved therapy for > > hepatobiliary disorders but in infants and children compliance is > > compromised because it is formulated exclusively as capsules, or > > tablets. AIM: To determine the pharmacokinetics and bioequivalence > > of a new liquid formulation of ursodeoxycholic acid (Ursofalk > > suspension) with a standard capsule (Ursofalk) in a randomized, > > unblinded, crossover designed study of 24 healthy adults. METHODS: > > Equivalence was based on single bolus oral plasma pharmacokinetics > > and biliary ursodeoxycholic acid enrichments after repeat doses. > > Biliary bile acid composition and hydrophobicity index were also > > compared. Ursodeoxycholic acid was measured in duodenal bile by high- > > performance liquid chromatography and in plasma by mass > > spectrometry. RESULTS: The mean percentage biliary ursodeoxycholic > > acid enrichment after administration of the suspension was not > > significantly different from that obtained with capsules (44.2 +/- > > 11.7% vs. 46.9 +/- 10.2%, respectively). The equivalence ratio was > > 0.94 (95% CI: 0.8-1.1), establishing bioequivalence between > > suspension and capsules. Both formulations reduced the biliary > > hydrophobicity index and no differences in bile acid composition > > were observed between formulations. The plasma pharmacokinetics of > > both formulations was similar and the tolerability of the suspension > > was excellent. CONCLUSIONS: A new liquid formulation of > > ursodeoxycholic acid suitable for paediatric patients is > > pharmacologically bioequivalent to capsules when given as single, or > > repeated oral doses. > > > > PMID: 15771757 > > > > Best regards, > > > > Dave > > (father of (19); PSC 07/03; UC 08/03) > > > > > > > >> I kept meaning to ask and then forgetting. What is the difference > >> between Urso and Urso forte? > >> Lee > > > > > > > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 Interesting JD. When you say you couldn't tolerate it, why? Hives, itching, diarrhea, stomach pains? It might be interesting to talk to their representative about this. You are coming to the conference aren't you? I'd love to meet you. Lee > > Lee > > I recently switched from generic to brand name URSO as the generic > produced > untolerable side effects. As it turns out for me I can tolerate > neither.(My > Hep hasn't heard this one yet!) My hep said the drug makers use > different > " binders " that deliver the med to the body in somewhat different ways. > He > has worked with a few PSC types that can tolerate one but not the > other, > usually more tolerant of the brand name URSO 250. I think I have , as I > understand it, creating for him the first in a third category, someone > who > can take neither. Some of us get ALL the breaks! Anyone else out there > have > side effects so sever that you had to D/C an Actigal/URSO product, or > am I > alone on this one? > > All the Best > > jd, 44 > UC 1973, Jpouch 2000, Chronic Pouchitis 2001, PSC 2004, Stage 3 > ston City, IL > krmpotich@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 Lee For me it was severe urgency with no stool to follow. Some diarrhea, but primarily the urgency and burning. Felt like someone torched the internal pouch. Couldn't sleep......... every 30-60 minute bathroom runs, etc. First trial left me this way for 6 days and nights, second trial 2 days. This most recent trial (this week) crashed after only 48 hours of brand name administration at 2750 mg/day, and I am currently smarting as a result. Unsure what next steps might be, and am rescheduling an earlier hep revisit as a result. I am at least in the back of my mind considering surgical removal of the pouch hoping to gain tolerance to several drugs (that trigger the trots and or urgency) I need to take, but can't and possibly getting rid of some of the fatigue secondary(?) to an mild but a chronically inflamed pouch. I would also discontinue daily CIPRO, and a couple other drugs related to pouch dysfunction as a result. Of course at this point I have discussed none of this with anyone other than my wife, so I am unsure if it is reasonable plan given the situation. I dislike the idea although it is mine(!), but have learned first hand what a lousy quality of life inflammation can bring through a diseased colon of the past. I have more less been told that it would be odd for a stage 3 guy to have so much fatigue related to the liver at this point. Of course, this was told to me by the same hep that said a liver biopsy was a Tylenol type encounter! What does everyone think???? Looking for points of view and experience here! In terms of the conference, I too will be one of those forced to watch by the sidelines. I know the experience would be therapeutic, cathartic, and a lot of fun, perhaps next year. Such a trip is inconsistent for a guy hanging on to a job by a thread and racked with fatigue and a lack of stamina just doing the mundane daily activities.Quality of life is consistently poor, and seems work takes all I have and that is crappy at best. I suspect failing some significant intervention, that I will be forced into disability in the coming months. All the Best jd, 44 UC 1973, Jpouch 2000, Chronic Pouchitis 2001, PSC 2004, Stage 3 ston City, IL krmpotich@... Re: Lee - URSO Forte > > Interesting JD. When you say you couldn't tolerate it, why? > Hives, itching, diarrhea, stomach pains? It might be interesting to > talk to their representative about this. You are coming to the > conference aren't you? > I'd love to meet you. > Lee > > > > > > Lee > > > > I recently switched from generic to brand name URSO as the generic > > produced > > untolerable side effects. As it turns out for me I can tolerate > > neither.(My > > Hep hasn't heard this one yet!) My hep said the drug makers use > > different > > " binders " that deliver the med to the body in somewhat different ways. > > He > > has worked with a few PSC types that can tolerate one but not the > > other, > > usually more tolerant of the brand name URSO 250. I think I have , as I > > understand it, creating for him the first in a third category, someone > > who > > can take neither. Some of us get ALL the breaks! Anyone else out there > > have > > side effects so sever that you had to D/C an Actigal/URSO product, or > > am I > > alone on this one? > > > > All the Best > > > > jd, 44 > > UC 1973, Jpouch 2000, Chronic Pouchitis 2001, PSC 2004, Stage 3 > > ston City, IL > > krmpotich@... > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 Jd, Somewhere in my readings that suggested we start lower and then increase or perhaps it was my son's Dr. but we did not start on a high dose of Urso. We started with 500 [2-250's] for a couple of days then 1000mg and then 1250 which for his weight at that time was approximately 20mg/kg/day. Did you try this approach? Lee On Apr 27, 2005, at 10:06 AM, JD & MARLENE KRMPOTICH wrote: > > Lee > > For me it was severe urgency with no stool to follow. Some > diarrhea, but primarily the urgency and burning. Felt like someone > torched > the internal pouch. Couldn't sleep......... every 30-60 minute bathroom > runs, etc. First trial left me this way for 6 days and nights, second > trial > 2 days. This most recent trial (this week) crashed after only 48 > hours of > brand name administration at 2750 mg/day, and I am currently smarting > as a > result. Unsure what next steps might be, and am rescheduling an > earlier hep > revisit as a result. I am at least in the back of my mind considering > surgical removal of the pouch hoping to gain tolerance to several drugs > (that trigger the trots and or urgency) I need to take, but can't and > possibly getting rid of some of the fatigue secondary(?) to an mild > but a > chronically inflamed pouch. I would also discontinue daily CIPRO, and a > couple other drugs related to pouch dysfunction as a result. Of course > at > this point I have discussed none of this with anyone other than my > wife, so > I am unsure if it is reasonable plan given the situation. I dislike > the idea > although it is mine(!), but have learned first hand what a lousy > quality of > life inflammation can bring through a diseased colon of the past. > > I have more less been told that it would be odd for a stage 3 guy to > have so > much fatigue related to the liver at this point. Of course, this was > told to > me by the same hep that said a liver biopsy was a Tylenol type > encounter! > What does everyone think???? Looking for points of view and experience > here! > > In terms of the conference, I too will be one of those > forced to > watch by the sidelines. I know the experience would be therapeutic, > cathartic, and a lot of fun, perhaps next year. Such a trip is > inconsistent > for a guy hanging on to a job by a thread and racked with fatigue and > a lack > of stamina just doing the mundane daily activities.Quality of life is > consistently poor, and seems work takes all I have and that is crappy > at > best. I suspect failing some significant intervention, that I will be > forced into disability in the coming months. > > All the Best > > jd, 44 > UC 1973, Jpouch 2000, Chronic Pouchitis 2001, PSC 2004, Stage 3 > ston City, IL > krmpotich@... > > Re: Lee - URSO Forte > > >> >> Interesting JD. When you say you couldn't tolerate it, why? >> Hives, itching, diarrhea, stomach pains? It might be interesting to >> talk to their representative about this. You are coming to the >> conference aren't you? >> I'd love to meet you. >> Lee >> >> >>> >>> Lee >>> >>> I recently switched from generic to brand name URSO as the generic >>> produced >>> untolerable side effects. As it turns out for me I can tolerate >>> neither.(My >>> Hep hasn't heard this one yet!) My hep said the drug makers use >>> different >>> " binders " that deliver the med to the body in somewhat different >>> ways. >>> He >>> has worked with a few PSC types that can tolerate one but not the >>> other, >>> usually more tolerant of the brand name URSO 250. I think I have , >>> as I >>> understand it, creating for him the first in a third category, >>> someone >>> who >>> can take neither. Some of us get ALL the breaks! Anyone else out >>> there >>> have >>> side effects so sever that you had to D/C an Actigal/URSO product, or >>> am I >>> alone on this one? >>> >>> All the Best >>> >>> jd, 44 >>> UC 1973, Jpouch 2000, Chronic Pouchitis 2001, PSC 2004, Stage 3 >>> ston City, IL >>> krmpotich@... >> >> >> >> >> >> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 That dosage is indeed about 20 mg/kg, so you are in the ballpark (a little short of 25-30). Arne 53 - UC 9/77 - PSC 4/00 Alive and (mostly) well in Minnesota -----Original Message----- From: [mailto: ] On Behalf Of Lee Bria Interesting, this is just the sort of answer that I was looking for from one of the reps. I was considering going with the larger dose so that he could take less pills per day. Thanks Arne. is only at 20mg per kg I think. He takes 1,250mg/day and is 137lbs. I will have to find that darn conversion table again. I will check this with his physician next time we see her. He has put on some weight so we might have to change it anyway. Lee Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 Lee Yes I did. This was the first of the three runs at URSO. I think the vernacular for this is " start low, go slow " . I made it on the generic stuff to 8 of the 9 tablets after maybe three weeks of slowing adding another tab every few days. Symptoms became undenialable at this point, and truthfully began perhaps a week earlier, just less pronounced.. Unfortunately by three weeks I also had a system nearly fully saturated with URSO and spent the next 6 days and nights strongly regretting it. As I said earlier, I have now had a repeat failure with the generic and one with the brand name. Wonder if anyone else out there experienced this??? I am currently thinking this is because I have chronic pouchitis for the past 3 years and am CIPRO dependent. The inflammation is low, but never gone, and thus the limiting factor for me with many things (food, drugs, etc.) is the irritable pouch. The hep tells me he sees other J pouch PSC patients, but no one with such a cranky pouch, so the theory seems to fit. Thanks for the idea, that is the kind of thing I am looking for. Please do remember the majority of those who do the J procedure do NOT develop pouchitis, and those that do, only a SMALL subset become chronic pouchitis cases. This group of the lucky few also tend to make up a significant majority of those (with bumby pouches) who go on to decide to surgically remove the pouch in favor of a standard ostomy. All the Best jd, 44 UC 1973, Jpouch 2000, Chronic Pouchitis 2001, PSC 2004, Stage 3 ston City, IL krmpotich@... Re: Lee - URSO Forte > > Jd, > Somewhere in my readings that suggested we start lower and then > increase or perhaps it was my son's Dr. but we did not start on a high > dose of Urso. We started with 500 [2-250's] for a couple of days then > 1000mg and then 1250 which for his weight at that time was > approximately 20mg/kg/day. Did you try this approach? > Lee > On Apr 27, 2005, at 10:06 AM, JD & MARLENE KRMPOTICH wrote: > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 This group of the lucky few also tend to make up asignificant majority of those (with bumby pouches) who go on to decide to surgically remove the pouch in favor of a standard ostomy.>>> JD, What about having the BCIR done which is also an internal pouch but doesn't involve the rectum? If you want more info just let me know. You live near St. Louis and that is one of only 3 or 4 places in the country that does the surgery. I've had mine for 11 years and except for a few minor glitches it has been great. Blessings, Barby-KS Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 Barby Yes, tell me more. That may be an option, and I could see where it may be enough to make a difference. The 3-4 CM of bowel that was left behind is of course always angry according to my routine scope results. The surgeon who built the pouch for me in St. Louis felt it was proper at the time to add sufficient control to leave a "thumbs width" or a "stump" of the colon behind to hook up the pouch without stripping the mucosal layer. I was asking for mucosal stripping of this segment, which as I understand it removes all the rest of the cells (in the stump) that could become harbingers for colon cancer. His experience was that folks who stripped this segment paid for it through less control, so I favored his sage advice. I think this inflammation also incites adjacent small bowel mucosa to join in and then......boom, your off and running. I had about 6 months of ok function in the beginning, 6 months of good function, and now for several years fight with a UC like acute gone chronic flaring pouch all the time. All the Bestjd, 44UC 1973, Jpouch 2000, Chronic Pouchitis 2001, PSC 2004, Stage 3ston City, ILkrmpotich@... Re: Lee - URSO Forte This group of the lucky few also tend to make up asignificant majority of those (with bumby pouches) who go on to decide to surgically remove the pouch in favor of a standard ostomy.>>> JD, What about having the BCIR done which is also an internal pouch but doesn't involve the rectum? If you want more info just let me know. You live near St. Louis and that is one of only 3 or 4 places in the country that does the surgery. I've had mine for 11 years and except for a few minor glitches it has been great. Blessings, Barby-KS Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 Thanks Arne , Next time I see that conversion chart I need to put a copy of it in my desk drawer. Thanks Lee > > That dosage is indeed about 20 mg/kg, so you are in the ballpark (a > little > short of 25-30). > > > Arne > 53 - UC 9/77 - PSC 4/00 > Alive and (mostly) well in Minnesota > > > > -----Original Message----- > From: [mailto: ] > On > Behalf Of Lee Bria > > Interesting, this is just the sort of answer that I was looking for > from one > of the reps. I was considering going with the larger dose so that he > could > take less pills per day. > Thanks Arne. > is only at 20mg per kg I think. He takes 1,250mg/day and is > 137lbs. I > will have to find that darn conversion table again. > I will check this with his physician next time we see her. He has put > on > some weight so we might have to change it anyway. > Lee > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 27, 2005 Report Share Posted April 27, 2005 Sorry I couldn't help you JD. I hope someone here has some advice for you. Lee > > Lee > > Yes I did. This was the first of the three runs at URSO. I > think > the vernacular for this is " start low, go slow " . I made it on the > generic > stuff to 8 of the 9 tablets after maybe three weeks of slowing adding > another tab every few days. Symptoms became undenialable at this > point, and > truthfully began perhaps a week earlier, just less pronounced.. > Unfortunately by three weeks I also had a system nearly fully > saturated with > URSO and spent the next 6 days and nights strongly regretting it. As I > said > earlier, I have now had a repeat failure with the generic and one with > the > brand name. Wonder if anyone else out there experienced this??? Quote Link to comment Share on other sites More sharing options...
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