Update on Giazo

According to The Fly on the Wall, the FDA granted approval for Salix to market Giazo, a tablet form of Balsalazide, early in February. The tablets will be yellow, imprinted with "BZT" on them, & contain 1.1 grams each of mesalamine. The brief post does not say WHEN this stuff will actually be available for dispensing, however. (An additional article on this site says that 250 mg Xifaxan will go generic soon, but not the 500 mg/dose.) / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazxal)

I believe it is 1.1 grams of balasalzide compressed and coated as a tablet instead of 750 mg in a gelatin capsule. Just another asacol hd to create a fresh brandname patent period. If at all possible refuse to use it. I will never use any of these rip off drugs and if a doctor insists I do, I will get another doctor.

Can't find dosage information but no doubt they tested at higher dosages to differentiate it for the timid MD that doesn't want to off label more than 9 pills of colazal because he is worried about getting sued.

Yup, Salix is trying to make some big bucks repackaging balsalazide into brandname tablets. I think Doors12 & GidHike made some interesting comments on the company's finances in the "Colazal discontinued?" thread. As to what/if anything they will do about brandname Colazal, stand by-- but as Gastro60 posted in the other thread, don't hold your breath!!!!! Niro, why are you taking both Apriso & Colazal if you have mild inflammation? 10 capsules daily + the rectal med sounds like super-high dosing. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)

Hi Old Hat,

I notice that if I take high doses (only of the oral) 5-ASA's, I get diarrhea. Even though I am taking 10 pills, it only amounts to ~3 g of mesalamine and this is sort of my threshold of not having diarrhea (still not perfect). The question is, is it reducing my inflammation by getting to the left side of my colon? If I take 9 pills of colazal, 8 pills of Apriso, or even 3 pills of Lialda, I get diarrhea. The only amount of inflammation left is approx 10 cm in my descending colon (high enough where the enemas won't reach). I don't seem to have a problem with taking Canasa or Rowasa, as I am guessing my stools are already formed by the time they reach where these drugs coat my colon.

At this point, I am scheduled to have a doctor's appointment in 3 weeks where I will probably do a calprotectin stool test to determine if I have inflammation and then, unfortunately, go on 6-MP if I do.

Hi AZYooper,

My issue is this:

Based on my Oct. 2011 scope, I have 0 rectal or sigmoid inflammation thanks to Canasa + Rowasa. I have 0 right sided or transverse colon disease (not even via biopsies anymore - don't ask me how!). The only bit of inflammation I have left is 10 cm in my descending (left side) colon, a little higher than where the Rowasa will reach. The only way to get medicine to that area is via the oral route. This is when the doctor and I decided to start 9 pills of Colazal a day.

Unfortunately, I can't tolerate the higher doses of oral mesalamines without them causing diarrhea like stools and crazy amounts of gas (including the 9 pills of Colozal). I then switched to a "mix" approach and the doctor OKed it. I am still dealing with the gas right now, but with this combination of medicines, it appears that I am "better" in regards to the loose stool. The flip side though is, I don't think that enough of the medicine is getting to where it needs to. Obviously, when the medicine does get there, it works perfectly (see my rectum, sigmoid, right side of colon). This is my dilemma. I am switching to the Mylan today, because of the Colazal brand name issues. So let's see if that helps or hurts me any.

As far as the rectals, I take the Rowasa only 2x a week to maintain. The Canasa I take every day, but it doesn't cause me any issues or problems to take it (besides gas). So I just do it as a matter of habit at this point (I could probably taper down the usage to 2-3x a week).

The calprotectin test - it's been around for roughly 3-5 years, but they are still "proving" it works in trials. My insurance won't approve it yet for it's use w/ UC (considered experimental). However, doctors have ways to get around this! :) It definitely looks like it is the future though for tracking disease activity. If interested, here are some recent studies in regards to the test:

http://onlinelibrary.wiley.com/doi/10.1002/ibd.22917/abstract
http://www.ncbi.nlm.nih.gov/pubmed/19462421

Please let me know if you have any suggestions or tips as I would like to avoid Imuran/6-MP at this point, but I think I have exhausted all possibilities with the 5-ASA drugs the past 3 years and it's just time for me to get on with my life and stop worrying about the UC.

Red_34 said...
I'm sorry if I missed it in the other thread but does this mean that they are going to phase out the generic basalazide as well?

Not that I know of Sherry - it's just the brand name that was being made by Salix that was/is in question. The other 2 generics have different manufacturers (Mylan and Roxanne) and there has been no rumblings of them being discontinued.

Niro,

I googled the Calprotection test and it was approved way back in 2006 for UC and Crohns. I had never heard of it. Maybe more doctors have to request it or something for insurance to start paying. Maybe it's e4xpensive?

I get gas from colazal but not unpleasant or painful(just farts). I did get pretty bad acid reflux which I hadn't had in over 15 years. I stopped it by taking my colazal only in the middle of breakfast and dinner. I also eat 24 hr cultured yogurt every day that I make with VSL#3. There is a study in Europe on using coalzal and probiotics on diverticulopus that showed better results than colazal alone. Maybe this might get rid of the last bad area.

I have never used either brandname or the Watson(which is just the brandname in a different bottle). I use Mylan( about 18 months now) and used the other generic before that with zero problems.

I didn't know if you knew that colazal can be dumped onto apple sauce and the capsule tossed. Might be something in to try in case the gas is from the capsule but it sounds like you are just intolerant to higher doses.

I stopped bleeding and had almost no symptoms after 6 weeks of using 5ASAs BUT I still had looser stools and very mild urgency until I was on Colazal for 18 months. I started eating healthier but it took time. I can see why you want it over with.

The fecal calprotectin test is literal b.s.! A gastro at U. of Pennsylvania Medical School has been pushing it in the past couple of yrs. Thing is the 5-ASAs reduce inflammation, apparently by binding to NF Kappa B in the colon. However, as Niro points out, the meds themselves can induce or prolong diarrhea. One reason is that they are each a mixture of components, some intended to get them to the colon w/o metabolizing higher up in the G/I tract. Then there are the chemical dyes added for some nebulous reason, probably ease of marketing. Others are added to the mix to speed passage of the capsules thru factory machinery! (i.e., so that they don't clump together & clog it.) Therefore, what we take to reduce inflammation is still imperfect & can cause us side effects. Gastros can only add more meds to our regimen; that's what they've been trained to do. The FDA doesn't get adequate funding and/or a strong enough mandate to monitor drug production & there is no law governing cessation of production-- so we are victimized by Salix now over brandname Colazal-- because it doesn't turn a high enough profit to keep their corporate investors happy. This explains why many members here try to help themselves with dietary changes. There are foods, such as rice, that can mitigate med-induced D to a large extent. Then the Q becomes how much med the UCer needs to control/prevent bleeding in the gut. I also have a tricky descending colon, & brandname Colazal has been the only 5-ASA that deals with it-- so leave it to the money-grubbing devil investors to discontinue it ... totally unfair to patients & few with power care. That's what it comes down to-- for us. @#$%&*!!!!!!!! / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)

P.S. to AZYooper: dumping the med out of the capsule & into applesauce is only intended as a last resort for patients with swallowing difficulties. It is not a very effective way to medicate the colon. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)

OldHat - hmmm....why is the calprotectin test literal bs? I don't think it's perfect, but I am reading more and more clinical trial data out there that proves it does help. It's not the end all, be all....but it's definitely something to have in the arsenal.

AZYooper - it is FDA approved, but most insurance companies still deem it "investigative" for a UC diagnosis/management of healing prediction. I guess this is why there are still on going trials on it. It costs roughly $275-300 for the test. My doctor said he would use another code (not a UC diagnostic code) for the test if he were to ask for it, so I would pay my normal 10% co-insurance ($30).

I asked a friend who works for the US Patent Office about Giazo and this is what he said:

"Salix is a slightly more benign company than some, Giazo is an old drug and of course has to have a bad food coloring in it. Salix takes old drugs and repackages them, no real research."

Wonder how they get away with no research? Isn't that required by the FDA?

P.S. to all concerned: for UPDATED forecast on Giazo + brandname Colazal dispensing, see Gastro60's new weekend post on page 5 of the "Colazal discontinued?" thread. / Old Hat (31 yrs with left-sided UC; presently in remission taking brandname Colazal)