NEW Colonoscopy prep approved by the FDA

The US Food and Drug Administration (FDA) has approved a new colon-cleansing drug, a dual-acting stimulant and osmotic laxative, for colonoscopy preparation. A previously available, low-volume oral phospho-soda preparation was removed from the market for safety reasons.

The advantage of a small-volume solution for bowel preparation is greater patient compliance, as use of large-volume cleansing preparations may be a deterrent to some patients for having the procedure. Increased use of screening colonoscopy and cleaner bowel allowing high-quality colonoscopy may improve screening rates and cancer detection.

Study Synopsis and Perspective

The FDA has approved Prepopik, a new bowel preparation for cleansing the colon before colonoscopy.

When it becomes available, the dual-acting stimulant and osmotic laxative will be notable for its low volume, representing "the lowest volume active ingredient colon preparation available — with 10 ounces of prep solution," according to a news release.

The preparation consists of 2 packets of sodium picosulfate, magnesium oxide, and citric acid. In a split-dose regimen, patients dissolve the first packet of powder into water and drink the orange-flavored solution the night before a scheduled colonoscopy, and then do the same for the second packet the morning of the procedure.

If that split-dose regimen cannot be performed, patients may also take the drug as a day-before regimen in the afternoon and evening before a colonoscopy.

Patients are also advised to drink additional fluids during and after use of the preparation to reduce the risk for fluid and electrolyte imbalance.

That is fantastic! I am not due for another colonoscopy for another 2-8 years, so hopefully this will be standard proceedure. On my first and last I had to drink the gallon of go-litely or whatever. It made me sicker than a dog, and I broke out into this red rash and had petechiae on my cheeks from getting sick. And that was after maybe 3 8-10 ounce glasses filled with ice. Not at all cool.

Mashie

Great information. Available by prescription in October 2012. Appears slightly superior in colon cleansing to the traditional PEG solution. Prepopik has a bit more transient effect on electrolytes but is well tolerated. Anything that encourages screening colonoscopy (that is safe) is a bonus in my book.

I envy all of you who will be able to use the new product, it sounds like a Godsend. Unfortunately for patients with compromised renal function, the sodium and magnesium based compounds in Prepopik would be a disaster. For me at least, it'll be jugs of PEG prep and Dulcolax. As long as it gets the job done.

While newly approved in the USA, this product has in fact been available and in use outside the USA for long time. In Canada it is known as Pico-Salax®, in other places, Pico-prep, Picolax and Citra-Fleet. It is essentially a bottle of magnesium Citrate and Dulcolax® tablets in singe package.The dry magnesium oxide and citric acid form magnesium citrate in solution.

Dulcolax (bisacodyl) and Sodium Picosulfate are the same core molecule. Bisacodyl has acetate side chains that come off very easily (which is whil it needs to be enteric coated for oral use), and Sodium Picosulfate has sodium sulfate side chains, which are more stable. They are 'snipped' off by the bacteria in the Colon. Once the side chains are gone, bisacodyl and sodium picosulfate are identical.

Pricing will be interesting to watch. Pico-Salax is about $20 in Canada, Picoprep in Australia is about $8, Citra-Fleet in the UK is about $6. My guess is the price in the USA will probably be about $60 however. The cost to manufacture is literally pennies.

While the volume of Prepoptik® is small, the total fluid consumption required is not a whole lot less than other colonoscopy preps. It takes a lot of water to flush everything out. There are reports of serious electrolyte issues in the literature resulting from inadequare fluid intake, especially among the elderly.

This is the first sodium picosulfate product approved in the USA. There has been a Sodium Picosulfate 'docket' at the FDA for about a decade . For anyone who wants to try this, sodium picosulfate can often be found on eBay (Dulcolax liquid or Dulcolax Perles) in liquid form. Add 10mg worth of Sodium Picosulfate to a bottle of citrate of magnesia and you have effectively a sachet of Prepoptik® less the orange flavoring.

No doubt, any prep is going to have some downside, but this certainly sounds promising. I'm not due for a colonoscopy until 2016, and then perhaps it will be commonplace!

I know when I had my first exam, the volume of the Go-Litely made me sick as a dog to the point that I was so dehydrated that getting the IV started on the day of the exam was a real problem. Let's hear it for something new!

Jeeze! Sounds like I'm in chemistry again. I'm glad someone knows what's going on. Mattheww,

the $60 price tag sounds about right since the US bares the brunt of drug costs for everyone else but you would thing that since this is such a simple drug combo for a common use,they would cut us a break.

Yes - this is available in Canada - Pico-Salax and the identical, but cheaper Purg-Odan.

I had it as prep for my colonoscopy very recently - my wife couldn't believe how well I tolerated the "purge". She had her colonscopy 2 years ago with the old terrible stuff.

Purg-Odan goes down very easily. The key is lots of follow up fluids including electrolytes - e.g. Gatoraide.

My surgeon said I was nice and clean. What I thought would be a horrible experience wasn't bad at all!

Is having a few colonics not thorough enough to compensate for the drugs to accompolish a sufficient clean out before a colonoscopy? I'm thinking the colonics wouldn't suffice or especially our types would be ready and willing to get a clean out that way. Any MD experienced could know the answer to this. I'd like to be wrong, that is, it would be GREAT if even a few days of colonics could accompoish what the terrible drugs do in the way of a clean out before the test.

Mattheww50: Thanks so much for all your scientific information on this and other kinds of preps. My next "scope" is due in Nov., so perhaps it will be available in the U.S. by then.

My big complaint has been that even following the prep. instructions to a "T", I still am not that clean. I resolved to do a final two quart tap water flush the morning of the procedure.

Darlene, colonics can do the job well, but they would have to be done right before the procedure AND an oral laxative would be essential to get the small bowel to empty. This is what was done when colonoscopies were first done in the U.S., using oral products and enemas 'til clear in hospital. The insurance companies had convulsions over the hospital time.

I am due for a colonoscopy in a few weeks, and the Dr. wants me to use this horrible stuff which rips out one's insides. I bought a long, thick colon tube made of flexable, yet firm silicone which prevents turning back on itself in the colon. I have tried it and know it gets 30" into my colon, which means it should get cleansing solution all the way tothe caecum. The Dr. says enemas only clean out the last 10" of the colon. This setup should do a lot better. I am anxious to prove the Dr. wrong!

klyster3

^^^^ Let's hope you're right, because otherwise, they'll just reschedule you for another time and you'll have to do the prep anyway. Is the prep really THAT bad? I had a colonoscopy a little over a year ago and I was dreading the prep. It really wan't that bad, and I have very sensitive system. I figure if someone like me can get through it...

My doctor forbids enemas as a prep. Like klyster3, she says it only cleans out the lower colon. I would disagree, but she's so adamant that I just prefer to take the prescribed prep, rather than argue with her.

I have to go through the procedure every 5 years. My father died from colon cancer, and that is a horrible way to die. By the time he went to the doctor, it had spread through him. He just wasted away for 2 years.

Yes ladydocisin -- the prep is horrible. Each time I returned to the pot the last time, I sat trembling from exhaustion, in credible pain while my insides repeatedly dropped out,, sweats, and nausia. Is that bad enough??

klyster3

I really don't understand the fear and loathing for the clean out. I used the gallon of go lytely and a bottle of Citrate of Magnesia with one Dulcolax tablet and had no cramps and the job was finished in seven hours.

I have had two colonoscopies. For the first I was prescribed NuLYTELY and for the second, HalfLytely. I was able to tolerate both to the end. Both times the Gastroenterologist reported my prep was excellent. I did find the HalfLytely was easier, just because the volume was less.

The Doctor did ask how I liked it in comparison. They said they had recently switched and were finding it was providing much better results. I suspect more patients had problems dealing with the larger volume and were more prone to not finish the NuLYTELY.

Some people are just less tolerant to large volumes of laxative.

Well, I was just down right illergic to the stuff I believe. I can understand the vomiting, but the rash. Mmmm, not so much.

Mashie

I also hate the chemical prep but is is necessary. Enemas or colonics alone just wont do the trick. I do start out with two salt water and baking soda enemas and then do the chemical pre, mixed with apple juice. I cant drink apple juice for two months afterwards.

Great news! For my first colonoscopy, I had to drink two gallons and the second one I had to drink two liters. Anything less would be great.

Just had my first colonoscopy a few weeks ago. prep consisted of 2 ducolax tablets taken and 3 hours later 2 more. Then a half gallon over a 2 hour period of Mirilax and then 8 hours of off-and-on the toilet, it was actually very tolerable...and effective! When I went for my test the next morning I was as clean as a whistle, and no side effects other that I was getting pretty hungry.

Having a barium enema tomorrow morning, (tueday) had 2 doses of picolax, first one emptied me , much like getting rid of an enema, 2nd one didnt seem to do much, not sure if im clean enough or not, will see tomorrow,

I don't understand all the continual changes in clean-out protocol for a colonoscopy. The first couple I had, they allowed you to choose between the "drink a gallon" method or a 2-day fast and drink about 16-oz. I chose the latter and everything was good. The last one I had, there were no options. You had to follow one specific protocol. Next one, I am doing it my way: fasting and a colon hydrotherapy session. Worst case senerio is that I have to reschedule if they don't like what they see.

BTW, the thing I am not sure I will do is try to talk them into letting me get the colonoscopy w/o anesthesia. I had a sigmoidoscopy (sp?) many years ago w/o anesthesia and the only pain was in my groin. As the Dr forced the scope deeper, it felt like my balls were going to explode. I guess it was from pressure on the prostate??? Whatever, I understand some people get colonoscopies w/o anesthesia and do fine.

Every once in a while, I think I should go ahead and get a colonoscopy, but then I read someting like what dunstall said above (felt like my balls were going to explode), and decide that I simply don't trust doctors to be ultra-careful when doing this procedure. Yes, I realize that most are, but then there's that small percentage of jackasses out there who are not. I am aware of two instances where the bowel was perforated by a careless physician, and the patients went through hell for months in rehab.

Hooray!! That old two gallon prep was a real horror show for me. I did not know which end to have nearest the toilet and at many times it seemed it was a even heat with both ends needing to release simultaneously - I real that can be avoided.