Apriso ER 0.375 Capsules

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Aroz
New Member


Date Joined Apr 2010
Total Posts : 4
   Posted 4/2/2010 7:53 PM (GMT -6)   
If anyone has been given the same dosage please get back with me.  My 23 year old
daughter was diagnosed with UC today after a colonoscopy.  Her Gastro doctor put her on Apriso ER capsules to be taken 8 times a day.  Isn't this too much?  In searching this drug I see the normal dosage is four times a day. Eight seems a bit extreme to me.  If anyone has any advice please get back with me.  I will be in contact with her doctor just to make sure he wants her to take all eight a day.
 
Thanks
Aroz

fruitgirl
Veteran Member


Date Joined Feb 2009
Total Posts : 6776
   Posted 4/2/2010 11:16 PM (GMT -6)   
Hi Aroz and welcome to HealingWell. Can I ask how extensive your daughter's UC is (left-sided, pancolitis, etc?). I'm sorry to hear she was diagnosed, but I'm glad that you found us. Send her over here, too, if she needs some support!

I'm on Apriso, but am only taking four 0.375 per day, so a total of 1.5g of mesalamine (the active ingredient). Most other mesalamine drugs (Asacol and Lialda, for example), have a maximum daily dose of 4.8g of mesalamine per day. So even at eight Apriso, that's still only 3.0g.

The reason that Apriso has such a lower daily dose is because it supposedly delivers the mesalamine in a much more effecient manner. However, Apriso is a fairly new drug, so it kind of remains to be seen whether or not this is really the case. I can say that I am maintaining a very solid remission on it, though. Apriso isn't actually indicated for inducing remission (to my knowledge, anyway), just maintaining remission. So that's perhaps why your daughter's GI has her on eight per day.

At any rate, I don't think it will be damaging, but do check with her doctor. Also know that the colon isn't very effecient at absorbing mesalamine, so very little drug is actually entering her bloodstream.

I highly suggest that she asks her doctor about mesalamine suspension enemas. They help just about everyone who trys them. Studies show that people who use them every night in conjuction with oral meds achieve remission more quickly than those who only use oral meds, and that people who use them twice weekly in conjuction with oral meds stay in remission for longer than those who only use oral meds. I also encourage her to start taking a good, high-quality probiotic.
Co-Moderator, UC Forum
Status: Remission since May 2009!
Symptoms began in November 2008, ~4 weeks after giving birth to my son
Diagnosed with pancolitis on 1/30/09
Meds: Apriso (4 0.375g pills ONCE!! daily), mesalamine enema twice weekly, Natural Factors Ultimate probiotic 12/12 Formula, multivitamin.  Used prednisone (starting dose 40 mg) to get into remission.
 
 


bhb5764
Regular Member


Date Joined Nov 2009
Total Posts : 105
   Posted 4/3/2010 2:53 PM (GMT -6)   
My doctor has me take eight Apriso capsules (4 in the A.M. and 4 in the P.M.) when I am in a flare. I haven't noticed any negative side effects, but I also haven't noticed any improvement from an increase in Apriso alone. I too was a little concerned about the dose because everything I read said that 4 pills was the recommended dose. However, I didn't see anything that said that 4 was the maximum dose. I think I'll ask my doctor about it the next time I see him and let you know what he says.
B.
10 years of UC
Currently taking: VSL#3, Apriso, Entocort


Aroz
New Member


Date Joined Apr 2010
Total Posts : 4
   Posted 4/3/2010 6:40 PM (GMT -6)   
Hi Fruitgirl,
 
My daughter was diagnosed with moderately severe ulcerative colitis (558.9) found in the entire colon. Her ulcers are mainly in the sigmoid colon. Her original medication was 3 flagyl and 2 cipro a day given by her internist. She is supposed to continue the flagyl and cipro as well as start her new medication (given by her GI doctor) with 8 apriso capsules a day, so 13 pills a day. This seems to be a lot of medication for her to take, but she started today. When do you seem to have improvement after starting apriso? She has felt the best when she was on a liquid diet prior to her colonoscopy.
 
Thanks for your quick response!
I look forward to hearing from you.
 

Jayciel
New Member


Date Joined Apr 2010
Total Posts : 1
   Posted 4/12/2010 6:38 PM (GMT -6)   
Hi,
My husband was just diagnosed as well last week with UC. His GI doctor also has him on 8 capsules a day of Apriso. I two am concerned about the high dosage. After reading some of these posts I am wondering if the high dosage is just given initially to get things under control. We have an appointment in a few days so I plan to ask the doctor then. I am also concerned about how new the drug is and how much is known about it and its effectiveness. I will post here when I see what the doctor says about the dosage.

quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/12/2010 9:49 PM (GMT -6)   

    I'm actually in disbelief.....the highest apriso dosage is 4 a day....not 8!!!  Please call the doc or pharmacy to clarify, or email the company itself.  I found the following chart regarding IBD oral meds (all are found in the US), and as you see, 4 daily is the limit.

     

    I got it from this site:

    http://www.aetna.com/products/rxmedicare/data/Medicare2009/GI2009/inflammatoryboweldisease.html

     

     

     

     

    A. Quantity limits:

    According to the Ulcerative Colitis Practice Guidelines from the American College Gastroenterology (ACG), these agents may be dosed up to a maximum dose as indicated below.  A quantity of each drug will be considered medically necessary as indicated in the table below.

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    Apriso 1.5 grams 0.375 grams Up to 120 capsules in 30 days (4/day)
    Asacol 4.8 grams 400 mg Up to 360 tablets in 30 days (12/day)
    Asacol HD 4.8 grams 800 mg Up to 180 tablets in 30 days (6/day)
    Azulfidine 6 grams 500 mg Up to 360 tablets in 30 days (12/day)
    Canasa 1500 mgs 1000 mg Up to 60 suppositories in 30 days (2/day)
    balsalazide, Colazal 6.75 grams 750 mg Up to 270 capsules in 30 days (9/day)
    Dipentum 3 grams 250 mg Up to 360 capsules in 30 days (12/day)
    Lialda 4.8 grams 1.2 grams Up to 120 tablets in 30 days (4/day)
    Pentasa 4.8 grams 250 mg Up to 600 capsules in 30 days (20/day)
    Pentasa 4.8 grams 500 mg Up to 300 capsules in 30 days (10/day)
    sulfasalazine 6 grams 500 mg Up to 360 tablets in 30 days (12/day)


    >>

Aetna

*Heather* I give suggestions, do with them what you will.
Status: ...Asacol 3 @ 2x daily; Salofalk enema @ 3rd night (nightly/ flares, tapered/maintenance)
~diagnosed January 1989 UC (proctosigmoiditis)
~Bentylol 20mg as needed; Ranitidine; Effexor XR 37.5mg (depression), Pulmicort/Airomir (asthma) 
~vitamins/minerals/supplementsProbiotics....(RenewLife Ultimate Flora Critical Care+Primadophilus Reuteri pearls+Fortify. @ bedtime
~Metamucil capsules 6 twice daily with meals; Vitamin D 2000 IU
~URSO for PSC (or PBC) 500mg X 2 daily (LFTs back to NORMAL!!)
My doc's logic.. "TREAT (FROM)BOTH ENDS"  worth it !!!
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/13/2010 11:24 AM (GMT -6)   
bumping this up because it's important info.....please read the Apriso column!!!

q

fruitgirl
Veteran Member


Date Joined Feb 2009
Total Posts : 6776
   Posted 4/13/2010 11:40 AM (GMT -6)   
Yes, quincy, but we know that people take more than 12 400 mg Asacol/day....
Co-Moderator, UC Forum
Status: Remission since May 2009!
Symptoms began in November 2008, ~4 weeks after giving birth to my son
Diagnosed with pancolitis on 1/30/09
Meds: Apriso (4 0.375g pills ONCE!! daily), mesalamine enema twice weekly, Natural Factors Ultimate probiotic 12/12 Formula, multivitamin.  Used prednisone (starting dose 40 mg) to get into remission.
 
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/14/2010 1:35 AM (GMT -6)   
Apriso works differently, and the guidelines are there from the manufacturer, not the doctors.

There are treatment dosages and tapered to maintenance dosages...if one needs a higher amount of one med, maybe something more efficient will work better.

To double the daily limit dosage means the doctor has made a mistake....my perspective.

Best for whomever to email the company itself and get the answer.

I will also add....what doctor would force a patient to take a pill 8 times a day?


quincy

fruitgirl
Veteran Member


Date Joined Feb 2009
Total Posts : 6776
   Posted 4/14/2010 10:17 AM (GMT -6)   
Yes, but the guidelines for Asacol say 12/day and we know for a fact that people take more than that. I don't see the difference that you're arguing. It's still only 3g of mesalamine.

I've asked my doc about what we'd do if I'm in a flare, and Apriso 4/day plus nightly Rowasa isn't cutting it, and he said we could either up my Apriso or switch to Asacol.
Co-Moderator, UC Forum
Status: Remission since May 2009!
Symptoms began in November 2008, ~4 weeks after giving birth to my son
Diagnosed with pancolitis on 1/30/09
Meds: Apriso (4 0.375g pills ONCE!! daily), mesalamine enema twice weekly, Natural Factors Ultimate probiotic 12/12 Formula, multivitamin.  Used prednisone (starting dose 40 mg) to get into remission.
 
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/14/2010 4:31 PM (GMT -6)   
I'm not arguing, I'm passing on information that some aren't aware of.
I'm shocked that 8 Apriso as a starter med and my opinion is that it's remiss of the doctor. We sometimes shouldn't look at the total amount and say Oh, that's not a high dosage, we should ask why does one need a lower dosage....Why start at the ultimate highest dosage when it's not even in the daily limit????



For you..you didn't start at 8.

Yes, there are some who break the rules....absolutely.....but if Apriso is designed to be effecient in treatment at a lower dosage, then maybe a higher dosage isn't necessary?

There are dispersal methods based on ph level and bacteria level...a higher dosage to start is careless, especially when patients can have side effects. Starting at lower dosages and increasing is more common sense.



It seems a negative conclusion can come of it as well as a waste of $$ to me.



Patients need to read, research and get smart about meds....ask the pertinent questions and even email the company. If the company says...never over 4 daily, then I see a problem . If the company says, yes...but blah, blah, blah....then it seems the patient has eyes open and is aware of meds.



Many complain about the pharmaceutical companies having $$$ as their goals, but there's no excuse for doctors not being aware of the optimum working dosage of medications.



quincy

fruitgirl
Veteran Member


Date Joined Feb 2009
Total Posts : 6776
   Posted 4/14/2010 4:36 PM (GMT -6)   
I didn't mean "arguing" as in heated...maybe "presenting" would be better.

Anyway, Apriso ISN'T indicated for induction of remission--just maintenance. So perhaps that's why docs are Rx-ing the higher rate for induction of remission.
Co-Moderator, UC Forum
Status: Remission since May 2009!
Symptoms began in November 2008, ~4 weeks after giving birth to my son
Diagnosed with pancolitis on 1/30/09
Meds: Apriso (4 0.375g pills ONCE!! daily), mesalamine enema twice weekly, Natural Factors Ultimate probiotic 12/12 Formula, multivitamin.  Used prednisone (starting dose 40 mg) to get into remission.
 
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/14/2010 4:38 PM (GMT -6)   
read my above response.

OK...presenting. Treatment dosage is 4, maintenance is 2 I believe.

q

quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/14/2010 4:43 PM (GMT -6)   
http://www.firstreportnow.com/images/misc/apriso_may.pdf


Again...interesting info, however....I didn't read it all.



q

fruitgirl
Veteran Member


Date Joined Feb 2009
Total Posts : 6776
   Posted 4/14/2010 4:50 PM (GMT -6)   
Nope. Sorry, but "Indications and Wsage" (in the prescribing information) say "Apriso is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults." Under "Dosage and Administration" the same info says "Four Apriso capsules once daily in the morning with or without food."

So maintenance is four, as that's the only thing is indicated for. The studies in that article didn't show induction of remission.
Co-Moderator, UC Forum
Status: Remission since May 2009!
Symptoms began in November 2008, ~4 weeks after giving birth to my son
Diagnosed with pancolitis on 1/30/09
Meds: Apriso (4 0.375g pills ONCE!! daily), mesalamine enema twice weekly, Natural Factors Ultimate probiotic 12/12 Formula, multivitamin.  Used prednisone (starting dose 40 mg) to get into remission.
 
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/14/2010 5:13 PM (GMT -6)   
OPTION FOR UC
APRISO is bringing the INTELLICOR
delivery system to the treatment of
UC, thereby addressing some of the
obstacles faced by healthcare professionals
in the treatment of the disease.
The delayed- and extendedrelease
delivery of APRISO is key in its
ability to focus treatment both where
it is needed and when it is needed.


Same article. What am I missing here? Many assume 5ASA is a maintenance med not a treatment...not true.

But treatment and maintenance could mean that it can be continually used once the disease has acquiesced.


Gotta find the 2 per day articles.

I don't buy the 8....regardless.

q

fruitgirl
Veteran Member


Date Joined Feb 2009
Total Posts : 6776
   Posted 4/14/2010 8:58 PM (GMT -6)   
If you look at prescribing info for Asacol and Lialda (under indications/usage), it talks about using it to treat mild to moderate active colitis...meaning treating a flare. Apriso says nothing about that, only about maintaining remission. You have to look at the prescribing info, specificall the indications for use.
Co-Moderator, UC Forum
Status: Remission since May 2009!
Symptoms began in November 2008, ~4 weeks after giving birth to my son
Diagnosed with pancolitis on 1/30/09
Meds: Apriso (4 0.375g pills ONCE!! daily), mesalamine enema twice weekly, Natural Factors Ultimate probiotic 12/12 Formula, multivitamin.  Used prednisone (starting dose 40 mg) to get into remission.
 
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/14/2010 11:24 PM (GMT -6)   
Yes, I understand that fact....not disputing it.


Salix itself states it as a treatment for long-term management of UC.....so, in effect maintenance is actual treatment when one has no symptoms.



http://www.salix.com/products/apriso/

fruitgirl
Veteran Member


Date Joined Feb 2009
Total Posts : 6776
   Posted 4/15/2010 12:00 AM (GMT -6)   
Ok, but these people are in flares (at least I'm assuming so, as they are newly diagnosed). My assumption is that since Apriso is prescribed at 4/day to maintain remission, it's likely that more than 4/day will be needed to induce remission. Many docs have patients taper to lower levels of Asacol when they reach remission.
Co-Moderator, UC Forum
Status: Remission since May 2009!
Symptoms began in November 2008, ~4 weeks after giving birth to my son
Diagnosed with pancolitis on 1/30/09
Meds: Apriso (4 0.375g pills ONCE!! daily), mesalamine enema twice weekly, Natural Factors Ultimate probiotic 12/12 Formula, multivitamin.  Used prednisone (starting dose 40 mg) to get into remission.
 
 


quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/15/2010 12:50 AM (GMT -6)   
OK...fine, but have you read any info on that specifically? I haven't as of yet....and still looking.

will email the company I guess.
q

Levi
Veteran Member


Date Joined Nov 2009
Total Posts : 1537
   Posted 4/15/2010 8:24 AM (GMT -6)   
I have been seriously considering switching to Apriso, but it does seem like the drug is lacking in potency if the max dose is for maintenance.

Surely it can't be standard practice to take four Apriso per day while in remisson, and immediatley switch to another mesalamine if you start flaring, can it?

quincy
Elite Member


Date Joined May 2003
Total Posts : 25561
   Posted 4/15/2010 9:34 AM (GMT -6)   
I guess that's my question too.

q

fruitgirl
Veteran Member


Date Joined Feb 2009
Total Posts : 6776
   Posted 4/15/2010 10:23 AM (GMT -6)   
I think it's just that they haven't done studies yet to see how it works for inducing remission. They probably wanted to get it on the market quickly (to compete with Lialda before it got too big of a market share), so just did the studies about maintaining remission, because there are probably more patients in remission than patients in a flare.

FWIW, I've asked my doc, and he said that if/when I flare, we could try upping my Apriso. He didn't see any reason not to, other than that my insurance might not cover a higher dose, no matter how he writes the Rx.
Co-Moderator, UC Forum
Status: Remission since May 2009!
Symptoms began in November 2008, ~4 weeks after giving birth to my son
Diagnosed with pancolitis on 1/30/09
Meds: Apriso (4 0.375g pills ONCE!! daily), mesalamine enema twice weekly, Natural Factors Ultimate probiotic 12/12 Formula, multivitamin.  Used prednisone (starting dose 40 mg) to get into remission.
 
 


Levi
Veteran Member


Date Joined Nov 2009
Total Posts : 1537
   Posted 4/15/2010 1:22 PM (GMT -6)   
I just talked to the nurse and she sent the doc a note about my request. She said they would probably start me at 375mg.

Levi
Veteran Member


Date Joined Nov 2009
Total Posts : 1537
   Posted 4/16/2010 4:06 PM (GMT -6)   
I just got my first Apriso prescription filled. Anybody have any advice on what a daily dosage should be?

I was taking two Asacol HD tabs/day (1.6g)

All the nurse said was that they put four per day but knew I wouldn't take that many. The did that so the Rx would last longer. I didn't get the call so I couldn't ask a follow up question. I'm at a loss...

Would taking one Apriso in the morning and one Asacol later in the day be feasible? Would 375mg of Apriso mesalamine equal the 1.6g of mesalamine from Asacol? That's how lost I am. I really have no clue about the correlation between the dosages of the different meds...
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