# Rifaximin antibiotic



## SarahD

Hi guys,

When I saw my consultant earlier in the week we discussed treatment options for me and, since I'm a bit reluctant to go on Aza at the moment, she suggested the antibiotic Rifaximin. I've done a bit of a google search and have managed to find information on a few trials for this drug, but not many personal accounts. Has anyone here taken Rifaximin or know much about it? 

I'm following the LOFFLEX diet at the moment, after 4 weeks on elemental, and whilst I'm doing so much better than I was prior to this I still have some mild pain. I see my doctor again for a review in 2 months time and I'd like to be geared with a bit more knowledge about Rifaximin so that I can make an informed decision about my treatment.

Sarah


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## Jennifer

Sorry I've never taken or heard of it before. Do you know why they chose that antibiotic and not any other? Maybe Judith might have some more information on it that will help (Judith if I'm tagging you too often please let me know  ).


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## Miss Underestimated

That drug is in the news right now, at least here in the US - for causing more side effects.


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## Judith

Hi Guys,
Sorry for the long response time. I was trying to find as much information as possible on Rifaximin.

Crabby you are not tagging me too often, dont worry..... unless you find me not responding to your tags. Hit me up again or just make sure you are tagging the right person.  There has been some confusion with another Judith (plus "C") and there is a Judy as well. If I am ignoring anything please please let me know 

SarahD, I will give you as much information as I have regarding Rifaximin (also known as Xifaxan - by Salix Pharmaceuticals, Inc.), without boring you with the clinical pharmacology (unless you want that stuff). There is not a TON of information out there on this particular antibiotic because it is "fairly" new.
- Approved in 2004 in the United States for Traveler's Diarrhea.

- Was previously marketed in Italy since 1985 under the name Normix (also known as Rifaximin from Alfa Wassermann Pharmaceuticals).

- Xifaxan / Rifaximin has subsequently been approved for use in the US for GI Tract bacterial overgrowth in Irritable Bowel Syndrome (IBS) and Hepatic Encephalopathy (HE, a liver disease that can cause GI bacterial overgrowth)

- I was having a great deal of trouble finding the information about Rifaximin's Side Effect News stories that Miss Underestimated was referring to. Would you mind posting a link? I could not find it. 

- The CrohnsForum.com site has a Wiki entry about Xifaxan / Rifaximin HERE

- There is a Thread also on CrohnsForum.com that you might find of interest. I was shocked by the cost of this drug. Ouch!
Interesting Thread about Xifaxan / Rifaximin

Here are a couple of articles in case you are interested:
- Study On Xifaxan / Rifaximin and IBS (Italy) http://www.wjgnet.com/1007-9327/15/2628.asp

- Xifaxan / Rifaximin and Crohn's Disease (Italy) http://pheniciagroup.com/articledetail2.asp?ArticleID=36

I will add some key points about this drug in my next post.


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## Judith

Key Points about Xifaxan / Rifaximin:

- Xifaxan / Rifaximin is a "fairly" new antibiotic supplied by Salix Pharmaceuticals in the US Salix Pharmaceuticals, Inc. Website

- What is "New and Improved" about Xifaxan / Rifaximin over (most) other antibiotics, is that it is a Non-Systemic Antibiotic. This means that (unlike almost all antibiotics) it is not distributed throughout the entire body after you take it. The drug is taken by mouth and most of it continues down the gastrointestinal tract until it is expelled in the feces. In contrast to most other antibiotics that are distributed throughout the entire body. In patients that have bacterial overgrowth restricted to the GI tract side effects can be minimized if the drug is not distributed to body areas where it is not needed. This Non-Systemic feature of the antibiotic makes it attractive for use in patients with bacterial overgrowth restricted to the Gastrointestinal Tract.

- This drug is a Pregnancy Category C. This means that it should not be taken in pregnancy unless _absolutely_ necessary. There have been no exhaustive studies in pregnant women taking this drug but studies of Rifaximin in pregnant animal models have found a higher incidence in birth defects over pregnant animals that were not given the drug.

- There are some warnings for Xifaxan / Rifaximin that are typical for strong antibiotics in general (or for any medication) and are not specific to Rifaximin only. Examples of these warnings include:

1. Possibility of having an allergic reaction to the drug (this is a possibility for any drug). An allergic reaction to a drug should not be ignored as it may be fatal.

2. Possibility of generating "Bacteria that are Resistant to the Antibiotic" - This can occur with the use of any antibiotic and is not specific to Rifaximin.

3. _Clostridium difficile _overgrowth, aka _C. diff_, aka CDAD (_Clostridium difficile _Associated Diarrhea). _Clostridium difficile _is a pathogenic type of bacteria that can produce toxins which are harmful to the GI tract. Normally, the bacteria that are supposed to reside within out intestinal tract keep the _C. diff _at bay. But, sometimes when you take a strong antibiotic, the "good" bacteria can get killed off which can allow the pathogenic _C. diff _to invade. _C. diff _infections vary widely in their symptoms from no symptoms at all, diarrhea requiring hospitalization, to _C. diff_ infections that can be fatal. The possibility of acquiring a _C. diff _infection is something to be concerned about when taking any of the stronger antibiotics and is not a warning specific to Rifaximin only.

4. One warning that is specific to Rifaximin is that people with severe liver problems appear to get more of the drug distributed throughout the body (Systemic Rifaximin) rather than having the drug stay predominantly in the GI tract.

5. Although Rifaximin can be taken with or without food, if it is taken within 2 hours of a meal that contains high amounts of fat the drug will be found at higher levels throughout the entire body (and not restricted to the GI tract as it is supposed to do).

6. Also, Rifaximin is NOT for use in people that have a bacterial infection that is systemic or outside of the GI tract.

7. Rifaximin is generally used to treat intestinal overgrowth of _E. coli _bacteria. Rifaximin DOES NOT WORK on certain species of bacteria that can cause GI Tract problems so it is recommended to test what species of bacteria has overgrown and is causing the GI Tract problems.

8.  Most people that take Rifaximin have their GI upset subside relatively quickly (average is about 1.5 days), but some people can actually have their symptoms worsen. Rifaximin should be discontinued if this occurs (under the advisement of your doctor, of course).

9. Patients that take Rifaximin report the following side effects more often than patients taking placebo:
- Headache - (10% Rifaximin; 9% Placebo)

- Swelling of the Extremities (Arms/Legs/Hands/Feet) - (15% Rifaximin; 8% Placebo)

- Nausea - (14% Rifaximin; 13% Placebo)

- Dizziness - (13% Rifaximin; 8% Placebo)

- Fatigue / Tired Feeling - (12% Rifaximin; 11% Placebo)

- Ascites (Fluid buildup in the abdomen in the space under the muscle and outside of the GI Tract) - (11% Rifaximin; 9% Placebo)

- Muscle Spasms - (9% Rifaximin; 7% Placebo)

- Abdominal Pain - (9% Rifaximin; 8% Placebo)

- Anemia - (8% Rifaximin; 4% Placebo)

- Itchiness - (9% Rifaximin; 6% Placebo)

- Shortness of Breath / Dyspnea - (6% Rifaximin; 4% Placebo)

There are other side effects seen with Rifaximin use. I have attached the document HERE.

As with any newish drug the type of side effects and drug interactions will continue to be added as they are discovered. So, obviously take all of this information with that in mind.

I hope it helped in your decision somewhat. I respect that you are interested in what goes into your body and are taking an active role in your treatment. Let me know if there is something you might be interested in that I missed. 
Judy

PS- It may be expensive depending on your insurance. I know that if your insurance company does pay they might require documentation that you have already tried "other drugs in the same class"...... some insurance companies do not pay at all.  I dont know your insurance situation but I posted a couple of ways Salix Pharmaceutical offers to help in THIS THREAD. I would get any financial approval in advance though... just to be sure.


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## SarahD

Judy, all I can say right now is thank you so much! You are an asset to our forum and I really appreciate you taking the time to put all that information together for me. 

I'm quite surprised at the small % difference in side effects between Rifaximin and placebo for several of the side effects you listed. I'll take a better look at the document you attached later today. I do have one question, but not too sure if you'll be able to answer it or not. I was wondering about the dosage regime, so what dose is generally used in Crohns and for how long? I did come across a study suggesting 800mg twice a day had significantly better outcome than 800mg once a day (and the once a day regime was no better than placebo). David's thread on Crohnsforum.com mentions 550mg three times a day for two weeks.

I'm in the UK so thankfully I don't have the worry of insurance, but I haven't heard much about this particular antibiotic being used here. My consultant told me that she has another patient taking Rifaximin so I'm hoping that means you can get it under the NHS. I'm currently following the LOFFLEX diet, with partial success, so Rifaximin or Azathiprine are my plan B options. Hopefully neither will be needed but I feel it's better to gather the information now than wait until the last minute and have to make a decision with no knowledge of what I'm choosing between.

Thanks again Judy 

Sarah


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## SarahD

Crabby said:


> Sorry I've never taken or heard of it before. Do you know why they chose that antibiotic and not any other? Maybe Judith might have some more information on it that will help (Judith if I'm tagging you too often please let me know  ).


Hi Crabby, I've tried Cipro and Flagyl before with no success and some horrible side effects from the Cipro, so I think that's why they weren't recommended this time. My consultant wants me to go on Azathioprine which I'm a bit reluctant to do right now, so her other suggestion was the Rifaximin.


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## Judith

SarahD said:


> Judy, all I can say right now is thank you so much! You are an asset to our forum and I really appreciate you taking the time to put all that information together for me.
> 
> I'm quite surprised at the small % difference in side effects between Rifaximin and placebo for several of the side effects you listed. I'll take a better look at the document you attached later today. I do have one question, but not too sure if you'll be able to answer it or not. I was wondering about the dosage regime, so what dose is generally used in Crohns and for how long? I did come across a study suggesting 800mg twice a day had significantly better outcome than 800mg once a day (and the once a day regime was no better than placebo). David's thread on Crohnsforum.com mentions 550mg three times a day for two weeks.
> 
> I'm in the UK so thankfully I don't have the worry of insurance, but I haven't heard much about this particular antibiotic being used here. My consultant told me that she has another patient taking Rifaximin so I'm hoping that means you can get it under the NHS. I'm currently following the LOFFLEX diet, with partial success, so Rifaximin or Azathiprine are my plan B options. Hopefully neither will be needed but I feel it's better to gather the information now than wait until the last minute and have to make a decision with no knowledge of what I'm choosing between.
> 
> Thanks again Judy
> 
> Sarah


Thank you for the Thanks!   I just hope it helps.

Your Lofflex diet sounds excellent! It also sounds difficult but probably worthwhile if you can figure out some triggers. Try to hang in there. 

You mentioned a reaction to Cipro. Mind if I ask what that was?

It is totally understandable that you are reluctant to start the Aza. There can be pretty significant side effects but, some people do very well with it. Hopefully, as you said, neither drug will be necessary. (Crossing fingers for you!)

You were interested in the dosage for Rifaximin. I am so sorry, but I will be of little help here. It only appears the treatment courses are short-intermediate in duration. As you mentioned, David's post mentioned 2 weeks, I saw that study you mentioned with the 800 mg dosage (our dosage in the states is 200mg and 550mg I believe for the non-extended dose version).

I think they are still trying to optimize the dosing strategy for Crohn's. Here are a couple of papers I came across. Basically, from 2 weeks to 16? weeks in duration. The last abstract even discusses "stacking" with other antibiotics.

I believe use of Rifaximin in Crohn's is too new to have a rigid strategy for dosing. It likely depends on the patient's response to the drug as well. Sorry couldnt give you a better answer. I dont know.  There are quite a few on CrohnsForum.com that have taken the drug personally and they will probably be a better resource on the dosing topic than I.

If you go to the "Search" tab at the top of the page and type in Rifaximin (show posts) and in a separate search type in "Xifaxan" (show posts) you will probably find some super-helpful folks. 


*Couple of Papers on Dosing:*

*Some different studies of Rifaximin in Crohn's Disease *http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3237300/pdf/WJG-17-4643.pdf


> Rifaximin in Crohn's Disease
> Further to an open-label study where rifaximin 200 mg tid administered for 16 wk to 29 patients with active Crohn’s disease reduced Crohn’s disease activity index (CDAI) score by more than 40% and induced clinical remission in 59% of cases[22], and a recent retrospective analysis of the charts of 68 patients receiving adjunctive therapy with rifaximin (mean dose 600 mg/d for 16 wk) showing remission in up to 70% of cases[23], two controlled studies were carried out.
> 
> A multicenter, double-blind, placebo controlled trial including 83 patients with mild-to-moderate Crohn’s disease[24] found that monotherapy with rifaximin 800 mg bid for 12 wk was superior to placebo in promoting clinical remission (CDAI < 150), which was observed in 52% of cases compared with 33% in the placebo group. The difference in remission rates, however, was statistically significant (P = 0.032) only between the subgroups of patients with baseline values of C reactive protein above the upper normal limit.
> 
> A recent, international, multicenter, randomised study enrolling 402 patients from 55 centers in Europe and Israel demonstrated that an extended intestinal release formulation of rifaximin 400 mg in daily doses of 400-1200 mg bid for 12 wk was significantly superior to placebo in inducing remission (as defined as a CDAI < 150).
> 
> The best results were observed at the dose of 800 mg bid (remission rate 62.2% vs 42.6% in the placebo group: P = 0.005) and the effects were maintained during a subsequent 12-wk follow-up without treatment[25].


*Extended Release Rifaximin Study *http://dx.doi.org/10.1053/j.gastro.2011.11.032


> This study is for an Extended Release Version of Rifaximin
> Results
> At the end of the 12-week treatment period, 62% of patients who received the 800-mg dosage of rifaximin-EIR (61 of 98) were in remission, compared with 43% of patients who received placebo (43 of 101) (P = .005). A difference was maintained throughout the 12-week follow-up period (45% [40 of 89] vs 29% [28 of 98]; P = .02). Remission was achieved by 54% (56 of 104) and 47% (47 of 99) of the patients given the 400-mg and 1200-mg dosages of rifaximin-EIR, respectively; these rates did not differ from those of placebo. Patients given the 400-mg and 800-mg dosages of rifaximin-EIR had low rates of withdrawal from the study because of adverse events; rates were significantly higher among patients given the 1200-mg dosage (16% [16 of 99]).
> 
> Conclusions
> Administration of 800 mg rifaximin-EIR twice daily for 12 weeks induced remission with few adverse events in patients with moderately active CD.


*"Stacking" Rifaximin and other Antibiotics in Crohn's Disease (Abstract only)*http://www.nature.com/ajg/journal/v106/n4/full/ajg201172a.html

Good Luck! And, hoping all of this info is unnecessary. 
Judy


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## SarahD

Thanks again Judy  

I can discuss dosage with my consultant at my next appointment but at least I have a few things to compare to now. Like you say, it's a fairly new treatment for Crohns so there's no rigid treatment regime yet. I'm not keen to be a guinea pig, but Rifaximin does seem to be an attractive option over Azathioprine. 

Regarding the cipro side effects, I had quite a few. The worst was psychological - I was becoming really agitated and paranoid (and I am usually very level-headed). I also felt like I couldn't catch my breath and my heart beat would become irregular. I remember having to stick my head out of the window on a freezing cold evening just so that I could breathe a bit better. I think it was more just a feeling of not being able to breathe rather than actually not being able to breathe, if that makes any sense? I ended up having a telephone consult with my GP who halved my dosage of the Cipro and I felt so much better with 24 hours of the reduced dose. To top this off, after about 5-days on Cipro and Flagyl (together) I then developed a couple of yeast infections that just wouldn't go away for weeks and weeks, even after treatment from my GP. I really wasn't in a good place and was really struggling with the Crohns at this time and unfortunately the Cipro and Flagyl didn't seem to help.  

I've come along way on elemental and LOFFLEX. It has been really hard work but worthwhile even if I'm still not feeling 100%. I will do a search for Xifaxan, thanks for the tip - I'd only searched for Rifaximin so far.

Thanks a lot Judy,

Sarah


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## JohnnyRottenAppleseed

here is an interesting article about using Xifaxan as a 1st line antibiotic for C Diff.

http://www.hindawi.com/journals/grp/2011/106978/

My insurance didn't approve the Xifaxan so i ordered it super cheap from alldaychemist. I'm starting today or tmrw. 550mg x2 day for 1 or 2 weeks if i don't have any side effects.


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## JohnnyRottenAppleseed

Here is another recent study. It's for IBS, but many IBD sufferers have IBS symptoms as well.

“We found that rifaximin and lubiprostone have the lowest level of harmful side effects of all the well-studied drug therapies for IBS," Pimentel said.

http://www.endonurse.com/news/2012/03/researchers-identify-ibs-drugs-with-fewest-side-e.aspx


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## JohnnyRottenAppleseed

so I did 4 days of Xifaxan last week. I noticed major improvement in bloating but nothing else. I'm in a flare so not in the best situation to test it out. I was hoping to make it 7-14 days at 1200mg per day. That is the protocol for SIBO (Small Intestinal Bacterial Overgrowth).


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## Judith

SarahD said:


> Thanks again Judy
> 
> I can discuss dosage with my consultant at my next appointment but at least I have a few things to compare to now. Like you say, it's a fairly new treatment for Crohns so there's no rigid treatment regime yet. I'm not keen to be a guinea pig, but Rifaximin does seem to be an attractive option over Azathioprine.
> 
> Regarding the cipro side effects, I had quite a few. The worst was psychological - I was becoming really agitated and paranoid (and I am usually very level-headed). I also felt like I couldn't catch my breath and my heart beat would become irregular. I remember having to stick my head out of the window on a freezing cold evening just so that I could breathe a bit better. I think it was more just a feeling of not being able to breathe rather than actually not being able to breathe, if that makes any sense? I ended up having a telephone consult with my GP who halved my dosage of the Cipro and I felt so much better with 24 hours of the reduced dose. To top this off, after about 5-days on Cipro and Flagyl (together) I then developed a couple of yeast infections that just wouldn't go away for weeks and weeks, even after treatment from my GP. I really wasn't in a good place and was really struggling with the Crohns at this time and unfortunately the Cipro and Flagyl didn't seem to help.
> 
> I've come along way on elemental and LOFFLEX. It has been really hard work but worthwhile even if I'm still not feeling 100%. I will do a search for Xifaxan, thanks for the tip - I'd only searched for Rifaximin so far.
> 
> Thanks a lot Judy,
> 
> Sarah


Cipro is a funny drug. Some people have no psych symptoms on it and others (especially elderly people) can have major psychotic breaks. And the yeast infection issue - that can occur with any antibiotic that messes up your microbial balance. Some are worse than others. I am glad you are doing better on the LOFFLEX though. Good luck with your doctor's appointment.


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## Judith

JohnnyO said:


> so I did 4 days of Xifaxan last week. I noticed major improvement in bloating but nothing else. I'm in a flare so not in the best situation to test it out. I was hoping to make it 7-14 days at 1200mg per day. That is the protocol for SIBO (Small Intestinal Bacterial Overgrowth).


Hi JohnnyO. You didnt take less than the dosage prescribed did you? Or, you took 4 days of your Xifaxan and are not yet finished with your course of treatment? I hope you are feeling better soon!


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## JohnnyRottenAppleseed

I started cipro flagyl yesterday. I've been passing blood and pus for weeks. I feel better already!


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## JohnnyRottenAppleseed

Judith said:


> Hi JohnnyO. You didnt take less than the dosage prescribed did you? Or, you took 4 days of your Xifaxan and are not yet finished with your course of treatment? I hope you are feeling better soon!


Iwas hoping to go 2 weeks but I have an abscess or something going on so I did 4 days Xifaxan  at 1200mg a day. Now On cipro flagyl for gut infection.


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