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Claims for Patent: 8,946,252

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Claims for Patent: 8,946,252

Title:Methods of treating traveler's diarrhea and hepatic encephalopathy
Abstract: Treatment of traveler's diarrhea using in subjects having hepatic encephalopathy using gastrointestinal specific antibiotics is disclosed. One example of a gastrointestinal specific antibiotic is rifaximin.
Inventor(s): Forbes; William (Raleigh, NC), Bortey; Enoch (Chapel Hill, NC)
Assignee: Salix Pharmaceuticals, Ltd (Raleigh, NC)
Application Number:13/654,978
Patent Claims: 1. A method of reducing the risk of overt hepatic encephalopathy (HE) recurrence in a subject comprising: identifying a subject having Traveler's Diarrhea (TD) that also has hepatic insufficiency; determining if the subject's Child-Pugh score is Child-Pugh Class C or if the subject's model end stage liver disease (MELD) score is 25 or greater; and administering between 1000 and 1200 mg of rifaximin daily and cautiously to the subject if his or her Child-Pugh score is Child-Pugh Class C or if his or her MELD score is 25 or greater.

2. The method of claim 1, wherein the hepatic insufficiency is hepatic encephalopathy.

3. The method of claim 1, wherein the subject is administered 1100 mg of rifaximin.

4. The method of claim 3, wherein the subject is administered 550 mg of rifaximin BID.

5. The method of claim 1, wherein the subject is a human.

6. The method of claim 1, wherein the rifaximin comprises tablets for oral administration comprising one or more of colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, or titanium dioxide.

7. The method of claim 1, wherein the clearance rate of rifaximin is decreased in a population of subjects with hepatic insufficiency as compared to a population of subjects without hepatic insufficiency.

8. The method of claim 1, wherein the elimination rate of rifaximin is decreased in subjects with hepatic insufficiency as compared to subjects without hepatic insufficiency.

9. The method of claim 1, wherein the systemic exposure to rifaximin is increased in a population of subjects with hepatic insufficiency as compared to a population of subjects without hepatic insufficiency.

10. The method of claim 1, wherein the serum level of rifaximin is increased in a population of subjects with hepatic insufficiency as compared to a population of subjects without hepatic insufficiency.

11. The method of claim 1, comprising administering 1100 mg of rifaximin per day to a patient for more than 28 days.

12. The method of claim 11, comprising administering rifaximin to the subject for 6 months or longer.

13. The method of claim 12, comprising administering rifaximin to the subject for 1 year or longer.

14. A method to reduce the risk of overt hepatic encephalopathy (HE) recurrence in a subject suffering from Traveler's Diarrhea (TD), comprising: identifying a subject that has had overt HE and also TD; determining the severity of the subject's HE; administering between 1000 and 1200 mg of rifaximin daily and cautiously for TD to the subject if the HE is severe.

15. The method of claim 14, wherein the subject is administered 1100 mg of rifaximin.

16. The method of claim 15, wherein the subject is administered 550 mg of rifaximin BID.

17. The method of claim 14, wherein the subject is a human.

18. The method of claim 14, wherein the rifaximin comprises tablets for oral administration comprising one or more of colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, or titanium dioxide.

19. The method of claim 14, wherein the clearance rate of rifaximin is decreased in a population of subjects with hepatic insufficiency as compared to a population of subjects without hepatic insufficiency.

20. The method of claim 14, wherein the elimination rate of rifaximin is decreased in subjects with hepatic insufficiency as compared to subjects without hepatic insufficiency.

21. The method of claim 14, wherein the systemic exposure to rifaximin is increased in a population of subjects with hepatic insufficiency as compared to a population of subjects without hepatic insufficiency.

22. The method of claim 14, wherein the serum level of rifaximin is increased in a population of subjects with hepatic insufficiency as compared to a population of subjects without hepatic insufficiency.

23. The method of claim 14, comprising administering 1100 mg of rifaximin per day to a patient for more than 28 days.

24. The method of claim 23, comprising administering rifaximin to the subject for 6 months or longer.

25. The method of claim 24, comprising administering rifaximin to the subject for 1 year or longer.

26. The method of claim 1, further comprising selecting for treatment if his or her Child-Pugh score is Child-Pugh Class C or if his or her MELD score is 25 or greater.

27. The method of claim 14, further comprising selecting for treatment if his or her Child-Pugh score is Child-Pugh Class C or if his or her MELD score is 25 or greater.
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