Introducing XIFAXAN 550 mg (rifaximin) approved for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age. XIFAXAN 550 mg is a nonsystemic treatment option providing efficacy and tolerability for control of HE recurrence.
HE is a disease marked by an intractable cycle of relapse and remission, followed almost inevitably by relapse. Episodes of acute encephalopathy can be reversed; however, people with chronic liver disease are consistently susceptible to future relapse.1
It is estimated that 50% to 70% of cirrhotic patients will go on to develop overt HE.2
XIFAXAN 550 mg is proven to reduce the risk of overt HE recurrence and reduce HE-related hospitalizations over a 6-month period.3 Treatment with XIFAXAN 550 mg is believed to affect gut flora balance for control of HE.3,4
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Complete Prescribing Information
Reference: 1. Merck Manual Home Edition. http://www.merck.com/mmhe/index.html. Accessed January 7, 2010.
2. Tavares de Melo R, Charneski L, Hilas O. Rifaximin for the treatment of hepatic encephalopathy. Am J Health-Syst Pharm. 2008;65:818-822.
3. XIFAXAN [prescribing information]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2010.
4. De Leo C, Eftimiadi C, Schito GC. Rapid disappearance from the intestinal tract of bacteria resistant to rifaximin. Drugs Exp Clin Res. 1986;12:979-981.
XIFAXAN 200 mg (rifaximin) is indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in patients ≥12 years of age. Escherichia coli is the most common cause of travelers’ diarrhea in Latin America, the Caribbean, and Africa.1 XIFAXAN 200 mg, a minimally absorbed (<0.4%) enteric antibiotic, targets pathogenic E coli without causing long-term changes to gut flora balance. XIFAXAN 200 mg is proven to treat travelers’ diarrhea, stopping symptoms in 79.2% of patients.*
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*In a randomized, double-blind, placebo-controlled study conducted in Mexico, Guatemala, and Kenya, the efficacy of XIFAXAN 200 mg (orally 3 times a day for 3 days) was evaluated in 254 adult subjects with travelers' diarrhea. Stool specimens were collected before treatment and 1 to 3 days following the end of treatment to identify enteric pathogens, predominantly E coli. The clinical efficacy of XIFAXAN 200 mg was assessed by the time to return to normal, formed stools and resolution of symptoms.
Reference: 1. Yates J. Traveler’s diarrhea. Am Fam Physician. 2005;71:2095-2100.
Important Safety Information about XIFAXAN 550 mg
XIFAXAN® 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age. In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores >25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued.
The most common adverse reactions occurring in >8% of patients in the clinical study were edema peripheral (15%), nausea (14%), dizziness (13%), fatigue (12%), ascites (11%), muscle spasms (9%), pruritus (9%), and abdominal pain (9%).
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Important Safety Information about XIFAXAN 200 mg
XIFAXAN® (rifaximin) 200 mg Tablets are indicated for the treatment of patients (≥12 years of age) with travelers’ diarrhea caused by noninvasive strains of Escherichia coli. XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than E coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24 to 48 hours and alternative antibiotic therapy should be considered. E coli has been shown to develop resistance to rifaximin in vitro. However, the clinical significance of such an effect has not been studied.
In clinical trials, XIFAXAN was generally well tolerated. The most common side effects (vs placebo) were flatulence 11.3% (vs 19.7%), headache 9.7% (vs 9.2%), abdominal pain 7.2% (vs 10.1%), rectal tenesmus 7.2% (vs 8.8%), defecation urgency 5.9% (vs 9.2%), and nausea 5.3% (vs 8.3%).
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