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Uses

Hepatic Encephalopathy

Reduction of Risk of Recurrence

Rifaximin is used for reduction of risk of recurrence of overt hepatic encephalopathy in adults.

The comparative efficacy of rifaximin used alone or in conjunction with lactulose for prevention of overt hepatic encephalopathy recurrence has not been established. Some experts recommend that rifaximin be used as an adjunct to lactulose for prevention of hepatic encephalopathy recurrence in patients who have had at least 1 episode of overt hepatic encephalopathy while receiving lactulose alone. Rifaximin has not been studied for reduction of risk of recurrence of overt hepatic encephalopathy in patients with scores exceeding 25 on the model for end-stage liver disease (MELD).

Efficacy and safety of rifaximin for reduction of risk of recurrence of overt hepatic encephalopathy were evaluated in a randomized, placebo-controlled, double-blind study in adults who were in remission from hepatic encephalopathy (Conn score of 0 or 1) after having 2 or more episodes of hepatic encephalopathy associated with chronic liver disease during the previous 6 months. A total of 299 adults (mean age 56 years [81% younger than 65 years of age], 61% male, 86% white, 67% with Conn score of 0, 68% with asterixis grade 0, 27% with MELD score 10 or less, 64% with MELD score 11-18, 9% Child-Pugh class C) were randomized to receive rifaximin 550 mg or placebo twice daily for 6 months or until the drug was discontinued because of a breakthrough episode of hepatic encephalopathy or another reason (e.g., adverse effects, request to withdraw). Concomitant use of lactulose was permitted (91.4% of those receiving rifaximin and 91.2% of those receiving placebo also received lactulose). The primary end point was time to first breakthrough episode of overt hepatic encephalopathy (defined as a marked deterioration in neurologic function and an increase from a baseline Conn score of 0 or 1 to a score of 2 or more or an increase from a baseline Conn score of 0 to a score of 1 plus a 1-unit increase in asterixis grade). Comparison of Kaplan-Meier estimates of event-free curves showed that rifaximin reduced the risk of hepatic encephalopathy episodes by 58% compared with placebo during the 6-month treatment period; 22% of patients in the rifaximin treatment group and 46% of patients in the placebo group experienced breakthrough episodes of overt hepatic encephalopathy. Efficacy of rifaximin was consistent regardless of gender, baseline Conn score, duration of current remission, and presence or absence of diabetes mellitus. During the 6-month treatment period, rifaximin also reduced the risk of hepatic encephalopathy-associated hospitalizations by 50% compared with placebo; hepatic encephalopathy-associated hospitalizations were reported in 14 and 23% of patients in the rifaximin and placebo groups, respectively.

Treatment

Although safety and efficacy have not been established, rifaximin also has been used for the treatment of hepatic encephalopathy and is designated an orphan drug by FDA for treatment of this condition.

Efficacy of rifaximin for the treatment of hepatic encephalopathy has been evaluated in several controlled studies and adjunctive use of the drug appears to be effective in reducing blood ammonia concentrations and decreasing the severity of neurologic manifestations. In one double-blind, dose-ranging study, 54 adults with cirrhosis and mild to moderate hepatic encephalopathy were randomized to receive 600, 1200, or 2400 mg of rifaximin daily in 3 divided doses for 7 days. Rifaximin treatment at the 2 higher dosages (1200 or 2400 mg daily) was associated with an improvement in the portal-systemic encephalopathy index (based on mental state, asterixis, number connection test time, EEG mean cycle frequency, and blood ammonia concentrations). In another double-blind study, 58 adults with cirrhosis and portosystemic encephalopathy were randomized to receive 1200 mg of rifaximin daily for 15 days or 30 g of lactulose daily for 15 days. Although clinical improvement in manifestations of portosystemic encephalopathy was reported for both drugs and correlated with reductions in serum ammonia concentrations, data suggested that rifaximin may be better tolerated than lactulose. Clinical improvement was also reported in a case series of 55 adults with cirrhosis and grade 1, 2, and 3 portosystemic encephalopathy treated with rifaximin (1200 mg daily in 3 divided doses) in conjunction with lactulose therapy at a dosage sufficient to induce 2 or 3 evacuations daily.

A meta-analysis of 12 randomized, controlled trials comparing rifaximin to nonabsorbable disaccharides (e.g., lactulose, lactitol) or to other oral anti-infectives (e.g., neomycin, paromomycin) was conducted to assess the efficacy and safety of rifaximin for the treatment of hepatic encephalopathy in adults. Results from an analysis of the 7 studies that compared rifaximin to nonabsorbable disaccharides indicated that resolution or clinical improvement of hepatic encephalopathy occurred with both types of treatment; analysis of the 5 studies that compared rifaximin to other anti-infectives indicated that efficacy of rifaximin was similar to that of neomycin or paromomycin. A combined analysis of all 12 studies indicated that rifaximin was associated with fewer adverse effects than the other treatments.

Information from the American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) regarding the management of hepatic encephalopathy, including recommendations for treatment and prevention of recurrence, is available at http://www.aasld.org.

Irritable Bowel Syndrome with Diarrhea

Rifaximin is used for the treatment of irritable bowel syndrome (IBS) with diarrhea in adults.

Efficacy and safety of rifaximin for the treatment of IBS with diarrhea have been evaluated in 3 randomized, double-blind, placebo-controlled, phase 3 studies.

TARGET 1 (NCT00731679) and TARGET 2 (NCT00724126) were identically designed studies that included a total of 1258 adults who met Rome II criteria for diarrhea-predominant IBS (mean age 46 years, 24-30% male, 89-94% white, 4-10% black); patients with constipation-predominant IBS (according to Rome II criteria) were excluded. After a screening phase of 7-13 days, patients were randomized in a 1:1 ratio to receive rifaximin 550 mg or placebo 3 times daily for 14 days followed by a 10-week treatment-free evaluation period. The primary end point was the proportion of patients who had adequate relief of global IBS symptoms for at least 2 of the 4 weeks during the first month of the treatment-free evaluation period (primary evaluation period). This end point (adequate relief) was defined as a ''yes'' by the patient to a once-weekly subject global assessment question: ''In regard to all your symptoms of IBS, as compared with the way you felt before you started the study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms?''. During the primary evaluation period, adequate relief was experienced by 41% of patients treated with rifaximin and 31-32% of patients treated with placebo. Substantially more patients in the rifaximin group experienced continued relief through 3 months compared with those in the placebo group. In addition, an exploratory, composite end point (defined as at least 30% improvement from baseline in abdominal pain and weekly mean stool consistency score less than 4 for at least 2 of the 4 weeks during the primary evaluation period) was achieved in 47% of patients treated with rifaximin compared with 36-39% of those treated with placebo.

TARGET 3 evaluated efficacy and safety of repeat courses of rifaximin for the treatment of diarrhea-predominant IBS. A total of 2579 adults received open-label rifaximin for 14 days followed by a 4-week treatment-free evaluation period. Of the 2438 evaluable patients, 1074 (44%) responded to initial rifaximin treatment (defined as the composite end point of at least a 30% improvement from baseline in abdominal pain and at least a 50% reduction in the number of days per week with a daily stool consistency of Bristol Stool Scale type 6 or 7). These responders were then followed for recurrence for up to an additional 20-week treatment-free period. A total of 636 initial responders subsequently had recurrence of IBS symptoms (return of abdominal pain or lack of stool consistency for at least 3 weeks during a 4-week follow-up period); the median time to recurrence was 10 weeks (range 6-24 weeks). Patients who experienced recurrence were then enrolled in a double-blind, placebo-controlled, repeat treatment phase and randomized in a 1:1 ratio to receive rifaximin 550 mg or placebo 3 times daily for 2 additional 14-day repeat treatment courses separated by 10 weeks. The primary end point of this randomized portion of the study was the proportion of patients who were responders to repeat treatment in the composite outcome of at least a 30% improvement from baseline in IBS-related abdominal pain and at least a 50% reduction in the number of days per week with a daily stool consistency of Bristol Stool Scale type 6 or 7 during the 4 weeks following the first 14-day repeat treatment course. Response at 4 weeks after completion of the first repeat treatment course was achieved by 38% of patients treated with rifaximin and 31% of those treated with placebo. During the 10-week treatment free follow up period, 17.1 or 11.7% of patients treated with rifaximin or placebo, respectively, had no recurrence of signs and symptoms of IBS.

Travelers' Diarrhea

Rifaximin is used for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults and adolescents 12 years of age and older.

Rifaximin is not effective in and should not be used for the treatment of diarrhea complicated by fever or bloody stools or for the treatment of diarrhea caused by pathogens other than E. coli. Rifaximin is not effective in and should not be used for the treatment of travelers' diarrhea caused by Campylobacter jejuni. In addition, efficacy of the drug has not been established for the treatment of travelers' diarrhea caused by Shigella or Salmonella.(See Precautions Related to Treatment of Travelers' Diarrhea under Cautions: Warnings/Precautions.)

In a multicenter, randomized, double-blind, placebo-controlled study in 380 adults with travelers' diarrhea, including 43 cases caused by enteroaggregative E. coli, treatment with rifaximin (200 mg 3 times daily for 3 days) was associated with a more rapid resolution of diarrhea and an increased rate of clinical cure (defined as 48 hours without unformed stools and without fever or 24 hours without watery stools, no more than 2 soft stools, and absence of other clinical symptoms) compared with placebo. The primary study end point was the median elapsed time after initiating therapy to the passage of the last unformed stool (time to the last unformed stool [TLUS]) and was 32.5 hours in patients treated with rifaximin and 59-60 hours in those treated with placebo. The rate of clinical cure within 5 days (120 hours) of initiating therapy was 79% in those treated with rifaximin and 60-61% in those treated with placebo. Treatment with a higher rifaximin dosage (400 mg 3 times daily) did not provide additional clinical benefit. In this study, the overall rate of microbiological cure (i.e., the absence of E. coli or other pathogen in stool cultured after 72 hours of therapy) in those treated with rifaximin (69%) was similar to the microbiologic cure rate in those treated with placebo (67%).

The most common cause of travelers' diarrhea worldwide is noninvasive enterotoxigenic strains of E. coli, but travelers' diarrhea may be caused by various other bacteria, including enteroadherent and other E. coli pathotypes, C. jejuni, Shigella, Salmonella, Aeromonas, or Plesiomonas. In some cases, travelers' diarrhea is caused by parasitic enteric pathogens (e.g., Giardia duodenalis [also known as G. lamblia or G. intestinalis], Cryptosporidium, Cyclospora, Entamoeba histolytica, Dientamoeba fragilis) or viral enteric pathogens (e.g., norovirus, rotavirus, astrovirus).

Travelers' diarrhea caused by bacteria may be self-limited and often resolves within 3-7 days without anti-infective treatment. If diarrhea is moderate or severe, associated with fever or bloody stools, persisting longer than 3 days, or extremely disruptive to travel plans, short-term (1-3 days) treatment with an anti-infective usually is recommended. Since bacteria are the most common cause of travelers' diarrhea (80-90% of cases), an anti-infective directed against enteric bacterial pathogens is used for empiric treatment. The US Centers for Disease Control and Prevention (CDC) and other experts state that a fluoroquinolone (e.g., ciprofloxacin, levofloxacin) generally is considered the anti-infective of choice for empiric treatment, including self-treatment, of travelers' diarrhea in adults. Azithromycin can be used as a treatment alternative for individuals who should not receive fluoroquinolones (e.g., children, pregnant women) and is a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., South and Southeast Asia) or those who have not responded after 48 hours of fluoroquinolone treatment. Rifaximin can be considered an alternative when the causative organism is enterotoxigenic E. coli; however, since it may be difficult for travelers to distinguish between invasive and noninvasive diarrhea and since travelers would have to carry a back-up anti-infective, the overall usefulness of rifaximin for empiric self-treatment of travelers' diarrhea remains to be determined.

Although safety and efficacy have not been established, rifaximin has been used in some adults for prevention of travelers' diarrhea. Because travelers' diarrhea is a relatively nonthreatening illness that usually is mild and self-limiting and can be effectively treated and because of the risks of widespread use of prophylactic anti-infectives (i.e., potential adverse drug reactions, selection of resistant organisms, increased susceptibility to infections caused by these or other organisms), CDC and other experts state that anti-infective prophylaxis for prevention of travelers' diarrhea is not recommended for most travelers.

For additional information on treatment and prevention of travelers' diarrhea, .

Dosage and Administration

Administration

Rifaximin is administered orally without regard to meals.

Dosage

Hepatic Encephalopathy

For reduction of risk of recurrence of overt hepatic encephalopathy in adults, the recommended dosage of rifaximin is 550 mg twice daily.

For the treatment of hepatic encephalopathy in adults, rifaximin has been given in a dosage of 600-1200 mg daily (usually in 3 divided doses) for 7-21 days .

Irritable Bowel Syndrome with Diarrhea

For the treatment of irritable bowel syndrome (IBS) with diarrhea in adults, the recommended dosage of rifaximin is 550 mg 3 times daily for 14 days. If symptoms recur, up to 2 additional courses of rifaximin may be given using the same 14-day regimen.

Travelers' Diarrhea

For the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults and adolescents 12 years of age or older, the recommended dosage of rifaximin is 200 mg 3 times daily for 3 days. If diarrhea worsens or persists for more than 24-48 hours after initiating rifaximin, the drug should be discontinued and an alternative anti-infective considered.

Special Populations

Hepatic Impairment

Rifaximin dosage adjustment is not necessary in patients with hepatic impairment; however, the drug should be used with caution in patients with severe hepatic impairment (Child-Pugh class C).(See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Renal Impairment

The pharmacokinetics of rifaximin have not been specifically studied in patients with renal impairment; however, clinically important changes in rifaximin elimination are not expected in those with renal impairment since the drug is poorly absorbed from the GI tract and is almost entirely excreted in feces as unchanged drug.

Geriatric Patients

The pharmacokinetics of rifaximin have not been specifically studied in geriatric patients 65 years of age or older.(See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Cautions

Contraindications

Rifaximin is contraindicated in patients with known hypersensitivity to rifaximin, other rifamycin anti-infectives, or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions, including exfoliative dermatitis, rash, angioedema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus, and anaphylaxis, have been reported during postmarketing experience. Such reactions have occurred as soon as 15 minutes after a dose of rifaximin.

Precautions Related to Treatment of Travelers' Diarrhea

Rifaximin should not be used for the treatment of diarrhea complicated by fever or bloody stools or for the treatment of diarrhea known or suspected to be caused by pathogens other than Escherichia coli (e.g., Campylobacter jejuni, Salmonella, Shigella).

If diarrhea worsens or persists for more than 24-48 hours after initiating rifaximin, the drug should be discontinued and treatment with another anti-infective considered.

Interactions

Concomitant use of rifaximin with drugs that are P-glycoprotein (P-gp) transport inhibitors (e.g., cyclosporine) may substantially increase rifaximin systemic exposure. In patients with hepatic impairment, a potential additive effect of reduced hepatic metabolism and concomitant use with P-gp inhibitors may further increase rifaximin exposures. Caution is advised if concomitant use of rifaximin and a P-gp inhibitor is necessary.(See Drug Interactions.)

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) have been reported in patients receiving nearly all anti-infectives, including rifaximin, and may range in severity from mild diarrhea to fatal colitis.C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

CDAD should be considered in the differential diagnosis of patients who develop diarrhea during or after anti-infective therapy. Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, anti-infective therapy not directed against C. difficile should be discontinued whenever possible. Patients should be managed with appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Selection and Use of Anti-infectives

Rifaximin is not suitable for the treatment of systemic bacterial infections because plasma concentrations of the drug are low and variable following oral administration.(See Description.)

To reduce development of drug-resistant bacteria and maintain effectiveness of rifaximin and other antibacterials, the drug should be used only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.

When selecting or modifying anti-infective therapy, results of culture and in vitro susceptibility testing should be used. In the absence of such data, local epidemiology and susceptibility patterns should be considered when selecting anti-infectives for empiric therapy.

Specific Populations

Pregnancy

Data are not available regarding the use of rifaximin in pregnant women. In animal reproduction studies, teratogenic effects (e.g., ocular, oral and maxillofacial, cardiac, and lumbar spine malformations) were observed in rats and rabbits at rifaximin dosages approximately 0.9-5 times and 0.7-33 times, respectively, the recommended human dosage (600-1650 mg daily).

Lactation

It is not known whether rifaximin is distributed into human milk, affects human milk production, or affects the breast-fed infant.

Benefits of breast-feeding and the importance of rifaximin to the woman should be considered along with the potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Pediatric Use

Hepatic encephalopathy: Safety and efficacy of rifaximin have not been established in children and adolescents younger than 18 years of age.

Irritable bowel syndrome (IBS) with diarrhea: Safety and efficacy of rifaximin have not been established in children and adolescents younger than 18 years of age.

Travelers' diarrhea: Safety and efficacy of rifaximin have not been established in children younger than 12 years of age.

Geriatric Use

Hepatic encephalopathy: There were no overall differences in safety or efficacy between patients 65 years of age and older and younger adults in clinical studies (19% of patients were 65 years of age or older); other reported clinical experience has not identified differences in response between geriatric and younger patients, but greater sensitivity in some older individuals cannot be ruled out.

IBS with diarrhea: There were no overall differences in safety or efficacy between patients 65 years of age and older and younger adults in clinical studies (11% of patients were 65 years of age or older); other reported clinical experience has not identified differences in response between geriatric and younger patients, but greater sensitivity in some older individuals cannot be ruled out.

Travelers' diarrhea: Experience in those 65 years of age or older is insufficient to determine whether they respond differently than younger patients.

Hepatic Impairment

Rifaximin should be used with caution in patients with severe hepatic impairment (Child-Pugh class C). Although dosage adjustments are not necessary in patients with hepatic impairment, severe hepatic impairment results in increased rifaximin systemic exposure.

In patients with a history of hepatic encephalopathy, mean rifaximin exposure (area under the plasma concentration-time curve [AUC]) is higher than that reported in healthy individuals. When rifaximin dosage of 550 mg twice daily was evaluated in patients with a history of hepatic encephalopathy, mean systemic exposure in those with mild, moderate, or severe hepatic impairment was approximately 10-, 14-, or 21-fold higher, respectively, than systemic exposure reported in healthy individuals. Clinical trials evaluating rifaximin in patients with a history of hepatic encephalopathy did not include patients with scores exceeding 25 on the model for end-stage liver disease (MELD).

Renal Impairment

The pharmacokinetics of rifaximin have not been specifically studied in patients with renal impairment. Clinically important changes in rifaximin elimination are not expected since the drug is poorly absorbed from the GI tract and is almost entirely excreted in feces.

Common Adverse Effects

Hepatic encephalopathy: Adverse effects occurring in 5% or more of patients receiving rifaximin and at a higher rate than that reported with placebo in clinical trials include peripheral edema, nausea, dizziness, fatigue, ascites, muscle spasms, pruritus, abdominal pain, anemia, depression, nasopharyngitis, upper abdominal pain, arthralgia, dyspnea, pyrexia, and rash.

IBS with diarrhea: Adverse effects occurring in 2% or more of patients receiving rifaximin and at a higher rate than that reported with placebo in clinical trials include nausea and increased ALT concentrations.

Travelers' diarrhea: Adverse effects occurring in 2% or more of patients receiving rifaximin and at a higher rate than that reported with placebo in clinical trials include headache.

Drug Interactions

Drugs Metabolized by Hepatic Microsomal Enzymes

Rifaximin is a substrate of cytochrome P-450 (CYP) isoenzyme 3A4. Based on in vitro studies, rifaximin is not expected to inhibit CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, or 3A4.

Although in vitro studies indicate that rifaximin induces CYP3A4, drug interaction studies with midazolam (a CYP3A4 substrate) indicate that therapeutic dosages of rifaximin do not have clinically important effects on the activity of intestinal or hepatic CYP3A4. In patients with normal hepatic function, pharmacokinetic interactions between rifaximin and drugs metabolized by CYP3A4 are not expected. However, it is not known whether rifaximin can have a clinically important effect on the pharmacokinetics of such drugs in patients with hepatic impairment who have increased plasma concentrations of rifaximin.

Drugs Affecting or Affected by P-glycoprotein Transport

Rifaximin is a substrate of P-glycoprotein (P-gp) transport in vitro. Concomitant use of rifaximin and a P-gp inhibitor (e.g., cyclosporine) may result in substantially increased rifaximin exposures.

Although in vitro studies indicate that rifaximin inhibits P-gp transport, the effect of the drug on P-gp transport in vivo is unknown.

Drugs Affecting or Affected by Organic Anion Transport Polypeptides

Rifaximin is a substrate of organic anion transporting polypeptides (OATP) 1A2, 1B1, and 1B3 in vitro; the drug is not a substrate of OATP2B1.

Although in vitro studies indicate that rifaximin inhibits OATP1B1, 1A2, and 1B3, the effect of the drug on these transporters in vivo is unknown.

Cyclosporine

In healthy individuals, concomitant use of rifaximin (single 550-mg dose) and cyclosporine (single 600-mg dose) results in an 83- and 124-fold increase in rifaximin peak plasma concentrations and area under the plasma concentration-time curve (AUC), respectively. Because cyclosporine inhibits P-gp and OATPs and is a weak inhibitor of CYP3A4, the relative contributions of these effects on rifaximin pharmacokinetics are unknown. In addition, the clinical importance of increased rifaximin systemic exposures in patients receiving cyclosporine is unknown.

Midazolam

Concurrent use of rifaximin (200 mg orally 3 times daily for 3 or 7 days) and a single dose of midazolam (2 mg IV or 6 mg orally) did not substantially alter systemic exposure or elimination of midazolam or its major metabolite (1'-hydroxymidazolam). Concurrent use of rifaximin (550 mg orally 3 times daily for 7 or 14 days) and midazolam (single 2-mg IV dose) resulted in slightly decreased midazolam peak plasma concentrations and AUC; this effect is not considered clinically important.

Dosage adjustment is not necessary if midazolam and rifaximin are used concomitantly.

Hormonal Contraceptives

Concurrent use of rifaximin (200 mg orally 3 times daily for 3 days) and a single dose of an oral estrogen-progestin combination contraceptive (ethinyl estradiol 70 mcg in fixed combination with norgestimate 500 mcg) did not substantially alter the disposition of ethinyl estradiol and norgestimate. Concurrent use of rifaximin (550 mg 3 times daily for 7 days) and a single dose of an oral estrogen-progestin combination contraceptive (ethinyl estradiol 25 mcg in fixed combination with norgestimate 250 mcg) resulted in a 25 and 13% decrease in peak plasma concentrations of ethinyl estradiol and norgestimate, respectively; the mean AUCs of norgestimate metabolites were decreased by 7-11% but the AUC of ethinyl estradiol was not affected. The clinical importance of these effects on estrogen-progestin combination contraceptives is not known.

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