Drugs Details

Drugs Info of Xifaxan
Drugs Details
  • Drugs Type  : FDA
  • Date : 21st Mar 2015 08:10 am
  • Brand Name : Xifaxan
  • Generic Name : rifaximin (Pronunciation: rif AX i min)
Descriptions

XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25-acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below:

 

XIFAXAN® (rifaximin) Structural Formula Illustration

XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin.

Inactive ingredients:

Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.

Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.

What are the possible side effects of rifaximin (Xifaxan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rifaximin and call your doctor at once if you have a fever or diarrhea that is watery or bloody.

Less serious side effects are more likely, and may include:

  • bloating, gas, stomach pain;
  • feeling like you need to empty your bowel urgently;
  • feeling like your bowel is not completely empty;
  • nausea, vomiting, constipation;
  • headache, dizziness;
  • tired feeling;...

Read All Potential Side Effects and See Pictures of Xifaxan »

What are the precautions when taking rifaximin (Xifaxan)?

Before taking rifaximin, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (rifampin, rifabutin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Xifaxan »

This monograph has been modified to include the generic and brand name in many instances.

Indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN  and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or  prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When  culture and susceptibility information are available, they should be considered in selecting or modifying  antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may  contribute to the empiric selection of therapy.

Travelers' Diarrhea

XIFAXAN 200 mg is indicated for the treatment of patients ( ≥ 12 years of age) with travelers'  diarrhea caused by noninvasive strains of Escherichia coli [see WARNINGS AND PRECAUTIONS, CLINICAL  PHARMACOLOGYand Clinical Studies].

Limitations of Use

XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli.

Hepatic Encephalopathy

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. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.

XIFAXAN has not been studied in patients with MELD (Model for End-Stage Liver Disease) 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 [see WARNINGS AND PRECAUTIONS,  Use in Specific Populations, CLINICAL PHARMACOLOGY].

Dosage Administration

Dosage For Travelers' Diarrhea

The recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. XIFAXAN can be administered orally, with or without food [see CLINICAL PHARMACOLOGY].

Dosage For Hepatic Encephalopathy

The recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day, with or without food [see CLINICAL PHARMACOLOGY].

How Supplied

Dosage Forms And Strengths

XIFAXAN is a pink-colored biconvex tablet and is available in the following strengths:

  • 200 mg – a round tablet debossed with “Sx” on one side.
  • 550 mg – an oval tablet debossed with “rfx” on one side.

Storage And Handling

The 200 mg tablet is a pink-colored, round, biconvex tablet with “Sx” debossed on one side. It is available in the following presentations:

NDC 65649-301-03, bottles of 30 tablets
NDC
65649-301-41, bottles of 100 tablets
NDC 65649-301-05, carton of 100 tablets, Unit Dose

The 550 mg tablet is a pink-colored, oval, biconvex tablet with “rfx” debossed on one side. It is available in the following presentations:

NDC 65649-303-02, bottles of 60 tablets
NDC
65649-303-03, carton of 60 tablets, Unit Dose

Storage

Store XIFAXAN Tablets at 20–25°C (68–77°F); excursions permitted to 15–30°C (59-86°F). See USP Controlled Room Temperature.

Manufactured for: Salix Pharmaceuticals, Inc. Raleigh, NC 27615. Revised: March 2014

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Travelers' Diarrhea

The safety of XIFAXAN 200 mg taken three times a day was evaluated in patients with travelers' diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic.

Discontinuations due to adverse reactions occurred in 0.4% of patients. The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irritation.

All adverse reactions for XIFAXAN 200 mg three times daily that occurred at a frequency ≥ 2% in the two placebo-controlled trials combined are provided in Table 1. (These include adverse reactions that may be attributable to the underlying disease.)

Table 1: All Adverse Reactions With an Incidence ≥ 2% Among Patients Receiving XIFAXAN Tablets, 200 mg Three Times Daily, in Placebo-Controlled Studies

MedDRA Preferred Term Number (%) of Patients
XIFAXAN Tablets, 600 mg/day
N = 320
Placebo
N = 228
Flatulence 36 (11%) 45 (20%)
Headache 31 (10%) 21 (9%)
Abdominal Pain NOS* 23 (7%) 23 (10%)
Rectal Tenesmus 23 (7%) 20 (9%)
Defecation Urgency 19 (6%) 21 (9%)
Nausea 17 (5%) 19 (8%)
Constipation 12 (4%) 8 (4%)
Pyrexia 10 (3%) 10 (4%)
Vomiting NOS 7 (2%) 4 (2%)
*NOS: Not otherwise specified

The following adverse reactions, presented by body system, have also been reported in < 2% of patients taking XIFAXAN in the two placebo-controlled clinical trials where the 200 mg tablet was taken three times a day for travelers' diarrhea. The following includes adverse reactions regardless of causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Lymphocytosis, monocytosis, neutropenia

Ear and Labyrinth Disorders: Ear pain, motion sickness, tinnitus

Gastrointestinal Disorders: Abdominal distension, diarrhea NOS, dry throat, fecal abnormality NOS, gingival disorder NOS, inguinal hernia NOS, dry lips, stomach discomfort

General Disorders and Administration Site Conditions: Chest pain, fatigue, malaise, pain NOS, weakness

Infections and Infestations: Dysentery NOS, respiratory tract infection NOS, upper respiratory tract infection NOS

Injury and Poisoning: Sunburn

Investigations: Aspartate aminotransferase increased, blood in stool, blood in urine, weight decreased

Metabolic and Nutritional Disorders: Anorexia, dehydration

Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, muscle spasms, myalgia, neck pain

Nervous System Disorders: Abnormal dreams, dizziness, migraine NOS, syncope, loss of taste

Psychiatric Disorders: Insomnia

Renal and Urinary Disorders: Choluria, dysuria, hematuria, polyuria, proteinuria, urinary frequency

Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea NOS, nasal passage irritation, nasopharyngitis, pharyngitis, pharyngolaryngeal pain, rhinitis NOS, rhinorrhea

Skin and Subcutaneous Tissue Disorders: Clamminess, rash NOS, sweating increased

Vascular Disorders: Hot flashes NOS

Hepatic Encephalopathy

The data described below reflect exposure to XIFAXAN 550 mg in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days). The safety of XIFAXAN 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebo-controlled clinical trial (n = 140) and in a long term follow-up study (n = 280). The population studied had a mean age of 56.26 (range: 21-82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black. Ninety-one percent of patients in the trial were taking lactulose concomitantly. All adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in XIFAXAN 550 mg-treated subjects than in the placebo group in the 6-month trial are provided in Table 2. (These include adverse events that may be attributable to the underlying disease).

Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Receiving XIFAXAN and at a Higher Incidence Than Placebo

MedDRA Preferred Term Number (%) of Patients
XIFAXAN Tablets 550 mg TWICE DAILY
N = 140
Placebo
N = 159
Edema peripheral 21 (15%) 13 (8%)
Nausea 20 (14%) 21 (13%)
Dizziness 18 (13%) 13 (8%)
Fatigue 17 (12%) 18 (11%)
Ascites 16 (11%) 15 (9%)
Muscle spasms 13 (9%) 11 (7%)
Pruritus 13 (9%) 10 (6%)
Abdominal pain 12 (9%) 13 (8%)
Abdominal distension 11 (8%) 12 (8%)
Anemia 11 (8%) 6 (4%)
Cough 10 (7%) 11 (7%)
Depression 10 (7%) 8 (5%)
Insomnia 10 (7%) 11 (7%)
Nasopharyngitis 10 (7%) 10 (6%)
Abdominal pain upper 9 (6%) 8 (5%)
Arthralgia 9 (6%) 4 (3%)
Back pain 9 (6%) 10 (6%)
Constipation 9 (6%) 10 (6%)
Dyspnea 9 (6%) 7 (4%)
Pyrexia 9 (6%) 5 (3%)
Rash 7 (5%) 6 (4%)

The following adverse reactions, presented by body system, have also been reported in the placebo-controlled clinical trial in greater than 2% but less than 5% of patients taking XIFAXAN 550 mg taken orally two times a day for hepatic encephalopathy. The following includes adverse events occurring at a greater incidence than placebo, regardless of causal relationship to drug exposure.

Ear and Labyrinth Disorders: Vertigo

Gastrointestinal Disorders: Abdominal pain lower, abdominal tenderness, dry mouth, esophageal variceal bleed, stomach discomfort

General Disorders and Administration Site Conditions: Chest pain, generalized edema, influenza like illness, pain NOS

Infections and Infestations: Cellulitis, pneumonia, rhinitis, upper respiratory tract infection NOS

Injury, Poisoning and Procedural Complications: Contusion, fall, procedural pain

Investigations: Weight increased

Metabolic and Nutritional Disorders: Anorexia, dehydration, hyperglycemia, hyperkalemia, hypoglycemia, hyponatremia

Musculoskeletal, Connective Tissue, and Bone Disorders: Myalgia, pain in extremity

Nervous System Disorders: Amnesia, disturbance in attention, hypoesthesia, memory impairment, tremor

Psychiatric Disorders: Confusional state

Respiratory, Thoracic, and Mediastinal Disorders: Epistaxis

Vascular Disorders: Hypotension

Postmarketing Experience

The following adverse reactions have been identified during post approval use of XIFAXAN. Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to XIFAXAN.

Infections and Infestations

Cases of C. difficile-associated colitis have been reported [see WARNINGS AND PRECAUTIONS].

General

Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported. These events occurred as early as within 15 minutes of drug administration.

Read the Xifaxan (rifaximin) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Effects Of Rifaximin On Cytochrome P450 Enzymes

In vitro studies have shown that rifaximin did not inhibit cytochrome P450 isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 and CYP3A4 at concentrations ranging from 2 to 200 ng/mL [see CLINICAL PHARMACOLOGY]. Rifaximin is not expected to inhibit these enzymes in clinical use. An in vitro study has suggested that rifaximin induces CYP3A4 [see CLINICAL PHARMACOLOGY]. However, in patients with normal liver function, rifaximin at the recommended dosing regimen is not expected to induce CYP3A4. It is unknown whether rifaximin can have a significant effect on the pharmacokinetics of concomitant CYP3A4 substrates in patients with reduced liver function who have elevated rifaximin concentrations.

Concomitant P-glycoprotein Inhibitors

An in vitro study suggested that rifaximin is a substrate of P-glycoprotein. Co-administration of cyclosporine, a potent P-glycoprotein inhibitor, with rifaximin resulted in 83-fold and 124-fold increases in rifaximin mean Cmax and AUC∞ in healthy subjects. The clinical significance of this increase in systemic exposure is unknown [see CLINICAL PHARMACOLOGY].

Read the Xifaxan Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Travelers' Diarrhea Not Caused By Escherichia coli

XIFAXAN was not found to be effective in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than Escherichia coli.

Discontinue XIFAXAN if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered.

XIFAXAN is not effective in cases of travelers' diarrhea due to Campylobacter jejuni. The  effectiveness of XIFAXAN in travelers' diarrhea caused by Shigella spp. and Salmonella spp. has not  been proven. XIFAXAN should not be used in patients where Campylobacter jejuni, Shigella spp., or  Salmonella spp. may be suspected as causative pathogens.

Clostridium difficile-Associated Diarrhea

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.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Development Of Drug Resistant Bacteria

Prescribing XIFAXAN for travelers' diarrhea in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Severe (Child-Pugh C) Hepatic Impairment

There is increased systemic exposure in patients with severe hepatic impairment. The clinical trials were limited to patients with MELD scores < 25. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations and Clinical Studies].

Concomitant Use With P-glycoprotein Inhibitors

Concomitant administration of drugs that are P-glycoprotein inhibitors with rifaximin can substantially increase the systemic exposure to rifaximin. Caution should be exercised when concomitant use of rifaximin and a P-glycoprotein inhibitor such as cyclosporine is needed. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-glycoprotein inhibitors may further increase the systemic exposure to rifaximin [see DRUG INTERACTIONS and Pharmacokinetics].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Malignant schwannomas in the heart were significantly increased in male Crl:CD® (SD) rats that received rifaximin by oral gavage for two years at 150 to 250 mg/kg/day (doses equivalent to 2.4 to 4 times the recommended dose of 200 mg three times daily for travelers' diarrhea, and equivalent to 1.3 to 2.2 times the recommended dose of 550 mg twice daily for hepatic encephalopathy, based on relative body surface area comparisons). There was no increase in tumors in Tg.rasH2 mice dosed orally with rifaximin for 26 weeks at 150 to 2000 mg/kg/day (doses equivalent to 1.2 to 16 times the recommended daily dose for travelers' diarrhea and equivalent to 0.7 to 9 times the recommended daily dose for hepatic encephalopathy, based on relative body surface area comparisons).

Rifaximin was not genotoxic in the bacterial reverse mutation assay, chromosomal aberration assay, rat bone marrow micronucleus assay, rat hepatocyte unscheduled DNA synthesis assay, or the CHO/HGPRT mutation assay. There was no effect on fertility in male or female rats following the administration of rifaximin at doses up to 300 mg/kg (approximately 5 times the clinical dose of 600 mg/day, and approximately 2.6 times the clinical dose of 1100 mg/day, adjusted for body surface area).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well controlled studies in pregnant women. Rifaximin has been shown to be teratogenic in rats and rabbits at doses that caused maternal toxicity. XIFAXAN tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Administration of rifaximin to pregnant rats and rabbits at dose levels that caused reduced body weight gain resulted in eye malformations in both rat and rabbit fetuses. Additional malformations were observed in fetal rabbits that included cleft palate, lumbar scoliosis, brachygnathia, interventricular septal defect, and large atrium.

The fetal rat malformations were observed in a study of pregnant rats administered a high dose that resulted in 16 times the therapeutic dose to diarrheic patients or 1 times the therapeutic dose to patients with hepatic encephalopathy (based upon plasma AUC comparisons). Fetal rabbit malformations were observed from pregnant rabbits administered mid and high doses that resulted in 1 or 2 times the therapeutic dose to diarrheic patients or less than 0.1 times the dose in patients with hepatic encephalopathy, based upon plasma AUC comparisons.

Post-natal developmental effects were not observed in rat pups from pregnant/lactating female rats dosed during the period from gestation to Day 20 post-partum at the highest dose which resulted in approximately 16 times the human therapeutic dose for travelers' diarrhea (based upon AUCs) or approximately 1 times the AUCs derived from therapeutic doses to patients with hepatic encephalopathy.

Nursing Mothers

It is not known whether rifaximin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from XIFAXAN, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of XIFAXAN 200 mg in pediatric patients with travelers' diarrhea less than 12 years of age have not been established. The safety and effectiveness of XIFAXAN 550 mg for HE have not been established in patients < 18 years of age.

Geriatric Use

Clinical studies with rifaximin 200 mg for travelers' diarrhea did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger subjects.

In the controlled trial with XIFAXAN 550 mg for hepatic encephalopathy, 19.4% were 65 and over, while 2.3% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment

The pharmacokinetics of rifaximin in patients with impaired renal function has not been studied.

Hepatic Impairment

Following administration of XIFAXAN 550 mg twice daily to patients with a history of hepatic encephalopathy, the systemic exposure (i.e., AUCτ) of rifaximin was about 10-, 13-, and 20-fold higher in those patients with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, respectively, compared to that in healthy volunteers. No dosage adjustment is recommended because rifaximin is presumably acting locally. Nonetheless, caution should be exercised when XIFAXAN is administered to patients with severe hepatic impairment [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY and Clinical Studies].

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No specific information is available on the treatment of overdosage with XIFAXAN. In clinical studies at doses higher than the recommended dose (> 600 mg/day for travelers' diarrhea or > 1100 mg/day for hepatic encephalopathy), adverse reactions were similar in subjects who received doses higher than the recommended dose and placebo. In the case of overdosage, discontinue XIFAXAN, treat symptomatically, and institute supportive measures as required.

ContrainDications

Hypersensitivity

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 [see ADVERSE REACTIONS].

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

Rifaximin is an antibacterial drug.

Pharmacokinetics

Absorption

Travelers' Diarrhea

Systemic absorption of rifaximin (200 mg three times daily) was evaluated in 13 subjects challenged with shigellosis on Days 1 and 3 of a three-day course of treatment. Rifaximin plasma concentrations and exposures were low and variable. There was no evidence of accumulation of rifaximin following repeated administration for 3 days (9 doses). Peak plasma rifaximin concentrations after 3 and 9 consecutive doses ranged from 0.81 to 3.4 ng/mL on Day 1 and 0.68 to 2.26 ng/mL on Day 3. Similarly, AUC0-last estimates were 6.95 ± 5.15 ng•h/mL on Day 1 and 7.83 ± 4.94 ng•h/mL on Day 3. XIFAXAN is not suitable for treating systemic bacterial infections because of limited systemic exposure after oral administration [see WARNINGS AND PRECAUTIONS].

Hepatic Encephalopathy

After a single dose and multiple doses of rifaximin 550 mg in healthy subjects, the mean time to reach peak plasma concentrations was about an hour. The pharmacokinetic (PK) parameters were highly variable and the accumulation ratio based on AUC was 1.37.

The PK of rifaximin in patients with a history of HE was evaluated after administration of XIFAXAN, 550 mg two times a day. The PK parameters were associated with a high variability and mean rifaximin exposure (AUCτ) in patients with a history of HE (147 ng•h/mL) was approximately 12fold higher than that observed in healthy subjects following the same dosing regimen (12.3 ng•h/mL). When PK parameters were analyzed based on Child-Pugh Class A, B, and C, the mean AUCτ was 10-, 13-, and 20-fold higher, respectively, compared to that in healthy subjects (Table 3).

Table 3: Mean (± SD) Pharmacokinetic Parameters of Rifaximin at Steady-State in Patients with a History of Hepatic Encephalopathy by Child-Pugh Class1

  Healthy Subjects
(n = 14)
Child-Pugh Class
A
(n = 18)
B
(n = 7)
C
(n = 4)
AUCtau (ng•h/mL) 12.3 ± 4.8 118 ± 67.8 161 ± 101 246 ± 120
Cmax (ng/mL) 3.4 ± 1.6 19.5 ± 11.4 25.1 ± 12.6 35.5 ± 12.5
Tmax2 (h) 0.8 (0.5, 4.0) 1 (0.9, 10) 1 (0.97, 1) 1 (0, 2)
1Cross-study comparison with PK parameters in healthy subjects
2Median (range)
Food Effect In Healthy Subjects

A high-fat meal consumed 30 minutes prior to XIFAXAN dosing in healthy subjects delayed the mean time to peak plasma concentration from 0.75 to 1.5 hours and increased the systemic exposure (AUC) of rifaximin by 2-fold (Table 4).

Table 4: Mean (± SD) Pharmacokinetic Parameters After Single-Dose Administration of XIFAXAN Tablets 550 mg in Healthy Subjects Under Fasting and Fed Conditions (N = 12)

Parameter Fasting Fed
Cmax (ng/mL) 4.1 ± 1.5 4.8 ± 4.3
Tmax1 (h) 0.8 (0.5, 2.1) 1.5 (0.5, 4.1)
Half-Life (h) 1.8 ± 1.4 4.8 ± 1.3
AUC (ng•h/mL) 11.1 ± 4.2 22.5 ± 12
1Median (range)

XIFAXAN can be administered with or without food [see DOSAGE AND ADMINISTRATION].

Distribution

Rifaximin is moderately bound to human plasma proteins. In vivo, the mean protein binding ratio was 67.5% in healthy subjects and 62% in patients with hepatic impairment when XIFAXAN 550 mg was administered.

Metabolism and Excretion

In a mass balance study, after administration of 400 mg 14C-rifaximin orally to healthy volunteers, of the 96.94% total recovery, 96.62% of the administered radioactivity was recovered in feces almost exclusively as the unchanged drug and 0.32% was recovered in urine mostly as metabolites with 0.03% as the unchanged drug. Rifaximin accounted for 18% of radioactivity in plasma. This suggests that the absorbed rifaximin undergoes metabolism with minimal renal excretion of the unchanged drug. The enzymes responsible for metabolizing rifaximin are unknown.

In a separate study, rifaximin was detected in the bile after cholecystectomy in patients with intact gastrointestinal mucosa, suggesting biliary excretion of rifaximin.

Specific Populations

Hepatic Impairment

The systemic exposure of rifaximin was markedly elevated in patients with hepatic impairment compared to healthy subjects. The mean AUC in patients with Child-Pugh Class C hepatic impairment was 2-fold higher than in patients with Child-Pugh Class A hepatic impairment (see Table 3), [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Renal Impairment

The pharmacokinetics of rifaximin in patients with impaired renal function has not been studied.

Drug Interactions

In vitro drug interaction studies have shown that rifaximin, at concentrations ranging from 2 to 200 ng/mL, did not inhibit human hepatic cytochrome P450 isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, and 3A4.

In an in vitro study, rifaximin was shown to induce CYP3A4 at the concentration of 0.2 μM.

An in vitro study suggests that rifaximin is a substrate of P-glycoprotein. In the presence of P-glycoprotein inhibitor verapamil, the efflux ratio of rifaximin was reduced greater than 50% in vitro. Following co-administration of a single 600-mg dose of cyclosporine, a potent inhibitor of P-glycoprotein and a weak inhibitor of CYP3A4, OATP, and BCRP, with a single dose of rifaximin 550 mg, rifaximin mean Cmax was increased 83-fold, from 0.48 to 40.0 ng/mL; mean AUC∞ was increased 124-fold, from 2.54 to 314 ng.h/mL.

An inhibitory effect of rifaximin on P-gp transport was observed in an in vitro study. The effect of rifaximin on P-gp transporter inhibition was not evaluated in vivo.

Midazolam

The effect of rifaximin 200 mg administered orally every 8 hours for 3 days and for 7 days on the pharmacokinetics of a single dose of either midazolam 2 mg intravenous or midazolam 6 mg orally was evaluated in healthy subjects. No significant difference was observed in the metrics of systemic exposure or elimination of intravenous or oral midazolam or its major metabolite, 1'-hydroxymidazolam, between midazolam alone or together with rifaximin. Therefore, rifaximin was not shown to significantly affect intestinal or hepatic CYP3A4 activity for the 200 mg three times a day dosing regimen.

After XIFAXAN 550 mg was administered three times a day for 7 days and 14 days to healthy subjects, the mean AUC of single midazolam 2 mg orally was 3.8% and 8.8% lower, respectively, than when midazolam was administered alone. The mean Cmax of midazolam was also decreased by 4-5% when XIFAXAN was administered for 7-14 days prior to midazolam administration. This degree of interaction is not considered clinically meaningful.

The effect of rifaximin on CYP3A4 in patients with impaired liver function who have elevated systemic exposure is not known.

Oral Contraceptives Containing 0.07 mg Ethinyl Estradiol and 0.5 mg Norgestimate

The oral contraceptive study utilized an open-label, crossover design in 28 healthy female subjects to determine if rifaximin 200 mg orally administered three times a day for 3 days (the dosing regimen for travelers' diarrhea) altered the pharmacokinetics of a single dose of an oral contraceptive containing 0.07 mg ethinyl estradiol and 0.5 mg norgestimate. Results showed that the pharmacokinetics of single doses of ethinyl estradiol and norgestimate were not altered by rifaximin.

Effect of rifaximin on oral contraceptives was not studied for XIFAXAN 550 mg twice a day, the dosing regimen for hepatic encephalopathy.

Microbiology

Mechanism of Action

Rifaximin is a non-aminoglycoside semi-synthetic antibacterial derived from rifamycin SV. Rifaximin acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase resulting in inhibition of bacterial RNA synthesis.

Drug Resistance and Cross-Resistance

Escherichia coli has been shown to develop resistance to rifaximin in vitro. However, the clinical significance of such an effect has not been studied.

Rifaximin is a structural analog of rifampin. Organisms with high rifaximin minimum inhibitory concentration (MIC) values also have elevated MIC values against rifampin. Cross-resistance between rifaximin and other classes of antimicrobials has not been studied.

Activity In Vitro and in Critical Infections

Rifaximin has been shown to be active against the following pathogen in clinical studies of infectious diarrhea as described in the Indications and Usage (1) section: Escherichia coli (enterotoxigenic and enteroaggregative strains).

For HE, rifaximin is thought to have an effect on the gastrointestinal flora.

Susceptibility Tests

In vitro susceptibility testing was performed according to the Clinical and Laboratory Standards Institute (CLSI) agar dilution method M7-A9 [see REFERENCES]. However, the correlation between susceptibility testing and clinical outcome has not been determined.

Clinical Studies

Travelers' Diarrhea

The efficacy of XIFAXAN given as 200 mg orally taken three times a day for 3 days was evaluated in 2 randomized, multi-center, double-blind, placebo-controlled studies in adult subjects with travelers' diarrhea. One study was conducted at clinical sites in Mexico, Guatemala, and Kenya (Study 1). The other study was conducted in Mexico, Guatemala, Peru, and India (Study 2). Stool specimens were collected before treatment and 1 to 3 days following the end of treatment to identify enteric pathogens. The predominant pathogen in both studies was Escherichia coli.

The clinical efficacy of XIFAXAN was assessed by the time to return to normal, formed stools and resolution of symptoms. The primary efficacy endpoint was time to last unformed stool (TLUS) which was defined as the time to the last unformed stool passed, after which clinical cure was declared. Table 5 displays the median TLUS and the number of patients who achieved clinical cure for the intent to treat (ITT) population of Study 1. The duration of diarrhea was significantly shorter in patients treated with XIFAXAN than in the placebo group. More patients treated with XIFAXAN were classified as clinical cures than were those in the placebo group.

Table 5: Clinical Response in Study 1 (ITT population)

  XIFAXAN
(n=125)
Placebo
(n=129)
Estimate (97.5% CI) P-Value
Median TLUS (hours) 32.5 58.6 1.78a
(1.26, 2.50)
0.0002
Clinical cure, n (%) 99 (79.2) 78 (60.5) 18.7b
(5.3, 32.1)
0.001
a Hazard Ratio
bDifference in rates

Microbiological eradication (defined as the absence of a baseline pathogen in culture of stool after 72 hours of therapy) rates for Study 1 are presented in Table 6 for patients with any pathogen at baseline and for the subset of patients with Escherichia coli at baseline. Escherichia coli was the only pathogen with sufficient numbers to allow comparisons between treatment groups.

Even though XIFAXAN had microbiologic activity similar to placebo, it demonstrated a clinically significant reduction in duration of diarrhea and a higher clinical cure rate than placebo. Therefore, patients should be managed based on clinical response to therapy rather than microbiologic response.

Table 6: Microbiologic Eradication Rates in Study 1 Subjects with a Baseline Pathogen

  XIFAXAN Placebo
Overall 48/70 (68.6) 41/61 (67.2)
E. coli 38/53 (71.7) 40/54 (74.1)

The results of Study 2 supported the results presented for Study 1. In addition, this study provided evidence that subjects treated with XIFAXAN with fever and/or blood in the stool at baseline had prolonged TLUS. These subjects had lower clinical cure rates than those without fever or blood in the stool at baseline. Many of the patients with fever and/or blood in the stool (dysentery-like diarrheal syndromes) had invasive pathogens, primarily Campylobacter jejuni, isolated in the baseline stool.

Also in this study, the majority of the subjects treated with XIFAXAN who had Campylobacter jejuni isolated as a sole pathogen at baseline failed treatment and the resulting clinical cure rate for these patients was 23.5% (4/17). In addition to not being different from placebo, the microbiologic eradication rates for subjects with Campylobacter jejuni isolated at baseline were much lower than the eradication rates seen for Escherichia coli.

In an unrelated open-label, pharmacokinetic study of oral XIFAXAN 200 mg taken every 8 hours for 3 days, 15 adult subjects were challenged with Shigella flexneri 2a, of whom 13 developed diarrhea or dysentery and were treated with XIFAXAN. Although this open-label challenge trial was not adequate to assess the effectiveness of XIFAXAN in the treatment of shigellosis, the following observations were noted: eight subjects received rescue treatment with ciprofloxacin either because of lack of response to XIFAXAN treatment within 24 hours (2), or because they developed severe dysentery (5), or because of recurrence of Shigella flexneri in the stool (1); five of the 13 subjects received ciprofloxacin although they did not have evidence of severe disease or relapse.

Hepatic Encephalopathy

The efficacy of XIFAXAN 550 mg taken orally two times a day was evaluated in a randomized, placebo-controlled, double-blind, multi-center 6-month trial of adult subjects from the U.S., Canada and Russia who were defined as being in remission (Conn score of 0 or 1) from hepatic encephalopathy (HE). Eligible subjects had ≥ 2 episodes of HE associated with chronic liver disease in the previous 6 months.

A total of 299 subjects were randomized to receive either XIFAXAN (n=140) or placebo (n=159) in this study. Patients had a mean age of 56 years (range, 21-82 years), 81% < 65 years of age, 61% were male and 86% White. At baseline, 67% of patients had a Conn score of 0 and 68% had an asterixis grade of 0. Patients had MELD scores of either ≤ 10 (27%) or 11 to 18 (64%) at baseline. No patients were enrolled with a MELD score of > 25. Nine percent of the patients were Child-Pugh Class C. Lactulose was concomitantly used by 91% of the patients in each treatment arm of the study. Per the study protocol, patients were withdrawn from the study after experiencing a breakthrough HE episode. Other reasons for early study discontinuation included: adverse reactions (XIFAXAN 6%; placebo 4%), patient request to withdraw (XIFAXAN 4%; placebo 6%) and other (XIFAXAN 7%; placebo 5%).

The primary endpoint was the time to first breakthrough overt HE episode. A breakthrough overt HE episode was defined as a marked deterioration in neurological function and an increase of Conn score to Grade ≥ 2. In patients with a baseline Conn score of 0, a breakthrough overt HE episode was defined as an increase in Conn score of 1 and asterixis grade of 1.

Breakthrough overt HE episodes were experienced by 31 of 140 subjects (22%) in the XIFAXAN group and by 73 of 159 subjects (46%) in the placebo group during the 6-month treatment period. Comparison of Kaplan-Meier estimates of event-free curves showed XIFAXAN significantly reduced the risk of HE breakthrough by 58% during the 6-month treatment period. Presented below in Figure 1 is the Kaplan-Meier event-free curve for all subjects (n = 299) in the study.

Figure 1: Kaplan-Meier Event-Free Curves1 in HE Study (Time to First Breakthrough-HE Episode up to 6 Months of Treatment, Day 170) (ITT Population)

View Enlarged Table

When the results were evaluated by the following demographic and baseline characteristics, the treatment effect of XIFAXAN 550 mg in reducing the risk of breakthrough overt HE recurrence was consistent for: sex, baseline Conn score, duration of current remission and diabetes. The differences in treatment effect could not be assessed in the following subpopulations due to small sample size: non-White (n=42), baseline MELD > 19 (n=26), Child-Pugh C (n=31), and those without concomitant lactulose use (n=26).

HE-related hospitalizations (hospitalizations directly resulting from HE, or hospitalizations complicated by HE) were reported for 19 of 140 subjects (14%) and 36 of 159 subjects (23%) in the XIFAXAN and placebo groups respectively. Comparison of Kaplan-Meier estimates of event-free curves showed XIFAXAN significantly reduced the risk of HE-related hospitalizations by 50% during the 6month treatment period. Comparison of Kaplan-Meier estimates of event-free curves is shown in Figure 2.

Figure 2: Kaplan-Meier Event-Free Curves1 in Pivotal HE Study (Time to First HE-Related Hospitalization in HE Study up to 6 Months of Treatment, Day 170) (ITT Population)

View Enlarged Table

REFERENCES

Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Persistent Diarrhea

For those patients being treated for travelers' diarrhea, discontinue XIFAXAN if diarrhea persists more than 24-48 hours or worsens. Advise the patient to seek medical care for fever and/or blood in the stool [see WARNINGS AND PRECAUTIONS].

Clostridium difficile-Associated Diarrhea

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 antibiotics alters the normal flora of the colon which may lead to C. difficile. Patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If diarrhea occurs after therapy or does not improve or worsens during therapy, advise patients to contact a physician as soon as possible [see WARNINGS AND PRECAUTIONS].

Administration With Food

Inform patients that XIFAXAN may be taken with or without food.

Antibacterial Resistance

Counsel patients that antibacterial drugs including XIFAXAN should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When XIFAXAN is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by XIFAXAN or other antibacterial drugs in the future.

Severe Hepatic Impairment

Patients should be informed that in patients with severe hepatic impairment (Child-Pugh C) there is an increase in systemic exposure to XIFAXAN [see WARNINGS AND PRECAUTIONS].

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

RIFAXIMIN - ORAL

 

(rif-AX-i-min)

 

COMMON BRAND NAME(S): Xifaxan

 

USES: This medication is used to treat diarrhea caused by the common bacteria known as E. coli ("traveler's diarrhea"). Rifaximin should not be used if you have a fever or bloody diarrhea. This medication stays in the digestive system and is not absorbed into the blood. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Rifaximin is also used to prevent a brain problem caused by liver disease (hepatic encephalopathy). It may help to improve mental status.

 

HOW TO USE: Your dosage is based on your medical condition and response to treatment.

To treat traveler's diarrhea, take this medication by mouth with or without food as directed by your doctor, usually 3 times a day for 3 days.

To prevent hepatic encephalopathy, take this medication by mouth with or without food as directed by your doctor, usually 2 times a day.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

For traveler's diarrhea, continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Tell your doctor if you are still having diarrhea after 1-2 days, if you have bloody diarrhea, or if you have a fever along with the diarrhea. Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Xifaxan (rifaximin) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking rifaximin, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (rifampin, rifabutin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: live vaccines.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Xifaxan

Generic Name: rifaximin (Pronunciation: rif AX i min)

  • What is rifaximin (Xifaxan)?
  • What are the possible side effects of rifaximin (Xifaxan)?
  • What is the most important information I should know about rifaximin (Xifaxan)?
  • What should I discuss with my healthcare provider before taking rifaximin (Xifaxan)?
  • How should I take rifaximin (Xifaxan)?
  • What happens if I miss a dose (Xifaxan)?
  • What happens if I overdose (Xifaxan)?
  • What should I avoid while taking rifaximin (Xifaxan)?
  • What other drugs will affect rifaximin (Xifaxan)?
  • Where can I get more information?

What is rifaximin (Xifaxan)?

Rifaximin is an antibiotic that fights bacterial infection only in the intestines.

Rifaximin works differently from other antibiotics because it passes through your stomach and into your intestines without being absorbed into your blood stream. Because rifaximin treats only the intestinal tract, it will not treat infections of other parts of the body.

Rifaximin is used to treat travelers' diarrhea caused by E. coli in adults and children who are at least 12 years old. Most people get this infection by eating food or drinking fluids that have been contaminated with the bacteria.

Rifaximin is also used to lower the risk of worsened brain function, or hepatic encephalopathy (he-PAT-ik en-SEF-a-LOP-ath-ee), in adults with liver failure. Brain function can be affected when the liver stops working and cannot remove toxic substances from the body.

Rifaximin may also be used for other purposes not listed in this medication guide.

Xifaxan 200 mg

round, brown, imprinted with XS

What are the possible side effects of rifaximin (Xifaxan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rifaximin and call your doctor at once if you have a fever or diarrhea that is watery or bloody.

Less serious side effects are more likely, and may include:

  • bloating, gas, stomach pain;
  • feeling like you need to empty your bowel urgently;
  • feeling like your bowel is not completely empty;
  • nausea, vomiting, constipation;
  • headache, dizziness;
  • tired feeling; or
  • swelling in your hands, feet, or torso.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Xifaxan (rifaximin) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about rifaximin (Xifaxan)?

Rifaximin works differently from other antibiotics because it passes through your stomach and into your intestines without being absorbed into your blood stream. Because rifaximin affects only the intestinal tract, it will not treat infections of other parts of the body.

You should not use take this medication if you are allergic to rifaximin or medications such as rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), or rifapentine (Priftin).

Before you take rifaximin, tell your doctor if you have severe liver disease, diarrhea with fever, or diarrhea that is watery or has blood in it.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Rifaximin will not treat a viral infection such as the common cold or flu, or any form of diarrhea that is caused by a virus.

Call your doctor if your symptoms do not improve after 24 hours, or if they get worse while taking rifaximin. Rifaximin does not treat all bacterial forms of traveler's diarrhea.

Side Effects Centers
  • Xifaxan

Patient Detailed How Take

What should I discuss with my healthcare provider before taking rifaximin (Xifaxan)?

You should not use take this medication if you are allergic to rifaximin or medications such as rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), or rifapentine (Priftin).

If you have any of these other conditions, you may need a rifaximin dose adjustment or special tests:

  • severe liver disease;
  • diarrhea with a fever; or
  • watery or bloody diarrhea.

FDA pregnancy category C. It is not known whether rifaximin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether rifaximin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take rifaximin (Xifaxan)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Rifaximin can be taken with or without food.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Rifaximin will not treat a viral infection such as the common cold or flu, or any form of diarrhea that is caused by a virus.

Call your doctor if your symptoms do not improve after 24 hours, or if they get worse while taking rifaximin. Rifaximin does not treat all bacterial forms of traveler's diarrhea.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Xifaxan

Patient Detailed Avoid Taking

What happens if I miss a dose (Xifaxan)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Xifaxan)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking rifaximin (Xifaxan)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking rifaximin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What other drugs will affect rifaximin (Xifaxan)?

There may be other drugs that can interact with rifaximin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about rifaximin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 3.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Xifaxan

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI