XIFAXAN 200/MG FC TAB 12/FC TAB

Indications

Approved Uses

Treatment of traveler's diarrhea caused by noninvasive strains of Escherichia coli in adults and children 12 years and older, reduction in risk of overt hepatic encephalopathy recurrence in adults, treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Off-Label Uses

Small intestinal bacterial overgrowth (SIBO); pouchitis (adjunct/selected cases); diverticular disease/symptomatic uncomplicated diverticular disease (selected practices).

Dosage & Administration

Dosing by Condition

Traveler’s diarrhea (noninvasive E. coli): 200 mg orally three times daily for 3 days

Initial Dose

Traveler's Diarrhea: 200mg three times daily for 3 days.

Maintenance Dose

200mg three times daily for 3 days (traveler's diarrhea)

Maximum Dose

Traveler’s diarrhea: 200 mg PO three times daily (max 600 mg/day) for 3 days.

Children's Dosage

Traveler's diarrhea: approved for children ≥12 years at adult dose (200mg three times daily for 3 days). Not approved for children under 12 years for any indication.

Dose Adjustment Notes

Renal impairment: no dose adjustment generally required; hepatic impairment: use caution in severe hepatic impairment (Child-Pugh C) due to increased systemic exposure-no specific dose adjustment established.

How to Take

Swallow the tablet whole with water; may be taken with or without food; take exactly as prescribed and complete the course.

Side Effects

Common Side Effects

Nausea, abdominal pain, flatulence, headache, dizziness, fatigue, constipation; peripheral edema (swelling of hands/feet) can occur.

Side Effect Frequency

Varies by indication; commonly reported (1-10%) include nausea, headache, abdominal pain, dizziness, fatigue, flatulence/constipation. Peripheral edema and ascites are common mainly in hepatic encephalopathy populations; serious but uncommon includes C. difficile-associated diarrhea and hypersensitivity.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to rifaximin, other rifamycin-class antibacterials, or any component/excipient.

Warnings & Precautions

Traveler’s diarrhea limitation: not for diarrhea with fever and/or blood in stool or suspected invasive pathogens (e.g., Campylobacter, Shigella, Salmonella); reassess/stop and seek alternative therapy if symptoms worsen or persist beyond ~24-48 hours. Risk of CDAD. Use caution in severe hepatic impairment (Child-Pugh C) due to increased systemic exposure.

Age Restriction

Traveler’s diarrhea (noninvasive E. coli): approved for adults and pediatric patients ≥12 years. Hepatic encephalopathy recurrence reduction: adults ≥18 years. IBS-D: adults ≥18 years.

Drug Interactions

Drug Interactions

Key interaction: cyclosporine (strong P-gp inhibitor) can markedly increase rifaximin systemic exposure-use caution/monitor. Live oral vaccines (cholera, oral typhoid) may have reduced efficacy with concurrent antibiotics; avoid coadministration. Clinically significant warfarin/OCP interactions are not established but monitor INR if on warfarin as with other antibiotics.

Interaction Severity

MODERATE: cyclosporine (can increase rifaximin systemic exposure); AVOID/CONTRAINDICATED: live bacterial vaccines such as oral cholera vaccine (reduced vaccine efficacy).

Food Interaction

No clinically meaningful food restriction-may be taken with or without food.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Traveler's diarrhea: approved for children ≥12 years at adult dose (200mg three times daily for 3 days). Not approved for children under 12 years for any indication.

Elderly

Standard adult dosing; no specific adjustment required based on age alone

Kidney Impairment

No adjustment needed.

Liver Impairment

Child-Pugh A/B: no dosage adjustment. Child-Pugh C: no defined adjustment, but use with caution due to increased systemic exposure.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next dose; if close, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Complete the prescribed course for traveler’s diarrhea/IBS-D; for hepatic encephalopathy, do not discontinue without prescriber guidance due to risk of recurrence.

Overdose

In overdose, contact poison control/seek medical attention; manage with supportive care and symptomatic treatment (no specific antidote), and consider decontamination only if clinically appropriate soon after ingestion.

Patient Counseling

Complete the full prescribed course. For traveler’s diarrhea, seek medical care and do not self-treat if you have fever or blood in the stool, or if symptoms do not improve within 24-48 hours. This medicine works mainly in the gut with minimal absorption; it may cause reddish discoloration of urine/tears. Tell your prescriber about all medicines-especially cyclosporine (can increase rifaximin exposure) and anticoagulants (monitoring may be needed). Store below 30°C.

Monitoring Requirements

No routine lab monitoring is required for most patients; in hepatic encephalopathy or severe hepatic impairment, monitor clinical status (mental status/recurrence) and for hepatic decompensation, with periodic liver assessment as clinically indicated.

Pharmacology

Mechanism of Action

Inhibits bacterial RNA synthesis by binding the beta-subunit of bacterial DNA-dependent RNA polymerase, blocking transcription; acts primarily in the GI lumen with minimal systemic absorption.

Duration of Effect

Effect is tied to the dosing period: short-course therapy for traveler’s diarrhea/IBS-D; sustained benefit in hepatic encephalopathy requires continuous twice-daily dosing.

Half-Life

Approximately ~6 hours (systemic half-life; clinical relevance limited due to minimal absorption).

Bioavailability

<0.4% (minimal systemic absorption; primarily local GI activity).

Metabolism

Minimal metabolism; most is excreted unchanged in feces, with limited metabolism after any absorption.

Excretion

Primarily fecal (~97%); minimal urinary/renal excretion (<1%, often cited ~0.4%).

Protein Binding

Approximately 67% (reported range ~62-72%) when measurable in plasma.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 200mg rifaximin

Generic Availability

No

OTC Alternatives

No OTC alternative

Spectrum

Broad-spectrum

Antibiotic Class

Rifamycin

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