Xifaxan 200mg Tablets
It is used to prevent brain problems caused by very bad liver disease.It is used to treat travelers' diarrhea.It is used to treat irritable bowel syndrome with diarrhea (IBS-D).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antibiotic, Gastrointestinal
Pharmacologic Class
Rifamycin Antibiotic
Pregnancy Category
Category C
FDA Approved
May 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Xifaxan is an antibiotic that works mainly in your intestines to treat certain types of diarrhea, like traveler's diarrhea. Because it's not absorbed much into your body, it has fewer side effects than other antibiotics.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better. You can take this medication with or without food.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better. You can take this medication with or without food.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Stay hydrated by drinking plenty of fluids, especially if you have diarrhea.
- Follow a bland diet if experiencing diarrhea (e.g., BRAT diet: bananas, rice, applesauce, toast).
- Avoid dairy products, fatty foods, and spicy foods until diarrhea resolves.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Traveler's Diarrhea (TD): 200 mg orally three times daily for 3 days.
Dose Range:
200 - 200 mg
Condition-Specific Dosing:
Traveler's Diarrhea:
200 mg orally three times daily for 3 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
Traveler's Diarrhea (âĨ12 years of age): 200 mg orally three times daily for 3 days.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Dialysis:
Not significantly removed by dialysis due to minimal systemic absorption. No specific recommendations.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary, but systemic exposure is increased. Use with caution.
Pharmacology
Mechanism of Action
Rifaximin is a non-systemic antibiotic that acts locally in the gastrointestinal tract. It inhibits bacterial RNA synthesis by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase. This binding prevents bacterial transcription, leading to an antibacterial effect. Due to its poor systemic absorption, it maintains high concentrations in the gut lumen.
Pharmacokinetics
Absorption:
Bioavailability:
<0.4%
Tmax:
Approximately 1 hour
FoodEffect:
Food does not significantly alter the systemic exposure of rifaximin.
Distribution:
Vd:
Not available (due to minimal systemic absorption)
ProteinBinding:
Approximately 67% (in vitro)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 5-6 hours (systemic)
Clearance:
Not available (due to minimal systemic absorption)
ExcretionRoute:
Primarily fecal (>96% of dose), with less than 0.4% excreted in urine.
Unchanged:
>96% (in feces)
Pharmacodynamics
OnsetOfAction:
Rapid, typically within 24-48 hours for symptom improvement in Traveler's Diarrhea.
PeakEffect:
Not directly applicable for a locally acting antibiotic.
DurationOfAction:
Effects persist for the duration of treatment and shortly after, as it targets gut bacteria.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), such as:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Swelling in the arms or legs
Swelling of the abdomen
Shortness of breath
Depression
Fever
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur during or after antibiotic treatment)
Common Side Effects
Most people experience few or no side effects when taking this medication. However, if you notice any of the following side effects and they bother you or do not go away, contact your doctor:
Headache
Feeling dizzy, tired, or weak
Stomach pain or upset stomach
Muscle spasms
Nose or throat irritation
Joint pain
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), such as:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Swelling in the arms or legs
Swelling of the abdomen
Shortness of breath
Depression
Fever
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (a rare but potentially life-threatening condition called C. diff-associated diarrhea, or CDAD, may occur during or after antibiotic treatment)
Common Side Effects
Most people experience few or no side effects when taking this medication. However, if you notice any of the following side effects and they bother you or do not go away, contact your doctor:
Headache
Feeling dizzy, tired, or weak
Stomach pain or upset stomach
Muscle spasms
Nose or throat irritation
Joint pain
Reporting Side Effects
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Diarrhea that worsens or does not improve after 3 days of treatment.
- Bloody or black, tarry stools.
- Fever (especially if persistent or high).
- Severe abdominal pain or cramping.
- Signs of dehydration (e.g., decreased urination, dry mouth, extreme thirst, dizziness).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are experiencing diarrhea accompanied by fever or blood in your stool.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are experiencing diarrhea accompanied by fever or blood in your stool.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as using this drug for an extended period may increase the risk of a second infection. If you are taking this medication to treat travelers' diarrhea, contact your doctor immediately if your symptoms persist for more than 24 to 48 hours or worsen. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, overdose is unlikely to cause systemic toxicity.
- Possible gastrointestinal upset (nausea, vomiting, abdominal discomfort).
What to Do:
Contact a poison control center or emergency medical services immediately. Call 1-800-222-1222. Treatment is generally supportive.
Drug Interactions
Moderate Interactions
- Cyclosporine (increased systemic exposure of rifaximin due to P-gp inhibition)
- Warfarin (potential for altered INR, though clinical significance is low due to minimal systemic absorption)
Minor Interactions
- P-gp substrates (e.g., digoxin, dabigatran - theoretical increase in exposure, but clinically insignificant for most due to low rifaximin systemic levels)
Monitoring
Symptom Monitoring
- Resolution of diarrhea symptoms (frequency, consistency, urgency)
- Fever
- Abdominal pain
- Signs of dehydration
Special Patient Groups
Pregnancy
Category C. Animal studies have shown some evidence of fetal harm at high doses. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; use only if clearly needed.
Second Trimester:
Potential risk based on animal data; use only if clearly needed.
Third Trimester:
Potential risk based on animal data; use only if clearly needed.
Lactation
L3 (Moderately Safe). Due to minimal systemic absorption, rifaximin is considered to have low risk of excretion into breast milk and low risk of adverse effects in a breastfed infant. Monitor infant for diarrhea or candidiasis.
Infant Risk:
Low risk
Pediatric Use
Approved for Traveler's Diarrhea in patients 12 years of age and older. Safety and effectiveness in pediatric patients younger than 12 years of age have not been established for this indication.
Geriatric Use
No dosage adjustment is necessary based on age. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related pharmacokinetic differences are not expected to be clinically significant.
Clinical Information
Clinical Pearls
- Rifaximin is a gut-specific antibiotic with very low systemic absorption, making it ideal for treating localized GI infections with minimal systemic side effects.
- It is not effective for Traveler's Diarrhea caused by invasive bacteria (e.g., Campylobacter jejuni, Salmonella spp., Shigella spp.) or for diarrhea accompanied by fever or bloody stools.
- Patients should be advised to discontinue rifaximin and seek medical attention if diarrhea worsens or is accompanied by fever or blood in the stool.
- The 200mg strength is specifically indicated for Traveler's Diarrhea. Other strengths (e.g., 550mg) are used for different indications like Hepatic Encephalopathy and IBS-D.
Alternative Therapies
- Azithromycin (for Traveler's Diarrhea, especially in areas with fluoroquinolone resistance)
- Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin - for Traveler's Diarrhea, but resistance is increasing)
- Loperamide (symptomatic relief of diarrhea)
- Bismuth subsalicylate (symptomatic relief and mild antibacterial action)
Cost & Coverage
Average Cost:
$200 - $300 per 9 tablets (3-day course for TD)
Insurance Coverage:
Tier 2 or 3 (Brand-name drug, may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.