WARNINGS
XIFAXAN is not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN.
If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your healthcare provider if your diarrhea does not improve or worsens.
Talk to your healthcare provider before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.
Tell your healthcare provider if you are taking drugs called P-glycoprotein and/or OATPs inhibitors (such as cyclosporine) because using these drugs with XIFAXAN may lead to an increase in the amount of XIFAXAN absorbed by your body.
In clinical studies, the most common side effects for XIFAXAN were:
- HE: Peripheral edema (swelling, usually in the ankles or lower limbs), constipation, nausea (feeling sick to your stomach), fatigue (feeling tired), insomnia (trouble sleeping), ascites (a buildup of fluid in the abdomen), dizziness, urinary tract infection, anemia (low red blood cell levels), and itching
- IBS-D: Nausea (feeling sick to your stomach) and an increase in liver enzymes
XIFAXAN may affect warfarin activity when taken together. Tell your healthcare provider if you are taking warfarin because the dose of warfarin may need to be adjusted to maintain proper blood-thinning effect.
If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN because XIFAXAN may cause harm to an unborn baby or nursing infant. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
USES
XIFAXAN is a prescription antibiotic that works mainly in the digestive tract. XIFAXAN 550-mg tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. It is a 2-week treatment. In clinical trials, patients experienced lasting relief from abdominal pain and diarrhea.* You can be treated again up to 2 times if symptoms come back. Talk to your doctor before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.
In clinical trials, XIFAXAN provided lasting relief of abdominal pain and diarrhea.* If you’ve been living with IBS-D symptoms, it may be time to talk with your doctor about XIFAXAN.
HOW TO USE
Take one 550-mg tablet 3 times a day with or without food;
2 weeks of treatment, not continuous, daily prescription medication.
The most common side effects of XIFAXAN in IBS-D were nausea (feeling sick to your stomach) and an increase in liver enzymes.
N/A
OVERDOSE
No specific information is available on the treatment of overdosage with XIFAXAN. In clinical studies at doses higher than the recommended dose (greater than 600 mg per day for TD, greater than 1,100 mg per day for HE or greater than 1,650 mg per day for IBS-D), 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.
MISSED DOSE
Although you may feel better early in the course of treatment, XIFAXAN 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.
STORAGE
Store XIFAXAN Tablets at 20-degees C to 25-degress C (68-degrees F to 77-degrees F); excursions permitted to 15-degrees C to 30-degrees C (59-degrees F to 86-degrees F).
NOTES
Medication Guide: revision date N/A
Prescribing Information: revision date 10/2023
P-glycoprotein Inhibitors
Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs significantly
increased the systemic exposure of rifaximin. In patients with hepatic impairment,
a potential additive effect of reduced metabolism and concomitant P-gp inhibitors
may further increase the systemic exposure to rifaximin. Caution should be exercised
when concomitant use of XIFAXAN and a P-gp inhibitor such as cyclosporine is needed.
Warfarin
Changes in INR have been reported postmarketing in patients receiving rifaximin and
warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin
may be needed to maintain target INR range. See prescribing information for warfarin.
CYP3A4 Substrates
An in vitro study has suggested that rifaximin induces CYP3A4. However, in patients with normal liver function, XIFAXAN 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.
See the section WARNINGS above.
