Rifaximin

Irritable Bowel Syndrome, Diarrhea

DRUG STATUS

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Approvals

US(FDA), UK(BNF)

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Essential Medicine

NO

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Teratogenicity

Unlisted

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Pharmaceutical Class

Rifamycin Antibacterial

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Drug Ingredient

Rifaximin

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Summary

  • Rifaximin is primarily used to treat conditions like traveler's diarrhea caused by E. coli, irritable bowel syndrome with diarrhea (IBSD), and hepatic encephalopathy. It is also used off-label for small intestinal bacterial overgrowth (SIBO) and C. difficile-associated diarrhea.

  • Rifaximin works by inhibiting bacterial RNA synthesis, which prevents bacterial growth and replication in the gut. Since it has minimal systemic absorption, it effectively treats gut-specific infections without significantly affecting other parts of the body.

  • For traveler's diarrhea, the usual dosage is 200 mg three times a day for 3 days. For IBSD, it's 550 mg three times a day for 14 days. For hepatic encephalopathy, it's 550 mg twice a day for long-term use. Rifaximin is taken orally, with or without food.

  • Common side effects include headache, nausea, abdominal pain, and diarrhea. Rare but serious adverse effects include allergic reactions, liver dysfunction, and Clostridium difficile-associated diarrhea.

  • Rifaximin should be used cautiously in individuals with a history of liver disease. It is not recommended for those with hypersensitivity to rifaximin or any component of the formulation, or for the treatment of systemic infections. Pregnant or breastfeeding women should consult a healthcare provider before use.

Indications and Purpose

What is Rifaximin used for?

Rifaximin is used to treat traveler's diarrhea caused by E. coli, irritable bowel syndrome with diarrhea (IBS-D), and hepatic encephalopathy to prevent recurrence. It is also used off-label for small intestinal bacterial overgrowth (SIBO) and C. difficile-associated diarrhea. Rifaximin works by targeting gut bacteria, with minimal absorption into the bloodstream, reducing harmful bacterial overgrowth.

How does Rifaximin work?

Rifaximin is an antibiotic that works by inhibiting bacterial RNA synthesis. It specifically targets and binds to the bacterial enzyme RNA polymerase, preventing the transcription of bacterial DNA into RNA, which is essential for bacterial growth and reproduction. Unlike most antibiotics, Rifaximin has minimal systemic absorption, which allows it to remain concentrated in the gastrointestinal tract. This makes it effective for treating conditions caused by bacterial overgrowth, like traveler's diarrhea, IBS-D, and hepatic encephalopathy, while reducing the risk of systemic side effects.

Is Rifaximin effective?

Rifaximin has demonstrated effectiveness in clinical trials for conditions like traveler's diarrhea, irritable bowel syndrome with diarrhea (IBS-D), and hepatic encephalopathy. Studies show that Rifaximin significantly reduces symptoms of IBS-D, such as diarrhea and abdominal discomfort, and lowers the risk of recurrent hepatic encephalopathy episodes in patients with cirrhosis. Clinical evidence supports its ability to target gut bacteria without significant systemic absorption, making it a useful treatment with a favorable safety profile.

How does one know if Rifaximin is working?

The benefit of Rifaximin is evaluated through clinical trials and patient monitoring. In conditions like irritable bowel syndrome with diarrhea (IBS-D) and traveler's diarrhea, efficacy is measured by improvements in symptoms, such as reduced diarrhea frequency, abdominal pain, and bloating. In hepatic encephalopathy, Rifaximin's effectiveness is assessed by monitoring changes in mental status, ammonia levels, and recurrence rates of encephalopathy episodes. Ongoing evaluation involves patient reports, laboratory tests, and clinical assessments.

Directions for Use

What is the usual dose of Rifaximin?

For adults, the usual dose of rifaximin is:

  • Traveler's Diarrhea: 200 mg orally three times a day for 3 days.
  • Hepatic Encephalopathy: 550 mg orally twice a day.
  • Irritable Bowel Syndrome with Diarrhea (IBS-D): 550 mg orally three times a day for 14 days.

For children aged 12 years and older, the dose for traveler's diarrhea is the same as adults: 200 mg orally three times a day for 3 days. Dosing for other indications in children should be determined by a healthcare provider.

How do I take Rifaximin?

Rifaximin can be taken with or without food, as food does not significantly affect the absorption of the medicine. There are no specific food restrictions while taking Rifaximin. However, it’s important to follow the prescribed dosage instructions carefully, and ensure the full course of treatment is completed, even if symptoms improve, to help prevent bacterial resistance and ensure the infection is fully treated. Always consult with your healthcare provider if you have any concerns or specific dietary questions.

For how long do I take Rifaximin?

The typical duration of rifaximin use varies by condition:

  • Traveler's Diarrhea: Usually prescribed for 3 days.
  • Irritable Bowel Syndrome with Diarrhea (IBS-D): Typically used for 14 days.
  • Hepatic Encephalopathy: Often continued for an extended period, with ongoing treatment based on clinical response.

For Small Intestinal Bacterial Overgrowth (SIBO), treatment durations can range from 7 to 14 days, with some studies suggesting up to 12 weeks for optimal results.

How long does it take for Rifaximin to start working?

Rifaximin typically starts working within a few days of starting treatment, depending on the condition being treated. For example, in the case of traveler's diarrhea, improvement may be noticed within 1-2 days. For conditions like irritable bowel syndrome (IBS) with diarrhea, it may take a few weeks for full symptom relief. However, the time it takes to feel better can vary between individuals. Always follow the prescribed duration and dosage for optimal results.

How should I store Rifaximin?

Rifaximin should be stored at room temperature, typically between 20°C to 25°C (68°F to 77°F). It should be kept in a tightly closed container, away from moisture and heat, and out of reach of children. Do not store in the bathroom or in humid areas. Ensure the medication is kept in its original packaging to maintain its effectiveness.

Warnings and Precautions

Who should avoid taking Rifaximin?

Rifaximin should be used with caution in individuals with a history of liver disease, as it is primarily metabolized by the liver. It is contraindicated in patients with hypersensitivity to rifaximin or any component of the formulation. It should not be used for the treatment of systemic infections, as it is not effective against infections beyond the gastrointestinal tract. Pregnant or breastfeeding women should consult a healthcare provider before use.

Can I take Rifaximin with other prescription drugs?

Rifaximin has limited drug interactions due to its minimal systemic absorption. However, it may interact with drugs that affect the cytochrome P450 enzymes, particularly CYP3A4. Medications such as clarithromycin, ketoconazole, and ritonavir can potentially alter rifaximin’s metabolism. Patients on these drugs should be monitored, as adjustments in medication may be needed. Always consult a healthcare provider before combining treatments.

Can I take Rifaximin with vitamins or supplements?

Rifaximin has minimal interactions with vitamins or supplements. However, it may reduce the absorption of certain nutrients in the gastrointestinal tract, particularly in patients with prolonged use or those with gastrointestinal conditions. It’s important to monitor for vitamin deficiencies, such as vitamin K or B12, in long-term users. Always consult a healthcare provider before taking supplements alongside rifaximin.

Can Rifaximin be taken safely while pregnant?

Rifaximin is classified as a Category C drug during pregnancy, indicating that risk to the fetus cannot be ruled out. Animal studies have shown no direct harm, but adequate human studies are lacking. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Always consult a healthcare provider before using rifaximin during pregnancy.

Can Rifaximin be taken safely while breastfeeding?

Rifaximin is considered safe during breastfeeding, as it is minimally absorbed into the bloodstream and has low concentrations in breast milk. Limited evidence suggests that it poses a low risk to a nursing infant. However, it is always recommended to consult a healthcare provider before using rifaximin while breastfeeding to ensure safety for both mother and baby.

Is Rifaximin safe for the elderly?

In clinical studies involving older adults (65 years or older), this medication was found to be as safe and effective as it was in younger patients for treating hepatic encephalopathy (HE) and irritable bowel syndrome with diarrhea (IBS-D). However, there is not enough information to know if it works differently in older adults for treating travelers' diarrhea because not enough older adults were included in those studies. In IBS-D studies, only 11% of patients were 65 or older and only 2% were 75 or older.

Is it safe to exercise while taking Rifaximin?

Exercise is safe while taking Rifaximin. If you experience fatigue, dizziness, or abdominal pain during activity, stop and consult your doctor.

Is it safe to drink alcohol while taking Rifaximin?

Alcohol consumption does not directly affect Rifaximin, but alcohol may worsen conditions like liver issues. Moderation is recommended; discuss specific concerns with your doctor.