Colidur

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Colidur

Property Description
Active ingredient Rifaximin
Form Film-coated tablet
Pharmacological class Non-systemic Antibiotic
Origin Semisynthetic derivative
Route of administration Oral

Colidur is a specialized prescription medicinal product administered via the oral route, featuring the sole active substance Rifaximin. This medicine is supplied as a film-coated tablet and functions as a single active ingredient product. Rifaximin is chemically classified as a semisynthetic derivative of the Rifamycin class of antibiotics, a property specifically engineered to prevent absorption and confirm its intended chemical profile.

Colidur’s Pharmacological Classification and Origin

The drug is classified as a broad-spectrum antibacterial agent, officially making it an antibiotic because of its mechanism to inhibit bacterial RNA synthesis. However, its functional classification is precisely that of a non-systemic antibiotic. This specific non-systemic profile is what sets Colidur apart, as the medication is intended to remain confined to the digestive tract, in contrast to systemic antibiotics that enter the general circulation.

The unique low systemic absorption of Colidur ensures the drug's activity is maximized within the lumen of the gut. This limits systemic presence and focuses its antibacterial drug effects precisely where gastrointestinal pathologies originate. This gastrointestinal site-specific action is clinically recognized for its relevance in managing conditions tied to bacterial overgrowth.

What is the General Purpose of Colidur?

The general therapeutic purpose of Colidur is to address conditions linked to pathological bacterial overgrowth or imbalance within the intestinal environment, known as gut microbiota dysbiosis. A typical scenario involves managing the bacterial component of certain chronic gastrointestinal disorders. The localized action in the gut means the drug helps manage these issues by reducing the populations of susceptible intestinal bacteria directly at the site of concern, which is the key practical benefit of utilizing this low systemic absorption agent.

What side effects are possible with Colidur?

Official Safety Profile and Adverse Reactions

The possible side effects and safety characteristics of Rifaximin (Colidur) are established and classified according to standard government regulatory documentation, such as the EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information. Adverse reactions are grouped by the affected physiological system, known as the System Organ Class (SOC), and categorized by frequency of occurrence.

Frequency-Classified Adverse Reactions

The most frequently observed adverse reactions, classified as Common in official documents (may affect up to 1 in 10 people), typically involve Gastrointestinal disorders such as abdominal pain, abdominal distension, and diarrhea, as well as Nervous system disorders including dizziness and headache. Uncommon effects (may affect up to 1 in 100 people) span multiple systems, including anaemia, insomnia, and urinary tract infections.

Reactions categorized as Not Known (frequency cannot be estimated from available data) include severe events such as Anaphylactic reactions, Angioedema, and severe cutaneous reactions like Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Serious Adverse Reactions and Safety Constraints

Official labeling documents specific, clinically significant risks, notably Clostridium difficile-Associated Diarrhea (CDAD), a risk associated with nearly all antibacterial agents that can occur during or after treatment.

Population-specific safety statements include the constraint that Rifaximin is associated with substantially increased systemic exposure in patients with severe hepatic impairment (Child-Pugh Class C). The medication is also noted in regulatory labels to be avoided during pregnancy unless the benefit outweighs potential fetal harm, based on animal study data. Furthermore, a non-serious, expected effect is a reddish discoloration of the urine, which is due to the chemical nature of the rifamycin derivative.

This regulatory structure defines the formal safety profile, focusing on established risks and specific limitations documented by government health authorities.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Rifaximin overdose is established through mandated emergency procedures and guidance on general supportive measures, reflecting the drug’s low systemic absorption. Overdose is defined by regulatory agencies based on the clinical necessity for immediate medical intervention.

️ When Immediate Medical Help is Required

Official documentation provides specific instructions on when patients must contact emergency services. Immediate medical help is required if a known or suspected overdose results in severe clinical manifestations, which include:

  • Collapsed state or loss of consciousness (inability to be awakened).
  • Seizure.
  • Trouble breathing.

For any known or suspected overdose, regardless of the presence of these severe signs, individuals are directed to seek immediate medical attention and contact a poison control center as mandated by official health authorities.

️ Regulatory Management Approach

The documented management of Rifaximin overdose is based entirely on non-specific support measures. Symptomatic treatments and supportive care are officially described in regulatory documents as the standard management approach. The official prescribing information does not document the existence of a specific antidote for Rifaximin overdose, nor does it specify unique monitoring requirements or population-specific considerations within the overdose section.

Therapeutic Uses of Colidur

What Colidur Treats: Main Uses and Benefits

Colidur is commonly used across three key therapeutic areas focused on symptoms related to gastrointestinal tract disturbances and their systemic consequences. The medication is applied in domains where additional symptomatic support is needed, may contribute to easing the overall symptom load and may support the patient during difficult episodes by easing distress.

The primary conditions for which the medication is generally used include Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D), reducing the risk of recurring overt Hepatic Encephalopathy (HE) in adults with liver disease, and the treatment of acute Travelers' Diarrhea.

Relief for Symptom Clusters

Colidur is generally used to provide supportive symptomatic relief for adults experiencing chronic and recurring manifestations of IBS-D. It may assist with managing symptom clusters that become intense or disruptive, such as persistent diarrhea, abdominal pain, and uncomfortable bloating, contributing to the maintenance of functional stability.

For patients with underlying liver conditions, the drug is considered relevant to reduce the risk of recurring HE, where it may support the maintenance of cognitive stability, easing the burden of confusion and behavioral changes associated with systemic imbalance.

“Applied in domains where additional symptomatic support is needed, contributing to easing the overall symptom load.”

In acute clinical scenarios, such as noninvasive Travelers' Diarrhea, it is commonly used when short-term symptomatic assistance is needed. It is applied to ease challenging symptoms that interfere with daily functioning, such as sudden, frequent, watery stools and abdominal discomfort, assists with easing the impact of the episode.


Quick Fact: Relief for Chronic Diarrhea Colidur is used for managing symptoms related to heightened physiological activity in the gut, relevant in conditions involving recurrent or episodic manifestations like IBS-D.

Eligibility and Restrictions for Use

Who Can and Cannot Use Colidur?

Official regulatory labeling strictly defines the populations who are eligible for Colidur (Rifaximin) and those who are formally excluded from its use.

Contraindications and Exclusions

Use is contraindicated (prohibited) in any patient with a known hypersensitivity to the active substance Rifaximin, any other rifamycin antimicrobial agent, or any component in the formulation.

Colidur is not recommended for diarrhea complicated by the presence of fever or blood in the stool, or for Travelers' Diarrhea caused by pathogens other than noninvasive E. coli.

Population-Specific Rules

Population Group Eligibility Status Regulatory Constraint
Adults (HE/IBS-D) Eligible Approved for ge 18 years of age for all non-TD indications.
Children Restricted Safety and efficacy not established for those under 12 years for any indication.
Severe Liver Disease Caution/Restricted Caution in severe hepatic impairment (Child-Pugh C); use is not studied in MELD scores > 25.
Pregnancy/Lactation Not Recommended Precautionary measure due to lack of human data; risk to infant cannot be formally excluded.

Official labeling uses these specific population rules to define the boundaries for use, ensuring the medicine is confined to its studied and authorized patient groups. Eligibility is primarily structured around age, underlying liver status, and the precise nature of the gastrointestinal condition.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

  • Medicinal product categories with documented interactions: P-glycoprotein (P-gp) Inhibitors, Oral Anticoagulants.
  • Specific interacting medicines (if explicitly listed): Cyclosporine, Warfarin.
  • Mechanistic basis of interactions (only if stated in label): Rifaximin is documented as a substrate of the P-glycoprotein (P-gp) efflux transporter. The interaction with anticoagulants is linked to changes in the International Normalized Ratio (INR).
  • Timing-based interaction rules (if applicable): No mandatory administration timing separation is documented. The medicine can be taken with or without food.
  • Population-specific interaction notes (if applicable): Systemic exposure is markedly increased in patients with Severe Hepatic Impairment (Child-Pugh Class C).
  • Interaction-related restrictions: Concomitant administration with other systemic rifamycin antimicrobial agents is officially not recommended.

Official Interaction Statements

  • Co-administration with potent P-glycoprotein Inhibitors causes a profound increase in Rifaximin systemic exposure, documented in studies as a 124-fold increase in AUC. Caution is required when combining these agents.
  • Use with Oral Anticoagulants (such as Warfarin) requires careful monitoring of the INR, as both increases and decreases have been reported. Adjustments in the anticoagulant dose may be necessary.
  • Rifaximin caused no significant effect on the pharmacokinetics of tested CYP3A4 substrates in clinical studies.

Connection to the overall interaction profile:

The official regulatory documents define the interaction structure of Rifaximin primarily through its status as a P-gp substrate, focusing on the potential for increased systemic exposure. The key documented constraints are the need for caution with P-gp inhibitors and the mandatory monitoring procedures for patients concurrently receiving oral anticoagulants. No drug-drug contraindications are formally listed in the prescribing information, and the profile reflects the non-systemic nature of the medicine.

Mechanism of Action

How Colidur works

Localized Control of Gut Microbial Function

This drug acts as an inhibitor specifically against the bacterial DNA-dependent RNA Polymerase found in susceptible bacteria within the gut lumen. Because the medication is minimally absorbed into the systemic circulation, this targeted molecular interaction suppresses the growth and metabolic function of these microorganisms, resulting in a modulation of the gut microbiota composition.

Direct Regulation of Intestinal Inflammation

Beyond its effect on bacteria, the drug engages with human host cells by activating the Pregnane X Receptor (PXR) in the gut lining. This activation initiates a signaling cascade that modulates (dampens) the activity of the Nuclear Factor kappa B ( NF-kappa B) pathway, leading to a reduction in localized inflammatory signaling.

Downstream Reduction of Circulating Toxins

The combined action of microbial inhibition and host modulation results in a downstream physiological consequence: a decrease in the bacterial production of absorbable substances, notably nitrogenous toxins. This reduction in the production and subsequent absorption of these metabolites from the gut leads to a decrease in the concentration of circulating toxins.

Dosage and Administration Information

Colidur (Rifaximin) is an oral medication with administration governed by specific, fixed-dose regimens tied to the condition being managed. The medicine is supplied as film-coated tablets in 200 mg and 550 mg strengths. It is administered exclusively via the oral route and may be taken with or without food, establishing flexibility in the timing of intake.

The official schedule and duration of use are distinct for each application. For acute episodes of Travelers' Diarrhea, the standard administration involves taking 200 mg three times a day (TID) for a total course duration of 3 days. This regimen is used for adults and pediatric patients aged 12 years and older.

For the management of Irritable Bowel Syndrome with Diarrhea (IBS-D), the required dosage is 550 mg three times a day (TID) over a 14-day course. The established protocol allows for a patient to be retreated up to two times with the same 14-day schedule should symptoms recur. In contrast, administration for the reduction of recurring Hepatic Encephalopathy (HE) risk is typically a chronic, long-term regimen of 550 mg two times a day (BID).

Use of the medication requires completion of the entire prescribed course. Standard procedure for a missed dose is to take the dose as soon as remembered, unless it is almost time for the next scheduled dose, in which case the missed dose is skipped to avoid a double dose. A procedural caution is noted regarding use in patients with severe hepatic impairment (Child-Pugh Class C).

Recent Clinical Evidence

Research evidence / Overview of Studies for Colidur

Evidence for use in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Colidur has been evaluated in large, short-to-intermediate-term randomized controlled trials (RCTs) to address the fluctuating manifestations of IBS-D. The research examined outcomes related to physical discomfort, such as the achievement of overall global symptom relief, including improvements in abdominal pain and stool consistency. The findings describe patterns observed in the studies where the measured outcomes for global symptom relief were tracked between the groups receiving the treatment and those receiving a placebo (an inactive substance). Research highlights changes measured during the study period related to patient-reported outcomes.

Evidence for use in Reducing the Risk of Recurring Hepatic Encephalopathy (HE)

Research focusing on HE prevention involved large, long-term, randomized, placebo-controlled trials. These studies monitored the primary event: the time to first breakthrough episode of overt HE. Secondary research examined outcomes related to daily functioning, such as HE-related hospitalization rates. The main study reported measurements that were tracked between the treatment and placebo groups in the time elapsed before the first HE event was observed. Trials described patterns in measured outcomes related to hospitalizations in the treatment group compared to the placebo group.

Evidence for use in Acute Travelers' Diarrhea

The clinical evaluation involved several short-term, randomized, placebo-controlled trials. The research explored outcomes describing episodic or acute changes, focusing on the Time to Last Unformed Stool (TLUS) and the achievement of clinical cure (symptom resolution). Studies show patterns related to the TLUS measurements, which were tracked carefully across the brief follow-up intervals. The research describes the structure of the short treatment course and the short post-treatment observation period.

What is Still Uncertain About the Research for Colidur

Long-term effects are not fully established across all indications, as the most definitive evidence typically covers intermediate durations (e.g., up to 6 months). Data for certain groups remain insufficient, including evidence for use in children or adolescents. Comparative evidence is lacking in some contexts, such as the investigation into use of the drug alone versus in combination with other standard therapies for certain conditions. Findings describe group patterns, and research does not determine whether an individual will respond similarly.

How should Colidur be stored and disposed of?

Official Storage and Disposal Instructions

Colidur (Rifaximin) tablets must be stored and discarded based strictly on regulatory requirements to maintain product stability and ensure public safety.

Storage/Disposal Aspect Regulatory Requirement
Temperature Store at controlled room temperature (20 C to 25 C / 68 F to 77 F), with permitted excursions up to 30 C (86 F).
Environmental Protection Keep from freezing, and protect from excess heat and moisture.
Packaging Keep the medicine in its original container, which must remain tightly closed.
Child Safety Must be stored out of the sight and reach of children.

Disposal

Expired or unused Colidur must be disposed of in accordance with local regulations. It is generally not recommended to flush this medicine down the toilet. If a local take-back program is unavailable, the FDA advises removing the tablets from the container, mixing them with an undesirable substance (e.g., used coffee grounds), and placing the mixture in a sealed bag before throwing it in the household trash. All identifying information on the original container must be obscured before disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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