Inteflora

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Inteflora

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Inteflora

Property Description
Active ingredient Saccharomyces boulardii (INN)
Pharmacological Class Probiotic Agent / Antidiarrheal Microorganism
Origin Natural (Yeast Strain)
Form Capsules and Oral Powder in Sachets
Type Single-ingredient Biotherapeutic Agent

What Type of Medicine is Inteflora and What is it Made Of?

Inteflora is identified as a biotherapeutic agent, with the single active ingredient Saccharomyces boulardii (INN), placing it within the pharmacological group of Probiotic agents and Antidiarrheal microorganisms. The product is of natural origin, derived from a non-pathogenic yeast strain that is internationally recognized for its utility in supporting the gut environment.

The formulation utilizes lyophilized (freeze-dried) Saccharomyces boulardii cells, preserving the viability of the live microorganisms. Inteflora is designed for the oral route of administration, and is notably offered in two distinct, stable dosage forms: pharmaceutical capsules and tasteless oral powder presented in individual sachets, facilitating use across various patient groups.

Inteflora's Core Purpose and Unique Probiotic Identity

The general purpose of Inteflora is to support gastrointestinal health and promote microflora restoration, a function for stabilizing the intestinal environment during periods of stress or change. Its typical use scenario involves providing support when the gut's natural microbial composition is disturbed.

A key differentiating feature of Saccharomyces boulardii is its yeast nature, which sets it apart from common bacterial probiotics. This unique non-bacterial status is a vital functional property, as it means the organism is intrinsically resistant to degradation by many antibacterial agents. Its capacity to maintain viability under these conditions, coupled with its ability to exert trophic effects on the intestinal lining, is the established foundation for its use in mitigating issues associated with an imbalance of the intestinal microflora.

Regulatory References

  1. Saccharomyces boulardii - MedlinePlus

What side effects are possible with Inteflora?

Possible Side Effects and Safety Information

The safety profile of Inteflora (Saccharomyces boulardii) is classified by regulatory documents according to the frequency and nature of documented adverse reactions. The medicine is a live yeast strain, and its safety characteristics reflect both common, expected gastrointestinal changes and rare, serious systemic risks.

Adverse Reaction Classification

Classification Organ System Documented Reactions
Common Gastrointestinal disorders Flatulence, Constipation
Very Rare Immune system disorders Anaphylactic reactions
Very Rare Infections and infestations Fungemia (Saccharomyces bacteraemia)

The most commonly listed adverse reactions involve the Gastrointestinal system, often presenting as flatulence or changes in stool consistency, which are generally non-serious. Severe systemic reactions, categorized as Very Rare, include severe allergic reactions, such as anaphylaxis, and the risk of Fungemia.

Serious Safety Considerations and Restrictions

Official labels define strict limitations for use due to the risk of the live yeast causing a systemic fungal infection (fungemia) in specific clinical environments. Inteflora is Contraindicated in high-risk groups, including:

  • Critically ill patients
  • Immunocompromised patients (e.g., those with severely weakened immune systems)
  • Patients with a Central Venous Catheter (CVC)

These constraints are in place because the risk of fungemia is significantly increased in these vulnerable populations. Regulatory safety notes also specify that the product's sachets or capsules should not be opened in the immediate vicinity of patients with a CVC to prevent potential environmental contamination.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory classification for Inteflora notes that specific acute overdose symptoms related to chemical toxicity are generally not reported in prescribing information. As a non-absorbed biotherapeutic agent, the active ingredient, Saccharomyces boulardii, is not absorbed into the bloodstream, and any over-consumption is expected to be excreted via the gastrointestinal tract.

Severe Complications and Urgent Action

While acute overdose symptoms are not documented, regulatory warnings highlight a rare but life-threatening risk of systemic infection. The most serious outcomes documented in official records are fungemia (a fungal infection in the blood) and sepsis.

This severe outcome is primarily concentrated in specific patient populations, including critically ill patients, those with a weakened immune system (immunocompromised), or individuals with a central venous catheter (CVC). In these groups, the risk for the systemic spread of the yeast is highest.

When to Seek Immediate Medical Help

Official regulatory guidance mandates that immediate medical attention must be sought in all cases of suspected overdose.

  • Contact a Poison Control Center immediately.
  • Seek emergency medical care if any severe manifestations occur, including passing out, having a seizure, or experiencing trouble breathing.

Management for confirmed systemic infection involves the cessation of Inteflora and subsequent administration of antifungal treatment, as no specific antidote is known.

Therapeutic Uses of Inteflora

What Inteflora Treats: Main Uses and Benefits

Inteflora is used for managing conditions characterized by acute diarrheal episodes and gastrointestinal microflora disturbances. Its therapeutic application is considered relevant for handling symptoms that interfere with daily comfort. The therapeutic role of this agent includes supporting general intestinal health in conditions presenting with systemic or localized discomfort.

The medication is commonly used across conditions presenting with acute episodes of diarrhea, for providing supportive relief against symptoms of Antibiotic-Associated Diarrhea (AAD), Traveler's Diarrhea, and plays a role in managing the risk of recurrence of C. difficile infection (CDI). It is applied in clinical settings that involve acute or unstable symptom patterns. The use of Inteflora supports general well-being during symptomatic phases.

“This supportive agent may assist with easing the duration of acute episodes and managing stool consistency disturbances.”


Supportive Role: Managing Diarrhea Symptoms

Inteflora is generally used to provide short-term symptomatic assistance when symptoms related to altered bowel movement patterns and acute intestinal distress become more noticeable, and assists with maintaining functional stability.

Regulatory References

  1. NAFDAC Greenbook Admin

Eligibility and Restrictions for Use

Who Can and Cannot Use Inteflora?

Eligibility for Inteflora (Saccharomyces boulardii) is determined by strict rules in official regulatory documents, primarily to mitigate the risk of systemic fungal infection (fungemia) in vulnerable individuals.

Contraindicated Populations (Must Not Use)

Use of Inteflora is absolutely contraindicated in patients who are critically ill, hospitalized, or immunocompromised, due to the heightened risk of severe infection. This prohibition also applies to patients with a Central Venous Catheter (CVC), a known hypersensitivity to yeast, or a Gastrointestinal wall perforation.


Restricted or Conditional Use

Certain populations require caution or have conditional restrictions based on official labeling:

Population Regulatory Status Constraint Basis
Pregnancy/Lactation Avoid Use Insufficient data to establish safety
Older Adults Caution Advised Potential increased risk of fungal infection
Preterm Infants Use Not Established Insufficient data, especially in low birth weight infants

Age Eligibility: The medicine is generally approved for use in adults and children, provided no contraindications are present. Specific formulations may also be contraindicated for patients with hereditary metabolic disorders (e.g., galactose intolerance) if certain excipients are present.

What should I know about interactions with other medicines?

The official regulatory interaction profile for Inteflora (Saccharomyces boulardii) is primarily defined by its identity as a live, non-systemic yeast strain. This identity establishes the conditions under which its viability or intended effect may be diminished by co-administered substances or administration procedures.

Contraindicated Drug Combinations

  • Oral or Systemic Antifungal Drugs: Co-administration with the class of antifungal medicinal products is strictly contraindicated in regulatory documents. This is a pharmacodynamic antagonism, as antifungal agents are designed to destroy fungi, which include the active ingredient of Inteflora, leading to a loss of its therapeutic effect.

️ Substance and Procedural Constraints

  • Food and Drink: The product must not be mixed with very hot liquids or food (temperatures exceeding sim 50 C), iced liquids, or alcoholic drinks. These substances cause physical or chemical inactivation, destroying the viability of the live microorganism during administration, thereby compromising the intended effect.

Pharmacokinetic Interactions

  • Metabolic and Transporter Systems: Regulatory information states that no clinically significant pharmacokinetic interactions (e.g., involving CYP enzymes or drug transporters) are established or documented, consistent with the product’s local, non-systemic action in the gastrointestinal tract.

Mechanism of Action

Inteflora, containing the probiotic yeast Saccharomyces boulardii CNCM I-745, primarily operates within the gastrointestinal lumen and on the intestinal epithelium through multiple biochemical processes. The yeast secretes specific proteases that target and degrade bacterial toxins, such as the enterotoxins and cytotoxins produced by Clostridium difficile. This enzymatic action results in the cleavage of the toxin molecules and their receptors on host cells.

At the cellular level, S. boulardii components modulate host intracellular signaling. They can interfere with the nuclear translocation and activity of the transcription factor NF-kappaB, a key regulator of the cellular inflammatory response. Limiting NF-kappaB activity subsequently restricts the transcriptional rate and secretion of pro-inflammatory cytokines within the intestinal wall, leading to a modulation of the localized inflammatory milieu. Additionally, the yeast promotes the production of Short-Chain Fatty Acids (SCFAs) by the resident microbiota, which serve as trophic substrates for colonocytes, thus supporting the maintenance and maturation of the intestinal barrier function.

Dosage and Administration Information

How to Use Inteflora (Saccharomyces boulardii 250 mg)

Inteflora (containing the probiotic yeast Saccharomyces boulardii) is administered to support proper delivery of the active ingredient. The following information describes the administration procedures.


Dosing and Frequency

The standard route of administration for Inteflora is oral.

Population Group Standard Dosing Frequency
Adults & Children 1 to 2 capsules or sachets (250 mg each) Twice daily (BID)

The duration of treatment is generally 1 to 3 weeks.


Administration and Preparation Rules

Preparation procedures are intended to protect the live culture:

  • Capsules: Must be swallowed whole with water.
  • Sachets/Opened Capsules: The powder should be mixed with a non-hot liquid (e.g., water) or soft food immediately before consumption.

Special Procedural Constraints

  • Temperature Restrictions: Inteflora must not be mixed with, or taken with, liquids or food that are too hot (above 50 °C) or iced.
  • Alcohol Restriction: The product must not be mixed with or consumed alongside alcoholic beverages.
  • Pediatric Use: For infants and small children (under 6 years), the capsule must be opened, and the contents mixed into a beverage or food to prevent the risk of choking.

Recent Clinical Evidence

Inteflora: Recent Clinical Evidence

Clinical research on Inteflora, a probiotic containing Saccharomyces boulardii, has focused primarily on its role in managing and preventing diarrhea, particularly that associated with antibiotic use.

Phase 3 Trials: Core Findings

Studies assessed how the drug affected the body at a cellular and systemic level, with research evaluating the drug's effect on symptoms in participants with mild to moderate intestinal imbalances.

  • Primary Studies: The largest studies evaluated change in diarrhea duration and stool consistency. Research noted that the proportion of participants who experienced a certain level of symptom change was different in the treatment group compared to the placebo group.
  • Combination Use: Secondary analyses have examined Inteflora's role when studied alongside standard therapy, such as antibiotics. The research explored whether combining treatments was associated with different outcomes compared to using the standard therapy alone.

Safety and Tolerability Profile

Clinical trials documented adverse events and explored its use in participants with pre-existing conditions, including compromised immune function.

Adverse Event Category Key Findings in Clinical Trials
Common Events The most frequently reported events included increased flatulence and bloating. These events did not typically require participants to leave the study.
Serious Events Serious adverse events were infrequent. Rare cases of fungemia (fungal presence in the blood) have been reported, primarily in hospitalized patients with a central venous catheter or those with severely weakened immune systems.

Limitations and Future Research

Evidence remains limited regarding Inteflora's use in patients with severe underlying disease or those with serious infections. Research is ongoing to assess the effect on pain and the timing of symptom changes. Further research is also planned to examine whether the drug may be studied for other related digestive conditions beyond acute diarrhea.

Frequently Asked Questions (FAQ)

Common questions about Inteflora (FAQ)

Q: Does Inteflora interact with commonly used over-the-counter pain relievers?

A: Regulatory documents state that co-administration with oral or systemic antifungal drugs is strictly contraindicated as it nullifies the product's effect. For commonly used over-the-counter pain relievers, no severe interaction is established. However, the potential for gastrointestinal issues may be noted.

Q: How quickly does Inteflora start working?

A: Official information indicates that viable Saccharomyces boulardii cells generally reach stable concentrations within the gut after approximately three days of continuous daily use. The speed at which a change in symptoms is noted may vary.

Q: Is Inteflora safe to take with common vitamin supplements?

A: Official information and studies indicate that no specific interaction is known between Saccharomyces boulardii and common vitamin or mineral supplements. Since the medicine works locally in the digestive system and is not absorbed into the blood, it is not expected to interfere with how vitamins are used by the body. The consideration of co-administering any medications or supplements is generally recommended.

Q: What is the difference between Inteflora and a standard dietary supplement for the same condition?

A: Inteflora is classified differently across various global markets, sometimes as a biotherapeutic agent (a type of medicine) or a dietary supplement. These classifications establish the level of regulatory oversight for the product's quality, efficacy, and safety. Its unique status as a live yeast strain is a key feature that distinguishes it from common bacterial probiotics.

Q: Are there known interactions between Inteflora and common blood pressure medicines?

A: According to the official product information, Inteflora acts locally within the gastrointestinal tract and is not absorbed into the bloodstream in healthy individuals. For this reason, no clinically significant interactions with systemic drugs, such as most blood pressure medicines, are established or documented.

Q: What is the expected long-term safety profile of Inteflora?

A: Official safety summaries indicate that the active ingredient, Saccharomyces boulardii, has been studied over periods of up to 15 months in healthy adults using recommended doses. Long-term safety beyond this specific period is not consistently documented in all regulatory summaries.

Q: Does Inteflora interact with oral contraceptives?

A: The official product information indicates that Inteflora has a local, non-systemic action in the gut, meaning it does not enter the main bloodstream. Therefore, pharmacokinetic interactions that might affect how systemic medications, such as oral contraceptives, are absorbed or metabolized are not established or documented.

Q: How does Inteflora compare to other prescription medicines for this purpose?

A: Inteflora is a unique, non-bacterial live yeast strain. This characteristic provides intrinsic resistance to many antibacterial agents (antibiotics). This resistance is a functional property that differentiates it from many bacterial probiotics, allowing it to maintain its activity during co-administration with certain standard therapies.

Q: Can Inteflora be taken with or without food?

A: Regulatory documents state that the product can be taken before or after food. Regulatory documents emphasize that it must not be mixed with or consumed alongside liquids or foods that are too hot, too cold, or alcoholic.

Q: Are there specific symptoms that require immediate medical attention while taking Inteflora?

A: Official safety information highlights the very rare risk of severe reactions, such as anaphylaxis or systemic infection (fungemia) in high-risk patients. Symptoms such as high fever or chills have been associated with serious adverse events.

Q: Are there any known interactions with herbal supplements and Inteflora?

A: Official sources do not document specific interactions with herbal supplements. However, the product's effectiveness will be compromised if it is taken with antifungal agents, as these drugs are designed to destroy fungi, which includes the product's active ingredient.

Q: Does Inteflora cause drowsiness or affect the ability to drive?

A: Official regulatory documents and product labels state that no studies have been performed or reported on the product's effect on a person's ability to drive or use machinery. The product's main actions are confined to the gastrointestinal tract.

Q: What happens if I miss a scheduled time to take Inteflora?

A: According to standard drug administration guidelines referenced in official documents, if a dose is missed, it should be taken as soon as the user remembers. If it is almost time for the next scheduled dose, the missed dose should be skipped entirely, and the regular schedule resumed. It is important that doses are not doubled.

Q: What should I do if I accidentally take more Inteflora than usual?

A: Official safety information indicates that taking more than the prescribed amount is highly unlikely to cause severe effects. Overdose typically results in mild, temporary gastrointestinal symptoms, such as increased gas or constipation. Official documents state that mild effects are typically resolved by discontinuing or reducing the dose.

Q: Is it necessary to finish the entire course of Inteflora if I start to feel better?

A: The duration of treatment is typically specified as one to three weeks. However, for certain uses, such as supporting the gut during or after antibiotic use, official medical guidelines often recommend continuing the treatment course for a set period, which may be up to four weeks in total.

Q: How is Inteflora usually eliminated from the body?

A: Official pharmacokinetic properties confirm that Inteflora is a non-systemic product, meaning it is not absorbed into the bloodstream. The active ingredient, the yeast cells, are primarily eliminated via the stools. It is usually no longer detectable in the body a few days after stopping the treatment.

How should Inteflora be stored and disposed of?

Inteflora must be stored under specific conditions mandated by regulatory labeling to maintain the viability of the active ingredient. The product is required to be kept at Controlled Room Temperature, which ranges from 20 C to 25 C (68 F to 77 F), and must be protected from both heat and moisture [2.1, 2.2].

Required Conditions

Storage Classification Regulatory Requirement
Temperature Restriction DO NOT FREEZE the product [2.1].
Packaging Store in the original container and keep the bottle tightly closed [2.2].
Post-Opening Stability After opening, certain presentations require storage in the refrigerator (2 C to 8 C) to extend stability [2.2].
Safety Warning The product must be stored OUT OF THE REACH OF CHILDREN [2.3].
Special Handling Capsules or sachets must not be opened near patients with a central venous catheter due to the risk of airborne contamination [1.2].

Expired or unused medication must be disposed of in accordance with local requirements and the specific instructions provided on the packaging [2.5].

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

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