Interlac

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Interlac

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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 Interlac

Property Description
Active Ingredient Lactobacillus reuteri Protectis (DSM 17938 strain)
Form Oral drops (liquid suspension), capsules, or tablets
Pharmacological Class Probiotic (Food Supplement)
Common Use Supporting general digestive health and gut flora balance
Origin Natural human gut bacterium strain

Identity, Classification, and Composition

Interlac is a specialized probiotic preparation classified as a food supplement, whose unique identity rests on its active ingredient: the live bacterial strain Lactobacillus reuteri Protectis (DSM 17938). This specific strain is clinically recognized for its function in human digestive systems and is derived from a natural, non-pathogenic human source. It belongs to the high-level pharmacological class of probiotic modulators, introducing viable live microorganisms to the gut. The product is available for oral administration in multiple forms, including oral drops (a liquid suspension) and solid forms such as oral capsules or chewable tablets.

Available Forms and Unique Formulation

Unlike many generic formulations, a key feature of the liquid Interlac drops is the use of an oil base (often medium chain triglycerides) instead of a water-based medium. This specific vehicle is essential for protecting the viability of the live microorganisms, ensuring they remain stable and active until consumed. The active ingredient's distinctive origin from human breast milk provides a distinct point of differentiation compared to other common probiotics.

General Purpose and Mechanism

The general purpose of Interlac is to promote and maintain overall digestive health by supporting the balance of the gut's commensal microbiota. The strain’s core biological mechanism involves the temporary colonization of the gastrointestinal tract and the unique production of a natural antimicrobial compound called reuterin. This production capability helps manage the microbial environment, thereby supporting a stable intestinal system. The safety profile of this specific strain has been affirmed across various populations, including infants. Interlac is typically used when the gut flora needs temporary assistance to restore its natural equilibrium.

Regulatory References

  1. PubMed study on L. reuteri safety

What side effects are possible with Interlac?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and safety characteristics for Interlac (Lactobacillus reuteri Protectis DSM 17938), strictly based on governmental regulatory and public health safety documentation.

Adverse Reaction Scope

Category Regulatory Description
Common/Expected Reactions Mild and transient effects classified under Gastrointestinal Disorders, such as subjective increases in stomach gas or bloating.
Serious Adverse Reactions Symptoms indicative of a very serious allergic reaction (e.g., severe dizziness, swelling, trouble breathing) are officially classified as rare events.
System-Organ Classes Primarily associated with Gastrointestinal Disorders and, rarely, Immune System Disorders.

Population-Specific Safety Considerations

The safety profile includes specific constraints for highly vulnerable populations due to the product containing live microorganisms.

Regulatory warnings have been issued for the use of live microbial products in preterm infants in hospital settings due to the serious, documented risk of invasive, potentially fatal disease (e.g., bacteremia or fungemia). The risk of adverse effects from probiotics is also officially noted to be greater for people with severe illnesses or compromised immune systems than for healthy individuals.

Administration-Agnostic Safety Notes

The safety framework notes a limitation concerning the use of live microorganisms alongside certain medications. Concomitant administration near antibiotics or antifungals may prevent the product from working effectively. Additionally, the increase in stomach gas or bloating may be observed as an initial effect when commencing use, aligning with general time-related safety patterns.

These official classifications ensure that the primary safety concerns are directed toward specified, highly vulnerable populations and the low-frequency risk of severe allergic events, while general tolerability is described as favorable in healthy populations.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Interlac (Lactobacillus reuteri Protectis DSM 17938), classified as a probiotic food supplement, emphasizes a low risk of acute systemic toxicity.

Documented Overdose Manifestations

Official documents confirm the absence of severe systemic adverse effects following ingestion of large excesses. The only documented clinical presentation associated with high intake is mild, transient gastrointestinal discomfort, such as increased flatulence or bloating, which is not classified as a toxic event. Treatment is mandated to be symptomatic and supportive, as no specific antidote is known or required.

When to Seek Urgent Medical Help

Regulatory authorities require that immediate medical attention or consultation with a Poison Control Center be sought if severe, unexpected, or anomalous clinical signs manifest after an overdose. This is essential to rule out complications not directly related to the product's low toxicity profile. Routine clinical monitoring is generally not specified for otherwise healthy individuals. Specific safety notes exist for severely immunocompromised individuals, where any substantial ingestion should prompt immediate medical evaluation due to the theoretical, though rare, possibility of systemic infection.

Therapeutic Uses of Interlac

What Interlac Treats: Main Uses and Benefits

Interlac contains a specific strain of probiotic bacteria intended for use as a dietary supplement to contribute to the balance of the gut flora. The product is utilized to help support a healthy digestive environment.

Quick Facts: Therapeutic Domains

  • Supports a balanced gastrointestinal tract.
  • Assists in maintaining the natural state of the gut micro-organisms.
  • Contributes to digestive wellness.

In the context of the overall digestive system, Interlac is generally regarded as a supplementary measure for individuals seeking to maintain intestinal flora equilibrium. The use of this type of product is often considered when the normal balance of gut bacteria may be disrupted. This includes, but is not limited to, supporting digestive comfort in infants or helping to re-establish a balance following certain environmental or dietary shifts. The role of probiotics in the management of specific conditions is an area of ongoing study, and patients should follow the guidance of their healthcare providers.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Interlac — official regulatory information

Interlac (Lactobacillus reuteri Protectis DSM 17938) is typically classified as a probiotic food supplement, and its eligibility profile is primarily based on established safety data and specific government warnings concerning high-risk populations.


Eligibility scope

Classification Population or Condition
Use is Prohibited Preterm infants in hospital settings must not be administered products containing live microorganisms due to the risk of serious invasive disease and death [FDA Warning].
Use Requires Caution/Conditional Individuals with a severely weakened immune system (e.g., due to chemotherapy or HIV) or those with severe underlying diseases.
Use is Generally Permitted Healthy subjects of all ages, including infants (1+ month), children, adults, and older adults.

Age, Pregnancy, and Condition Status

Category Eligibility Status (as documented)
Age-related Eligibility Use is established and permitted across the general population; however, the FDA has not approved any probiotic product for use as a drug in infants of any age.
Pregnancy and Lactation Use is generally permitted for both pregnant and breastfeeding women, with no explicit contraindication listed in regulatory documentation.
Condition-specific Restrictions Contraindicated in individuals with a known allergy or hypersensitivity to any product ingredient. Non-use is advised for patients with diarrhea lasting more than two days and accompanied by high fever.

Connection to the overall eligibility profile: Regulatory documents define Interlac eligibility by documenting its safety for non-immunocompromised subjects of all ages while issuing explicit warnings that prohibit use in vulnerable populations, specifically hospitalized preterm infants. Conditional use is required for patients with severely compromised immunity due to the rare, documented risk of infection associated with live microorganisms.

What should I know about interactions with other medicines?

Interlac is a probiotic preparation containing the live bacterial strain Lactobacillus reuteri Protectis (DSM 17938). Its official regulatory interaction profile is primarily defined by factors that compromise the viability of the live microorganism, not classic pharmacokinetic drug–drug interactions (DDIs) involving enzyme systems or plasma concentration changes.


Interaction scope

Medicinal product categories with documented interactions:

  • Antimicrobial Agents (e.g., Antibiotics/Antifungals)
  • Substances that pose a risk of systemic infection in compromised populations.

Mechanistic basis of interactions (only if stated in label):

  • Pharmacodynamic Incompatibility: The action of antimicrobial medicines is destructive to the active live microorganism.
  • Physical Incompatibility (Thermal): Destruction of the live microorganism by heat.

Timing-based interaction rules (if applicable):

  • Official regulatory guidance advises a time separation between the administration of Interlac and antimicrobial agents, such as antibiotics, to preserve the viability of the live culture.

Population-specific interaction notes (if applicable):

  • Immunosuppressed Patients: Caution is documented regarding the use of live probiotic bacteria in patients with severe immunodeficiency or those receiving immunosuppressive therapy.

Interaction-related restrictions:

  • The product must not be mixed with hot liquids or hot food due to the thermal destruction of the active ingredient.

Connection to the overall interaction profile

Regulatory documents define the interaction structure for Interlac around the essential need to maintain live culture integrity. The constraints center on physical administration conditions and the timing of co-administration with other substances that are bactericidal. No data is documented in regulatory labels regarding pharmacokinetic parameters such as CYP enzyme inhibition or alteration of co-administered drug plasma concentrations.

Mechanism of Action

How Interlac Works: Mechanism of Action

The biological effect of Lactobacillus reuteri Protectis (DSM 17938) is achieved through three key mechanistic domains acting locally within the gut environment.

Microbial Ecosystem Management

This domain focuses on the strain's ability to directly influence the microbial composition of the gut lumen. The strain engages in competitive exclusion against undesirable bacteria and synthesizes reuterin, a broad-spectrum antimicrobial molecule that acts as an inhibitor of pathogen growth. This action alters the ratio of specific microbial populations.

Gut-Nerve Sensitization Modulation

The strain modulates the gut’s sensory signaling by targeting specific receptors, such as TRPV1, on enteric sensory neurons. This interaction functionally down-regulates nerve excitability and the release of neuropeptides like Substance P, resulting in a reduction of afferent neural input from the gut wall.

Intestinal Immune and Barrier Regulation

This mechanism involves direct communication with host cells via pattern recognition receptors like TLR2. This communication shifts the balance of cytokine production and promotes regulatory immune cells (Tregs). By enhancing the integrity of tight junction proteins, this mechanism increases the resistance of the epithelial layer to external factors.

Dosage and Administration Information

Official Administration Guidelines for Interlac

Interlac is an oral preparation, typically containing the probiotic Lactobacillus reuteri strain DSM 17938 (often branded as L. reuteri Protectis). The following instructions detail the standardized procedures for its administration.


Administration Scope Procedural Detail
Route of Administration Oral
Dosing Schedule 5 drops (delivering 10^8 colony-forming units [CFUs] of L. reuteri DSM 17938)
Frequency Pattern Once daily
Timing in Relation to Meals May be taken with or without food
Age-Group Rules The daily dosage of 5 drops is standardized for infants, children, and adults.

Procedural Steps

The correct use of Interlac requires specific preparation and administration steps:

  1. Preparation: The bottle must be shaken well before each use to ensure the contents are thoroughly mixed.
  2. Dispensing: The bottle is turned upside down, and 5 drops are dispensed.
  3. Administration: The drops can be placed onto a spoon, added to a drink, or mixed with food.
  4. Special Condition: The preparation must not be mixed with liquids or food that is hot (e.g., above 122°F or 50°C) to protect the live bacteria.

Missed-Dose Rules

If a dose is forgotten, the user should continue with the next scheduled dose at the usual time; a double dose should not be taken to compensate for the missed one. These instructions provide a clear, consistent structure for administering the specific probiotic dose daily, ensuring product integrity and standardized intake across all user groups.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Interlac

This overview summarizes the research that was studied for Interlac’s active ingredient, Lactobacillus reuteri Protectis (DSM 17938), focusing on the types of evidence available, the patient groups examined, and the areas where research is still developing. This information is purely descriptive of the evidence landscape and does not constitute medical advice or treatment recommendations.


Evidence for Use in Infant Colic (Excessive Crying)

Research has primarily examined the ingredient's role in infants experiencing colic, a condition characterized by fluctuating or episodic manifestations of excessive crying and fussing. The available evidence is largely drawn from short-term Randomized Controlled Trials (RCTs) and systematic reviews, including detailed meta-analyses.

Studies reported how symptoms evolved in the observed populations. Some research reported specific measurements of crying duration in the intervention group compared to the placebo group. The patterns described in research were noted to be most frequently reported in studies focusing on exclusively or predominantly breastfed infants. In contrast, research exploring short-term symptom changes in infants who were formula-fed found variable measurements.

Evidence for Use in Acute Gastroenteritis

Research examined outcomes related to episodic or acute changes, specifically monitoring the total duration of watery diarrhea and the frequency of watery stools in children. The available data comes from short-term Randomized Controlled Trials (RCTs), where the ingredient was evaluated in children as an adjunctive measure alongside standard oral rehydration therapy. Findings consistently position the ingredient as an adjunctive measure alongside the required rehydration protocols.

Evidence in Special Populations and Uncertainties

Research has explored how symptoms change over time across different populations. For infants with colic, studies describe patterns related to feeding type, with the most frequently measured patterns reported in exclusively breastfed infants. Additionally, research was conducted in both children and adults for the functional chronic constipation indication.

The broader evidence landscape indicates that data are still emerging in several key areas. The long-term effects are not fully established, as the follow-up durations were limited across most studied conditions. Also, comparative evidence is lacking to fully contextualize the ingredient's patterns against other established probiotic strains used for similar outcomes.

Frequently Asked Questions (FAQ)

Common questions about Interlac (FAQ)

Q: What is Interlac and what is it used for?

Interlac is a brand name for a medication containing the active ingredient lactulose. Lactulose is a synthetic sugar that works primarily as an osmotic laxative. It is used to treat constipation by drawing water into the colon, which softens the stool and promotes bowel movements.

It is also used to treat a serious liver disease complication called hepatic encephalopathy (HE). In HE, Interlac works to reduce the amount of ammonia in the blood, which helps improve brain function.


Q: How should I take Interlac for constipation?

Interlac is typically taken by mouth as an oral solution. The dose for constipation can vary, but it's generally taken once daily. It can take 24 to 48 hours before a full laxative effect is noticed. It is important to drink plenty of fluids while taking this medication.

  • Measuring the Dose: Always use the measuring device provided with the medication, such as a marked spoon or cup, to ensure accuracy.
  • Mixing: You can mix the dose with water, fruit juice, or milk to improve the taste, if necessary.

Do not take more than the prescribed dose and consult your healthcare provider if constipation persists or worsens.


Q: What should I do if I miss a dose of Interlac?

If you are taking Interlac for constipation and you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time to make up for a missed dose.

If you are taking Interlac for hepatic encephalopathy, missing a dose could impact the control of your condition. Contact your healthcare provider for specific instructions on how to handle a missed dose in this circumstance.


Q: Does Interlac cause any side effects?

Yes, like all medications, Interlac can cause side effects. The most common side effects, especially at the start of treatment, are gastrointestinal and may include:

  • Bloating
  • Gas (flatulence)
  • Stomach rumbling
  • Abdominal cramps or discomfort
  • Diarrhea (This usually indicates that the dose is too high and should be reported to your doctor.)

These common side effects are often mild and may lessen as your body adjusts to the medication.

Less common, but more serious side effects include severe diarrhea, vomiting, or dehydration. You should seek medical advice immediately if you experience severe side effects.


Q: Can I take Interlac with other medications?

Before starting Interlac, you must inform your doctor and pharmacist about all other medications, over-the-counter drugs, vitamins, and herbal supplements you are currently taking.

Interlac may interact with certain other medicines. For example, some antacids may interfere with the effects of lactulose. Also, because Interlac causes diarrhea in high doses, it could potentially affect the absorption of other oral medications taken at the same time.

Your healthcare provider can review your medications to ensure Interlac is safe for you to take.

How should Interlac be stored and disposed of?

Official Storage and Disposal Instructions

The storage of Interlac, a probiotic containing live Lactobacillus reuteri Protectis (DSM 17938), is governed by specific regulatory requirements to maintain the viability of the microorganisms and ensure public safety.

Requirement Type Official Regulatory Statement
Temperature and Light Store at or below 25 C (77 F); must be protected from high heat and direct light.
Handling Prohibition Do not freeze the product, as freezing can negatively affect the shelf-life and stability.
Child Safety Mandatory instruction to keep the product out of the sight and reach of children and pets.
Disposal Do not dispose of expired or unused product by flushing it down the toilet or pouring it into a drain.
Container Rule Keep the container tightly closed when not in use.

Following these official constraints ensures the stability of the live culture until the product's defined use-by date.

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

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