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Tiorfan Nourrisson

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Tiorfan Nourrisson

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Treatment option:

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.

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Overview of Tiorfan Nourrisson

Property Description
Active ingredient Racecadotril (a synthetic prodrug)
Form Granules for oral suspension (sachets)
Pharmacological class Pure Intestinal Antisecretory Agent
Common use Symptomatic treatment of acute diarrhea
Origin Synthetic organic compound

The Core Identity and Composition: Racecadotril

Tiorfan Nourrisson is a pharmaceutical preparation containing the synthetic prodrug, Racecadotril, specifically tailored for the pediatric population, including infants and young children. The use of the term Nourrisson emphasizes its primary focus on the youngest patient group. This medicine is a single-substance product delivered as fine granules for oral suspension, packaged in individual sachets, which is a key design feature for simple delivery via the oral route to children. Racecadotril acts as a rapidly acting prodrug that converts to the active metabolite, thiorphan.

Pharmacological Classification and Antidiarrheal Type

Tiorfan Nourrisson belongs to the highly specialized pharmacological class of antidiarrheal drugs known as pure intestinal antisecretory agents. This classification signifies a targeted approach to managing fluid imbalances within the gastrointestinal tract. Racecadotril functions specifically as an enkephalinase inhibitor, a mechanism that is distinct from traditional antidiarrheals that work by reducing the rate of intestinal motility. This peripheral action ensures that the therapeutic effect is concentrated on controlling the hypersecretion of water and electrolytes without disrupting the gut's normal movement.

General Therapeutic Purpose for Acute Diarrhea

The general purpose of this medicine is the symptomatic treatment of acute, watery diarrhea by controlling the underlying physiological cause of fluid over-secretion. By reducing the flow of excessive fluid into the intestine, Racecadotril helps to normalize the volume and consistency of stools. This antisecretory approach is designed to assist in easing the core symptoms of acute diarrhea in children. The formulation's primary use is to support the patient through such an episode while preserving natural gut function.

Regulatory References

  1. NIH PubChem ID 107751
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What side effects are possible with Tiorfan Nourrisson?

Possible side effects and safety information

The officially documented adverse effects for the medicine are classified primarily within the Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders. These classifications are used by government health authorities to organize and communicate the known risks of the medicine.


Adverse Reaction Scope

Classification Frequency Documented Adverse Reactions (SOC)
Common ge 1/100 to < 1/10 Headache (Nervous System Disorders)
Uncommon ge 1/1,000 to < 1/100 Rash, Erythema (Skin Disorders)
Not Known Cannot be estimated Angioedema, Urticaria, Anaphylactic shock, DRESS, Pruritus, Erythema multiforme (Immune/Skin Disorders)

Serious Adverse Reactions: Official labels note potentially life-threatening reactions with unknown frequency, specifically Angioedema (swelling of the face, tongue, lips, or eyelids), Anaphylactic shock, and Severe Cutaneous Adverse Reactions (SCARs) such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Angioedema may occur at any time during therapy.

Population-Specific Safety Considerations: The medicine is not recommended for infants under three months of age. Caution is required when administering to patients with severe renal or hepatic impairment due to limited safety data. The product is not to be administered to pregnant or breastfeeding women as adequate human data are lacking.

Safety-Related Restrictions and Limitations: Use is restricted to short-term symptomatic treatment only, and safety for chronic diarrhea has not been established. The medicine should not be administered when bloody or purulent stools and fever are present. Furthermore, a safety restriction is in place for patients with specific hereditary sugar intolerances (fructose, glucose-galactose) due to an excipient in the formulation. The co-administration with Angiotensin-Converting Enzyme (ACE) inhibitors (e.g., enalapril, lisinopril) is officially associated with an increased risk of Angioedema.


Resulting Safety Structure

The safety profile is structured to identify common, often mild effects like headache, while critically flagging rare, serious hypersensitivity and immune system reactions as major risks. This is complemented by explicit constraints on use defined by pre-existing patient conditions and the presence of certain symptoms, limiting the medicine's use to a well-defined acute context. The regulatory documentation emphasizes that the medicine is not for prolonged use and includes a specific warning about the increased risk of Angioedema when used concurrently with ACE inhibitors.

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Overdose and Emergency Response

The official regulatory documentation for Tiorfan Nourrisson (Racecadotril) defines the overdose profile primarily by an extensive absence of acute adverse effects, rather than a list of specific severe symptoms.

Overdose and when to seek help

Overdose Scope Official Regulatory Findings
Documented overdose presentations No cases of overdose have been reported in the official prescribing information.
Physiological systems affected No harmful effects were described in adults administered single doses up to 20 times the therapeutic dose.
Dose-related or exposure-related factors Doses equivalent to 2 g were tested in adults, confirming a lack of acute toxicity at these levels.
Population-specific overdose notes The available safety data regarding high-dose exposure is derived from studies conducted in adults, not specifically the pediatric population.
Emergency-response statements No specific antidote is documented or specified in the official labeling. Management would be symptomatic and supportive.
When immediate medical help is required The official labeling does not define specific, mandatory emergency actions, but a healthcare professional should always be consulted for advice following suspected overexposure.

Overdose classifications (high-level)

Classification Official Regulatory Findings
Severity classification Defined by a lack of reported undesirable effects following high-dose exposure.
Regulatory basis Summaries of Product Characteristics (SmPC) from national medicines authorities.
Overdose-context constraints The lack of harmful effects is constrained to single doses only, as tested in clinical studies.

Official overdose statements:

  • No clinical manifestations of overdose are documented in the official regulatory sources.
  • Single doses significantly above the therapeutic dose were tolerated without reported harmful effects in clinical studies.
  • No specific antidote is identified in the official prescribing information.

Connection to the overall overdose profile: Regulatory documents establish the overdose profile based on observed safety data, confirming a high margin of safety for acute toxicity of the active substance. This high safety margin means that the labeling does not define a list of severe, acute symptoms or specific procedural interventions like gastric decontamination. Accordingly, the requirement to seek medical attention is driven by the general need to consult for any suspected overexposure, rather than by regulator-mandated action for documented severe symptoms.

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Therapeutic Uses of Tiorfan Nourrisson

This medication is commonly used to provide supportive relief during sudden, symptomatic episodes of acute diarrhea in infants (over three months) and young children.


Symptom Management and Clinical Context

Tiorfan Nourrisson is applied across domains where additional symptomatic support is needed, primarily addressing symptom clusters related to heightened physiological activity leading to fluid loss. These patterns are associated with symptoms such as frequent, high-volume, and excessively fluid stools. The medication is commonly used as a complementary symptomatic treatment for acute diarrhea in young children and may be part of symptomatic management in situations involving acute gastroenteritis.

The primary focus of symptomatic management is a reduction in the volume and frequency of these watery bowel movements, which contributes to easing the overall symptom load and may assist in managing the overall length of the acute diarrheal episode.

“This medicine is applied in clinical settings that involve acute or unstable symptom patterns, typically as a complementary measure used alongside Oral Rehydration Solutions (ORS).”

Tiorfan Nourrisson is relevant for managing symptoms associated with systemic imbalance where patients experience a significant risk of dehydration. The supportive benefit plays a role in managing symptoms related to systemic imbalance, helping to reduce the burden of fluid loss, thereby supporting general well-being during symptomatic phases.


Quick Fact: Relief for Watery Stools

Symptom Domain Key Benefit
High Stool Fluidity & Frequency Helps reduce the volume and frequency of defecation.
Risk of Fluid Loss/Dehydration Assists with easing the symptomatic burden of fluid loss.

Regulatory References

  1. SMC regulatory assessment
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Eligibility and Restrictions for Use

Eligibility Scope

The eligibility for Tiorfan Nourrisson (Racecadotril pediatric granules) is strictly defined by regulatory authorities based on age, prior history, and comorbid conditions.

Classification Population or Condition
Approved Use Infants and children older than 3 months of age.
Contraindicated Infants less than 3 months old (due to lack of data).
Contraindicated Patients with a known hypersensitivity to racecadotril or a history of Severe Cutaneous Adverse Reactions (SCARs).
Contraindicated Patients with specific hereditary metabolic disorders (e.g., fructose intolerance, glucose-galactose malabsorption) due to the presence of excipients like sucrose.
Must Not Be Administered Children with renal or hepatic impairment (due to a lack of study data in this specific patient group).
Not Recommended Patients with diarrhea showing bloody/purulent stools and/or high fever, or in cases of chronic or antibiotic-associated diarrhea.
Not Recommended Pregnant or breastfeeding women (due to insufficient clinical data in these populations).

Official Eligibility Structure

The official label establishes that this product is contraindicated for infants under three months of age and for patients with hypersensitivity or hereditary sugar intolerances. Furthermore, the use of Tiorfan Nourrisson is not recommended in children with accompanying high fever or specific signs of infection, and it is prohibited in pediatric patients with underlying renal or liver impairment.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation for Racecadotril (the active substance in Tiorfan Nourrisson) indicates a specific pharmacodynamic interaction and a low potential for pharmacokinetic interactions.

Documented Interaction Patterns

The most critical documented interaction is with Angiotensin-Converting Enzyme Inhibitors (ACEIs), a class of medicines that includes compounds such as captopril, enalapril, lisinopril, perindopril, and ramipril.

Interaction Type Interacting Substance Official Regulatory Statement
Pharmacodynamic Risk ACE Inhibitors (e.g., Captopril) Co-administration may augment the risk of Quincke’s oedema (angioedema).
Lack of Kinetic Interaction Loperamide or Nifuroxazide Concomitant treatment does not modify the kinetics of Racecadotril.

Interaction Classifications and Restrictions

Official regulatory information states that there are no medicinal product combinations formally classified as contraindicated (prohibited) for use with this medicine. Racecadotril has been shown to not inhibit or induce major CYP enzyme isoforms (3A4, 2D6, 2C9, 1A2, and 2C19) to a clinically relevant extent, suggesting a low potential for metabolic drug interactions. Furthermore, no mandatory timing separation rules for administration with other medicines, food, alcohol, or herbal products are included in the regulatory text.

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Mechanism of Action

Enzyme-Mediated Signaling Modulation

Tiorfan Nourrisson is a prodrug that is rapidly converted to its active metabolite, thiorphan, which functions as a peripheral inhibitor of the enzyme neutral endopeptidase (NEP), also known as enkephalinase. NEP is a membrane metallopeptidase located on the brush border of the intestinal epithelium. This inhibition blocks the breakdown of endogenous enkephalins, naturally occurring opioid peptides in the gastrointestinal tract, leading to their elevated local concentration.


Intracellular Pathway Modulation and Secretory Control

The accumulated enkephalins specifically engage the mathbfdelta-opioid receptors on the intestinal epithelial cells. Receptor activation initiates a G-protein-coupled signaling cascade that inhibits the enzyme adenylyl cyclase, resulting in a reduction of the intracellular second messenger cyclic AMP (cAMP). Modulating this key pathway suppresses the hypersecretion of water and electrolytes, specifically chloride ions, into the intestinal lumen.


System-Level Physiological Consequence

This mechanism results in a net decrease in the secretion of water and electrolytes across the intestinal wall, providing a highly localized antisecretory action. This effect modulates fluid transport without influencing basal intestinal motility or disrupting normal gastrointestinal transit time.

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Dosage and Administration Information

Official Administration Protocol

Tiorfan Nourrisson is administered via the oral route as a prepared suspension. The dosage is strictly determined by the child’s body weight, following a guideline of 1.5 mg/kg per dose, and is intended only for infants older than three months. The treatment is structured around a precise frequency pattern of three times daily (TID). Doses should preferably be administered at the beginning of the three main meals, ensuring timely intake.

Preparation and Context of Use

For proper administration, the granules from the sachet must be mixed completely into a small amount of food, water, or milk in a feeding-bottle. The mixture must be stirred well and administered immediately after preparation to ensure the full dose is received. This medicine is intended only for use as a supportive measure and must be administered together with oral rehydration solution (ORS) and appropriate dietary measures.

Treatment Duration and Limits

The duration of treatment is determined by the patient's recovery. Administration should continue until the patient passes two normal stools. Under no circumstances must the treatment exceed an absolute limit of seven days, which defines the short-term scope of the medicine's application. If a dose is missed, treatment should continue at the next scheduled time; the missed dose should not be doubled or compensated for, maintaining the regular three-times-daily schedule.

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Recent Clinical Evidence

Tiorfan Nourrisson: Recent Clinical Evidence

Overview of Efficacy

Clinical research has evaluated the efficacy of the active substance in Tiorfan Nourrisson (racecadotril) in children for the management of acute watery diarrhea. Studies have primarily focused on reducing the severity and duration of diarrhea episodes. Racecadotril acts as an enkephalinase inhibitor, aiming to reduce the hypersecretion of water and electrolytes into the intestine.

Key Findings from Trials

Randomized controlled trials (RCTs) have compared racecadotril plus oral rehydration solutions (ORS) versus placebo plus ORS in pediatric patients. The primary endpoints assessed in these studies include the total stool output and the duration of diarrhea episodes.

Research has explored whether the addition of racecadotril to oral rehydration solutions was associated with a measurable reduction in the overall duration of diarrhea compared to ORS alone. Some studies have suggested a trend toward earlier cessation of diarrhea when racecadotril was included, but findings have been mixed regarding a statistically significant difference in all populations.

Safety and Tolerability

Clinical trials have investigated the safety profile of racecadotril in the pediatric population. The compound is generally considered to be well-tolerated in short-term use. Adverse events reported in trials were typically mild to moderate and included vomiting, constipation, or rash. No specific concerns regarding systemic side effects were commonly reported across the major studies reviewed.

Conclusion

The evidence suggests that racecadotril is evaluated as an adjunct therapy to oral rehydration solutions for acute diarrhea in children. Its main effect is hypothesized to be localized to the intestinal tract.

Key Studies & References

  1. Racecadotril in the treatment of acute diarrhoea in children: a meta-analysis (PIDSP Journal)
  2. AWMSG SECRETARIAT ASSESSMENT REPORT: Racecadotril (Hidrasec®) 10 mg and 30 mg granules for oral
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Frequently Asked Questions (FAQ)

Common questions about Tiorfan Nourrisson (FAQ)

Q: How long after starting Tiorfan Nourrisson should the diarrhea begin to slow down?

A: Clinical research has examined how quickly the medicine works when used as an adjunct to oral rehydration solution (ORS).

Studies indicate that stool output may be reduced within the first 24 to 48 hours of starting the medicine. Some research has shown a shorter median duration of diarrhea when the drug is included in the treatment protocol.


Q: Is a slight skin rash a serious side effect of Tiorfan Nourrisson?

A: According to the official product information, rash and erythema (redness of the skin) are classified as uncommon side effects (may affect up to 1 in 100 people).

However, rare, potentially life-threatening reactions such as Severe Cutaneous Adverse Reactions (SCARs) or angioedema (swelling) are also documented in the medicine’s safety profile.


Q: Does Tiorfan Nourrisson cause constipation after the diarrhea stops?

A: Constipation has been reported as an adverse event associated with the use of the medicine in clinical trials.

Official regulatory documents list common and uncommon side effects, but the frequency of constipation is not specifically categorized. The regulatory text does not specify its occurrence specifically after the diarrhea has completely stopped.


Q: Can Tiorfan Nourrisson interact with blood pressure medicines?

A: Official regulatory documents detail a specific interaction risk with a class of blood pressure medicines called Angiotensin-Converting Enzyme Inhibitors (ACEIs).

Co-administration with an ACEI may augment the risk of Quincke’s oedema (angioedema), which is swelling of the face, tongue, or throat. No other critical interactions with blood pressure medicines are explicitly documented.


Q: Is Tiorfan Nourrisson suitable for all causes of acute diarrhea?

A: The medicine is not recommended for all types of acute diarrhea.

The official eligibility criteria state that it is not recommended for diarrhea if it is accompanied by a high fever, or if the stools contain blood or pus. Furthermore, the medicine is restricted to short-term symptomatic use only.


Q: What does the term 'antisecretory agent' mean in simple terms?

A: Tiorfan Nourrisson is classified as a pure intestinal antisecretory agent.

This means the medicine works by reducing the excessive secretion of water and electrolytes (salts) into the intestine, helping to control the volume of the stool without affecting the intestine’s normal movement or motility.


Q: Why is it important to stop giving the medicine after two normal stools?

A: Official guidelines instruct that administration of the medicine should continue only until the patient passes two normal stools.

This instruction defines the short-term scope of the medicine's application and guides when the treatment should be procedurally determined to be complete. The treatment must not exceed an absolute limit of seven days.


Q: What information is still 'missing' in the official safety documents for the drug?

A: Official safety information indicates that there is limited or insufficient data regarding the medicine’s use in specific patient populations.

These populations include those with severe renal or hepatic impairment (kidney or liver problems), as well as pregnant or breastfeeding women.


Q: Can Tiorfan Nourrisson be given to my child at the same time as paracetamol or ibuprofen?

A: Official documentation on product interactions states that there are no medicinal product combinations formally classified as contraindicated (prohibited) for use with this medicine.

Additionally, no mandatory timing separation rules for administration with other medicines are included in the regulatory text.


Q: Does Tiorfan Nourrisson have a taste or specific flavor?

A: Official labeling describes the product as granules for oral suspension which must be mixed with food or liquid for immediate use.

While the presence of sugars is noted due to a contraindication for hereditary sugar intolerances, the specific taste or flavor is not described in official summary documents.


Q: Is Tiorfan Nourrisson a prescription-only medicine?

A: Regulatory data for this specific dosage form in some countries indicates that it is a prescription-only medicine (classified as List I).

This classification indicates that the medicine is supplied based on a prescription from an authorized practitioner.


Q: What are the signs of dehydration that parents should look for while the child is on Tiorfan Nourrisson?

A: While not a part of the drug's label itself, authoritative medical sources emphasize that signs of dehydration parents should look for include: dry mouth or tongue, a lack of tears when crying, fewer wet diapers than usual, and sunken eyes.

The medicine is required to be used with oral rehydration solution (ORS) to help prevent severe dehydration.


Q: Does Tiorfan Nourrisson help with abdominal pain related to diarrhea?

A: The medicine's official purpose is the symptomatic treatment of acute, watery diarrhea by controlling the underlying physiological cause of fluid over-secretion.

Clinical trials have primarily focused on the duration of diarrhea and stool output, and abdominal pain has not been consistently reported as a primary endpoint in the core regulatory studies reviewed.


Q: Is Tiorfan Nourrisson available in different strengths?

A: Official documents define the dose for infants based on the child's weight, and the product is specified as the Nourrisson (infant) strength.

Racecadotril, the active substance, is available in different strengths that are tailored for use in different age groups.


Q: Are there different forms of Tiorfan (e.g., capsule vs. oral powder)?

A: The specific product, Tiorfan Nourrisson, is supplied as granules for oral suspension packaged in individual sachets.

Regulatory documents for racecadotril in other age groups indicate that other formulations, such as capsules, exist for use in adults and older patients.


Q: What is the purpose of the excipients (non-active ingredients) in the sachet?

A: The official documents do not detail the precise technical role of all non-active ingredients (excipients).

However, they highlight the presence of excipients, such as sugars, that lead to a safety restriction for patients with specific hereditary sugar intolerances.


Q: What is the difference between the 'nourrisson' (infant) strength and the 'enfant' (child) strength?

A: Official documentation for the Nourrisson (infant) strength establishes its use for the youngest approved patients, specifically infants older than three months.

The dosage is strictly defined by a weight-based protocol to ensure accuracy for this age group.


Q: Can Tiorfan Nourrisson be used for diarrhea caused by food poisoning?

A: The medicine's exclusion criteria apply regardless of the cause of the diarrhea.

Therefore, the medicine is not recommended for diarrhea if the child has a high fever or if the stools contain blood or pus, which can occur with infectious causes.


Q: Do studies suggest Tiorfan Nourrisson reduces the need for hospitalization?

A: Clinical evidence has explored the outcome of 'failure of rehydration,' which is a factor associated with the need for hospitalization.

Research suggests that the addition of racecadotril to oral rehydration solution (ORS) may reduce the risk of rehydration failure.


Q: Has Tiorfan Nourrisson been studied in children in countries outside of Europe?

A: Clinical research referenced in authoritative reports includes studies conducted on children in various countries outside of Europe.

These locations include regions such as Peru, India, Kenya, Ecuador, and Russia.


Q: Is there evidence that Tiorfan Nourrisson reduces the risk of needing rehydration therapy?

A: Clinical evidence reports on the primary outcome of 'failure of rehydration' (the need for more intensive rehydration).

Research suggests that the use of racecadotril with ORS may reduce the risk of rehydration failure.


Q: What are the potential risks for patients with severe dehydration while taking this drug?

A: The official drug label requires the medicine to be used together with oral rehydration solution (ORS).

General authoritative medical guidance states that risks associated with severe dehydration include electrolyte imbalance, potential kidney issues, and shock, underscoring the importance of adequate rehydration.

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How should Tiorfan Nourrisson be stored and disposed of?

Storage and Disposal Requirements

The storage and disposal instructions for Tiorfan Nourrisson (racecadotril granules for oral suspension) are defined by official regulatory documentation to ensure product stability and environmental safety.


Storage Conditions

Requirement Official Rule
Temperature Does not require any special storage conditions.
Container Must be kept in the original container (sachets).
Child Safety Keep out of the sight and reach of children.

The granules are single-dose and intended for immediate administration after preparation; consequently, no post-reconstitution storage is permitted.


️ Disposal Instructions

Official regulations require that unused or expired Tiorfan Nourrisson must not be thrown away via wastewater or household waste. Disposal must occur via local pharmaceutical collection systems, as directed by a pharmacist or local waste service, to help protect the environment.

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

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