Overview of Hidrasec Infants

Property	Description
Active ingredient	Racecadotril
Form	Granules for oral suspension (in sachet)
Pharmacological class	Antisecretory Antidiarrheal Agent
Primary Mechanism	Enkephalinase Inhibitor
Origin	Synthetic compound

What Type of Medicine is Hidrasec Infants and Its Composition?

Hidrasec Infants is a specific prescription medicine whose active core is the synthetic prodrug Racecadotril, classified as an antisecretory antidiarrheal agent. This compound belongs to the unique pharmacological class of enkephalinase inhibitors, meaning it specifically targets an enzyme in the gut. The differentiation of the product lies in its precise formulation for the paediatric population. The active metabolite, Thiorphan, preserves the body's natural signaling compounds, which ultimately reduce excessive fluid secretion in the intestine. Racecadotril's primary action is to reduce intestinal secretion of water and electrolytes, a property clinically recognized for its effectiveness in managing acute diarrhoea.

Pharmaceutical Form and General Therapeutic Purpose

This preparation is provided as granules for oral suspension contained within a sachet, a dosage form distinctively designed for the oral route of administration in infants older than three months. The inclusion of sucrose as a major excipient in the granules is a composition feature that facilitates palatability and ease of mixing, which is essential for administration to young patients. The general therapeutic purpose of this medicine is to provide symptomatic relief for acute, watery diarrhoea. By directly addressing the underlying hypersecretion of water and electrolytes, the drug helps decrease the sheer volume and liquidity of the stools, a critical step in managing acute fluid loss without interfering with the normal movement of the bowels.

What side effects are possible with Hidrasec Infants?

Possible Side Effects and Safety Information

The safety profile for Hidrasec Infants (Racecadotril) is primarily classified by the frequency and organ system involved, as documented in regulatory sources.

Frequency-Classified Adverse Reactions

Adverse reactions are grouped according to standard regulatory definitions (Common: ge 1/100 to < 1/10; Uncommon: ge 1/1,000 to < 1/100; Not Known: frequency cannot be estimated from available data):

Classification	Example Reactions	System-Organ Class
Common	Headache	Nervous System Disorders
Uncommon	Rash, Erythema, Tonsillitis	Skin, Infections and Infestations
Not Known	Angioedema, Urticaria, DRESS	Skin and Subcutaneous Tissue Disorders

Safety Restrictions and Serious Adverse Reactions

The most serious documented safety concerns are Angioedema (swelling of the face, tongue, or eyelids) and other Severe Cutaneous Adverse Reactions (SCARs), such as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms), which are potentially life-threatening but reported with a Not Known frequency, typically based on post-marketing experience. Treatment must not be restarted in patients who have experienced a severe skin reaction.

Usage is subject to several high-level restrictions. The medicine is not to be administered to infants less than three months old or to patients with known severe renal or hepatic impairment due to a lack of safety data. Furthermore, due to the presence of sucrose, the medicine is contraindicated in individuals with rare hereditary problems like fructose intolerance or sucrase-isomaltase deficiency. Treatment is typically not recommended to exceed seven days.

Overdose and Emergency Response

Overdose Scope: Official Regulatory Statement

Entity	Official Regulatory Statement
Documented Manifestations	No harmful effects, specific adverse events, or defined clinical symptoms have been described in connection with documented overdose cases.
Exposure Factors	Single doses equivalent to 20 times the therapeutic dose ( 2 g) were tolerated by adults without documented ill effects.
Emergency-Response	No specific immediate actions are explicitly mandated for an overdose of the drug itself, consistent with the documented lack of harmful effects.
Management	Management is confined to symptomatic and supportive treatment, as no specific antidote is known or detailed in official documents.

Overdose Classifications (High-Level)

The regulatory prescribing information for racecadotril establishes a benign overdose profile due to the absence of severe manifestations reported even at significant supratherapeutic exposure. This profile is derived from the Overdose Section (Section 4.9) of government-authorized prescribing information.

Connection to the overall overdose profile

The official regulatory documents define the overdose profile as being highly tolerant. The key finding is the absence of documented symptoms or serious outcomes following overdosage, even in cases referencing doses twenty times the therapeutic level. Consequently, the regulatory text does not mandate specific emergency procedures, special monitoring, or urgent help-seeking requirements unique to overexposure of this medicine. Any intervention is limited to general symptomatic support based on the clinical presentation of the patient.

Therapeutic Uses of Hidrasec Infants

What Hidrasec Infants Treats: Main Uses and Benefits

This medicine is commonly used for the symptomatic treatment of acute diarrhoea in infants. It is applied when supportive measures, such as Oral Rehydration Solution (ORS), alone are considered insufficient to control the clinical condition. The therapeutic indication is considered relevant for the complementary symptomatic treatment of acute diarrhoea in infants (older than three months) and children.

Symptom Relief and Clinical Context

Hidrasec Infants is relevant for easing symptoms related to heightened physiological activity in the gut. The medicine helps manage symptoms that create noticeable physiological strain, particularly the highly watery and frequent stools associated with significant fluid loss in the gut. It serves as additional symptomatic support alongside the essential use of ORS and is relevant when supportive symptom management is appropriate for addressing the severity of the fluid output.

The main therapeutic benefit is commonly used to help with the reduction in both the volume and liquidity of stools, which contributes to easing the overall burden of symptoms. This action provides support for patients during difficult episodes, which helps improve day-to-day comfort.

“This approach supports the management of acute episodes by targeting the frequency and volume of unformed stools, assisting with maintaining functional stability in infants.”

Quick Fact: Support for Symptoms Related to Excessive Fluid Loss

Regulatory References

Summary of Product Characteristics verified by the HPRA

Eligibility and Restrictions for Use

Hidrasec Infants is officially indicated for the complementary symptomatic treatment of acute diarrhoea in infants who are older than three months and in children. Use is specifically not recommended and the product must not be administered to infants who are less than three months old due to a lack of specific clinical data in this age group.

Use is strictly contraindicated in any patient with known hypersensitivity to the active substance or any of its components. Due to the sucrose content in the granules, the product is also contraindicated for patients with rare hereditary metabolic disorders, including fructose intolerance and glucose-galactose malabsorption syndrome.

Furthermore, the medicine must not be administered in cases of diarrhoea accompanied by bloody or purulent stools and high fever, as these signs may indicate an invasive infection. It is also not recommended for chronic diarrhoea or antibiotic-associated diarrhoea due to insufficient available data.

The product must not be administered to children with any degree of renal impairment or hepatic impairment (kidney or liver problems). Additionally, the medicine should not be administered during pregnancy or breastfeeding due to a lack of adequate human safety data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information describes specific interaction patterns for Hidrasec Infants (Racecadotril) that focus on a key pharmacodynamic risk and a documented lack of certain pharmacokinetic interactions.

Documented Interaction Patterns

Interaction Type	Interacting Substance/Class	Regulatory Finding
Pharmacodynamic Risk	ACE Inhibitors (Angiotensin-Converting Enzyme Inhibitors)	Co-administration may increase the risk of angioedema (swelling) due to interference with the bradykinin degradation pathway. Patients already receiving these require a careful risk assessment.
Lack of PK Interaction	Major CYP Enzymes (e.g., CYP3A4, 2D6)	Racecadotril and its metabolites do not inhibit or induce major liver enzymes to a clinically relevant extent, confirming a lack of metabolic interaction potential.
Lack of PK Interaction	Loperamide or Nifuroxazide	Co-administration is documented as not modifying the kinetics (exposure/plasma levels) of racecadotril.

Other Regulatory Notes

The medicine does not modify the protein binding of highly protein-bound active substances such as warfarin, digoxin, or phenytoin. There are no mandatory timing or separation requirements documented in the official regulatory labeling for co-administration with other medications. Food intake may delay the time to maximum concentration (Tmax) of the active metabolite, but it does not affect the overall bioavailability.

Mechanism of Action

Modulation of Endogenous Opioid Mediators

The mechanism of action centers on inhibiting the enzyme Neutral Endopeptidase (NEP), also known as Enkephalinase, which is found on the surface of intestinal cells. The active metabolite, Thiorphan, competitively blocks NEP, thereby preserving the body's natural inhibitory compounds, the Endogenous Enkephalins. This preservation extends the biological action of Enkephalins on local delta-opioid receptors, initiating a cascade that modulates signaling associated with heightened secretory states.

Inhibition of Fluid and Electrolyte Hypersecretion

Prolonged Enkephalin receptor activation leads to a significant decrease in cyclic AMP (cAMP), a key messenger that drives excessive fluid and electrolyte (Chloride, Cl^-) secretion into the intestine. This mechanism selectively influences the processes responsible for excessive fluid secretion by modifying epithelial function. The mechanism does not substantially influence normal intestinal motility (peristalsis). The mechanism exhibits peripheral action by restricting metabolite activity outside the Blood-Brain Barrier (BBB), ensuring its mechanistic focus remains within the digestive system.

Dosage and Administration Information

How to Use Hidrasec Infants

Hidrasec Infants 10 mg (Racecadotril) is a prescription medicine intended for the oral route of administration and must be used strictly according to prescribed guidelines.

Administration Protocol

This medication is provided as granules for oral suspension in a single-dose sachet. It functions as an adjuvant treatment and must always be administered together with Oral Rehydration Solution (ORS), which is essential for fluid and electrolyte replacement.

Feature	Official Use Instruction
Age Group	For infants older than three months only.
Preparation	Granules must be dispersed in a small amount of food or liquid (water or feeding-bottle), mixed well, and given immediately.
Dosing Frequency	Administer three times daily at regular intervals.

Weight-Based Dosing and Duration

Dosing is calculated based on the infant’s body weight, following a guideline of 1.5 mg/kg per dose.

Infant Weight Range	Daily Dosing Regimen
Less than 9 kg	One 10 mg sachet per dose (three times daily).
9 kg to 13 kg	Two 10 mg sachets per dose (three times daily).

The treatment should be continued until the infant passes two consecutive normal stools. The total duration of treatment must not exceed seven days. Use is not recommended for children with known hepatic (liver) or renal (kidney) impairment due to limited data.

Recent Clinical Evidence

Research evidence / Overview of studies for Hidrasec Infants

Evidence for Complementary Symptomatic Treatment of Acute Diarrhoea

The primary research for Racecadotril (the active ingredient in Hidrasec Infants) was studied in research scenarios alongside standard care, which includes Oral Rehydration Solution (ORS). This evidence base is built mainly from Randomized Controlled Trials (RCTs) and comprehensive analyses, known as Systematic Reviews and Individual Patient Data Meta-Analyses, that combined the findings of these short-term studies. The research examined the context of its use as an additional treatment for acute, watery diarrhoea, a condition characterized by high fluid loss and temporary physiological imbalance.

Core Study Designs and Measurements

Researchers designed the trials to measure specific clinical outcomes reflecting the duration and severity of the illness. Outcomes related to episodic or acute changes were observed in children who received Racecadotril plus ORS compared to children who received a placebo plus ORS. Studies measured specific outcomes, including the total time until recovery from diarrhoea and the volume and frequency of stools. These are outcomes that monitored physiological changes in fluid output and frequency.

Research in Special or Limited Populations

While the available data show patterns related to use in the target population (infants and young children), the official regulatory summaries note that data for infants under 3 months of age remain limited. Consequently, the results apply only to the populations studied. Data for certain subgroups, such as those defined by specific underlying health issues, also remain insufficient, meaning that subgroup findings are uncertain.

️ Evidence Certainty and Research Gaps

Authoritative systematic reviews and regulatory evaluations have assessed the overall body of evidence. Official reviews state that the overall weight of the evidence is frequently rated as moderate or low. This classification is due to several factors, including the fact that evidence quality varies across studies, and some primary trials were identified as having a moderate to high potential for bias. Research describes that while studies explored the short-term symptom patterns, the findings were sometimes mixed due to methodological variability (heterogeneity) across the different trials, contributing to uncertainty.

Key Studies & References

Frequently Asked Questions (FAQ)

Common questions about Hidrasec Infants (FAQ)

Q: Is Hidrasec Infants considered an antibiotic for diarrhea?

According to regulatory classification, Hidrasec Infants is defined as an antisecretory antidiarrheal agent. This means it works by reducing fluid secretion in the gut. It is classified as an enkephalinase inhibitor, which is a different pharmacological class than antibiotics.

Q: How does Hidrasec Infants differ from giving my child standard oral rehydration salts?

Hidrasec Infants and oral rehydration salts (ORS) have different roles in treating acute diarrhea. The medicine acts as an antisecretory agent by reducing the excessive loss of water and electrolytes from the intestine. Conversely, ORS is essential for replacing fluids and electrolytes that have already been lost. Official information states Hidrasec Infants is an adjuvant treatment, meaning it must always be used alongside ORS.

Q: Can an infant with a known allergy to lactose safely take this medicine?

The granules for oral suspension are manufactured without lactose. However, the formulation does contain sucrose. Official warnings advise that the medicine is not suitable for infants with rare hereditary problems such as fructose intolerance or sucrase-isomaltase deficiency, which are related to sugar metabolism.

Q: Can Hidrasec Infants powder be mixed into formula or breast milk, based on product information?

Yes, the official product information describes that the granules should be dispersed in a small amount of liquid or food. This includes mixing them with water or administering them via a feeding-bottle. Product information indicates that once the medicine is mixed, it is intended to be administered immediately.

Q: Why is the drug sometimes referred to by its generic name, racecadotril?

Racecadotril is the name of the active substance, or primary ingredient, contained within the product known as Hidrasec Infants. This active substance is responsible for the medicine's mechanism of action in the gut.

Q: Does the packaging mention any common allergens besides lactose?

The official list of excipients includes sucrose, colloidal anhydrous silica, polyacrylate dispersion, and apricot flavouring. The primary contraindications focus on the sucrose content, which makes it unsuitable for patients with certain hereditary sugar intolerances.

Q: Is there a distinction between the 'Infants' version and other versions of Hidrasec?

Yes, the different Hidrasec formulations are distinguished by their dosage strength and target weight group. The 'Infants' formulation contains 10 mg of racecadotril per sachet and is generally intended for infants under 13 kg. A 'Children' formulation is also available, which typically contains 30 mg per sachet for older children who weigh more than 13 kg.

Q: How common is it for infants to experience mild drowsiness with this medicine?

According to regulatory documentation, drowsiness has been reported, but it is classified as an uncommon side effect. Side effects are monitored and classified based on how often they occur in clinical studies or post-marketing surveillance.

Q: How quickly can parents generally expect to see an effect from the medicine?

Official pharmacokinetic data indicates that the process of inhibiting the enzyme responsible for hypersecretion in the intestine begins relatively quickly. This effect may be observed beginning about 30 minutes after the medicine is administered.

Q: Does the medicine need to be taken before, during, or after feeding?

Official product information states that the medicine is generally recommended to be taken at regular intervals throughout the day. While taking the medicine with food may slightly delay the time it takes to reach maximum concentration in the body, it does not change the total amount of medicine that is absorbed.

Q: What informational context is available regarding what happens if a baby vomits soon after a dose?

Regulatory warnings state that the medicine should not be administered in cases of prolonged or uncontrolled vomiting. This is due to the potential for reduced bioavailability, meaning the body may absorb less of the drug.

Q: What is the typical description of the flavor or taste of the oral powder?

The granules for oral suspension contain apricot flavouring, which is included as an excipient in the formulation. This flavouring is intended to assist with the palatability and ease of administering the product to young patients.

Q: Does official information clarify if this medicine has any effect on the baby's appetite?

The official product information does not list the medicine as having an effect on appetite as a side effect. However, a lack of appetite, particularly when combined with severe or prolonged diarrhea, is a finding that should be discussed with a healthcare professional.

Q: Is it possible for Hidrasec Infants to cause constipation, according to safety data?

Clinical study data indicates that the medicine is not primarily associated with causing constipation. The reported rate of secondary constipation with racecadotril was comparable to the rate observed in patients who were given a placebo (inactive substance).

Q: What information is provided about what to do if a baby is given slightly more than the usual amount?

Regulatory documents state that if a dose higher than prescribed is administered, medical advice should be sought immediately. Although sporadic cases of overdose have been reported so far without adverse events, contacting medical professionals is indicated as a precaution.

Q: Do official documents suggest any general dietary adjustments when using the drug?

Official documents strongly emphasize that the medicine must be administered along with oral rehydration solution (ORS). Beyond the mandatory use of ORS, the product information refers only to the use of 'usual dietary support measures' for diarrhea and does not specify mandatory food restrictions.

How should Hidrasec Infants be stored and disposed of?

How to Store and Dispose of Hidrasec Infants?

Storage Conditions

Official regulatory documentation requires that Hidrasec Infants 10 mg granules must be stored below 30 C. This temperature restriction is essential for maintaining the product's stability and quality. The product must also be kept out of the sight and reach of children as a mandatory safety measure.

Stability and Expiry

The granules must not be used past the expiry date which is printed on the sachet and the carton. No specific stability constraints are documented for the product after the sachet has been opened or the granules have been mixed.

Disposal Instructions

Unused or expired medicinal product, along with any waste material, must be disposed of in accordance with local requirements. This instruction ensures proper adherence to regional protocols for pharmaceutical waste management.

Hidrasec Infants