Hidrasec

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Hidrasec

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

Overview of Hidrasec

Quick Facts: Hidrasec (Racecadotril)

Property Description
Active ingredient Racecadotril (INN)
Pharmacological class Antisecretory Antidiarrheal Agent
Key Action Enkephalinase inhibition
Forms for Oral Use Capsules, Granules for suspension
Origin Synthetic compound (Pro-drug)

What is Racecadotril and Its Pharmacological Classification?

The medicine is fundamentally defined by its active ingredient, Racecadotril, a synthetic compound which functions as a pure antisecretory antidiarrheal agent. Racecadotril is specifically classified as an enkephalinase inhibitor. This high-level pharmacological classification is clinically recognized for its targeted effect, differentiating it from older antidiarrheal drugs that operate primarily by altering intestinal transit time. This specific enzyme-inhibiting action highlights that the drug modulates intestinal fluid without disrupting normal motility.

Composition and Available Forms for Administration

Racecadotril is provided for oral administration as a single-ingredient product, typically available in two main pharmaceutical preparations: hard capsules and granules for oral suspension. The unique feature of the granules formulation is its suitability for suspension, facilitating use in pediatric patients. The formulation is a pro-drug that is rapidly hydrolyzed to its active metabolite, Thiorphan, after ingestion. The manufacturing distinction ensures that the medicine can be delivered effectively to all intended patient groups, establishing a key differentiating factor in patient care.

General Purpose and Unique Antisecretory Action

The general purpose of Racecadotril is to manage the symptoms associated with acute diarrhea by mitigating the excessive loss of water and electrolytes. It functions as an antisecretory agent that directly addresses hypersecretion of fluid in the gut. The medication is used across various age groups as a supportive measure in managing typical diarrhea symptoms. This peripheral action is unique because it treats the fluid efflux problem at its source without significantly affecting the natural movement of the intestine.

Regulatory References

  1. NIH/NLM Diarrhea Information

What side effects are possible with Hidrasec?

Possible Side Effects and Safety Information

The safety profile for racecadotril is established through official regulatory documentation, which classifies adverse reactions by their frequency and the physiological system affected. The medicine's risk landscape is detailed without providing clinical advice or instructions for use, focusing strictly on label-documented facts.


Documented Adverse Reactions

The most frequently reported adverse reaction is Headache, which is officially categorized as Common (may affect up to 1 in 10 people) under Nervous system disorders. Uncommon reactions (may affect up to 1 in 100 people) primarily involve the skin, such as Rash and Erythema.

Many clinically significant reactions are classified as Not known (frequency cannot be estimated from available data), typically falling under Skin and subcutaneous tissue disorders and Immune system disorders.


Serious Safety Considerations

Regulatory sources explicitly document the potential for severe reactions, including Angioedema (localized swelling of the face, tongue, or lips), Anaphylactic shock, and other serious systemic allergic responses. These reactions, which can occur at any time during therapy, are rare but officially acknowledged in the safety labeling.

Safety Constraints for Specific Populations

Official prescribing information places constraints on use for specific patient groups due to limited safety data or known risks:

  • Renal and Hepatic Impairment: Not recommended for individuals with severe renal impairment or severe hepatic impairment.
  • Pregnancy and Lactation: Use is contraindicated due to insufficient human data.
  • Hereditary Intolerances: Contraindicated in patients with specific rare hereditary problems, such as hereditary fructose intolerance, related to excipients in the formulation.

These constraints define the boundaries of safe use as determined by government regulatory standards.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Racecadotril indicates that the documented overdose profile does not feature a classical dose-dependent toxicity syndrome. The administration of single doses up to 20 times the recommended therapeutic amount has been reported with no specific harmful effects or undesirable events in adult studies.


When Immediate Medical Help is Required

The primary guidance on seeking urgent help is centered on severe hypersensitivity reactions, which are classified as life-threatening and require rapid action. Immediate medical attention is required for the following manifestations:

Life-Threatening Manifestation Regulatory Action Mandate
Angioedema (swelling of face, lips, or tongue) that may cause upper airway obstruction Emergency treatment should be administered rapidly/promptly
Severe Cutaneous Adverse Reactions (SCARs), including DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) Treatment must be terminated immediately and permanently

Supportive Management and Monitoring

Management following a severe event must be symptomatic and supportive. Regulatory sources state that no specific antidote has been identified for the medicine. Consequently, all management follows recognised procedures for overdose.

In cases of severe reactions, close medical supervision and appropriate monitoring are required. This observation must be continued until there is complete and sustained symptom resolution.

Therapeutic Uses of Hidrasec

The primary therapeutic role of Racecadotril (Hidrasec) is the symptomatic management of acute diarrhea, which is an area that involves addressing symptoms related to heightened physiological activity. It is commonly used in clinical settings that involve acute or unstable symptom patterns.

This medication is applied across domains where additional symptomatic support is needed to address symptom clusters that may become intense or disruptive. It is relevant for easing symptoms related to systemic imbalance, helping to moderate the pronounced symptom of excessive loss of water and electrolytes. This supportive action assists with maintaining functional stability and contributes to easing the overall symptom load.

Key Applications and Benefits

The core indication is applied across conditions presenting with acute episodes, including acute gastroenteritis, and is relevant for managing high-volume, watery stools and excessive fluid loss. The medication is commonly used across patient groups, including adults and pediatric patients, during difficult episodes by easing distress and providing supportive relief that helps patients cope more steadily with symptom fluctuations.

“This supportive medication helps manage the acute, uncomfortable symptoms of high-output diarrhea.”

Quick Fact: Relief for Acute Diarrhea
Main Use Symptomatic management of acute, high-volume watery diarrhea.
Key Benefit Contributes to maintaining stability during episodes of fluid loss.
Patient Groups Commonly used for adults and pediatric patients.
Context Relevant in contexts involving heightened systemic burden.

Regulatory References

  1. Official HPRA Summary of Product Characteristics on Hidrasec

Eligibility and Restrictions for Use

Who Can and Cannot Use Hidrasec?

The eligibility for using Hidrasec (Racecadotril) is defined by regulatory labeling based on age, physiological status, and underlying health conditions.

Approved Populations and Restrictions

Hidrasec is indicated for use in adults and older adults, with no required dosage adjustment for the elderly. For pediatric use, the medicine is approved for infants older than three months and children (granule formulation). Use in infants less than three months old is generally not recommended due to a lack of available clinical data.

Contraindications and Prohibited Use

The medicine is strictly contraindicated for any patient with a known hypersensitivity to racecadotril or its ingredients, including those with certain rare hereditary metabolic disorders such as fructose intolerance or glucose-galactose malabsorption.

It must not be administered to pregnant or breastfeeding women, nor to children who have any degree of renal or liver impairment. Use is also not recommended if the diarrhea involves fever and bloody or purulent stools, or in cases of chronic diarrhea or antibiotic-associated diarrhea. Adults with existing renal or hepatic impairment should use the medicine with caution.

What should I know about interactions with other medicines?

Hidrasec Interactions with other medicines and products

This section details the officially documented interaction information for Racecadotril (Hidrasec) as specified in government regulatory sources.

Documented Pharmacodynamic Interaction

The primary interaction noted in official prescribing information is pharmacodynamic in nature and concerns a specific class of medicines:

  • Angiotensin-Converting Enzyme (ACE) Inhibitors: The concomitant administration of Racecadotril with ACE inhibitors, such as lisinopril, perindopril, or ramipril, is officially documented as potentially increasing the risk of angioedema.

Absence of Pharmacokinetic Interactions

Official regulatory data explicitly indicates that Racecadotril does not cause clinically relevant interference with common drug metabolism pathways or drug binding:

Interaction Type Regulatory Finding
Protein Binding No interference with the binding of strongly bound drugs (e.g., warfarin, digoxin, phenytoin).
Metabolic Enzymes No clinically significant inhibition or induction of cytochrome P450 (CYP) enzymes is documented.

Interaction-Related Constraints and Notes

  • Contraindications: There are no medicines formally classified as a contraindication based solely on drug-drug interaction risk with Racecadotril.
  • Timing: No mandatory timing separation or administration window is required between Racecadotril and other medicinal products.
  • Food, Alcohol, Supplements: Official labeling does not document any specific interactions with food, alcohol, or herbal products.
  • Specific Populations: Caution is advised in patients with hepatic or renal impairment, not due to a heightened interaction risk, but because of the general lack of specific clinical data in these populations.

Mechanism of Action

Racecadotril is an orally available pro-drug that is rapidly metabolized to its active metabolite, thiorphan. Thiorphan acts as a specific inhibitor of enkephalinase (neutral endopeptidase NEP, EC 3.4.24.11), an enzyme present on the brush border of the intestinal epithelium. Inhibition of enkephalinase prevents the degradation of endogenous enkephalins. The conserved enkephalins then bind to delta -opioid receptors on the enterocyte surface. This binding initiates a G-protein-coupled signaling cascade that reduces the activity of adenylate cyclase and subsequently decreases the intracellular concentration of cyclic AMP ( cAMP) within the secretory cells. The resultant lower cAMP level reduces the secretion of water and electrolytes, specifically chloride ions, into the intestinal lumen. This localized action produces a net decrease in fluid content in the intestine and does not modulate intestinal motility.

Dosage and Administration Information

How to Use Hidrasec (Racecadotril)

This information describes the administration of Hidrasec capsules (100 mg) for adults and granules (10 mg and 30 mg) for children.


Dosing and Administration

Route of Administration: The medicine is for Oral Use only.

Mandatory Co-Therapy: Hidrasec must be administered in conjunction with appropriate oral or parenteral rehydration therapy to compensate for fluid and electrolyte loss. This medicine does not replace the need for rehydration.

Patient Group Dosage Form Initial Dose Maintenance Dosing and Timing
Adults 100 mg hard capsule One capsule, regardless of the time of day. One capsule three times daily (t.i.d.), preferably before the main meals.
Children (over 3 months) 10 mg or 30 mg granules for oral suspension Dose is based on body weight at 1.5 mg/kg per dose, three times daily. Given at regular intervals, three times daily.

Preparation and Treatment Protocol

Preparation:

  • Adults: The hard capsule is swallowed whole.
  • Children (Granules): The contents of the sachet must be added to food or dispersed in a glass of water or a feeding bottle. The mixture must be stirred well and administered immediately.

Duration of Use: Treatment must be continued until two normal stools are recorded. The maximum duration of treatment must not exceed 7 days.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Hidrasec

Evidence for the Symptomatic Management of Acute Watery Diarrhea

The research for Racecadotril (Hidrasec) was studied for acute watery diarrhea, which is a condition associated with acute or disruptive episodes of excessive fluid loss. This area was evaluated in a landscape of Randomized Controlled Trials (RCTs) and systematic reviews that pool data from multiple trials. These studies were designed to monitor and compare how patients reported their experience and how symptoms changed over short periods.

In these trials, researchers examined outcomes related to physical discomfort and functional imbalance. The main outcomes studied included the duration of the diarrheal illness (the time to resolution) and the total volume of stool output over defined time intervals. Studies evaluated the time to recovery, and findings described patterns of reduced duration when used alongside standard oral rehydration solutions (ORS), compared to those receiving ORS alone. Research monitored stool volume during the initial 48 hours of treatment.

Evidence in Specific Age Groups and Clinical Settings

The available research base includes studies in distinct patient groups. Racecadotril was evaluated in pediatric patients, including infants and children over three months of age, as well as the adult population. Research explored how this medicine was observed in studies conducted during periods of increased symptom activity in these groups. Furthermore, studies observed responses in both outpatient and inpatient settings; results apply only to the populations studied, and findings may appear more related to hospitalized patients, who often reflect a higher symptom burden.

Long-Term Follow-up and What is Still Uncertain

The evidence collected in clinical trials mainly involves research exploring short-term symptom changes related to the acute episode. The follow-up durations used were limited, typically observing outcomes only up to 5 to 7 days. Consequently, long-term effects are not fully established, and data for certain groups remain insufficient, such as for the youngest infants. Scientific reviews indicate that the certainty remains low to moderate, citing methodological risk of bias and heterogeneity across trials.

Key Studies & References Summary of Product Characteristics (Racecadotril) - Granules for Oral Suspension (HPRA)

Frequently Asked Questions (FAQ)

Common questions about Hidrasec (FAQ)

Q: Is Hidrasec considered a first-line option for acute watery diarrhea?

Official prescribing information states that Hidrasec is indicated for the symptomatic treatment of acute diarrhea. It is typically used in cases where a specific treatment for the underlying cause is not necessary or possible. If a causal treatment is available, Hidrasec can still be used as a complementary measure to help manage the symptoms.

Q: How does Hidrasec fit into the overall management plan for acute diarrhea?

Hidrasec's primary role is to treat the symptoms of acute diarrhea. Regulatory guidance describes that it is administered in conjunction with appropriate oral rehydration therapy (ORT). This combined approach ensures that the medicine addresses the fluid loss while the ORT replaces necessary water and electrolytes lost from the body.

Q: Is Hidrasec intended only for short-term use, and why is the maximum duration limited?

The regulatory guidelines establish that the maximum duration of treatment with Hidrasec is not to exceed 7 days. This medicine is designed for short-term use to treat acute episodes of diarrhea. Long-term use is not recommended because official data on its effects over extended periods is currently insufficient.

Q: What does 'antisecretory agent' mean in simple, accessible terms?

Hidrasec is categorized as an antisecretory agent because it works by reducing the amount of water and electrolytes secreted into the intestine. This mechanism helps to reduce the watery stool output. Official information confirms this action is localized in the gut and does not interfere with the natural speed of digestion or intestinal movement.

Q: What are the described symptoms of a serious allergic reaction, like angioedema, that require immediate attention?

Official safety documentation notes that severe allergic reactions like angioedema can occur. Symptoms are described as swelling of the face, lips, tongue, or throat, which may be accompanied by difficulty swallowing. Swelling that obstructs the upper airway is described in regulatory sources as a condition where emergency treatment is necessary.

Q: Does Hidrasec contain any ingredients that are known to cause allergic reactions, apart from the active substance?

Official product information states that the medicine is contraindicated for individuals with a known hypersensitivity to the active ingredient or any excipients. Furthermore, the capsules contain lactose monohydrate, and its use is contraindicated in patients with rare hereditary problems such as galactose intolerance or glucose-galactose malabsorption.

Q: How is the action of Hidrasec generally compared to the function of loperamide?

Studies indicate that the drug's mechanism is different from motility-reducing agents like loperamide. Loperamide works primarily by slowing down gut movement, whereas Hidrasec works by reducing fluid secretion. Research has examined the symptomatic outcomes of both treatments.

Q: Are patients taking Hidrasec less likely to report constipation compared to other common anti-diarrhea drugs?

Regulatory-linked clinical data indicates that the reported rate of secondary constipation with Hidrasec was comparable to that observed with a placebo (a non-active treatment) during development. This difference is linked to its antisecretory action which does not slow intestinal movement. In post-marketing surveillance, constipation is reported as a rare or uncommon side effect.

Q: Does Hidrasec contain lactose or gluten?

Official product labeling confirms that Hidrasec capsules contain the excipient lactose monohydrate. While lactose content is explicitly noted, the regulatory documents available do not typically contain an explicit statement regarding the presence or absence of gluten.

Q: Is Hidrasec available over-the-counter (OTC) or does it require a prescription?

The availability of Hidrasec varies depending on the country or regional health authority. Official listings show that in some markets, it is classified as a Prescription-only Medicine (POM). However, in other regions, it may be available for purchase without a prescription. Its status is entirely market-dependent.

Q: How long does it usually take for Hidrasec to begin its symptomatic effect?

While the time to noticeable symptomatic relief may vary, official pharmacological data indicates that the initial inhibition of the targeted enzyme begins about 30 minutes after taking the medicine. The peak activity of the drug in the body is generally reached after approximately 2 hours with the standard adult dose.

Q: Does Hidrasec cause drowsiness or is it described as having little or no effect on alertness?

According to official product information, Hidrasec is described as having no or negligible influence on a person's ability to drive or operate machinery. This is explained by the medicine's activity being exclusively focused on the intestine (peripheral) with no known direct effects on the brain or central nervous system.

Q: Is constipation listed as a common or uncommon side effect of Hidrasec?

Official regulatory documents do not classify constipation as a common (1 in 10) or uncommon (1 in 100) side effect. Instead, it is associated with a lower frequency. Post-marketing surveillance reports list constipation as a rare or uncommon event.

Q: Is Hidrasec used for the treatment of traveller's diarrhea?

The official indication for Hidrasec, as defined by regulatory labels, is for the symptomatic treatment of acute diarrhea in adults and children. The labels do not specify 'traveller's diarrhea' as a unique or distinct indication separate from general acute diarrhea.

How should Hidrasec be stored and disposed of?

How to Store and Dispose of Hidrasec?

Official regulatory information outlines specific rules for the safe storage and disposal of Hidrasec (Racecadotril) to ensure product stability and environmental safety.

Official Storage Requirements

Storage Category Requirement
Temperature Constraint Store the medicine below 30 C (ambient temperature).
Packaging Keep the medicine in its original package to ensure protection from light.
Child Safety It must be kept strictly out of the sight and reach of children.

Disposal Instructions

When the product is expired or no longer needed, it must be disposed of responsibly. Official guidance prohibits discarding the capsules or granules via wastewater (e.g., flushing) or household trash. Instead, unused or unwanted medication should be returned to a pharmacist or a designated medicinal waste collection point. These measures are required to help protect the environment from medicinal waste.

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

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