Гидрасек

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Гидрасек

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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 Гидрасек

Property Description
Active ingredient Racecadotril (as a prodrug)
Form Capsules, Granules for oral suspension
Pharmacological class Antisecretory Antidiarrheal Drug (Enkephalinase Inhibitor)
Common use Symptomatic relief of acute watery diarrhea
Origin Synthetic

Гидрасек (Hydrasec) is a synthetic medicinal product intended for oral administration and categorized as an antidiarrheal agent. It is clinically recognized as an Enkephalinase Inhibitor, a distinct type of drug defined by its targeted antisecretory mode of action, which is to reduce the excessive loss of water and electrolytes into the intestine. The primary mechanism of Racecadotril involves selective inhibition of enkephalinase, which decreases intestinal fluid hypersecretion. This mechanism works by controlling the fluid loss in the gut.


Definition and Pharmacological Classification

Гидрасек belongs to the pharmacological class known as Other Antidiarrheals and is categorized under ATC code A07XA04. The medicine is a synthetic prodrug containing the single active ingredient, Racecadotril. It is often distinguished in the market by its formulation as granules for oral suspension, making it an option for pediatric patients. This non-motility-altering agent has a unique peripheral mode of action. The agent is characterized by its effectiveness and a favorable safety profile compared to placebo in the symptomatic treatment of acute diarrhea, supporting patient well-being during therapy.


Composition and Available Forms

The active substance, Racecadotril, functions as a prodrug that rapidly converts in the body to its active metabolite, Thiorphan. This compound is the selective inhibitor responsible for blocking the enzyme enkephalinase in the gut. To accommodate different target patient groups, the product is formulated in two primary dosage forms: capsules for adults and the specialized granules for oral suspension (powder for suspension) for pediatric patients. Both preparations contain Racecadotril along with necessary pharmaceutical excipients and are intended for oral administration, providing a flexible treatment option for acute watery episodes.

What side effects are possible with Гидрасек?

Possible Side Effects and Safety Information

The official safety profile for Racecadotril (Гидрасек) is structured by regulatory classifications based on the frequency and nature of adverse events reported in clinical data and post-marketing surveillance. The only side effect classified as common (ge 1/100 to < 1/10) in official labeling is headache, which is grouped under Nervous system disorders.


Adverse reactions involving the Skin and subcutaneous tissue disorders are also documented. These events, such as a rash or erythema, are generally classified as uncommon (ge 1/1,000 to < 1/100). However, more severe and clinically significant reactions, including angioedema (swelling of the face, tongue, or larynx), urticaria (hives), and Erythema multiforme, are recognized safety concerns. These severe hypersensitivity reactions are of not known frequency but are subject to continuous regulatory monitoring due to their potential seriousness, including the risk of anaphylactic shock [NIH MedlinePlus]. Such reactions, like angioedema, may occur at any point during treatment.


The regulatory label outlines specific safety restrictions. The medicine is contraindicated in patients with a known hypersensitivity to racecadotril or its excipients. Caution is also advised regarding use in patients with severe renal or hepatic impairment due to a lack of complete safety data for these populations. Additionally, the label notes that the concomitant use of Racecadotril with ACE inhibitors may heighten the risk of developing angioedema [EMA SmPC]. It is also officially noted that the administration of this medicine is not a substitute for standard oral rehydration therapy.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents regarding Racecadotril overdose indicate that clinical experience is highly limited. In studies, adults have tolerated single doses up to 20 times the standard therapeutic dose (2 g) without documenting adverse events or harmful effects. Consequently, no specific clinical signs, symptoms, or laboratory abnormalities are formally listed as resulting from an acute overdose. Additionally, no specific population-based overdose considerations are documented for pediatric, elderly, or renally/hepatically impaired patients.

Emergency Actions and Treatment:

No specific antidote is known for Racecadotril; therefore, treatment is officially designated as symptomatic and supportive.

For a suspected overdose, the patient or caregiver is instructed to contact the accident and emergency department of a local hospital or a doctor for advice.

Immediate medical help is mandatory if severe allergic reactions occur during treatment, which carries the risk of life-threatening complications. If angioedema (swelling) is associated with signs of upper airway obstruction, emergency treatment must be administered immediately. Upon the appearance of any signs suggestive of a severe skin reaction, the medicine must be withdrawn at once, and the patient requires close medical supervision until symptoms disappear.

Therapeutic Uses of Гидрасек

The primary purpose of Гидрасек (Racecadotril) is to offer targeted symptomatic relief during acute episodes of watery diarrhea, focusing on easing the most disruptive manifestations of the condition. The medicine is commonly used for symptomatic treatment in adults, and its benefits are also considered relevant for pediatric patients (infants and children).


Relieving Acute Symptoms and Restoring Comfort

This medication is commonly used for the symptomatic management of acute diarrhea, including common instances such as traveler's diarrhea and episodes related to infectious gastroenteritis. It is applied in situations where additional symptomatic support is needed to address sudden and significant symptoms related to heightened physiological activity in the gut.

The symptomatic relief provided helps to manage the excessive stool output, the very watery consistency of stools, and the resulting frequent urge for defecation. This focus on managing symptoms that interfere with daily comfort assists with managing the excessive stool output and helps maintain a sense of stability when symptoms are more noticeable.

“The primary benefit is in reducing the volume and frequency of watery stools, which supports the patient during difficult episodes by helping to ease the overall symptom burden.”

This support is generally considered relevant for both adults and pediatric patients who require supportive relief, assisting them to cope more steadily with the physical distress associated with symptoms related to systemic imbalance.


Quick Fact: Relief for High Stool Output and Frequent Defecation

Regulatory References

  1. Scottish Medicines Consortium (SMC) review of Racecadotril

Eligibility and Restrictions for Use

Who Can and Cannot Use Гидрасек? Official Eligibility Summary

The eligibility profile for Гидрасек (Racecadotril) is strictly defined by regulatory authorities based on age, physiological status, and underlying health conditions.


Approved and Restricted Populations

Population Group Eligibility Status (Regulatory)
Infants Approved for infants older than 3 months (granule form).
Adults and Older Adults Approved (capsule form); no dose adjustment is necessary for the elderly.
Pregnancy/Lactation Use is not recommended or must be avoided due to a lack of clinical data.
Renal/Hepatic Impairment Adult patients should be treated with caution due to limited data.

Absolute Contraindications (Must Not Use)

Official prescribing information mandates that the medicine must not be administered to specific groups:

  • Infants less than 3 months of age.
  • Patients with known hypersensitivity to Racecadotril or its excipients (e.g., lactose-linked disorders).
  • Individuals with a history of Severe Cutaneous Adverse Reactions (SCARs) from Racecadotril.
  • Diarrhea accompanied by bloody or purulent stools and fever (may indicate invasive disease).
  • Patients who reported angioedema with previous use of ACE inhibitors.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Racecadotril is characterized by a low potential for pharmacokinetic conflicts and one principal pharmacodynamic caution, as documented in official regulatory sources.

Drug-Drug Interactions

Co-administration with Angiotensin-Converting Enzyme (ACE) Inhibitors, such as enalapril, captopril, or lisinopril, is associated with a formally documented risk of augmenting angioedema (Quincke's oedema). Regulatory agencies advise caution when combining these specific drug classes.

Pharmacokinetic Interaction Profile

Official data confirms that Racecadotril's active metabolite, Thiorphan, does not inhibit or induce major Cytochrome P450 (CYP) enzymes or UGT conjugating enzymes to a clinically relevant extent. This indicates a minimal risk for exposure-altering interactions with many other medicines. Studies confirm that co-administration with other specific antidiarrheal agents, such as Loperamide or Nifuroxazide, does not modify the kinetics of Racecadotril.

Interactions with Food and Substances

Administration with food is documented to delay the time to peak plasma concentration (Tmax) of the active metabolite by approximately 1 to 1.5 hours. However, this interaction does not affect the total amount absorbed (AUC), meaning the overall bioavailability remains unchanged. Official documentation generally advises avoiding alcohol consumption during the treatment period due to a lack of comprehensive interaction data.

Mechanism of Action

Targeted Inhibition of Intestinal Enzymes

The drug functions via its active metabolite, Thiorphan, which acts as a selective competitive inhibitor of the enzyme Enkephalinase (Neutral Endopeptidase) found on the brush border of intestinal cells. By blocking this enzyme, the drug preserves the body's natural opioid peptides, Enkephalins, allowing their local concentration and effect on receptors to be maintained.


Antisecretory Cascade and Fluid Balance Modulation

The preserved Enkephalins activate delta-Opioid Receptors; this activation is coupled to the inhibition of Adenylyl Cyclase, thereby reducing levels of cAMP (Cyclic Adenosine Monophosphate) inside the intestinal cells. This reduction in cAMP directly blocks the excessive efflux (hypersecretion) of Cl^- ions and water into the intestinal lumen, modulating the mechanism of intestinal fluid secretion.


Peripheral Specificity and Motility Sparing Action

The active mechanism is strictly peripheral, confined to the gut wall due to its inability to cross the blood-brain barrier (BBB). Crucially, the mechanism does not interfere with the coordinated muscle contractions responsible for intestinal motility (peristalsis). The mechanism restricts its activity to fluid secretion pathways, leaving the processes governing intestinal motility generally unaltered.

Dosage and Administration Information

How to Use Гидрасек: Administration Guidelines

Гидрасек (Racecadotril) is an oral antisecretory agent whose administration follows a precise, short-term protocol. It is designed to be used adjunctively, meaning it is given in addition to Oral Rehydration Therapy (ORT) to help manage fluid and electrolyte loss.


Administration and Dosing Schedule

Population Approved Dosage Form Dosing Regimen Frequency & Timing
Adults Hard Capsules (100 mg) Initial dose of one 100 mg capsule, followed by the maintenance dose. Three times daily (t.i.d.), preferably before the main meals. Initial dose can be taken anytime.
Pediatrics Granules for Oral Suspension (10 mg or 30 mg) Dose is calculated according to body weight (approximately 1.5 mg/kg per dose). Three times daily (t.i.d.).

Duration and Administration Constraints

The total course of treatment is short-term and must not exceed seven days. The administration of Гидрасек is discontinued immediately upon a specific clinical observation. The instruction is to stop the medicine when the patient has passed two normal, formed stools, regardless of the total days elapsed, provided the seven-day limit is not exceeded.

Pediatric granules must be prepared correctly before use. The sachet contents should be mixed thoroughly with food or a small amount of water (e.g., 1 teaspoon) and administered without delay. For older patients, no dosage adjustment is necessary; however, caution is applied for patients with renal or hepatic impairment due to limited clinical data.

Recent Clinical Evidence

Research evidence / Overview of Studies for Гидрасек (Racecadotril)


Evidence for Use in Acute Watery Diarrhea in Children

The available research for racecadotril in children includes short-term Randomized Controlled Trials (RCTs). These studies were used to understand how symptoms change over time in infants aged 3 months and older and in young children experiencing acute, watery diarrhea. In these research contexts, the medicine was typically evaluated alongside Oral Rehydration Solution (ORS), which is the standard supportive care studied in these trials. Researchers monitored outcomes describing episodic or acute changes, such as the duration of the diarrhea episode and the total volume and frequency of diarrheic stools observed. Findings generally describe patterns observed in the studies, but the certainty remains low in some areas due to noted study heterogeneity and potential risk of bias in some older reports.


Evidence for Use in Acute Watery Diarrhea in Adults

For adults, evidence related to the use of racecadotril was also primarily established through Randomized Controlled Trials (RCTs). These trials applied in studies examining patient-reported experiences related to the condition, comparing the medicine against a placebo or other common active agents studied for diarrhea relief. The primary outcomes measured included the time to cessation of diarrhea and the proportion of patients who reported recovery within short time intervals. Individual Patient Data (IPD) meta-analyses have contributed to the broader evidence landscape, reporting on the frequency of unformed stools and noting the differences documented between study groups. However, research comparing the medicine against other active agents is limited, and studies exploring direct comparison with certain motility-altering drugs reported varying findings.


Follow-up Duration and Tracking Outcomes Beyond the Acute Phase

Research exploring short-term symptom changes typically defined follow-up durations that were limited, generally lasting up to 7 days, or until the acute symptoms were reported as resolved. There is limited information for long-term outcomes because research generally does not track patients' status or the durability of response after the acute diarrhea episode has fully subsided. Therefore, how symptoms evolve in the observed populations beyond the acute phase, or whether the use of the medicine was associated with the chances of a future recurrence, is not well characterized by the existing studies.

Key Studies & References

  1. Systematic review: racecadotril in the treatment of acute diarrhoea in children
  2. Summary of Product Characteristics (SPC) - Racecadotril (HPRA/EU regulatory data)

Frequently Asked Questions (FAQ)

Common questions about Гидрасек (FAQ)

Q: Is the way Гидрасек works similar to Loperamide (Imodium)?

According to official regulatory documents, Гидрасек is an antisecretory agent that works by reducing the excessive loss of water and electrolytes into the gut. This is distinct from motility-inhibiting medicines, which primarily work by slowing down the movement of the gut. Clinical data has noted that its motility-sparing mechanism results in a low risk of constipation, compared to medicines that slow gut movement.

Q: Does Гидрасек treat the cause of diarrhea or just the symptoms?

Гидрасек is officially indicated for the symptomatic relief of acute diarrhea. It works by targeting and modulating the mechanism of the symptom—the excessive loss of water and electrolytes—via its antisecretory action. It is intended for symptomatic relief and is not classified as an antibiotic.

Q: How quickly can a person expect to feel better after starting Гидрасек?

Studies and official information indicate that the pharmacological action of Гидрасек begins relatively quickly, with the inhibition of the target enzyme observed approximately 30 minutes after a single oral dose. The full clinical effect, described as rapid antidiarrheal action, is measured over the course of the short-term treatment.

Q: Can Гидрасек cause symptoms like drowsiness or headache?

Official safety information classifies headache as the only common side effect in the nervous system disorders category. Though generally uncommon, drowsiness has also been noted in a few cases reported during clinical trials.

Q: What kind of ingredients (excipients) are in the children's version of Гидрасек?

The children's granules for oral suspension contain the active substance, Racecadotril, alongside pharmaceutical excipients. These excipients typically include sucrose (a form of sugar), anhydrous colloidal silica, polyacrylate dispersion, and an apricot aroma.

Q: Is it normal to still have some diarrhea after the first day of taking Гидрасек?

The research indicates that symptoms may persist during the initial phase of treatment, as the median duration of relief is measured over a period of several days. Official instructions specify that treatment is intended to continue until two normal, formed stools are passed, provided the maximum duration is not exceeded.

Q: What should a person do if they suspect an allergic reaction to Гидрасек?

Official warnings note that if signs of a severe allergic reaction, such as a rash, hives, or swelling of the face, tongue, or throat (known as angioedema), occur, the regulatory label indicates that the use of the medicine is advised to be terminated immediately. If swelling affects the upper airways, official guidance suggests that emergency treatment be administered rapidly.

Q: Does taking Гидрасек interfere with the effectiveness of common pain relievers?

Regulatory data indicates a minimal risk for exposure-altering interactions with many other medicines. This is because the active metabolite of Гидрасек does not inhibit or induce the major Cytochrome P450 (CYP) enzymes to a clinically relevant extent, which are responsible for processing many common medications, including some pain relievers.

Q: Are there any dietary restrictions mentioned while taking Гидрасек?

The official product information does not list any specific food restrictions to avoid while taking Гидрасек. Administration with food is documented to cause a delay in the time it takes for the drug to reach its peak concentration in the body, but it does not affect the total amount of medicine absorbed.

Q: How long does the effect of one dose of Гидрасек typically last?

Following a standard oral dose, the plasma concentration of the active metabolite is typically present at levels that inhibit the target enzyme for up to 8 hours. This pharmacological duration relates to the intended frequency of administration.

Q: Does the official product information for Гидрасек mention use in people with Inflammatory Bowel Disease (IBD)?

According to official warnings, the use of Гидрасек for chronic diarrhea is generally not recommended due to a lack of sufficient clinical data in these long-term conditions. This recommendation covers chronic diseases such as Inflammatory Bowel Disease (IBD).

Q: What are the official warnings about taking Гидрасек if someone has diabetes?

Official warnings specifically address the use of the children's granules for patients with diabetes because the formulation contains sucrose (sugar). If the amount of sucrose (a source of glucose and fructose) taken in the daily dose exceeds a certain limit, the official warning states that this must be taken into account in the patient's daily sugar ration.

Q: Can Гидрасек be used for symptoms of traveler’s diarrhea?

Гидрасек is indicated for the symptomatic treatment of acute watery diarrhea in approved populations. It is important to note the absolute contraindication: the medicine must not be administered if the diarrhea is accompanied by bloody or purulent stools and fever, as this may indicate a need for different medical management.

Q: Are there different brand names for the same medicine as Гидрасек?

Yes, the active ingredient in Гидрасек, which is Racecadotril, is marketed globally under several different trade names. These commonly include names such as Tiorfan and Redotil, depending on the country or manufacturer.

How should Гидрасек be stored and disposed of?

How to Store and Dispose of Гидрасек?

This medicine must be stored and disposed of strictly according to the official instructions documented in regulatory labeling.


Storage Requirements

Official regulatory documents state that Гидрасек does not require any special storage conditions in terms of specific temperature or environmental controls.

  • Child Safety: It is a mandatory requirement to keep this medicine out of the sight and reach of children to prevent accidental ingestion.
  • Shelf-Life: The product must not be used after the expiry date (EXP) printed on the carton. This date refers to the last day of the stated month.

Disposal Instructions

To ensure environmental protection, official instructions prohibit common disposal methods:

  • Do not throw away any medicines via wastewater or household waste.
  • You must ask your pharmacist how to throw away medicines you no longer use.

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

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