Racy

Quick links to important sections

Racy

Treatment option:

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 Racy

Racy (Racecadotril) Quick Facts

Property Description
Active ingredient Racecadotril
Form Oral capsules, granules for suspension
Pharmacological class Enkephalinase Inhibitor
Common use Reduction of excessive intestinal secretion
Origin Synthetic compound (Prodrug)

What is Racy (Racecadotril) and What is its Classification?

The medicine Racy is fundamentally defined by its sole active component, Racecadotril, which is a synthetic compound acting as a single-ingredient product. Racecadotril is clinically recognized as a potent Enkephalinase Inhibitor and functions as an Antisecretory agent. This unique pharmacological classification targets a specific enzyme in the gut wall, setting it apart from agents that primarily affect intestinal movement.

Composition, Prodrug Nature, and Available Forms

Racecadotril is administered via the oral route and is chemically defined as a prodrug that undergoes rapid conversion to its active metabolite, Thiorphan, once in the body. This conversion process allows the substance to exert its therapeutic effects. Racy is commonly supplied in hard capsules and as granules for oral suspension. This formulation is a differentiating factor, positioning the product for easier administration, particularly for pediatric groups. Both forms utilize a solid vehicle containing excipients like lactose monohydrate to ensure efficient delivery of the prodrug.

General Purpose and Unique Mechanism Principle

The general therapeutic purpose of Racy is to achieve the reduced intestinal hypersecretion of water and electrolytes, thereby addressing the symptomatic fluid imbalance in the gut. Its mechanism involves the selective, opioid-independent Inhibition of Enkephalinase, which is localized to the intestinal epithelium. This targeted action helps manage fluid loss without significantly altering the natural rhythm or motility of the intestines. This controlled principle ensures the core benefit is achieved by regulating secretion, distinguishing it from agents that physically slow down the digestive process.

What side effects are possible with Racy?

Possible Side Effects and Safety Information

The official safety profile for Racy (Racecadotril) is defined by its classifications of adverse reactions, which include effects on the nervous system and, significantly, the skin and immune systems, as documented by regulatory authorities.

Frequency-Classified Adverse Reactions

Adverse effects are categorized by frequency, based on regulatory standards:

  • Common (may affect up to 1 in 10 people): Headache is the primary effect classified in this category.
  • Uncommon (may affect up to 1 in 100 people): Reactions include rash, erythema (skin redness), and tonsillitis.
  • Frequency Not Known: This category covers effects where frequency cannot be reliably estimated from available data, including serious hypersensitivity events like angioedema and anaphylactic shock, as well as various skin reactions like urticaria (hives) and erythema multiforme.

Serious Adverse Reactions and System-Organ Focus

Regulatory labeling specifies the potential for severe reactions, notably Angioedema (swelling of the face, tongue, or upper airway), which is described as potentially fatal. The product information also documents the risk of Severe Cutaneous Adverse Reactions (SCARs), including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which are also noted as potentially life-threatening or fatal. The most affected systems are the Skin and subcutaneous tissue disorders and the Immune system disorders.

Safety Constraints and Special Populations

Official safety documents define specific limitations on use:

  • Infants and Children: The medicine must not be administered to infants under three months of age. Use in pediatric patients with hepatic or renal impairment is restricted due to a lack of data.
  • Renal/Hepatic Impairment: Treatment should be undertaken with caution in adults with mild to moderate impairment.
  • Excipient Sensitivity: Use is constrained in individuals with certain intolerances, such as lactose or glucose-galactose malabsorption, due to formulation excipients.
  • Contextual Restriction: It is not recommended for use in cases of diarrhea accompanied by fever or bloody/purulent stools. Additionally, taking Racy with Angiotensin-Converting Enzyme (ACE) inhibitors may increase the risk of angioedema.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Racy

The information below is strictly based on data documented in government regulatory labeling, such as the Summary of Product Characteristics (SmPC) and equivalent prescribing information.

Documented Overdose Profile

Category Official Regulatory Statement
Documented Overdose Presentations Sporadic cases of overdose have been formally reported in the literature without the manifestation of adverse events.
Dose-Related Factors In adults, single exposures exceeding 2 g, equivalent to 20 times the therapeutic dose, have been administered, and no harmful effects were described in the official documentation.
Population-Specific Notes The observation regarding the lack of harmful effects following high single-dose exposure (above 2 g) specifically pertains to adults.

Emergency Response and Management

Category Regulatory Requirement
Required Management Principle In the event of a suspected overdose, the officially mandated procedure is to initiate symptomatic and supportive treatment.
When to Seek Urgent Help Emergency medical care is required for assessment and implementation of supportive treatment upon any suspected ingestion beyond the prescribed amount.
Antidote Status The official regulatory documentation for Racy does not specify the existence or absence of a dedicated antidote in the overdose section.

The overall regulatory profile for Racy establishes a high acute tolerance, noting that documented high-dose ingestion has not been associated with severe or harmful effects in adults. Consequently, the primary action required by regulatory authorities for a suspected overdose remains prompt medical attention to implement necessary supportive care.

Therapeutic Uses of Racy

What Racy Treats: Main Uses and Benefits

Quick Facts

  • Therapeutic Domain: Assists in the management of major depressive disorder (MDD).
  • Key Function: May promote improvement in mood and emotional well-being.
  • Benefit: Aims to help mitigate the frequency and intensity of depressive episodes.

Racy is an established therapeutic option for adults dealing with the symptoms of major depressive disorder (MDD). Its primary goal is to help individuals manage and reduce the effects associated with this condition.

The use of Racy aims to promote an improvement in persistent low mood, feelings of despair, and a loss of interest in activities that were once enjoyed. It may also assist in stabilizing emotional state and improving sleep patterns that are often disrupted by depression. The overall focus of therapy with Racy is to support functional capacity and enhance the quality of life for individuals living with MDD.

It is important to understand that Racy is part of a comprehensive treatment plan that often includes counseling or other forms of therapeutic support. Medication is often a component in managing the condition, though individual responses may vary. The decision to use Racy and the expected benefits should be thoroughly discussed with a qualified healthcare provider.

Eligibility and Restrictions for Use

The eligibility profile for Racy (Racecadotril) is defined by regulatory agencies across strict population domains. Use is allowed for adults and children older than three months of age, and dose adjustment is not required for older adults.

Regulatory Classification Affected Population
Contraindicated Patients with known hypersensitivity to the drug or excipients, or specific hereditary sugar intolerances (e.g., lactose or fructose intolerance).
Absolute Exclusion Infants less than 3 months old. Diarrhea presenting with bloody or purulent stools and fever (indicates invasive disease), and antibiotic-associated diarrhea.
Not Recommended Pregnant and breastfeeding women (due to lack of clinical data). Concomitant use with ACE inhibitors (increased angioedema risk).
Use With Caution Adults with renal or hepatic impairment (limited data).

Use in children with severe kidney or liver impairment is not established and is therefore restricted. The regulatory profile strictly controls the patient population by setting clear restrictions based on age, organ function, and specific clinical presentation of the diarrheal condition.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Racy is defined by a specific pharmacodynamic risk and a documented absence of major pharmacokinetic interference, as detailed in regulatory documents.

Pharmacodynamic Interactions and Restrictions Racy has a documented pharmacodynamic interaction with Angiotensin-Converting Enzyme (ACE) Inhibitors, including captopril and enalapril. Co-administration with these medicines may increase the risk of angioedema. Due to this specific risk, Racy is formally contraindicated in patients who have a history of angioedema previously associated with the use of any ACE Inhibitor. This restriction is based on an official additive effect.

Metabolic and Exposure Interactions Regulatory data indicate a low potential for pharmacokinetic interaction with many common drug classes. Studies confirm that Racy and its metabolites do not inhibit nor induce major Cytochrome P450 enzymes (CYP1A2, CYP3A4, CYP2D6) to a clinically relevant extent. Additionally, the medicine does not modify the protein binding of highly protein-bound substances like warfarin or digoxin. The kinetics and exposure of Racy are not modified when co-administered with other treatments such as Loperamide or Nifuroxazide.

Drug-Food and Population Considerations The effect of food intake is limited to the rate of absorption: food delays the time to peak plasma concentration (Cmax) but does not alter the overall bioavailability (AUC). Regulatory documents also note that due to limited data, use in patients with renal or hepatic impairment requires caution.

Mechanism of Action

Selective Protection of Endogenous Opioids

The action begins when the active metabolite, Thiorphan, selectively targets the enzyme Enkephalinase (Neutral Endopeptidase, NEP) located on the intestinal wall. Thiorphan acts as a competitive inhibitor of this enzyme, preventing the rapid enzymatic degradation of the body's natural opioid mediators, Enkephalins. This inhibition elevates the local concentration of Enkephalins, thereby initiating the cellular cascade that modulates intestinal secretion.

Intracellular Regulation of Fluid Secretion

The sustained action of the protected Enkephalins activates specific delta-Opioid Receptors, triggering a sequence that inhibits Adenylyl Cyclase. This enzyme inhibition leads to a localized decrease in the intracellular second messenger, Cyclic Adenosine Monophosphate (cAMP), within the intestinal cells. The resulting low cAMP level directly suppresses the channels responsible for the transport of chloride ions ( Cl^-) and water into the gut lumen, establishing the drug's purely antisecretory effect.

Peripheral Action and Motility Maintenance

The overall mechanism produces physiological modulation solely within the gastrointestinal tract, as the active molecule does not cross the blood-brain barrier. This focused, peripheral action modulates the hypersecretion of fluid without affecting the natural movement or contractility (motility) of the gut muscles, which represents a key distinction of this mechanism.

Dosage and Administration Information

Administration and Official Dosing Regimens

Racy (Racecadotril) is administered exclusively via the oral route, with the specific pharmaceutical form dependent on the patient's age. The instructions for administration are structured around the patient population, the dose, and a limited duration of use.


Administration Scope

Administration Scope Details
Route of Administration Oral route only.
Dosing Schedule (Adults) 100 mg three times daily (TID). The first dose may be taken immediately, regardless of the time of day.
Dosing Schedule (Children) The dose is determined by body weight, typically 1.5 mg/kg per dose, three times daily at regular intervals.
Timing in Relation to Meals Capsules should be taken preferably before the main meals.
Preparation Requirements Granules for oral suspension must be mixed with a small amount of water, milk, or food and consumed immediately after preparation.

Special Procedural Conditions

Treatment must be continued until the passage of two normal stools is recorded. Regardless of the clinical response, the total duration of treatment must not exceed 7 days. Dosing adjustment is generally not required for older adults. However, use in patients with renal or hepatic impairment requires caution, as specific dose recommendations are limited.

Recent Clinical Evidence

Research evidence / Overview of studies for Racy (Racecadotril)

The clinical research for Racy has focused exclusively on the treatment of acute diarrhea, which is a condition involving outcomes related to systemic or functional imbalance. The application of Racy was explored through many short-term randomized controlled trials (RCTs), systematic reviews, and meta-analyses to examine the medicine's use across different age groups. Research provides context about what has been observed so far about how symptoms change over time when Racy was evaluated in these contexts. The clinical research consistently examines measured outcomes related to stool output and time to recovery across different age groups.


Evidence for Use in Acute Diarrhea in Adults

For adults, the research primarily was evaluated in settings involving conditions characterized by fluctuating or episodic manifestations of acute diarrhea. Studies explored how long it took for symptom cessation, which is an outcome describing episodic or acute changes. Researchers also monitored the percentage of patients reporting recovery within defined time intervals.

Available data indicate patterns related to the time measured for symptom resolution in the observed adult populations. The findings describe patterns observed in the studies that typically reported outcomes during the first week of illness. The results apply only to the populations studied in these specific trial settings.


Evidence for Use in Acute Diarrhea in Children

Racy was studied for acute diarrhea in infants (starting at three months old), children, and adolescents, often in the context of it being applied in studies examining patient-reported experiences alongside standard care, which includes Oral Rehydration Solution (ORS). Studies monitored outcomes linked to the severity of the fluid loss, such as the total volume or weight of stool output over a 48-hour period, and the median time measured until symptom cessation.

Scientific reports describe measured differences between treatment groups in both the time required for symptom cessation and the measured stool output compared to children who received only ORS. However, evidence is limited for children who are younger than three months old. Limited information is available in the research for patients with severe underlying liver or kidney impairment.


Racy's Performance Against Placebo and Other Treatments

The research utilizes head-to-head randomized trials where Racy was compared against inactive placebo and other agents. These studies examined endpoints related to the speed of recovery and certain related outcomes related to physical discomfort, such as secondary constipation. Findings were mixed regarding certain specific endpoints, and research is ongoing to address these methodological concerns and clarify results in specific subgroups.

Frequently Asked Questions (FAQ)

Common questions about Racy (FAQ)

Q: Why do doctors prescribe Racy instead of older options?

A: Regulatory documents indicate that Racy has a unique mechanism of action. It is described as a purely antisecretory agent that works locally in the intestine to reduce the excessive flow of water and electrolytes. This specific action is noted because it modulates secretion without affecting the intestinal movement, according to regulatory documents.

Q: How quickly can I expect Racy to start working?

A: Official pharmacological data indicates that the medicine begins working in the body relatively quickly. The inhibition of the enzyme responsible for its action in the intestines starts approximately 30 minutes after oral administration, with the maximum level of activity typically reached about two hours after the dose.

Q: Does Racy need time to build up in the body?

A: Racy is a prodrug, meaning it converts rapidly into its active form once in the body, with maximum concentration achieved in about an hour. Because the medicine is intended for short-term, acute use, its therapeutic effect relies on prompt action rather than a long period of build-up to a steady state.

Q: How long do the effects of Racy typically last?

A: The therapeutic effect from a single dose typically lasts for about eight hours. The recommended administration schedule is three times daily, which is consistent with this approximate duration of activity.

Q: If I miss a dose of Racy, what usually happens?

A: Official guidance notes that if a dose is missed, it is typically taken as soon as it is remembered. However, if the time is close to the next scheduled dose, the regulatory instruction indicates that the missed dose should be skipped.

Q: Is it normal to feel a difference right away after starting Racy?

A: The onset of the medicine's pharmacological action begins about 30 minutes after it is taken. This rapid activity means that the biological process that reduces fluid secretion in the gut starts soon after the first dose.

Q: Does Racy interact with common pain relievers like Advil or Tylenol?

A: Regulatory data indicates that Racy has a low potential for causing metabolic interactions with many other drugs. This is because it does not significantly interfere with the major enzymes (Cytochrome P450) responsible for breaking down most other commonly used medicines.

Q: Can Racy affect how birth control pills work?

A: Official data suggests a low potential for Racy to cause pharmacokinetic drug-drug interactions. Since the medicine does not significantly inhibit or induce the major enzymes responsible for breaking down hormonal treatments, therefore, it is considered unlikely to modify the effectiveness of oral contraceptives based on this mechanism.

Q: Can Racy make a person feel tired or drowsy?

A: Although Racy acts peripherally in the gut, official regulatory documents may sometimes list side effects like fatigue or drowsiness. Patients are advised in the official information to consult a healthcare professional regarding any effects experienced.

Q: Is Racy known to cause weight gain or weight loss?

A: Based on the official safety documents, weight gain or weight loss are not listed among the classified adverse drug reactions (side effects) reported in clinical studies.

Q: What happens if someone accidentally takes too much Racy?

A: Regulatory documents indicate that there have been sporadic cases of overdose reported, and no adverse events have been described in these instances. However, in case of accidental overdose, immediate medical attention is generally recommended in the official labeling.

Q: How does Racy compare to other drugs that treat the same condition?

A: Clinical trials compared Racy to both an inactive placebo and other anti-diarrheal agents. Findings indicated Racy has a generally similar tolerability profile to placebo and a specific finding of less secondary constipation compared to some other treatments.

Q: What does the FDA or EMA say about the evidence for Racy?

A: Official regulatory agencies, such as the FDA and EMA, have approved the medicine based on clinical evidence that consistently demonstrated its effectiveness in reducing stool output and shortening the duration of acute diarrhea, especially when used alongside standard oral rehydration therapy.

Q: How long after stopping Racy do the effects wear off?

A: The active substance in Racy, its metabolite, is eliminated relatively quickly from the body. Official pharmacological data indicates that the elimination half-life is approximately three hours after the last dose.

Q: Is it possible to develop a tolerance to Racy over time?

A: Studies and official information indicate that Racy’s action is localized to the gastrointestinal tract and is opioid-independent. For this reason, official clinical documents do not suggest that physical dependence or tolerance develops during the short-term, recommended period of use.

Q: Why is Racy sometimes prescribed for conditions other than the main one?

A: Official regulatory documents state that the medicine is exclusively indicated for the symptomatic treatment of acute diarrhea. Its use for other conditions is not supported by the official product information.

Q: Does Racy come in different strengths?

A: Yes, Racy is generally available in two primary marketed forms. The official forms include hard capsules, typically 100 mg for adults, and granules for oral suspension, which are available in different lower strengths for use in children.

Q: Can Racy cause emotional or mood changes?

A: Official regulatory safety documents do not list emotional or mood changes among the classified adverse drug reactions that have been reported from clinical trials.

Q: What should I do if a common side effect of Racy is bothersome?

A: Official guidance notes that a consultation with a healthcare professional is advised if any side effects become bothersome or severe.

Q: Are there specific symptoms that mean Racy is working?

A: Clinical studies evaluate the effectiveness of the medicine based on measurable outcomes, such as a reduction in the total volume of stool output and a shortened overall time required for recovery from diarrhea.

Q: Is it necessary to get blood tests while taking Racy?

A: Official regulatory documents do not specify any requirement for routine blood tests or other therapeutic drug monitoring procedures while taking Racy for the symptomatic treatment of acute diarrhea.

Q: Can people who have had an allergic reaction to other drugs take Racy?

A: The medicine is strictly contraindicated (must not be used) in patients with known hypersensitivity to the drug itself or its excipients (non-active ingredients). Furthermore, official safety data warns against its use in patients who have a history of angioedema related to ACE inhibitor medicines.

Q: Why do some people report Racy didn't work for them?

A: Clinical trial data sometimes showed mixed findings regarding certain study endpoints, and the research results are only strictly applicable to the patient groups studied. This inherent variability in response suggests that variation in individual patient outcomes is possible.

Q: Are there any reported cases of Racy causing dependence?

A: The medicine’s mechanism is local to the gut and functions by protecting the body’s natural opioid-like substances, making it opioid-independent. Official documents confirm that Racy has minimal central nervous system activity, which reduces the potential for physical dependence.

Q: Is Racy considered a first-line treatment?

A: Treatment guidelines and regulatory authorities often position Racy as an effective adjunct (or add-on) therapy. This means it is typically recommended for use alongside the core and most essential treatment for acute diarrhea, which is Oral Rehydration Solution (ORS).

Q: Are there special warnings for people with heart problems using Racy?

A: Official regulatory warnings are primarily focused on the potential for an increased risk of angioedema (swelling) when the medicine is taken together with certain blood pressure medications called Angiotensin-Converting Enzyme (ACE) inhibitors.

Q: Does Racy lose its effectiveness if stored improperly?

A: To ensure that its therapeutic effect is preserved, Racy must be stored as specified in the official packaging. This includes keeping it at a controlled room temperature, typically below 25 °C or 30 °C, and protecting it from excessive heat and moisture.

Q: Can Racy affect my driving ability?

A: Official regulatory documents generally state that the medicine has minor or no influence on the ability to drive or operate machinery. This is consistent with its primary mechanism of action being localized only to the gastrointestinal tract.

Q: What is the overall safety profile of Racy according to regulators?

A: Regulators define the safety profile by classifying adverse reactions based on frequency. The most common side effect is headache, while official warnings emphasize the importance of recognizing serious, though rare, hypersensitivity events like angioedema (swelling) and severe skin reactions.

How should Racy be stored and disposed of?

Storage Requirements

Official regulatory documents require that Racy (Racecadotril) must be stored at a controlled room temperature, typically below 25°C or 30°C, and must be protected from both high heat and environmental moisture. It is explicitly mandated that the medicine should not be refrigerated or frozen, as this can affect its stability. The product must be kept in its original container to maintain its integrity until use.

Child Safety and Disposal

All forms of Racy must be stored out of the sight and reach of children, as stated in the official labeling. Disposal instructions prohibit discarding expired or unused medicine in household waste or wastewater (e.g., flushing). The product must be disposed of according to local pharmaceutical waste regulations, typically by returning it to a pharmacy or an authorized take-back program.

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

Available in countries:

Equivalent of Racy found in:

A-Z Index: