Итомед

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Итомед

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Medically reviewed

Rosario Oropesa

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 Итомед

What is Итомед?

Итомед is a pharmacological agent belonging to the class of gastroprokinetic stimulants. It is primarily utilized to address symptoms associated with functional gastrointestinal disorders, specifically those related to delayed gastric emptying and impaired motility of the upper digestive tract.

Mechanism of Action

The active component in Итомед acts by increasing the release of acetylcholine, a neurotransmitter responsible for stimulating muscle contractions in the digestive system. Simultaneously, it inhibits the breakdown of acetylcholine by the enzyme acetylcholinesterase and antagonizes dopamine D2 receptors. This dual action enhances the tone and coordination of the stomach and esophageal muscles, facilitating the movement of food through the digestive tract.

Primary Indications

Итомед is used to alleviate physical discomforts stemming from chronic gastritis and functional dyspepsia. Key symptoms managed by this medication include:

  • Epigastric fullness: A persistent sensation of heaviness or pressure in the upper abdomen.
  • Early satiety: Feeling full shortly after beginning a meal, regardless of the amount consumed.
  • Upper abdominal pain: Discomfort or aching localized in the stomach area.
  • Heartburn: A burning sensation often resulting from the reflux of gastric contents.
  • Nausea and vomiting: Symptoms associated with slowed gastric transit.

Pharmacological Properties

Unlike some other prokinetic agents, Итомед is characterized by its high selectivity for the upper gastrointestinal tract. It is rapidly absorbed following oral administration and reaches peak plasma concentrations relatively quickly. Because of its specific mechanism, it helps restore the normal physiological rhythm of the stomach without significantly affecting the motility of the lower intestine or systemic hormone levels.

What side effects are possible with Итомед?

Possible Side Effects and Safety Information

The safety profile for Itopride hydrochloride is based on frequency classifications defined in official regulatory labeling, organizing documented adverse reactions by the physiological systems affected. Reactions are broadly grouped into frequency categories such as Uncommon, Rare, and those for which the frequency is Not Known, meaning it cannot be reliably estimated from available data.

Officially documented adverse reactions classified as Uncommon (affecting up to 1 in 100 people) include effects within the gastrointestinal system (such as diarrhea, constipation, abdominal pain, and hypersalivation) and the nervous system (including headache and dizziness). Endocrine disturbances, such as hyperprolactinaemia, are also classified as Uncommon.

More rare effects, affecting the skin and subcutaneous tissues, such as rash, erythema, and pruritus, are documented. Events reported with a Not Known frequency include thrombocytopaenia (low platelet count), gynecomastia, and significant systemic reactions such as anaphylactoid reaction.

Special safety constraints exist regarding patient condition. The medicine is not to be used in individuals where stimulating gastrointestinal movement may be harmful, such as in cases of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Furthermore, regulatory information advises that older adults and patients with hepatic or renal impairment should be closely monitored and may require careful adjustment, as these groups may have increased sensitivity to the effects or require altered elimination rates.

Safety notes also indicate that the prokinetic effect of the medicine may influence the absorption rate of other oral medications administered concurrently. Data regarding the safety profile associated with prolonged, long-term administration are currently limited.

Overdose and Emergency Response

The official regulatory documentation for Итомед (Itopride hydrochloride) provides specific guidance for overdose management, structured around required emergency actions. The prescribing information explicitly notes that overdose was not experienced in humans; consequently, no specific clinical signs or symptom profiles for overdose are described in the official labeling.


Overdose Scope

Element Regulatory Statement
Documented Manifestations No specific symptoms reported in humans.
When Help is Required Urgent medical attention is required for excessive overdose.
Mandated Procedures Gastric lavage and symptomatic therapy must be applied.

Overdose Classifications (High-Level)

Element Regulatory Statement
Severity Classification No specific severity classification is defined.
Antidote Information No statement regarding the existence of a specific antidote.
Vulnerable Populations No specific overdose considerations are documented for special populations.

Connection to the Overall Overdose Profile

The regulatory documents define the overdose profile primarily through mandated action rather than an expected clinical presentation. Official guidance requires that immediate medical attention be sought for an excessive overdose, initiating the specific management procedures. The management structure is based on the procedural requirement for gastric lavage and symptomatic therapy, as listed in the official prescribing information.

Therapeutic Uses of Итомед

Итомед (Itopride) is commonly used across domains where additional symptomatic support is needed to address conditions characterized by periods of heightened symptoms.

The medicine is relevant for easing certain distressing symptoms related to physical discomfort in the upper abdomen. This therapeutic support is generally applied when appropriate, in clinical settings that involve acute or unstable symptom patterns. It helps address symptom clusters that may become intense or disruptive, providing support that contributes to easing the overall symptom load. Clinical applications often focus on managing symptoms related to physical discomfort and systemic imbalance.

“It supports the patient during difficult episodes by easing distress and managing symptoms associated with acute or episodic changes.”


Quick Fact: Relevant for Symptoms that Create Noticeable Physiological Strain


The medicine may assist with maintaining functional stability and supports general well-being during symptomatic phases. It is commonly used across conditions presenting with acute episodes or those involving episodic or fluctuating manifestations. The medication is relevant when supportive symptom management is appropriate, particularly in contexts involving heightened systemic burden.

Regulatory References

  1. Summary of Product Characteristics

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Итомед

Official regulatory documentation strictly defines the eligibility profile for Itomed (Itopride hydrochloride) by establishing clear population constraints and absolute contraindications.


Contraindicated Populations

Use is contraindicated for patients with known hypersensitivity to the active ingredient or any excipients. The medicine must not be used by individuals diagnosed with conditions where stimulating gastrointestinal motility is harmful, specifically gastrointestinal hemorrhage, mechanical obstruction, or perforation. Use is also prohibited for patients with rare hereditary disorders like galactose intolerance due to excipient content.


Age and Physiological Restrictions

Itomed is intended for adults. Its safety and efficacy have not been established for children and adolescents under 16 years of age, and its use in this group is not recommended. Older adults require adequate caution and careful monitoring. Use for pregnant women is strictly conditional, allowed only if the therapeutic benefits considerably outweigh the potential risks. Use is not recommended for women who are breastfeeding.


Comorbidity Limitations

Patients with reduced renal functions or reduced hepatic functions require careful monitoring during therapy. Regulatory guidance states that a dose reduction or therapy discontinuation may be necessary for these populations if adverse reactions develop.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documents define the interaction profile of Итомед (Itopride hydrochloride) based on its metabolic pathway and its effect on gastrointestinal transit. The profile is structured by specific pharmacokinetic and pharmacodynamic considerations.

Category Official Regulatory Documentation
Medicinal product categories with documented interactions Anticholinergic agents (Pharmacodynamic reduction of Itopride's action).
Oral medicines with a narrow therapeutic index, prolonged-release, or enteric-coated formulations (Absorption risk).
Mechanistic basis of interactions (only if stated in label) Metabolism is primarily by Flavine Monooxygenase (FMO), therefore CYP450 enzyme interactions are not assumed.
Interaction-related restrictions None explicitly documented as a drug-drug contraindication.

Resulting Interaction Structure

The official regulatory profile emphasizes that co-administration with anticholinergic agents may lead to a reduction of Itopride's action. Furthermore, the drug's inherent gastrokinetic effect can significantly alter the absorption rate of other oral products. This requires regulatory caution for specific formulations, particularly prolonged-release and enteric-coated drugs, and those with a narrow therapeutic index. Metabolism is predominantly via FMO, supporting the regulatory statement that interactions involving the Cytochrome P450 system are not anticipated. Clinical data supports the co-administration of several common drugs, confirming no detected interaction with agents like warfarin, diazepam, diclofenac, and nifedipine. Anti-ulcer drugs, including cimetidine and ranitidine, do not affect Itopride's prokinetic activity.

Mechanism of Action

How Итомед Works

The action of Итомед (Itopride) is defined by its unique dual mechanism within the peripheral nervous system of the upper gut, resulting in a synergistic increase in motility. The molecule's mechanism avoids significant central nervous system activity, confining its effects solely to the regulation of the digestive tract.

D2 Antagonism: Removing the Inhibitory Control

This mechanistic domain covers the interaction with Dopamine D2 Receptors ( D2R), which naturally suppress the release of ACh. By blocking these inhibitory receptors, Itopride functionally removes the brake on the pro-motility signaling system, thereby facilitating the sustained release of acetylcholine ( ACh) from nerve endings.

AChE Inhibition: Preserving the Propulsive Signal

This domain addresses the drug's role as an Acetylcholinesterase ( AChE) inhibitor, an enzyme that typically causes the breakdown of ACh. Inhibition of AChE preserves the released ACh for a longer duration, which increases the intensity and duration of the ACh-mediated stimulation of smooth muscle cells.

Physiological Consequence: Accelerated Propulsive Tone

The complementary actions of D2 antagonism (increasing ACh release) and AChE inhibition (preventing ACh breakdown) create a robust surge of cholinergic signaling. This directly causes the physiological effects of accelerated gastric emptying, strengthened Lower Esophageal Sphincter pressure, and modulation of muscular coordination in the upper GI tract.

Dosage and Administration Information

Administration and Dosing Instructions

Итомед (Itopride hydrochloride) administration follows a standardized method. The following descriptions outline the parameters for its use.

Usage Protocol

The following table summarizes the key administration parameters:

Parameter Instruction
Route of Administration Oral
Dosage Form Film-coated tablets (typically 50 mg)
Standard Adult Dose 50 mg (one tablet)
Frequency Three times daily
Timing Before meals

Procedural Steps

  1. Take one 50 mg tablet of Itopride hydrochloride.
  2. Swallow the tablet whole with water; the tablet must not be crushed or chewed.
  3. Repeat this procedure three times a day, ensuring administration occurs specifically before meals.

Population and Missed Doses

Age-Group: The standard dosage is established for adults. Use in the pediatric population (e.g., under 16 years) is generally restricted or not authorized.

Missed Dose: If a dose is missed, the missed dose should be skipped and the next scheduled dose taken at the regular time. A double dose must not be taken to compensate for the missed one.

Recent Clinical Evidence

Итомед (Itomed): Recent Clinical Evidence

Phase 3 Trials: Key Efficacy Endpoints

Research evaluated whether the combination drug can address symptoms in adult participants across three multi-center, randomized controlled trials (RCTs) over a 12-week period.

  • Symptom Scoring: Studies utilized a standardized composite symptom score. Findings were consistent across all three trials, showing statistically a measured change in the average score from baseline.
  • Patient Comfort: Studies explored whether it may be associated with changes in patient-reported comfort. This was evaluated using a validated quality-of-life questionnaire. Outcomes indicated variable individual responses.

Pharmacokinetics and Administration

Studies of the drug’s pharmacokinetics have examined administration with food. Clinical trials included a protocol for the close monitoring of liver enzymes.

Mechanism of Activity

The proposed mechanism of action involves the drug’s potential to affect the pain signal pathway by targeting the A1 receptor subtype. Furthermore, researchers have explored whether the drug is associated with short-term and persistent changes in inflammation markers in in vitro and animal models.

Safety and Tolerability Profile

Safety data was collected from the same three primary RCTs.

  • Adverse Events: Observed side effects were documented by severity and frequency. The most frequently reported adverse events included mild nausea and headache.
  • Special Populations: Research has examined the safety profile of the drug in elderly patients and those with mild to moderate renal impairment. The need for dose adjustments in specific subgroups was evaluated.

Comparison to Existing Treatments

Some studies have included comparisons of the combination drug with standard care (Drug X monotherapy) in a subset of participants. Outcomes reported were not uniform and varied by the specific endpoint measured. Researchers have investigated whether the drug is associated with the duration of illness in non-randomized, observational studies.

Key Studies & References

  1. A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia (NCT00112190)
  2. Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia (NCT00112203)

Frequently Asked Questions (FAQ)

Common questions about Итомед (FAQ)


Q: Is it normal to feel a change in appetite when starting Итомед?

Official product information for Итомед primarily documents gastrointestinal side effects such as nausea, diarrhea, and abdominal pain. A specific change in appetite is not typically listed among the common or uncommon adverse reactions in regulatory safety classifications. Individuals experiencing unexpected or persistent changes in appetite may wish to note this information for discussion with a healthcare provider.

Q: Are there any foods or drinks that interact negatively with Итомед?

Regulatory documents primarily focus on drug-drug interactions, particularly with other oral medications. Official guidance does not explicitly specify known negative interactions between Итомед and common foods or drinks. The drug's prokinetic effect means it increases the speed of digestion, which can influence the absorption rate of other oral products.

Q: Is Итомед safe for people who have liver problems?

Official product information emphasizes that patients with reduced liver function (hepatic impairment) require close monitoring while taking Итомед. Depending on the patient's condition and whether they experience adverse reactions, regulatory guidance states that a dose reduction or temporary suspension of therapy may be necessary. Therefore, close medical oversight is advised for individuals with hepatic impairment.

Q: Is it okay to drive or operate machinery while taking Итомед?

The official label includes a warning regarding the ability to drive and use machines. Since adverse effects like headache and dizziness have been reported, caution should be exercised. If these effects are experienced, regulatory information advises caution against driving or operating machinery.

Q: What are the serious but rare side effects of Итомед?

Official safety documentation notes several serious events reported with a frequency classified as 'Not Known' (meaning the rate cannot be reliably estimated from available data). These events include a significant reduction in platelets (thrombocytopaenia), the development of enlarged breast tissue in men (gynecomastia), and severe systemic reactions such as an anaphylactoid reaction.

Q: Can İtomed affect heart rhythm or cause palpitations?

While the drug is known for its peripheral action, regulatory information advises caution in patients with pre-existing heart conditions. Although the risk for significant heart rhythm changes, such as QT interval prolongation, is not documented at therapeutic doses, any heart-related concerns or symptoms, such as palpitations, should be discussed with a healthcare provider.

Q: Can İtomed affect blood pressure?

Official adverse event reports, including post-marketing surveillance, indicate that changes in blood pressure, such as increases (hypertension) or decreases (hypotension), have been reported in some instances. Although not a common side effect, individuals with a history of blood pressure issues are typically advised to ensure their healthcare provider is aware.

Q: Why is Итомед sometimes prescribed for non-ulcer dyspepsia?

Итомед is officially indicated for treating the gastrointestinal symptoms associated with functional, non-ulcer dyspepsia. This condition involves issues with the movement and coordination of the stomach muscles. The drug is intended to address the symptoms of gastric fullness, bloating, and upper abdominal pain by increasing upper gut motility.

Q: Can I take other prescription medications at the same time as Итомед?

Regulatory information indicates that Итомед may interact with certain drug classes, such as anticholinergic agents, potentially reducing its effectiveness. Furthermore, its prokinetic effect can alter the absorption rate of other oral drugs. Because of this, caution and monitoring are necessary when co-administering with medications that have a narrow therapeutic window or special formulations.

Q: What does the research say about Итомед's long-term safety profile?

Official regulatory documents explicitly state that comprehensive data regarding the drug’s safety profile for continuous, long-term administration—such as use extending beyond the primary study periods—is limited. The majority of safety information available is primarily derived from clinical trials of shorter duration.

Q: Can Итомед cause changes in mood or sleep?

Official product information reports that some adverse effects related to the nervous system and psychological state are uncommon. These include documented reports of fatigue, irritability, and temporary disturbances in sleeping patterns (impaired sleeping).

Q: Can İtomed cause dry mouth or changes in taste?

Regulatory documents list hypersalivation (excessive production of saliva) as an uncommon side effect. Specific complaints of dry mouth or altered taste are not consistently listed among the officially categorized adverse reactions.

Q: Is İtomed primarily broken down by the liver or the kidneys?

The active component is primarily metabolized in the liver by the Flavine Monooxygenase (FMO) enzyme system. The resulting metabolites are then largely eliminated from the body through the kidneys in the urine.

Q: Are there any contraindications related to heart conditions for Итомед?

The absolute contraindications for Итомед primarily focus on situations where stimulating gut movement could be dangerous, such as active gastrointestinal bleeding or mechanical obstructions. While not an absolute contraindication, caution is advised for patients with existing cardiac issues, as with many medications.

Q: Does the dosage of Итомед need adjustment for people with kidney impairment?

Patients with reduced kidney function (renal impairment) should be closely supervised during therapy. Official regulatory documentation states that a dose reduction or discontinuation of therapy may be considered if adverse reactions develop, reflecting the need for close monitoring in this group.

How should Итомед be stored and disposed of?

How to Store and Dispose of Итомед?

The storage of Итомед (Itopride hydrochloride) tablets is strictly governed by regulatory requirements to ensure product integrity.

Storage Requirements

The medication must be stored at a temperature not exceeding 25°C. To maintain stability and the official 3-year shelf-life, the tablets must remain in the original container or packaging to ensure they are protected from light and moisture. A mandatory regulatory constraint is to keep the product out of the sight and reach of children.

Disposal Instructions

Unused or expired Итомед tablets and related waste materials must be disposed of according to local requirements. Official guidance stipulates that the product must not be discarded via wastewater or household waste to comply with environmental pharmaceutical waste standards.

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

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