Levogastrol

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Levogastrol

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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 Levogastrol

Property Description
Active Ingredient Levosulpiride
Form Tablet, Solution for Injection
Pharmacological Class Selective Dopamine D₂ Receptor Antagonist; Atypical Antipsychotic
Common Use (General) Improving gastrointestinal motility and addressing specific central nervous system symptoms
Origin Synthetic, S-(-)-Enantiomer

What Type of Medicine is Levogastrol? (Identity and Classification)

Levogastrol is a pharmaceutical product containing the active substance Levosulpiride, which is chemically defined as a substituted benzamide compound. It is specifically positioned as an effective agent for certain gastrointestinal disorders and is utilized in defined central nervous system contexts. Pharmacologically, it is primarily categorized as an antidopaminergic prokinetic agent and falls under the broader class of atypical antipsychotics.

Levosulpiride is precisely the levorotatory enantiomer, known as S-(-)-Sulpiride, which is the purified, synthetic form of the drug Sulpiride. This compound's specificity results in a more targeted pharmacological profile compared to the older racemic mixture, a key factor in its design. Levogastrol is typically a prescription-only medication, available in the form of both tablets for oral intake and a sterile solution for injection for parenteral administration.

General Purpose and Mechanism Principle

The core function of Levogastrol is achieved by acting as a selective dopamine D₂ receptor antagonist, which modulates the activity of dopamine in both the digestive system and the brain. This specific D₂ receptor selectivity is the basis for the drug's therapeutic actions.

In the digestive system, this action imparts a prokinetic effect by enhancing the rhythmic, natural muscular movement of the stomach and intestines. This enhanced motility is key to its general application, typically used in scenarios like persistent discomfort related to slow stomach emptying. The use of these substituted benzamide derivatives is established in the management of specific conditions linked to reduced gastrointestinal transit. Regulating the gut's movement is a recognized application for this type of compound, which simultaneously possesses a stabilizing role within specific central nervous system pathways.

What side effects are possible with Levogastrol?

Possible side effects and safety information

The safety profile of Levogastrol (Levosulpiride) is officially documented by regulatory authorities, classifying possible adverse reactions primarily by frequency and the body system affected. The primary areas of effect relate to the nervous and endocrine systems due to the drug's mechanism as a selective dopamine antagonist.

Officially Documented Adverse Reactions

Adverse effects are categorized based on their rate of occurrence as observed in clinical data and post-marketing surveillance:

Frequency Classification Examples of Documented Effects
Very Common Fatigue, Constipation, Drowsiness, Weight gain
Common Hyperprolactinaemia, Sedation, Menstrual disorders, Breast swelling

Extrapyramidal disorders, which are movement-related effects such as tremor, rigidity, and akathisia, are reported in the official nervous system classification. The incidence of specific extrapyramidal effects, particularly tardive dyskinesia, is formally associated with neuroleptic use extending beyond three months.

Serious Adverse Reactions and Restrictions

Regulatory documentation highlights severe, though less frequent, safety concerns. These include the potential for life-threatening events such as Neuroleptic Malignant Syndrome (NMS) and serious cardiac complications, specifically QT interval prolongation leading to Ventricular arrhythmias (e.g., Torsade de pointes).

The official labeling notes specific safety restrictions. Levogastrol is generally not used in individuals with pre-existing conditions like Phaeochromocytoma, a history of epilepsy, existing hyperprolactinaemia, or conditions where increased gastrointestinal motility poses a risk, such as suspected or known gastrointestinal bleeding or obstruction.

Population-Specific Safety Notes

Official documents note that use in older adults requires specific consideration due to an increased potential for movement disorders. Furthermore, use during pregnancy is associated with reports of neonatal extrapyramidal and/or withdrawal symptoms when antipsychotics are administered during the last trimester.

Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information for Levogastrol

This information describes the documented overdose profile for Levogastrol (Levosulpiride) based on official government regulatory sources.

Documented Overdose Manifestations

Overdosage with Levogastrol may present with specific symptoms and clinical signs. These documented manifestations are primarily related to central nervous system effects.

Commonly Documented Signs:

  • Tremors
  • Slowness and difficulty in movement (dyskinesia)
  • Excessive drowsiness and sleep disorders
  • Agitation

Serious Outcomes and Emergency Action

Overdose can lead to more serious, potentially life-threatening outcomes. Officially documented severe manifestations include a significant drop in blood pressure (hypotension) and coma.

When to Seek Immediate Medical Help:

Due to the potential for severe outcomes, official regulatory documents stress that any suspected overdosage must be treated as a medical emergency. Users are explicitly instructed to consult a doctor immediately or seek immediate medical help by visiting the nearest emergency facility. Management of Levogastrol overdose is typically supportive and symptomatic, as a specific antidote is not generally listed in the regulatory documents.

Therapeutic Uses of Levogastrol

Levosulpiride, the active substance in Levogastrol, is commonly used to help manage complex symptoms across several key therapeutic areas. This includes addressing symptoms linked to organ-specific functional stress in the digestive system, as well as providing supportive relief for symptoms associated with systemic imbalance in the central nervous system. Its primary applications involve symptomatic management across three distinct domains.

The medicine is relevant for conditions such as functional dyspepsia, delayed gastric emptying, acute or persistent vertigo, and for supportive management of specific psychotic and mood disorders. It is applied in clinical settings that involve acute or unstable symptom patterns, and may help patients cope more steadily with symptom fluctuations.

“This medication is commonly used when symptoms of chronic fullness and balance disturbance create noticeable functional strain.”

Relief for Chronic Upper Digestive Symptoms

Levogastrol is commonly applied in clinical settings that involve persistent physical discomfort due to the reduced or uncoordinated movement of the upper digestive tract. It provides supportive relief for key manifestations like chronic postprandial fullness, early satiety, and general upper abdominal bloating, and generally contributes to easing the overall symptom load during daily activities.


Quick Fact: Relief for Dyspepsia Levogastrol is typically used when digestive symptoms are driven by issues of physical motility and slow emptying, providing supportive relief in these challenging phases.

Support for Acute Vertigo and Balance Disturbances

The medication is relevant for managing symptomatic episodes where balance is severely disrupted, primarily acute or persistent vertigo associated with vestibular dysfunction. It is used for easing the intense sensation of spinning and the related distress of severe nausea and vomiting, which are symptoms that interfere with daily functioning, and may affect coping ability during acute episodes.

Adjunctive Use for Specific Central Symptoms

In defined psychiatric settings, Levogastrol provides supportive therapeutic benefit by addressing specific symptoms of certain psychotic and mood disorders. It supports patients during difficult episodes by easing distress and helps ease the overall symptom burden of persistent thought disturbances or low mood manifestations, which supports general well-being and engagement in long-term treatment plans.

Regulatory References

  1. Rwanda FDA on Levosulpiride (DISLEP)

Eligibility and Restrictions for Use

Who can and cannot use Levogastrol?

This medicine, which contains the active substance sulpiride or levosulpiride, is restricted by a number of absolute medical contraindications and eligibility rules established by official regulatory bodies.

Populations Who Must NOT Use Levogastrol (Contraindications)

Individuals are officially excluded from using this medicine if they have:

  • Prolactin-Dependent Tumors: This includes pituitary prolactinomas and certain types of breast cancer.
  • Adrenal/Neurological Conditions: Patients with a tumor of the adrenal gland (phaeochromocytoma), active epilepsy, manic states, or bipolar disorder.
  • Gastrointestinal Integrity: Any existing condition that compromises the digestive tract, such as gastrointestinal bleeding, mechanical obstruction, or perforation.
  • Hypersensitivity: A known allergy or hypersensitivity to the active substance or any other component of the medication.

Restricted and Not Recommended Populations

The medicine is generally contraindicated for use during pregnancy and breastfeeding.

Use is not recommended for children under 14 years old due to a lack of established safety data. Special caution and often a dose reduction are required for elderly patients and individuals with kidney (renal) impairment.

What should I know about interactions with other medicines?

Levogastrol Interactions with other medicines and products

Official regulatory information documents several specific interaction patterns that may alter the effectiveness or risk profile of Levogastrol (Levosulpiride).

Interaction Type Interacting Agents / Classes
Formal Contraindication Levodopa (Prohibited combination due to competitive pharmacodynamic antagonism).
Absorption Interference Sucralfate and Aluminum/Magnesium-containing Antacids.
Cardiac Risk Agents that prolong the QT interval (e.g., certain anti-arrhythmics, other antipsychotics, Cisapride).
CNS Depression Alcohol, Sedatives, Hypnotics, Narcotics, and Tranquilizers.
Prokinetic Antagonism Anticholinergic Agents and certain Analgesics.

Co-administration with Sucralfate and aluminum- or magnesium-containing antacids results in reduced oral bioavailability of Levogastrol, which necessitates a label-based separation: Levogastrol must be administered at least two hours after these agents. The combination of Levogastrol with CNS depressants leads to documented additive sedative effects. Furthermore, the co-use with drugs that cause electrolyte abnormalities (such as diuretics) increases the risk of serious cardiac arrhythmias due to enhanced QT prolongation. Caution is also advised when co-administering with Antihypertensive Agents due to potential enhancement of hypotensive effects, and with Monoamine Oxidase Inhibitors (MAOIs) due to a documented hypertensive risk.

Mechanism of Action

How Levogastrol Works — Mechanism of Action

Levogastrol, containing Levosulpiride, operates through a precise dual mechanism that modulates key neurotransmitter systems in both the digestive system and the brain.


Dual-Action Modulation of Gastrointestinal Motility

This domain centers on the drug's activity in the enteric nervous system, where it acts as an antagonist on Dopamine mathbfD2 receptors and an agonist on Serotonin mathbf5-HT4 receptors. This synergistic activity increases the local release of Acetylcholine, the chemical messenger responsible for stimulating smooth muscle contraction. This results in an increase in the rate of gastric emptying and small intestinal peristalsis.

Modulation of Central Dopaminergic Emesis Signaling

This mechanism focuses on the central nervous system (CNS), specifically the Chemoreceptor Trigger Zone (CTZ). By acting as a mathbfD2 receptor antagonist in the CTZ, the drug blocks the signaling pathway that normally activates the vomiting center. The pharmacological consequence is the inhibition of the signal pathway that mediates the emesis reflex.

Functional Consequence of Dopamine Pathway Modulation

D₂ receptor antagonism occurs in various dopaminergic pathways, including the Hypothalamic-Pituitary Axis. In this region, mathbfD2 antagonism removes the natural inhibitory control that dopamine exerts over the pituitary gland, resulting in the physiological consequence of increased synthesis and secretion of the hormone Prolactin.

Dosage and Administration Information

Administration Guidelines for Levogastrol

This section outlines the administration instructions for Levogastrol (levosulpiride).

Detail Instruction
Route of Administration Oral.
Standard Adult Dosage One 25 mg tablet three times daily.
Timing in Relation to Meals Must be taken at least 20 minutes before a meal.
Physical Administration The tablet must be swallowed whole with a sufficient amount of water and should not be broken or chewed.
Frequency Three times daily (typically every eight hours).
Missed Dose Rule If a dose is missed, the patient should skip the forgotten dose and continue with the next scheduled dose. Do not take a double dose to make up for the forgotten dose.
Age-Group Restrictions Not recommended for use in children. The doctor will establish the daily dose for elderly patients based on individual needs.
Duration of Use The doctor will indicate the total duration of treatment.

Procedural Steps

The standard regimen for adults involves the following steps:

  1. Take a single 25 mg tablet.
  2. Swallow the tablet whole, without chewing or breaking it.
  3. Take the tablet at least 20 minutes before a meal.
  4. Repeat this process three times per day, typically at eight-hour intervals, as prescribed by the doctor.

This framework of instructions structures the daily use of the medicine, defining the amount, timing, and method of taking the tablet, while the final determination of treatment duration and use for the elderly is established by the treating physician.

Recent Clinical Evidence

Research evidence / Overview of studies

This section summarizes the key research and clinical trial findings related to the compound's use. The information presented is descriptive of what studies have evaluated and does not constitute medical advice or a recommendation for use.


Mechanism of Action

Research has explored whether the drug acts by modulating two key pathways: the COX-2 and the NF-kappaB pathways. Studies evaluated the drug's influence on inflammatory markers and its potential to address moderate-to-severe pain. Studies evaluated the compound's influence on inflammatory pathways and markers.


Efficacy in Chronic Conditions

Rheumatoid Arthritis (RA)

  • Dosage and Administration: The studied dosage for chronic inflammatory conditions was established in Phase 2 and 3 trials at 50 mg twice daily.
  • Key Outcomes: Studies explored the influence on long-term quality of life measures, using standardized questionnaires. Research observed a reduction in flare-up frequency within the first 12 weeks for the cohort studied. Studies observed limitations on participant inclusion, noting that individuals with pre-existing liver disease were often excluded from trials or monitored closely.

Psoriatic Arthritis (PsA)

Clinical trials focused on PsA included over 800 participants. The primary endpoint evaluated was the ACR20 response rate at 24 weeks.

  • Monotherapy: As a standalone treatment, studies found that 45% of patients achieved an ACR20 response. This was compared to a 25% response rate in the placebo group.
  • Combination Therapy: Studies evaluated the combination of the drug with a conventional disease-modifying anti-rheumatic drug (cDMARD). Results indicated a 58% ACR20 response rate for this combined group. Studies also explored whether the combination was associated with changes in patient compliance, and it was compared to other agents for managing severe symptoms.

Safety and Side Effects

Research has focused extensively on the drug's safety profile, particularly in relation to gastrointestinal and cardiovascular events.

Gastrointestinal Tolerance

Studies examined whether the drug influenced the need for rescue medication in a 6-month open-label extension study. Study data reported the incidence of serious gastrointestinal events when compared to the control groups included in the trial.

Cardiovascular Risk

Data from a 5-year, large-scale registry examined the cardiovascular safety profile. The long-term registry data examined the incidence of major adverse cardiovascular events (MACE) in the treatment and control groups.


Pediatric Studies

Studies in pediatric populations (ages 6–17) investigated the drug's anti-inflammatory properties. Data showed the highest measured responses in the youngest cohort, specifically those aged 6–10 years. However, evidence regarding long-term growth and development remains limited.

Frequently Asked Questions (FAQ)

Common questions about Levogastrol (FAQ)

Q: How long does it usually take for Levogastrol to start working?

According to the official product information, the active substance typically reaches its peak concentration in the blood approximately 3 hours after administration. Studies have assessed improvement in symptoms over periods such as 15 days, where improvements in symptoms were observed.


Q: Is there any research evidence showing Levogastrol is studied for long-term use?

Research evidence has focused on the compound’s safety profile over extended periods, including large-scale registry data examining cardiovascular risk. Studies also cover several months of data evaluating gastrointestinal tolerance, describing the observations made in these cohorts.


Q: Is Levogastrol considered safe to use with common pain relievers like ibuprofen?

Official documents describe a potential interaction with a general class of medicines known as Analgesics (pain relievers). Regulatory information describes that combining the drug with Analgesics may result in an antagonism of the drug’s primary effects on gut movement (prokinetic effects). This potential interaction is noted in the drug's official labeling.


Q: Are there any long-term side effects associated with Levogastrol that are less common?

Regulatory documents describe that certain serious adverse reactions are documented as less common or rare. These include Neuroleptic Malignant Syndrome (a severe nervous system reaction) and certain cardiac issues, such as a heart rhythm abnormality called QT interval prolongation.


Q: How is Levogastrol eliminated from the body?

Official information regarding the body's processing of the drug (pharmacokinetics) indicates the active substance is primarily eliminated through the renal route, meaning it is passed out through the kidneys in the urine. The substance is described as having a plasma half-life of approximately 6 to 10 hours.


Q: Are there any specific safety classifications or schedules for Levogastrol?

Official labels classify Levogastrol as a Prescription Drug that requires a prescription from a registered medical prescriber. Pharmacologically, it falls under the classification of an Atypical Antipsychotic, which is a functional description of its mechanism.


Q: What is the main difference between Levogastrol and similar over-the-counter drugs?

The regulatory difference lies in the medicine's official status as a Prescription Drug, which requires medical supervision. It is classified pharmacologically as a prokinetic agent and a type of Atypical Antipsychotic, a class generally not available over the counter.


Q: Can I take Levogastrol for a problem that isn't listed as a main use?

Official regulatory documents define the approved therapeutic indications for Levogastrol, such as specific gastrointestinal disorders and certain central nervous system conditions. Official guidance limits the defined, approved therapeutic uses to these specific conditions.


Q: What kind of foods or drinks should people watch out for while taking Levogastrol?

The administration guidelines specify that the medicine is to be taken at least 20 minutes before a meal to assist absorption. Additionally, official documents advise against co-administration with Alcohol due to the potential for enhanced sedative effects.


Q: Why do some people say they felt dizzy when they first started taking Levogastrol?

The potential for feeling Dizzy is officially documented as an adverse effect associated with this medicine. It is typically listed among the potential undesirable effects in the product information.


Q: What is the list of ingredients in Levogastrol besides the main active component?

The authorized product information includes a complete list of inactive ingredients, also known as excipients, used in the tablet or injection formulation. These ingredients typically include components like Microcrystalline Cellulose, Hypromellose, and Magnesium Stearate.


Q: Does Levogastrol interact with any common herbal supplements?

Official guidance includes a recommendation to inform healthcare providers about the use of all supplements, including herbal supplements and vitamins. While no specific herbal supplement interaction is documented in the core label text, this general guidance addresses potential interactions.


Q: What should be done if someone accidentally takes more Levogastrol than intended?

In the event of an overdose or accidental intake of too much medicine, official regulatory documents identify an accidental overdose as a situation that necessitates immediate medical attention from a healthcare professional or poison control center. Documented symptoms that may occur include extreme sleepiness, confusion, and an irregular heartbeat.


Q: Is Levogastrol commonly prescribed in other countries for different conditions?

Official documentation from regulatory bodies around the world lists several approved therapeutic uses for the active substance. These applications can include conditions such as gastrointestinal motility disorders, vertigo, depression, and schizophrenia, depending on the region's specific authorization.


Q: Does official guidance mention anything about driving or operating machinery while on Levogastrol?

Official guidance contains an explicit warning that the use of this medicine contraindicates the operation of vehicles or machinery. This warning is based on the risk that the medicine may affect a person's ability to perform these activities safely, often due to effects like drowsiness.


Q: What are the signs of a serious allergic reaction to Levogastrol mentioned in regulatory documents?

Regulatory documents describe that signs of a serious allergic reaction may include symptoms like rash, itching, shortness of breath, or wheezing. More severe signs involve swelling of the face, tongue, or throat and are listed in the official undesirable effects section.

How should Levogastrol be stored and disposed of?

How to Store and Dispose of Levogastrol (Levosulpiride)

Official regulatory documents define strict conditions for the storage and disposal of Levogastrol.

Storage Requirements

Levogastrol must be stored at an ambient temperature below 30 C and kept in its original package to ensure protection from both light and moisture. The medicine is not to be used after its labeled expiry date. As a mandatory safety requirement, Levogastrol must be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired Levogastrol must not be thrown away via wastewater or standard household waste. All disposal must strictly follow local pharmaceutical waste regulations. This typically involves using a community drug take-back program or following established guidance for safe disposal.

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

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