Levomepromazina

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Levomepromazina

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 Levomepromazina

Property Description
Active Ingredient Levomepromazine (Methotrimeprazine)
Forms Tablet, Oral Solution, Solution for Injection
Pharmacological Class Psycholeptic / Typical Antipsychotic
General Purpose Sedation, Antipsychotic, Analgesic
Origin Synthetic (Phenothiazine derivative)

Identity and Pharmacological Class

Levomepromazina is a synthetic psycholeptic medication whose active component is Levomepromazine (Methotrimeprazine), which is classified as a low-potency typical antipsychotic or neuroleptic agent. This compound is chemically defined as a phenothiazine derivative and is assigned the Anatomical Therapeutic Chemical (ATC) code N05AA02. Levomepromazine is particularly distinctive among its class due to its multi-receptor antagonism, a feature that targets dopamine, histamine, and adrenergic sites. This broad activity is a key differentiating factor, granting it uniquely strong supplementary effects compared to more targeted antipsychotics.

Composition, Origin, and Available Forms

The medication is a monocomponent product consisting solely of the synthetic Levomepromazine, typically presented as the maleate salt for solid tablet and oral solution forms, or as the hydrochloride salt for the sterile solution for injection. This dual salt-form composition ensures versatility. Common trade names based on this International Nonproprietary Name (INN) include Nozinan and Levoprome. The availability of both oral forms and a solution for injection via the parenteral route allows for rapid administration in acute situations where immediate relief is necessary.

General Therapeutic Scope and Unique Properties

Levomepromazina’s complex profile is clinically recognized for enabling comprehensive symptom control beyond primary psychiatric stabilization. The drug is utilized for its ability to induce profound sedation for patients experiencing acute distress or intractable agitation. Furthermore, the medication is used for its non-narcotic pain-relieving capabilities, including the management of various forms of moderate to severe discomfort in combination therapy. This indicates that the medicine serves a role in relieving both physical and psychological suffering, making it useful in scenarios requiring concurrent management of pain and agitation, and for controlling severe nausea and vomiting.

What side effects are possible with Levomepromazina?

Possible Side Effects and Safety Information

The safety profile of Levomepromazina is characterized by effects across several system-organ classes, with particular caution needed for cardiovascular and neurological risks.

Key Adverse Reactions

Commonly reported side effects include sedation or drowsiness, orthostatic hypotension (a drop in blood pressure when standing, which may cause dizziness or fainting), and anticholinergic effects such as dry mouth and constipation. Other effects include extrapyramidal symptoms (movement disorders like tremor, rigidity, or motor restlessness, known as akathisia).

Serious Safety Considerations

Serious and potentially life-threatening risks include Neuroleptic Malignant Syndrome (NMS), a rare condition characterized by fever, muscle rigidity, altered mental status, and autonomic dysfunction, requiring immediate medical attention. Cardiovascular risks include QT prolongation, which can lead to serious ventricular arrhythmias like Torsades de Pointes and, rarely, sudden death. This risk is increased with higher doses or pre-existing heart conditions. Agranulocytosis (a severe decrease in white blood cells) has been reported rarely, necessitating regular monitoring of the complete blood count in some cases. Cases of Venous Thromboembolism (VTE) have also been associated with this class of medication.

Population and Contextual Safety Notes

The elderly are at increased risk for hypotension and extrapyramidal effects, particularly Parkinsonism-like symptoms, and may require a lower initial dosage. The use of Levomepromazina is generally contraindicated in patients with a history of agranulocytosis, risk of closed-angle glaucoma, or risk of urinary retention. Due to its sedative effects, patients should be advised against driving or operating machinery if experiencing drowsiness or disorientation.

Overdose and Emergency Response

An overdose of Levomepromazina (Methotrimeprazine) is officially documented to present with severe, exaggerated effects, primarily on the central nervous system and cardiovascular system. Manifestations include profound CNS depression, leading to drowsiness, confusion, and eventual loss of consciousness. Severe neurological effects such as convulsions (seizures) and exaggerated extrapyramidal symptoms are also noted.

Documented Critical Outcomes

Overdose carries the risk of potentially fatal complications, including severe hypotension (low blood pressure) and serious cardiac arrhythmias. The drug’s effect on QT interval prolongation may lead to Torsades de pointes. Furthermore, Neuroleptic Malignant Syndrome (NMS)—a life-threatening reaction—must be considered if unexplained fever occurs, mandating the immediate discontinuation of treatment.

Required Emergency Actions

If an overdose is suspected, immediate medical attention is required, and the individual must contact a doctor or nearest hospital casualty department immediately. Management is based on providing supportive and symptomatic treatment under close supervision. Official regulatory guidance explicitly states that Adrenaline (epinephrine) must not be used during overdose treatment. Specific populations, including children and the elderly, are noted as being particularly susceptible to severe effects like hypotension.

Therapeutic Uses of Levomepromazina

What Levomepromazine Treats: Main Uses and Benefits

Levomepromazine is generally applied across key therapeutic areas to manage pronounced and distressing symptoms, which may provide supportive relief in both acute psychiatric settings and complex supportive care scenarios. The medication is utilized as both an anti-emetic and a potent antipsychotic/sedative.

The medication is commonly used to help with symptoms in acute psychotic crisis, severe agitation, and multimodal symptom control in palliative care. It may be part of symptomatic management for severe psychomotor agitation, refractory nausea and vomiting, and pain management in advanced disease. It is relevant when supportive symptom management is appropriate and symptoms create noticeable physiological strain.


Acute Psychiatric Crisis and Severe Agitation

This domain generally covers the medication's use in stabilizing patients experiencing symptoms related to heightened physiological activity, such as severe psychomotor agitation and restlessness, commonly associated with conditions characterized by periods of heightened symptoms. The primary benefit is that it contributes to easing the overall symptom load and may assist with maintaining functional stability.

Multimodal Symptom Control in Palliative Care

Levomepromazine is often applied in clinical settings marked by increased discomfort or tension, particularly in palliative care for patients experiencing multiple symptoms that interfere with daily functioning. This use helps address symptom clusters that may become intense or disruptive. It supports general well-being during symptomatic phases and assists with maintaining functional stability when symptoms become more disruptive during flare-ups.


Quick Fact: Relief for Refractory Symptoms

This therapeutic domain is applied in addressing severe and persistent nausea and vomiting that have proven resistant to standard antiemetic treatments. The symptomatic relief provided supports the patient during difficult episodes by easing distress and assists with maintaining functional stability.

Eligibility and Restrictions for Use

Levomepromazina's eligibility profile is strictly defined by government regulatory documents, which establish definitive contraindications and mandated caution for specific patient groups. This framework determines who may use the medicine and who must be excluded from treatment based solely on established physiological risk factors documented in the product's prescribing information.

Absolute Contraindications

Group Regulatory Restriction
Cardiac History History of QT interval prolongation, ventricular arrhythmias, or Torsades de Pointes.
Hypersensitivity Known sensitivity to the medicine or its excipients.
Pediatric Use Contraindicated in children aged under 18 years for the oral tablet form.

Population Restrictions

Group Regulatory Status
Organ Impairment Avoided or used with caution in patients with liver dysfunction or severe renal impairment.
Pregnancy/Lactation Not recommended; use should be avoided as safety has not been established.
Older Adults Use requires caution due to increased susceptibility to effects like postural hypotension; ambulant patients over 50 years require specific assessment.
Comorbidities Caution is mandatory for epileptic patients (lowers seizure threshold) and those with specific ocular (glaucoma) or urological (retention) risks.

What should I know about interactions with other medicines?

Levomepromazina's interaction profile is characterized by several pharmacodynamic and pharmacokinetic effects, most notably those involving cardiac rhythm and central nervous system (CNS) function.

QT Interval and Cardiac Risk

Concomitant use is contraindicated with medicines known to prolong the QT interval (e.g., certain anti-arrhythmics like amiodarone, quinidine; some antibiotics, and other antipsychotics) due to a significant, additive risk of serious ventricular arrhythmias, particularly Torsades de pointes. The risk is also increased by co-administration with drugs that cause bradycardia or electrolyte imbalances (such as hypokalaemia).

Central Nervous System and Hypotension

Levomepromazina potentiates the action of other CNS depressants, including alcohol, opioids, general anaesthetics, and sedatives. This combination can lead to increased sedation, respiratory depression, and impaired vigilance, and should be avoided or used with extreme caution. The drug also enhances the effects of antihypertensives and nitrates, which may result in severe or sudden drops in blood pressure.

Other Significant Interactions

Co-administration with levodopa is generally not recommended due to mutual antagonism, which can reduce the effectiveness of both medications. Additionally, the absorption of Levomepromazina can be reduced by taking antacids or activated charcoal, requiring a dosing separation of at least two hours.

Mechanism of Action

Levomepromazine, a phenothiazine derivative, engages multiple receptor-mediated signaling pathways in the central nervous system through competitive antagonism. Its actions target a broad spectrum of neurotransmitter systems, including dopamine, serotonin, histamine, alpha-adrenergic, and muscarinic acetylcholine receptors.

Dopamine Receptor Modulation

Antagonism of dopamine D2 receptors in the mesolimbic and nigrostriatal pathways alters G-protein coupled receptor signaling. This key pathway effect modulates neuronal activity and influences the state of central nervous system processes.

Histamine and Serotonin Pathway Engagement

The compound acts on histamine H1 receptors and serotonin 5- HT2A/2C receptors. Blocking these specific receptors initiates molecular steps that shape systemic physiological outcomes, particularly those associated with the regulation of arousal and visceral reflexes.

Adrenergic and Cholinergic System Influence

Levomepromazine is also an antagonist at alpha-adrenergic receptors, primarily alpha1, and muscarinic acetylcholine receptors. This competitive binding mechanism influences pathways governing vascular tone and glandular secretion, thereby adjusting systemic physiological response through broad modulation of autonomous nervous system signaling.

Dosage and Administration Information

The use of Levomepromazina is characterized by specific administration guidelines that define both the route of delivery and the precise dosage titration. Administration includes Oral use (tablets or solution) and Parenteral use, including Intramuscular (IM) injection, Intravenous (IV) injection, and Continuous Subcutaneous (SC) infusion.

Administration Protocol and Dosage

Entity Description / Context
Route of administration Oral, Intramuscular, Intravenous, and Continuous Subcutaneous Infusion.
Dosing schedule Therapy is gradually increased (titrated) from a low starting dose. For ambulant patients, the initial total daily oral dose typically does not exceed 25 mg to 50 mg. For severe conditions, the maximum daily dose may be gradually increased up to 1 g (1000 mg). The usual parenteral dose for acute needs is 12.5 mg to 25 mg.
Frequency and timing The total daily dose is typically divided into multiple administrations. To minimize daytime effects, a larger portion of the dosage may be taken at bedtime. Parenteral injections for acute needs may be repeated every 6 to 8 hours.
Preparation requirements For IV administration, the solution for injection is diluted with an equal volume of normal saline immediately prior to use. For SC infusion, the dose is diluted with the calculated volume of normal saline.
Age-group administration Lower initial doses are required for older adults. For children, the total daily oral dose should not exceed 37.5 mg to 40 mg. Dose adjustment is also required with caution in patients with hepatic or renal impairment.
Procedural conditions Patients starting on high oral doses (100 mg to 200 mg) should remain in bed for the initial days. Missed doses are skipped if close to the next scheduled dose; doses must not be doubled.

Connection to the overall use protocol

The established instructions follow a systematic and cautious approach, structuring the use by defining appropriate routes for both chronic (oral) and acute (parenteral) administration. The requirement for gradual titration and the explicit limitations on maximum daily intake for certain populations ensure that the administration method aligns with the standard process for starting, adjusting, and maintaining therapy.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Summary of Compound Research

Research explored the biological effect of the compound, a phenothiazine derivative. Studies have investigated quality of life metrics in various patient groups involved in the research, particularly in the context of palliative care where the drug is frequently used for its multiple actions.


Core Clinical Studies

The primary body of evidence consists of randomized controlled trials (RCTs) and systematic reviews focused on Levomepromazine's use in different clinical contexts, particularly in psychiatry and supportive care.

Research in Schizophrenia

A Cochrane systematic review identified a small number of trials comparing Levomepromazine with other antipsychotics.

  • Key Findings: Research reported differences in specific symptom scales (like the Clinical Global Impression and Brief Psychiatric Rating Scale) when comparing Levomepromazine to typical antipsychotics like chlorpromazine and haloperidol. For instance, some studies suggested less tremor and a reduced need for anti-Parkinsonian medication with Levomepromazine compared to haloperidol. However, evidence quality was generally low, and data remain limited for confident conclusions.

Research in Nausea and Vomiting (Palliative Care)

Systematic reviews have consistently reported a lack of identified published randomized controlled trials examining the use of Levomepromazine specifically for the management of nausea and vomiting in adults receiving palliative care.

  • Clinical Context: Despite the absence of high-quality RCTs, the compound is widely used in palliative care settings, often based on expert opinion and extensive clinical experience, to manage complex symptoms like nausea, agitation, and delirium. Further randomized studies are needed to build a stronger evidence base in this area.

Safety and Tolerability Profile

Safety data collected across studies indicate that common adverse events include low blood pressure (hypotension) and sedation. The compound is known for its high binding affinity to multiple receptors, which contributes to its broad effects but also necessitates careful monitoring for side effects such as orthostatic hypotension.

Frequently Asked Questions (FAQ)

Common questions about Levomepromazina (FAQ)

Q: What is Levomepromazina prescribed for besides schizophrenia or severe pain?

Regulatory documents recognize this medicine for multiple purposes beyond severe pain or schizophrenia. These uses include the management of psychiatric conditions like bipolar disorder, as well as controlling severe nausea, vomiting, and agitation, especially in supportive or palliative care settings.


Q: Is Levomepromazina used for insomnia or just severe sleep issues related to psychosis?

Official sources describe the medicine as having strong sedative and hypnotic properties. This effect is primarily due to its action on histamine ( H1) receptors. These properties are associated with the management of severe agitation, anxiety, and sleep disturbances in various therapeutic contexts.


Q: What are the main differences between Levomepromazina and other older antipsychotic drugs?

Levomepromazina is classified as a phenothiazine derivative, similar to other older antipsychotics. Official descriptions, however, emphasize its unique broad-spectrum mechanism of action. This multi-receptor antagonism (affecting dopamine, serotonin, histamine, and adrenergic receptors) contributes to its particularly strong sedative and pain-relieving effects.


Q: How quickly does the sedating effect of Levomepromazina usually start to work?

Official pharmacokinetics data suggest the sedating effect of the oral form typically begins within approximately 30 minutes, though this can vary by individual. The medicine usually reaches its maximum concentration in the blood within two to three hours. For the faster-acting intramuscular injection, the onset is generally within 15 to 30 minutes.


Q: Is Levomepromazina the kind of drug you have to take forever, or just short-term?

The intended duration of treatment is dependent on the specific condition being managed. The oral form is commonly used for the long-term management of chronic psychiatric conditions. Conversely, the injection form is often reserved for acute, short-term situations, such as managing severe, immediate agitation.


Q: What is 'tardive dyskinesia' and is it a risk with Levomepromazina?

As a typical antipsychotic medication, Levomepromazina carries a known risk for movement disorders classified as extrapyramidal symptoms (EPS). These can include motor restlessness, tremor, and rigidity. The long-term risks associated with these types of symptoms are a topic best discussed with a specialist.


Q: Does Levomepromazina interact with common over-the-counter pain relievers?

Official product information states that this medicine has the potential to interact with certain non-prescription pain relievers. These interactions can be of moderate clinical significance. Examples of interacting medicines include common products containing acetaminophen or aspirin.


Q: How does Levomepromazina work to help with severe anxiety or agitation?

Regulatory texts explain that the medicine's sedative effects are primarily responsible for helping to manage severe anxiety and agitation. This action is largely due to the drug blocking histamine ( H1) and alpha-adrenergic receptors in the nervous system.


Q: Does Levomepromazina affect blood sugar levels or diabetes control?

Caution is explicitly required by regulatory documents when this medicine is administered to patients with diabetes. Like other medications in this class, it may be associated with effects that necessitate blood sugar monitoring.


Q: Does Levomepromazina affect the results of any common medical tests?

Official guidance indicates that patients taking this medicine for long periods may require additional monitoring due to its effects on the body. This may include periodic heart checks via ECGs (electrocardiograms) and standard blood tests.


Q: Is Levomepromazina used outside of a hospital setting, or only in inpatient care?

The medicine is administered in various settings depending on the route. Oral forms are commonly used for long-term management in non-acute or ambulant (outpatient) settings. Injections, however, are typically reserved for acute situations, often requiring a hospital or specialized care environment.


Q: How is Levomepromazina different from Promethazine, which sounds similar?

Levomepromazina is classified within the phenothiazine class. Official descriptions note that its pharmacological activity is similar to both Promethazine and Chlorpromazine. This similarity is particularly noted in its action as a histamine antagonist, which contributes to its strong sedative effects.


Q: Can Levomepromazina cause sensitivity to sunlight, and what precautions are needed?

The medicine is known to sensitize the skin to sunlight, which is called photosensitivity. Official advice includes precautions such as limiting time in the sun and avoiding tanning beds. Official advice includes the use of protective measures, such as sunscreen and clothing, when spending time outdoors.


Q: What is the average time it takes to see the full mental benefit, not just the sedation?

Regulatory guidance indicates that dosages for psychiatric conditions must be gradually increased, or titrated, in small steps. This means that the full mental benefit is typically realized over a variable period of dose adjustment, rather than immediately.


Q: Is it normal to feel more tired than usual for the first few weeks on Levomepromazina?

Sedation or drowsiness is listed as a very common and expected side effect of this medicine. Due to the need for gradual dose adjustment (titration), the sedative effects may be more noticeable in the initial stages of therapy as the body adapts.


Q: Are there any documented cases of severe allergic reactions to Levomepromazina?

Serious allergic reactions are a possibility with this medication. Official documents emphasize that severe allergic reactions require immediate medical attention. These symptoms may include rash, swelling of the face or throat, or trouble breathing.


Q: What kind of studies support the use of Levomepromazina for pain management?

The medicine's analgesic (pain-relieving) use is established and recognized in authoritative medical resources. It is particularly used for managing pain in combination therapy. However, specific high-quality studies like Randomized Controlled Trials (RCTs) for this indication are less commonly detailed in general regulatory summaries.


Q: Can Levomepromazina cause dry mouth, and what is advised for this side effect?

Dry mouth is a common anticholinergic effect of the medicine. Official guidance suggests several measures to help manage this effect. These include using sugarless gum or hard candy, drinking water, or using a saliva substitute.


Q: What precautions are advised if Levomepromazina is used in extremely hot weather?

Official warnings state that the medicine can reduce the body's ability to sweat, thereby increasing the risk of heat stroke. Official warnings detail precautions for use in hot weather, such as avoiding overheating activities, dressing lightly, and ensuring a high fluid intake.


Q: Does Levomepromazina affect a person's ability to focus or concentrate?

Official warnings indicate the medicine can cause effects like drowsiness, dizziness, or blurred vision. These effects may impact a person’s ability to maintain alertness, focus, or concentration. Regulatory warnings explicitly caution against driving or operating machinery due to these potential effects.


Q: Do official sources mention any long-term effects on the liver from Levomepromazina?

Official documents require caution and dose adjustment for patients with existing liver dysfunction, which confirms the medicine is processed by the liver. However, major regulatory documents do not extensively detail specific long-term adverse effects on a healthy liver.


Q: What research is available on using Levomepromazina for bipolar disorder symptoms?

Regulatory documents list Levomepromazina as a medication used for psychiatric diseases. This includes the management of symptoms associated with bipolar disorder.


Q: Do older studies show any particular risks for patients with dementia taking Levomepromazina?

Official cautions are required when using this class of older antipsychotics in patients with dementia. Research indicates an increased risk of serious adverse events in older patients with dementia treated with antipsychotics, a finding that requires ongoing review.


Q: How does Levomepromazina differ from a typical sedative?

Levomepromazina is classified as a typical antipsychotic. While it possesses strong sedative properties, its broader profile includes antipsychotic, analgesic, and antiemetic activities due to its ability to affect multiple receptors in the body.


Q: What is the half-life of Levomepromazina described in medical literature?

The half-life describes the time it takes for half of the medicine to be cleared from the body. This measure of clearance is described in scientific literature as typically ranging between 15 and 30 hours.

How should Levomepromazina be stored and disposed of?

How to Store and Dispose of Levomepromazina?

Regulatory documentation provides specific requirements for the storage and disposal of Levomepromazina, which vary by medication form.

Official Storage Conditions

Requirement Details (Based on Form)
Temperature Injection solution must be stored below 25 C.
Light Protection All forms must be stored in the original packaging to protect the medicine from light.
Child Safety It is mandatory to keep the medicine out of the sight and reach of children.
Stability Limits The injection solution must be used immediately after the ampoule is opened. The oral solution must be discarded 3 months after opening.

Disposal Instructions

Unused or expired Levomepromazina must be disposed of according to local regulatory requirements. The medication must not be discarded via household waste or flushed down the toilet, to prevent environmental contamination, with official guidance advising return to a pharmacy for safe disposal.

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

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