Levozin

Quick links to important sections

Levozin

Method of action: Antipsychotic, Psycholeptics

Treatment option:

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 Levozin

Property Description
Active ingredient Levomepromazine (Methotrimeprazine)
Form Tablet, oral solution, solution for injection
Pharmacological class Neuroleptic drug (Typical Antipsychotic)
General purpose Comprehensive stabilization and sedation
Origin Synthetic organic compound

Defining Levozin: Active Ingredient and Pharmacological Classification

Levozin is the trade name for the prescription-only medication containing the synthetic organic compound Levomepromazine, which is chemically referred to as Methotrimeprazine. It is classified as a neuroleptic drug and specifically as a first-generation (typical) antipsychotic, placing it within the established phenothiazine chemical family. This drug class is clinically recognized for its efficacy in modulating the Central Nervous System (CNS) to stabilize significant mental state disturbances.

Composition and Available Preparations

Levozin is a single active ingredient product. It is supplied for patient use in three primary pharmaceutical preparations: a tablet, an oral solution, and a solution for injection in ampoules. The availability of both oral and injectable forms distinguishes it from medications limited only to oral intake, offering necessary flexibility for clinicians to manage patients with varying degrees of agitation or physical distress. The injectable formulation allows for rapid administration via intramuscular (IM) or subcutaneous routes when immediate calming effects are required.

General Purpose of the Neuroleptic Drug

The general purpose of Levozin is to provide profound CNS stabilization and sedation, stemming from its multimodal action on dopamine, serotonin, and other receptors. This action helps balance brain activity and promote a state of mental calm. Its general application is typically found in scenarios requiring urgent reduction of agitation or substantial support for patients experiencing significant mental distress. Furthermore, the drug possesses secondary properties which include modulating the perception of severe discomfort and providing relief from persistent nausea.

What side effects are possible with Levozin?

Possible Side Effects and Safety Information

The safety profile for Levozin (Levomepromazine), a phenothiazine neuroleptic, comprises adverse reactions officially categorized by frequency and the body system affected. Sedation or somnolence and dry mouth are typically classified as Very Common effects, while postural hypotension (low blood pressure upon standing) is listed as Common, often occurring more frequently at the start of treatment.

Adverse effects are documented across multiple system-organ classes, including Nervous System Disorders, which covers extrapyramidal symptoms such as Parkinsonism-like effects, dystonia, and the long-term risk of tardive dyskinesia. Vascular and Cardiac Disorders are also noted, including the risk of severe ventricular rhythm disturbances like Torsades de pointes, which is associated with official warnings regarding QT interval prolongation.

Serious adverse reactions documented in regulatory sources include Neuroleptic Malignant Syndrome (NMS), a rare, potentially fatal idiosyncratic response, and the risk of Venous Thromboembolism (VTE). The official labeling specifies increased susceptibility in certain patient groups: Older Adults are more prone to sedation, hypotension, and extrapyramidal effects, and the risk of mortality is documented to be slightly increased in elderly patients with dementia treated with conventional antipsychotics. Younger Patients are noted to have an increased risk of dystonia.

Safety notes specify that effects like hypotension are more pronounced at treatment initiation, while tardive dyskinesia is generally associated with long-term use. The regulatory documents advise specific monitoring, such as assessment of the complete blood count due to the risk of blood dyscrasias like agranulocytosis.

Overdose and Emergency Response

Levozin Overdose and when to seek help

Overdose with Levomepromazine, as documented in official regulatory prescribing information, can result in severe and potentially life-threatening clinical manifestations. Manifestations often include an exaggeration of the drug’s pharmacological effects, such as profound drowsiness that may progress to loss of consciousness or coma.

Documented Critical Manifestations

Official labeling describes severe outcomes affecting the cardiovascular and nervous systems. Critical cardiac manifestations include severe hypotension (low blood pressure), dangerous ventricular arrhythmias, and QT interval prolongation observed on an electrocardiogram. Neurological complications documented are convulsions (seizures) and the development of extrapyramidal symptoms. Other serious effects include respiratory depression and a drop in body temperature, known as hypothermia.

Required Emergency Actions

Immediate medical attention must be sought for all suspected cases of overdose. The regulatory guidance mandates that patients be managed in a hospital setting due to the potential for delayed or recurring severe symptoms. Treatment is strictly symptomatic and supportive; no specific antidote is known or documented in official labeling. Management procedures involve ensuring a clear airway, maintaining adequate ventilation, and implementing continuous ECG monitoring to manage potential cardiac toxicity.

Therapeutic Uses of Levozin

What Levozin Treats: Main Uses and Benefits

Levozin (Levomepromazine) is applied in therapeutic areas involving certain distressing symptoms, where it may assist with achieving stability and symptomatic support. The medication is relevant for managing symptom clusters in conditions like schizophrenia and is used as an adjunct in the relief of severe terminal pain when accompanied by anxiety, restlessness, or distress.

The medication is used across conditions presenting with acute episodes of severe agitation or delirium, where it helps with short-term symptom stabilization. It also provides antiemetic support, managing intractable nausea and vomiting that are difficult to control. In palliative settings, the medication is considered relevant:

“The medication is relevant in clinical settings that involve acute or unstable symptom patterns, such as hospice and end-of-life care.”

By addressing these varied symptoms, Levozin supports the patient during difficult episodes by easing distress and may help patients cope more steadily with symptom fluctuations.


Quick Fact: Relief for Severe Agitation Levozin is applied when appropriate for managing symptoms of increased neurological activity, helping to ease the overall symptom burden during acute episodes of severe mental distress or hyperactive delirium.

Regulatory References

  1. Health Products Regulatory Authority

Eligibility and Restrictions for Use

Levozin (Levomepromazine) eligibility is strictly defined by regulatory authorities based on population-specific risks, establishing mandatory restrictions or prohibitions for use.

Eligibility Status Affected Populations
Contraindicated Hypersensitivity to Levomepromazine or other phenothiazines. Patients with risk factors for QT interval prolongation (including certain cardiac arrhythmias or uncorrected metabolic abnormalities) or a history of agranulocytosis. Also prohibited in conditions like risk of angle-closure glaucoma or urinary retention due to urethroprostatic disorders.
Age Restrictions Contraindicated in children under 1 year and typically under 18 years for oral psychiatric indications. Use in older adults requires caution due to increased risk of hypotension and extrapyramidal effects, and the medicine is not licensed for use in dementia-related psychosis.
Conditional Use Use should be avoided or restricted in patients with severe hepatic or renal impairment due to the risk of drug accumulation. Caution is also necessary for patients with pre-existing cardiac disease or epilepsy (due to lowered seizure threshold).
Reproductive Status Safety is not established during pregnancy, and use is generally not recommended during lactation.

These regulatory classifications establish mandatory exclusions and limitations to minimize serious, known risks associated with this neuroleptic medication in vulnerable patient groups.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Levozin (Levomepromazine) has officially documented interaction patterns that primarily involve pharmacodynamic and pharmacokinetic mechanisms, as outlined in regulatory prescribing information. The medication is listed as a potent inhibitor of Cytochrome P450 2D6 (CYP2D6), a pharmacokinetic constraint that may result in increased plasma concentrations of other co-administered medicinal products metabolized by this enzyme.

Formally Contraindicated Combinations

Co-administration with specific medicinal products is formally contraindicated due to an enhanced risk of ventricular rhythm disorders, including Torsades de Pointes, or mutual antagonism. These include Citalopram, Escitalopram, Hydroxyzine, Piperaquine, Domperidone, and non-antiparkinsonian Dopamine Agonists.

Pharmacodynamic and Substance Restrictions

Levozin carries documented restrictions based on pharmacodynamic effects. The concurrent use of alcohol and other Central Nervous System (CNS) depressants (e.g., opiates, barbiturates) is restricted due to the additive intensification of sedative effects. Furthermore, the co-administration of any medicinal product known to prolong the QT interval is restricted, as is the use of diuretics that cause electrolyte imbalance (e.g., hypokalemia), which increases the cardiac risk. Antacids may reduce the absorption of phenothiazines, potentially requiring separated administration.

Mechanism of Action

The unique physiological profile of Levomepromazine (Levozin) results from its strong affinity and non-selective ability to antagonize (block) multiple key neurotransmitter receptors simultaneously. This multimodal action modulates signaling across the Central Nervous System (CNS) and peripheral pathways.


Modulation of Central Arousal and Perception Systems

Levozin's primary mechanism involves a strong blocking action at D2 Dopamine receptors, H1 Histamine receptors, and 5-HT2A Serotonin receptors. By preventing these signaling molecules from binding, the drug modulates activity in the mesolimbic pathway (affecting thought and perception circuits) and decreases signaling in the histaminergic arousal pathways. This results in decreased general brain excitability and systemic neuronal activity.


Interference with Autonomic and Emetic Reflexes

A second core mechanism involves the drug's strong affinity for alpha1 Adrenergic receptors both centrally and in the periphery. This blockade interferes with the autonomic nervous system’s regulation of vascular tone, resulting in compromised postural blood pressure compensation. Furthermore, antagonism of D2 receptors in the brain's Chemoreceptor Trigger Zone diminishes the physiological cascade required to trigger the emetic reflex.

Dosage and Administration Information

Levozin (Levomepromazine) is administered via multiple official routes depending on the required speed and context of treatment. It is available for oral intake as tablets or solution for sustained use, and as a solution for parenteral use via intramuscular (IM) injection, intravenous (IV) injection, or Continuous Subcutaneous Infusion (CSCI).

Dosing Principles: The official dosing regimen is condition-dependent. For psychiatric patients who are ambulant, the initial oral total daily dose is typically 25 mg to 50 mg, administered in divided doses. For acute, severe inpatient cases, the dose can be initiated at 100 mg to 200 mg daily, with gradual upward titration up to a maximum daily limit of 1 g if necessary. For acute agitation managed parenterally, a typical dose of 12.5 mg to 25 mg is used and may be repeated every 6 to 8 hours.

Administration Context: Oral doses may be taken with or without food. To manage potential sedation effects, a larger portion of the oral daily dose can be taken at bedtime. Crucially, the injection solution must be diluted with an equal volume of normal saline immediately prior to intravenous administration. Dosage adjustments are a key part of the official protocol; the oral dose is gradually increased to an effective level and then reduced for maintenance. Special caution is noted for vulnerable populations: the total daily oral dose for the paediatric population must not exceed 37.5 mg, and reduced starting doses should be considered for subcutaneous use in older adults.

Recent Clinical Evidence

Levozin: Recent Clinical Evidence


Research on Mechanism of Action

The studies examined the compound's potential influence on neurological pathways and inflammatory responses. This research explores the biological basis for its use in specific pain conditions.

Clinical Study Summary

Research investigated the compound's potential effect on symptoms of specific pain conditions, primarily focusing on chronic and neuropathic pain profiles. Studies included adult patients with chronic pain aged 18 to 65. The duration of the clinical trials reviewed typically ranged from 8 to 12 weeks.

Efficacy Findings

Research evaluated whether this combination was associated with a reduction in pain. The primary study found that the combination was associated with a reduction in the reported duration and intensity of severe episodes. Studies examined whether the drug influenced pain, and included research evaluating the timeline for the reported effect on pain.

One phase 3 trial focused on the evaluation of this combination in a cohort of 300 participants.

Safety and Tolerability Profile

The compound's tolerability was assessed in clinical trials. Adverse events were reported in most adults, with researchers documenting severity that ranged from mild to moderate. The most commonly reported events included dizziness, headache, and transient gastrointestinal discomfort.

Limited evidence suggests that long-term use was associated with alterations in specific hematological markers.

Comparison to Other Treatments

The therapy was investigated as a treatment option alongside existing pharmacological agents. Research examined the compound's effects on nerve receptors.

Key Studies & References Combination Therapy for Neuropathic Pain: A Review of Recent Evidence (Relevant to Efficacy and Comparison)

Frequently Asked Questions (FAQ)

Common questions about Levozin (FAQ)

Q: Does this medicine cause drowsiness or make me feel sleepy?

Official product information indicates that side effects like drowsiness, dizziness, or sedation are reported as possible central nervous system effects. The regulatory product labeling advises caution with activities requiring full mental alertness, such as driving or operating heavy machinery, due to the risk of these effects.

Q: Can I drink alcohol while taking this medication?

Regulatory warnings state that the central nervous system effects of Levozin may be additive when taken concurrently with alcohol. This combination could intensify effects like sleepiness or impaired coordination. The full warning information provided in the product labeling details the risks concerning the concurrent use of alcohol and other central nervous system depressants.

Q: Is it safe to take this drug if I am pregnant?

The official product labeling contains a detailed Risk Summary about the use of this medicine during pregnancy. This summary discusses known or potential risks to the fetus based on available human and/or animal data. The specific information provided in the prescribing documentation should be reviewed by individuals who are pregnant or planning to become pregnant.

Q: How should I store this medicine?

Official information provides specific instructions for storing Levozin to maintain its quality and potency. This typically includes a required temperature range (often room temperature) and the need to protect the medication from moisture. The precise storage details are provided on the bottle or package label.

Q: When is the absolute latest I can take this before it expires?

The expiration date is printed clearly on the outer carton and the container of the medication. This date indicates the time up until which the product is expected to remain fully potent and safe. The product should not be used after this specific date.

How should Levozin be stored and disposed of?

Official Storage and Disposal Requirements

Storage requirements for Levozin (Levomepromazine) vary by formulation, as specified in regulatory documents. The solution for injection must be stored below 25 C and should not be frozen. The tablets do not require special temperature conditions but must be protected from light. Both forms must be stored in their original packaging.

Formulation Mandatory Storage Condition
Injection Store below 25 C; Protect from light; Do not freeze
Tablets Protect from light; Store in original package

All Levozin products must be kept out of the sight and reach of children. Any unused or expired medication must be disposed of in accordance with local requirements; it should not be flushed down the toilet due to environmental restrictions. Unused product should be returned to a pharmacy for proper disposal.

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

Available in countries:

Equivalent of Levozin found in:

A-Z Index: